cyrilzakka/clinical-trials huggingface dataset:
Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight

The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Body mass index ≥ 28 kg/m2 or ≥24kg/m² to \<28 kg/m2 with at least 1 of the following weight-related comorbidities: a) Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol/L, fasting low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, fasting high-density lipoprotein cholesterol (HDL-C) \<1.04 mmol/L, or the need for at least one lipid-lowering treatment to maintain normal lipid levels; c) Obstructive sleep apnea syndrome; d) Fatty liver; e) Cardiovascular disease; e) Polycystic ovary syndrome.
3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion Criteria:

1. Obesity known to be caused by monogenic mutations, other diseases, or medications.
2. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
3. A history of moderate to severe depression at any time in the past or a score of ≥15 on the PHQ-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders.
4. A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.
5. Plans to quit smoking during the study period
6. Allergic constitution (allergic to multiple medications or foods), or those known to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.
THE EFFECT OF tDCS IN THE TREATMENT OF CHRONIC PELVIC PAIN ASSOCIATED WITH ENDOMETRIOSIS

The purpose of this study is to determine if transcranial direct current stimulation (tDCS) is effective in the treatment of chronic pelvic pain associated with endometriosis


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old, non-menopausic, with the diagnosis of endometriosis by videolaparoscopy and biopsy, able to understand and write the Portuguese language, in treatment with isolated progestin for at least one month, that have worst daily pain in the analogue visual scale \> 4 cm in most of the days in the last month

Exclusion Criteria:

* left-handed women, endometriosis implantation in intestine, bladder or urether (surgical treatment indication), history of intense or frequent headache, chronic dermatologic disease, previous adverse effects to treatment with tDCS, seizures, severe cranial trauma with alteration of the cranial anatomy, metallic intracranial implants or pacemaker, history of pelvic inflammatory disease, non-compensated psychiatric disease, non-collaborative patients, history of neurologic, oncologic disease, heart, renal or hepatic failure.
Intravascular ECG During Insertion of Peripheral Inserted Central-venous Catheters: Replacement for Chest X-ray?

This study will provide further knowledge concerning the use of electrocardiography (ECG) signals for verification of peripherally inserted central catheter (PICC) tip placement. Furthermore, it will be investigating whether use of Intravascular ECG (IVECG) for this verification is just as good as or even better than the current standard method with chest X-ray. This can help promote a method that involves less radiation and increased safety for patients, while at the same time saving resources. If use of ECG signals from the PICC tip is an equally exact method for verification of correct PICC tip placement as chest X-ray verification, the IVECG could replace chest X-ray control.


Eligibility Criteria:
Inclusion Criteria:

* In need for PICC
* \>18 years old
* Competent to give consent

Exclusion Criteria:

* Not visible p-wave on surface ECG (electrocardiograph)
* Patients with known Atrial fibrillation or atrial flutter
* Implanted pacemaker (PM) and/or implanted Implantable Cardioverter Defibrillator (ICD)
* Not signed written informed consent
Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function

Cerebral blood flow is tightly regulated to ensure constant cerebral perfusion independently from systemic blood pressure fluctuations. This mechanism is termed cerebrovascular autoregulation and preserves adequate cerebral perfusion in a range between 50 and 150 mmHg of cerebral perfusion pressure. Upper and lower autoregulatory limits may vary individually. Beyond the autoregulatory range the protective autoregulatory response is lost, facilitating cerebral ischemia or hyperemia.

The cerebrovascular response may be altered during general anesthesia, through direct effects of anesthetic agents on the vascular tone, changes of arterial partial pressure of carbon dioxide or the administration of vasoactive substances. The association of perioperative impairment of cerebral autoregulation and postoperative cognitive function has been discussed controversially.

* continuous monitoring of cerebrovascular autoregulation using the correlation method
* based on near-infrared spectroscopy and invasive blood pressure measurement an index (COx) will be calculated
* autoregulation monitoring from anesthesia induction until emergence from anesthesia
* assessment of preoperative cognitive function during preanesthesia evaluation or on the day before surgery
* assessment of postoperative cognitive function between day 3 and 14 following surgery
* evaluation of subjective cognitive complaints or attention deficits 3 months after surgery

Eligibility Criteria:
Inclusion Criteria:

* elective major non-cardiac/non-vascular surgery
* anticipated surgical duration \>120 minutes
* age \>= 60 years
* indication for invasive blood pressure measurement
* native German speaker

Exclusion Criteria:

* history of cerebrovascular disease
* preexisting cognitive impairment
* history or presence of neurological disease
Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope

Study design will be a mix of retrospective (older Zeiss microscope previously in use at our surgery center) and prospective data collection with the Lumera and Callisto software.

The Lumera and Callisto software system will be used for all cataract surgeries including toric analyses and lens placement.

Needs Assessment

Research on this topic is needed as over 3 million cataract surgeries are performed in the United States each year. The number of surgeries performed is growing as baby boomers age. Reimbursements continue to decline, necessitating ever improving operating and surgical efficiencies in the operating room setting for physicians and small business owners to remain financially viable. New governmental regulations dictate that physician payments will be related to patient satisfaction and outcomes which may be better provided by newer and better surgical technologies.

The Lumera operating microscope and Callisto software system provide several features that may enhance operating room flow including HD video screen and co-observant microscopes that can be independently adjusted to help operating room staff anticipate the needs of the surgeon. Enhanced retroillumination would be expected to translate into fewer complications and more confidence during surgery which could lead to less operating time, phaco energy used and improved visual outcomes. The toric alignment assistance device may lead to more accurate toric placement and improved visual outcomes after surgery.

Target audience would include all cataract surgeons both high and lower volume.

There is currently a dearth of published literature on this technology and its benefits in routine cataract surgery. There are no registered similar trials on Clinicaltrials.gov

Eligibility Criteria:
Inclusion Criteria:

* Visually significant cataract

Exclusion Criteria:

* Not visually significant cataract
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department

Alcohol misuse amongst youth is a significant clinical and public health problem. The Emergency Department (ED) is an important setting for the treatment of alcohol-related problems as it is often the first point of contact between youth, their families, and the healthcare system. This pilot study will assess the feasibility and acceptability of a computer-based intervention in the ED for youth with alcohol-related presentations. The investigators research team will: (1) evaluate the methodological and operational processes involved in study recruitment and intervention implementation, (2) determine recruitment and retention rates, and (3) obtain preliminary data on the difference in alcohol consumption at different time points. The clinical and health service implications of this research will be used to plan further investigations designed to improve the standard of ED care among youth aged 12 to 16 with alcohol-related presentations. This research will also help optimize the planning and development of a full-scale randomized controlled clinical trial of a computer-based intervention designed to reduce higher-risk alcohol consumption and alcohol-related health and social problems in this target population.


Eligibility Criteria:
Study Inclusion Criteria:

* Youth aged 12 to 17 years who present to the Emergency Department (ED) with an alcohol-related problem.
* Medically stable

Alcohol involvement will be determined by youth self-report of drinking alcohol prior to event necessitating a visit to the ED and/or a positive Blood Alcohol Content (BAC).

Study Exclusion Criteria:

* Youth who require hospital admission
* Youth whose ED presentation is linked to drugs aside from alcohol
* Youth who report other drug use within the last 24 hours prior to ED presentation
* Youth who do not speak or understand English
* Youth who are currently enrolled in a treatment program for alcohol use
* Youth who are accompanied by a non-guardianship adult but are not considered Mature Minors
* Youth who do not have the capacity to give informed consent as determined by their attending ED physician
* Youth do not have regular access to their own telephone
Tissue Perfusion for Different Approaches of Brachial Plexus Block

To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application.


Eligibility Criteria:
Inclusion Criteria:

* patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria:

* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Renal or hepatic insufficiency
* Coagulation disorders
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced hepatocellular carcinoma.

This is a multi-center, multi-cohort, open-label phase 2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 alone or in combination with for the treatment of advanced hepatocellular carcinoma

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form voluntarily.
* Histologically or cytologically documented hepatocellular carcinoma.
* BCLC stage C, and non-resectable BCLC stage B .
* At least one measurable lesion according to RECIST criteria.
* ECOG of 0 or 1.
* Adequate organ function.
* Estimated life expectancy of ≥3 months.
* For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent

Exclusion Criteria:

* Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
* History of hepatic encephalopathy or liver transplantation.
* Clinical significance of hydrothorax, ascites or pericardial effusion.
* Central nervous system metastases and/or carcinomatous meningitis.
* Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
* Occurred arteriovenous thromboembolic events within 6 months before the first administration.
* Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
* Inadequately controlled arterial hypertension.
* Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
* Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
* Severe infections.
* Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
* Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
* Unable to receive an enhanced CT or MRI scan of the liver.
The Role of Visceral Hyperalgesia, Gastroesophageal Reflux Disease (GERD) and Esophageal Motility Disorder (EMD) in NCCP Patients

Noncardiac chest pain (NCCP) is a common clinical problem worldwide. In Hong Kong, it has been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary heart disease. Despite its benign nature, this condition causes anxiety, impairs quality of life and consumes a substantial amount of healthcare resources. While acid reflux and motility disorder in the esophagus are often attributed as the cause of NCCP, visceral hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of this condition. This research project aims to evaluate the role of visceral hyperalgesia in Chinese patients with NCCP. NCCP patients will be evaluated for the prevalence of gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and pH study. The visceral sensory and pain thresholds of these patients will be compared with asymptomatic controls.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy
* Age between 18-70

Exclusion Criteria:

* Gastroesophageal reflux disease
* Psychiatric illness
* Cerebrovascular accident
* Active peptic ulceration
* Heart failure or cardiac bradyarrhythmia
* Epilepsy
* Pregnancy or lactating female
* Previous hypersensitivity to muscle relaxant
Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis.

The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".

To this end, the study will take place as follows:

Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis


Eligibility Criteria:
Inclusion Criteria:

Control group:

* Subjects who have provided written informed consent
* Subjects covered by the national health insurance scheme
* Men or women aged between 25 and 85 years
* able to understand simple instructions and packaging instructions and able to give informed consent

Patients group:

* Patients who have provided written informed consent
* Patients covered by the national health insurance scheme
* Men or women aged between 25 and 85 years
* able to understand simple instructions and packaging instructions and to give their informed consent
* Suffering from hip osteoarthritis defined according to ACR criteria
* Most recent radiography examination less than 6 months earlier
* Radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification
* Presenting with an indication for total hip replacement, according to the surgeon's usual criteria

Exclusion Criteria:

Control group:

* Hip osteoarthritis or other arthrosis in the lower limbs
* Pregnant or breast-feeding women
* Disorders that may interfere with gait analysis
* Disorder that may be destabilized by gait analysis
* Neurological disease and/or motor neuron disease

Patients group:

* Contra-indication for total hip replacement
* Repeat surgery for total hip replacement
* Impossibility to use a standard implant
* Pregnant or breast-feeding women
* Inflammatory flare of the hip osteoarthritis
* Disorder that may interfere with gait analysis
* Disorder that may be destabilized by gait analysis
* Rapidly destructive hip osteoarthritis
* Neurological disease and/or motor neuron disease
* Hip dysplasia requiring THR to be completed using a graft
Vitality Acupunch Exercise Program for Older Adults With Sarcopenia

This project was aimed to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia.

A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a VA experimental or a control group. The experimental group received the VA program led by certified instructors 3 times per week and 40 minutes per session for 6 months; the control group continued with their regular daily activities. One pre-test and two post-tests, 3 months apart, were conducted.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 65 years old
* have been living in the facility for at least 3 months
* intact cognitive function with the Short Portable Mental Status Questionnaire score ≥ 8
* hand-grip strength \< 28 kg for men and \< 18 kg for women
* calf circumference \< 34 cm for men and \< 33 cm for women

Exclusion Criteria:

* have spinal cord injury
* have severe cardiovascular or pulmonary diseases
* have musculoskeletal diseases
Better Disease Control by Multidrug Regimen in Scabies

Scabies is associated with significant discomfort and social taboo. Existing treatment regimen frequently fails due to lack of patient compliance. We compared single use regimen to existing standard repeat application regimen for treatment of scabies.


Eligibility Criteria:
Inclusion Criteria:

* Willing patients
* Clinical diagnosis of scabies
* Within the age limits

Exclusion Criteria:

* Unwilling patients
* Patients with severe co-morbidities requiring long term medication
* Pregnant women
* Patients who don't fulfill the age limit criteria
Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients

Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) are effective therapies for advanced lung cancer patients bearing EGFR-activating mutations, but are not curative due to the invariable apparition of resistances. The investigator team have identified a new phenotype related to drug tolerance after EGFR-TKI treatment that shares several characteristics of a known process of Therapy-Induced Senescence (TIS), which could be a major event of drug tolerance in patients. Using cutting-edge technologies, patient-derived xenografts (PDX) and circulating tumor cells (CTC), the investigator team will perform an exhaustive characterization of the phenotypic and molecular changes associated with this drug-tolerant state in patients. Their results should lead to new therapeutic approaches to eliminate the reservoir of drug-tolerant cells and to prevent emergence of resistance mutations responsible for the relapse of patients.

LUNG-RESIST is a translational, monocentric and prospective research study on 40 patients whose objective is to characterize Drug Tolerant Cell (DTC) type cells in patients with a NSCLC carrying an EGFR mutation and to discover and monitor potentials biomarkers involved in this mechanism of resistance to osimertinib. The study will be offered to patients, and for whom the therapeutic decision was decided collegially during multidisciplinary molecular meetings (molecular Tumor Board). Following informed consent, patients will be registered in a single cohort. In this study, treatment with osimertinib is not studied and will be delivered according to current recommendations

Eligibility Criteria:
Inclusion Criteria:

* Patient with non operable and / or metastatic non-small cell lung cancer documented histologically.
* Pathological diagnosis of NSCLC carrying an EGFR activating mutation associated with sensitivity to the tyrosine kinase inhibitors (TKI) (exons 18, 19 and 21).
* Sufficient tissue sample quantity and quality for translational research
* Naïve TKI-treated EGFR patient who can receive first-line treatment with Osimertinib or second-line after chemotherapy

Exclusion Criteria:

* Any patient with an exon 20 EGFR mutation.
* Any disease or pathology that recommend not to perform blood samples collection
* Any psychological, family, geographical or social condition that could potentially, according to the investigator's judgment, prevent the collection of informed consent or interfere with compliance with the study protocol
* Patient with a resistance mutation of EGFR
* Patient under State Medical Assistance
* Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curatorship or safeguard of justice
Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure

This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy

This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma；
* Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)；
* Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ;
* Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC;
* Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1；
* EGFR postive and RAS wildtype；

Exclusion Criteria:

* Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma；
* History of hepatic encephalopathy within 6 months prior to the first dose of this study；
* Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose；
* Symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)