cyrilzakka/clinical-trials huggingface dataset:
SOFA and APACHE II Scoring Systems for Predicting Outcome of Neurological Patients Admitted in a Tertiary Hospital Intensive Care Unit

The aim of this study was to compare the discriminative power of commonly used scoring systems, namely the sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) in the intensive care unit of a tertiary care hospital.

This was a retrospective cross-sectional study including patients admitted to the ICU of TU Teaching Hospital with a neurological diagnosis from January 1, 2022, to December 31, 2022. This study uses data collected prospectively as part of the Nepal Intensive Care Research Foundation (NICRF) dataset. The ICU database contained information for all components of the APACHE II and SOFA score with physiological data collected for the length of ICU, and hospital stay. Both SOFA and APACHE II were calculated from the admission data or if not available from the earliest data recorded after admission in ICUs.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with neurological diagnosis in ICUs

Exclusion Criteria:

* Patients with missing data
* Patients with ICU length of stay \< 24 h
Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain

This study will be conducted to answer the following question: Does high power laser acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue and level of satisfaction in chronic nonspecific low back pain patients?

The aims of this study are:

1. To investigate the effect of high power laser acupuncture on pain in chronic nonspecific low back pain patients
2. To investigate the effect of high power laser acupuncture on back range of motion (flexion, extension, side bending and rotation) in chronic nonspecific low back pain patients.
3. To investigate the effect of high power laser acupuncture on function in chronic nonspecific low back pain patients.
4. To investigate the effect of high power laser acupuncture on quality of life in chronic nonspecific low back pain patients.
5. To investigate the effect of high power laser acupuncture on back muscle fatigue in chronic nonspecific low back pain patients.
6. To investigate the effect of high power laser acupuncture on level of satisfaction in chronic nonspecific low back pain patients.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be included in this study will be having all of the following criteria:

1. Age over 18 years of age.
2. Both genders (males and females).
3. Normal BMI ranges between 18.5:24.9 kg/m2.
4. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.

6) CNSLBP patients will be diagnosed based on the standard criteria, including pain and tenderness on lower back and a negative result for all special tests for lumber neurological examination.

Exclusion Criteria:

1. History of any surgical procedure in the back or the lower extremities.
2. Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
3. Patient with lumbar instability including spondylolisthesis.
4. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
5. Pregnancy.
Baricitinib Therapy in COVID-19

Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.

Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2 that inhibits JAK1- and JAK2-mediated cytokine release, was recently described using BenevolentAI's proprietary artificial intelligence-derived knowledge graph, as an agent that reduces the endocytosis into target cells, and to inhibit the entry. Based on its potential action on inhibition of SARS-CoV-2 entry, and on its known effects on reduction of cytokine release, baricitinib therapy was proposed in patients with moderate pneumonia to explore: the safety of this drug combined with antiviral (lopinavir-ritonavir) in COVID-19; as second outcome, to evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters, and reduction of ICU admission.

Baricitinib was combined with antivirals because it does not interact with them due to its prevalent renal elimination.

Eligibility Criteria:
Inclusion Criteria:

* SARS-Co-V2 positivitity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
* Age \>18 and \<85 years
* Presence of at least 3 of the following symptoms as present fever, cough, myalgia, fatigue.
* Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography, or pulmonary ultrasound.
* Peripheral capillary oxygen saturation (SpO2) \> 92% on room air at screening
* PaO2/FiO2 \>100-300 mmHg at arterial blood gas analysis.

Exclusion Criteria:

* Age \< 18 and \>85
* History of thrombophlebitis
* Latent tuberculosis infection (based on the positivity to QuantiFERON Plus positivity, Qiagen, Germany)
* Pregnancy and lactation
* History of malignancies over the previous 5 years, current diagnosis of malignancy
* Inability or unwillingness to sign a written consent.
* Transaminases values 4-fold higher than the upper normal limit.
* HBV and HCV positivity.
* Current Herpes zoster infection.
* Evidence of concomitant bacterial infections.
Perioperative Effect of Atenolol on Cytokine Profiles

Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure.

This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* elective abdominal, orthopedic, or gynecologic surgery
* ability to give informed consent
* ability to tolerate beta-blocker therapy
* ability to comply with follow-up requirements

Exclusion Criteria:

* currently receiving beta-blocker therapy
* EKG documented 2nd or 3rd degree heart block
* EKG documented sinus bradycardia
* Serum creatinine \> 2.0
* current treatment asthma
* history of rheumatoid arthritis
* history of Crohn's disease
* history of lupus
* history of inflammatory cancer
LATCH: Lactation Advice Thru Texting Can Help

The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \> 18 years
* Prenatal intention to breastfeed
* Prenatal enrollment \< 28 weeks gestation
* Have an unlimited text message cell phone plan
* Knows how to send a text message
* 5th grade literacy level

Exclusion Criteria:

* Lack of fluency in either English or Spanish
* Infant born premature (\<37 weeks)
* \> 3 days in NICU
* Any major maternal-newborn medical problem affecting breastfeeding
* Birth weight \<5lbs
Effect of Lyophilized Cornus Mas L. on Anthropometric and Biochemical Parameters in Metabolic Associated Fatty Liver Disease Patients

The aim of the study was to evaluate the effect of lyophilized Cornus mas L. fruit powder with/without diet therapy on biochemical parameters and anthropometric measurements in patients with metabolic associated fatty liver disease.

The main purpose of this study is to determine the efficacy of the lyophilized dried powder form of cornelian cherry (Cornus mas L.) grown in our country on nutritional status and biochemical parameters in patients with metabolic-associated fatty liver disease.

Sub-objectives of the study;

* Determination of the effect of cornelian cherry on blood glucose, and lipid parameters, and liver enzymes.
* Determination of anti-inflammatory, antidiabetic, and antioxidant effects of cornelian cherry in metabolic fatty liver patients.
* Determination of the effect of cornelian cherry on anthropometric measurements.

The aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic-associated fatty liver disease as a result of the consumption of powdered cornelian cherry (Cornus mas L.) that has been freeze-dried at -55 degrees with a Lyophilizer device for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years with metabolic associated fatty liver.
* Those who applied to the gastroenterology clinic
* Volunteers
* Those who signed the consent form

Exclusion Criteria:

* Those with \<18 to ≥65 years
* Those without ultrasonography results
* Those with \>20 g/day for men and 10 g/day for women alcohol consumption in the past 1 year
* Those with hepatitis B or C
* Those with chronic liver diseases associated with viral hepatitis, such as Wilson disease, hemochromatosis, and Cushing syndrome
* Those with autoimmune liver disease
* Those with a history of cardiovascular diseases, cancer, mental diseases, severe liver, and kidney dysfunction
* Those with thyroid diseases such as goiter, hypothyroidism, or hyperthyroidism
* Those with prolonged use of estrogen or regular consumption of drugs associated with fatty liver diseases, such as corticosteroid, methotrexate, tamoxifen, and amiodarone
* Pregnant, breastfeeding women
* Those with allergic to Cornus mas fruit
* Those with an unwillingness to continue the study
Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.

The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.

Eligibility Criteria:
Inclusion Criteria:

* 21 year or older
* medical diagnosis of gastrointestinal cancer (for example, gastric, biliary, or colorectal)
* experienced weight loss of at least 5% over the last 6 months
* ability to communicate in English
* ability to follow the research protocol

Exclusion Criteria:

* plan to have surgical procedures at the time of recruitment
* receive radiation therapy alone or in addition to chemotherapy during the study period
* undergo surgery during the study or in the months prior to the study
* no plan to have chemotherapy after the surgery
* any comorbidities that may affect the interpretation of study findings
* open burn sites or infected wounds
* esophageal cancer or pancreatic cancer
* life expectancy of less than 6 months as assessed by attending physician
Retinal Imaging Using NOTAL-OCT

Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)


Eligibility Criteria:
Inclusion Criteria:

1. Ability and agreement to give informed consent (IC)
2. Diagnosis of AMD or DR in SE by OCT
3. Ability to undergo OCT scans
4. VA of 20/160 or better in SE

Exclusion Criteria:

1. AMD and DR in the same SE
2. Evidence of macular disease other than AMD or DME in SE
A Prospective Multicenter Randomized Controlled Trial of Flexible And Navigable Suction Ureteral Access Sheath Combined With Needle Perc for the Treatment of Partial Staghorn Renal Calculi

The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about the safety of drug ABC. The main questions it aims to answer are:

* Does flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL
* Does flexible and navigable suction ureteral access sheath combined with needle perc result in more complications compared with PCNL Researchers will compare flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL to see if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi.

Participants will:

* Performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
* Visit the clinic after surgery 1 month and 3 month for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years
2. CT scan indicates partial staghorn calculi
3. Able to complete the study in accordance with the protocol requirements
4. Informed about the study and has signed the informed consent form

Exclusion Criteria:

1. Severe renal insufficiency (GFR \< 30 ml/min/1.73 m²)
2. Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
3. Renal stone volume \> 33.5 cm³
4. Renal stones or nephrocalcinosis caused by genetic diseases or definite metabolic disorders that have not been ruled out, such as renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc.
5. Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
6. History of previous open renal stone surgery
7. Patients with uncontrolled urinary tract infections
8. Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* At least one evaluable or measurable lesion according to RECIST v1.1
* Patient with advanced metastatic solid tumor with documented NRG1 fusion determined in a qualified local laboratory by molecular profiling using methods such as next generation sequencing \[DNA or RNA\] as routinely performed at CLIA or other similarly-certified laboratories.
* Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of MCLA-128:

  1. At least 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy OR
  2. At least 5 half-lives have passed since discontinuation of the systemic treatment
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Adequate organ function at the time of initiation of treatment administration
* Negative pregnancy test results in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry)
* Ability to give written, informed consent prior to treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice
* Not eligible or feasible to participate in a clinical trial
* Any condition that in the opinion of Merus may preclude appropriate use of the investigational medicine

Exclusion Criteria:

* Any untreated, symptomatic central nervous system (CNS) lesion
* Presence of an active and uncontrolled infection
* Leptomeningeal metastases
* Known hypersensitivity to any of the components of MCLA-128 or history of severe hypersensitivity reactions to human or humanized monoclonal antibodies, including therapeutic antibodies
* Presence of LVEF \<50% on the screening echocardiogram; or history or presence of any significant cardiovascular disease, including unstable angina or myocardial infarction within 12 months prior to treatment, congestive heart failure (NYHA Class III or IV), or ventricular arrhythmia requiring medication
* Presence of any other medical or psychological condition deemed by the Physician to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance

The objective of this research is to perform a pilot study on patients undergoing laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer) in which intraoperative CT imaging will be performed both prior to (but after induction of general endotracheal anesthesia) and during placement of the laryngoscope in order to better understand anatomic changes that occur during instrumentation of the oral cavity and oropharynx. The goals of the study are:

1. Develop a suite of de-identified images and surface renderings that qualitatively show how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic evaluation.
2. Create deformation models of the upper aerodigestive tract.

This data to be used for future retractor development as well as for virtual image guided surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract.

Exclusion Criteria:

* Patients who are unable to tolerate general anesthesia.
* Patients who are felt to be a "difficult airway" for induction of general endotracheal anesthesia.
* Patients with excessive dental restorations and amalgam.
Beijing Friendship Hospital Metabolic Surgery Database

Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.


Eligibility Criteria:
Inclusion Criteria:

* be able to receive metabolic surgery (LSG or LRYGB)

Exclusion Criteria:

* can not be able to understand and willing to participate in this registry with signature
A Randomised Controlled Trial, of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers

NAC-preHD is a phase II randomized placebo controlled study of oral NAC among premanifest HD gene expansion carriers, with clinical and radiological outcome at three years.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Huntingtin gene expansion carrier with \>= 39 CAG repeats
* Absence of unequivocal motor signs of HD - that is, UHDRS
* Diagnostic Confidence Level needs to be \<4 upon enrolment
* Expected to develop clinical HD within 10 years of trial enrolment using the Langbehn formula
* Availability of an informant for corroborative history
* Negative serum pregnancy test for women of childbearing potential
* If of childbearing potential, is able and agrees to remain abstinent or use adequate contraceptive methods
* Ability to tolerate MRI scans
* Ability to tolerate blood draws
* Able to comply with all study protocol requirements, according to the investigators judgement
* In the opinion of the investigator, medically, psychiatrically and neurologically stable at the time of enrolment

Exclusion Criteria:

* Diagnosis of clinical HD
* Known hypersensitivity to NAC
* Pregnancy, breastfeeding or intention to do so prior to the end of the study
* Exposure to any investigational drugs within 30 days of Baseline Visit
* Use of supplemental NAC
* Abnormalities in laboratory measurements, ECG or vital signs at screening, which precludes safe participation in the study
* Current or history of substance abuse within one year of Baseline visit
* Unstable psychiatric or acute medical illness including cancer, as determined by investigator
* Current use of antipsychotic medications or Tetrabenazine
* History of gene therapy, cell transplantation, or any experimental brain surgery
* History of attempted suicide or suicidal ideation within 12 months prior to screening
* Pre-existing structural brain lesion as assessed by a centrally read MRI scan during the screening period