cyrilzakka/clinical-trials huggingface dataset:
Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer

This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to light up tissue, and then converts the light information into ultrasound images. Photoacoustic imaging can provide images of the structure of tissues, as well as their function and the levels of molecules, such as the flow of blood in blood vessels and the level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a mass is benign (non-cancerous) or cancerous based on the molecular differences between cancer and normal tissue. It may be more accurate and less expensive than other imaging methods, and does not expose patients to radiation.

PRIMARY OBJECTIVES:

I. To assess the performance of photoacoustic imaging (PAI) in detection of ovarian cancer in a clinical setting and to help improve the design of the next generation hand held PAI probe.

SECONDARY OBJECTIVES:

I. To evaluate vasculature and oxygen saturation in lesions based on PAI-measurements.

OUTLINE:

Patients undergo PAI over 15-30 minutes prior to the ovarian excision.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be undergoing ovarian resection
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have had primary surgical excision
* Pregnant or lactating women
Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels

N-Acetylcysteine (NAC), an anti-oxidant, will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life.

A group of 18 participants will take either 1800, 3600 or 5400 mg per day of N-acetylcysteine (NAC) for 3 months in this dose escalation study. The investigators want to determine first if the 3600 mg dose per day is safe and might provide some efficacy. If the 3600 mg dose is safe, then additional participants will be treated with 5400 mg per day of NAC, for up to a total of 18 participants. If the 3600 mg per day dose is unsafe, then participants will be treated with the 1800 mg per day dose. Data from this pilot study will be used to determine the most safe and effective dose of NAC for a future clinical trial.

Patients with the m.3243A\>G mitochondrial mutation often have low brain glutathione levels. These low levels can reduce the repair processes in the brain to fix toxic chemicals that result from a mitochondrial disorder. The investigators are aware of a potent anti-oxidant, called N-Acetylcysteine (NAC), that may improve the brain glutathione level when taken in sufficient quantity. In turn, cognitive and motor skill impairment may improve as these toxic levels are reduced. will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-80 years
* Low brain glutathione (GSH) levels as determined by magnetic resonance spectroscopic imaging (MRSI)
* Individuals who carry, or are suspected of carrying the m.3243A\>G mitochondrial mutation (genetic confirmation of mutation required prior to initiation of NAC)

Exclusion Criteria:

* Individuals with normal brain glutathione levels
* Pregnant or lactating individuals
* Medically unstable as determined by the Principal Investigator
* Allergy to NAC or other sulfur-containing drug
* Inability to adhere to study protocol
Effects of Exercise on Energy Intake-Prescription of Resistance Exercise

Healthy young males will complete five trials in a randomized crossover counter-balanced order, including three different inter-set rest of resistance exercise in equal training volume, one repeated until failure and sedentary control. During each trial, blood samples will be collected.

The investigators hypothesized that different inter-set rest and training volume would affect subjective appetite and energy intake.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-30
* Healthy male

Exclusion Criteria:

* No acute or chronic musculoskeletal symptoms
* Smoking
* Alcohol or drug abuse
* Failure to conduct resistance exercise
A Phase IV Study of Huazhi Rougan Granule

A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome: Shi-Re-Zhong-Zu Zheng)


Eligibility Criteria:
Inclusion Criteria:

* ≥18 and≤65 years old;

  * Those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome;

    * Liver-to-spleen CT ratio ≤ 0.8; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver; ④ Voluntarily sign informed consent. The legal representative can sign informed consent on behalf of the patient who are unable to sign； ⑤ FPG≤7.0mmol/L 、HbA1c≤6.5%；ALT、AST、TBil≤2×ULN.

Exclusion Criteria:

* Fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (Reye syndrome), B-lipoprotein deficiency, localized fatty liver; Fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; Small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;；

  * Severe fatty liver with ascites, edema, hyponatremia, hypokalemia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;；

    * Those who had used any Chinese or Western drugs for the treatment of simple fatty liver within one month before randomization；

      * Pregnant or lactating women, women of childbearing age who do not take effective contraceptive measures (such as condoms, hormonal contraceptives, intrauterine devices) or male subjects who do not want to use contraception;；

        * Patients with serious primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, lung diseases, tumors, AIDS and other serious diseases that affect survival. For example: abnormal kidney function: creatinine higher than the upper limit of normal; Abnormal liver function: γ-GT\>200U/L or ALT \>2×ULN or AST\>2×ULN; A clinically significant arrhythmia；

          ⑥ According to the 2010 guidelines for the prevention and treatment of dyslipidemia, patients with dyslipidemia requiring lipid-lowering drugs intervention：TC≥6.99mmol/L（270mg/dl）or LDL-C≥4.92mmol/L（190mg/dl）；

          ⑦ Persons without or with limited capacity for civil conduct；

          ⑧ Those who has suspected or confirmed history of alcohol abuse (alcohol equivalent male≥40g/d, female ≥20g/d) or drug abuse；

          ⑨ Allergic to the components of this drug；

          ⑩ Those who participated in other clinical investigators within 3 months prior to screening；

          ⑪ The investigators consider she/he inappropriate to participate in this study。
Lonquek for Autologous Stem Cell Mobilization

The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed multiple myeloma or Hodgkins or non Hodgkin lymphoma at need of autologous stem cell transplantation.
* Disease must be chemosensitive or stable status to prior therapy before transplant.
* Age between 18 and 65 years inclusive.
* ECOG performance status 0, 1 or 2.
* Written informed consent.
* Adequate birth control in fertile patients.

Exclusion Criteria:

* Lymphoma patients that did not fulfill the inclusion criteria.
* Patients with factors predicting poor mobilization including \>3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like Melphalan, Fludarabine, \>2 courses of Revlimid, age \>65 years, platelets counts \<100x109/L, WBC\<2.5x109/L or WBC \> 35x109/L.
* Previous autologous stem cell transplantation.
* Inability to tolerate peripheral blood stem cell harvest.
* Peripheral venous access not possible.
Study in Patients With Breast Cancer Leptomeningeal Metastasis

Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.

This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD). LMD is notoriously difficult to treat, and prognosis is generally very poor, with most patients typically succumbing to the disease within a few months of its diagnosis. Conducting clinical trials is challenging for these reasons, and there are limited data regarding biological processes of LMD. The overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with LMD. The investigators propose a prospective observational study to establish (1) a translational collection protocol to comprehensively collect tissue, blood, and CNS samples, and (2) a therapeutic management program utilizing the Johns Hopkins Molecular Tumor Board, to provide multi-disciplinary treatment recommendations in a timely manner, and (3) collect outcome data that can be correlated with biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 or older
* History of breast cancer (any subtype)
* Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.
* Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.
* Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.

Exclusion Criteria:

* Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
* Not eligible for treatment of leptomeningeal disease.
Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

The primary objective of the present study is to evaluate the long-term observation, in terms of overall survival, of adult Ph+ ALL patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to GIMEMA protocol LAL2116.

Since the treatment after dasatinib and blinatumomab is not uniform and highly dependent on medical decisions, the primary aim of this ancillary trial is to evaluate the long-term follow-up of patients enrolled in the GIMEMA 2116, in terms of overall survival (OS). Furthermore, the secondary objectives are the collection of data and survival outcomes relative to the therapeutic choices carried out after dasatinib and blinatumomab (i.e. allo-SCT, autologous transplant, TKI maintenance, etc), duration of CMR, DFS, long-term safety profile. A correlation of survival outcomes (OS, DFS, etc) with the clinical and biological findings will be carried out with data collected at diagnosis and during the follow-up within the LAL2116 trial.

Eligibility Criteria:
Inclusion Criteria:

* Study LAL2217 Informed Consent signature.
* Patients enrolled in the GIMEMA LAL2116 protocol and who have completed the 12 months follow-up
Knowledge and Perception of Clinical Trial Participation in Breast Cancer Patients in Egypt

* Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation.
* This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries.


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients

Exclusion Criteria:

* Patients who refuse participation
Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.

Study to determine if whether or not exist an association between the tissue loss (ETW progression) and the frequency of an acidic diet. To accomplish the aim, a quantitative analysis of intraoral scans of study models will be performed to identify erosive tooth wear progression in a group of Chilean adolescents.

First, participants with different intake of dietary acids will be compared in terms of their baseline sociodemographic and clinical characteristics. Second, the association between baseline frequency of dietary acids and changes in volume loss over time will be evaluated using linear mixed models to account for the data structure (repeated assessments nested within teeth and teeth nested within children). Models will be adjusted for demographic factors, family socioeconomic position, health behaviours and chronic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male and female (age range 10-18) assisting in a school with low socioeconomic status.

They must have: -Complete record of questionnaires

* Baseline and Follow-up Intra oral scanners (with correct alignment when using Wearcompare software)
* BEWE scores
* Signed Inform consent

Exclusion Criteria:

* Patients not willing to participate
* Patients wearing orthodontic appliances
Outcome Predictors of Trachea-esophageal Fistula

In the present study, the investigator aim to evaluate the prevalence, factors affecting outcome and the outcome of neonates with tracheoesophageal fistula.

Tracheoesophageal fistula is a connection between the esophagus and the trachea.

Tracheoesophageal fistula (TEF) represents one of the most common congenital anomalies seen in infants, Infants with TEF classically present with respiratory distress, feeding difficulties, choking, and risk for aspiration. TEF is most commonly associated with other congenital anomalies, particularly cardiac defects. Esophageal atresia (EA) is a related congenital malformation with a similar presentation to TEF and can occur with or without the presence of a fistula.

Although the events leading to separation of the primitive trachea and esophagus are not completely understood, the most commonly accepted hypothesis is that a defect in the lateral septation of the foregut into the trachea and esophagus causes TEF and EA.

The trachea and esophagus develop from a common primitive foregut, and at approximately 4 weeks of gestation, the developing respiratory and gastrointestinal tracts are separated by epithelial ridges. The foregut divides into a ventral respiratory tract and a dorsal esophageal tract; the fistula tract is thought to derive from an embryonic lung bud that fails to undergo branching. These defects of mesenchymal proliferation are thought to lead to TEF formation.

The incidence of TEF is approximately 1 in 3500 births. EA and TEF are classified according to their anatomic configuration.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with tracheoesophageal fistula are/below the age of 28 days.

Exclusion Criteria:

* Patients above the age of 28 days.
* Patients diagnosed with other diseases.
* Patients with acquired tracheoesophageal fistula.
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

The purpose of this study is to evaluate the effects of transfusion of red blood cells in treating postoperative dizziness in patients with moderate postoperative anemia after total hip arthroplasty.

Hip arthroplasty is associated with bleeding and postoperative anemia. However, the optimal strategy for transfusing red blood cells (RBC) remains to be elucidated. Postoperative anemia may cause dizziness and fatigue which delays early mobilization after surgery and may trigger the transfusion of one or more RBC units. However, it is not known whether the administration of 1-2 units of RBC to patients suffering from moderate postoperative anemia (HB 7.5 - 10 g/dl) will improve postoperative dizziness.

Thus, this randomized controlled study aims to evaluate whether the administration of 1-2 RBC units on the first postoperative day improves postoperative dizziness in patients undergoing total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and able to give consent
* Hip arthroplasty or hip revision arthroplasty
* Haemoglobin \> 4.8 mmol/L and \< 6.0 mmol/L on the first postoperative day
* Dizziness score ≥ 2.

Exclusion Criteria:

* Large ongoing bleeding
* Has already received RBC during the current admission
* New onset of cardiac arrhythmia suspected to be related to anemia
* Severe ischemic heart disease
* Renal failure with dialyses or oligouria / anuria.
Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room.

Until now, the Mulhouse emergency department used a protocol for severe pain based on morphine titration. In order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil.

The primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. This new pain management protocol has been updated as part of the upcoming French High Authority for Health hospital certification, for which pain management is one of the priority criteria. This research does not change the routine care given to the patient.

Secondary objectives:

1. To assess the rapidity of pain relief with intranasal sufentanil compared to intravenous morphine titration
2. To compare the evolution over time of the pain with the old and new pain management protocol.
3. To assess the safety of sufentanil and morphine titration

Conduct of research:

When a patient is admitted to the Mulhouse emergency department with pain greater than or equal to 4 on the Numerical Scale, the triage nurse or doctor checks the eligibility criteria. If eligible, the nurse or doctor ensures that the patient does not object to the reuse of their data for this research. An information letter is also given to the patient.

Pain will be measured by numerical rating scale at initial assessment by the triage nurse (baseline), at 15mins, 30mins, 60mins and 2hours.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the Emergency Department of Mulhouse with a numerical pain rating scale \> 3 ;
* Patient who did not receive any analgesic except paracetamol in the 4 hours prior to admission ;
* Initial pain assessment with the triage nurse ;
* Patient does not object to the collection of data for the study.

Exclusion Criteria:

* Patient admitted directly to the shock room ;
* Initial pain assessment not performed in triage zone ;
* Numerical Scale \> 3 not corroborated by caregiver assessment: Algoplus \<2
* Onset of pain after triage nurse visit ;
* Patient with drug intoxication, altered consciousness, alcohol or drug use.
Effects of a Health Belief Model-Based Community Educational Program to Increase the Awareness of Atrial Fibrillation Among Older Adults: a Randomized Controlled Trial

The goal of this study is to evaluate the effects of a theory-based community educational program among older adults in the community on atrial fibrillation (AF) knowledge. It will also learn about their competency to detect irregular pulses and compliance to regular pulse check. The main questions it aims to answer are:

Do older adults in the community who received the Health Belief Model-based educational program have higher AF awareness?

Researchers will compare the educational program with the control, who receive an information leaflet about AF to see the effect on improving AF awareness.

Participants will:

Receive a 5-week Health Belief Model-based educational program or receive an information leaflet about AF.

Be reassessed immediately post-intervention and 3 month afterwards. Keep a logbook on their compliance to the advice of regular pulse palpation to detect AF pulse .


Eligibility Criteria:
Inclusion Criteria:

* adults aged 65 or older
* without a confirmed diagnosis of AF

Exclusion Criteria:

* cannot read Chinese
* with cognitive impairment (Abbreviated Mental Test ≤ 6)
* physical limitations in performing pulse palpation
Pain Neuroscience Education in Diabetic Neuropathy

To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

Pain neuroscience education (PNE) has shown to have immediate effects on various clinical signs and symptoms associated with central sensitization. Using a model of (innocuous, noxious and allodynia) PNE can be used in combination with exercise therapy, especially treating patients in which the nervous system has become increasingly hypervigilant. Teaching patients about the neuroscience of pain and lead to healthier and more positive attitudes and beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity participation and compromise their quality of life. PNE will be helpful in such patients so decreasing pain can improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* History of diabetic ≥ 5 years
* HbA1C higher and equal to 6.5 %
* Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) ≥ 12
* Mini Mental State Examination (MMSE) score ≥ 24

Exclusion Criteria:

* Known neurological disorder
* Foot ulcers/candidate of amputation
* Hearing impaired