cyrilzakka/clinical-trials huggingface dataset:
Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders

Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic vulnerability factors. To help the identification of these genetic factors and to improve genotype-phenotype correlation, the identification of endophenotype through the exploration of vulnerability characteristics in unaffected first degree relatives have been recommended. For this purpose, the investigator include bipolar patients, unaffected first degree relatives and control subjects to perform genetic association studies and subphenotype analyses. In this study the investigator will focus on subgroups defined according to the existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).

Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is highly variable and difficult to predict due to lack of biomarkers of response. To explore lithium response variability and to identify biomarkers of response, the investigator characterise lithium response using "ALDA" scale to conduct pharmacogenetic studies and pharmacokinetic studies of lithium extended release, in the subpopulation of patients treated with lithium. As lithium is a circadian agent, the investigator will also explore the links between lithium response and circadian phenotypes. Finally, using Li7 magnetic spectroscopy, the investigator will compare lithium brain distribution in a small sample of good and partial responders to lithium.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Bipolar I, II or Not Otherwise Specified (NOS) disorders
* Euthymic
* Age \> 18
* Affiliated to the French social health care system
* Somatic state compatible with a blood test
* Informed consent signed for the study
* European

Exclusion Criteria:

* Patients major protected
* Patients adopted
* Geographical origin of grandparents unknown
Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit

Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)\[1\]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.

There are several ways to assist families of patients in intensive care units \[2\], amongst them the use of a written document to explain the environment, therapies and possible outcomes.

Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.


Eligibility Criteria:
The study will enroll patient representant (family member or close friends designed by the family or pre-admission legal representant).

Inclusion Criteria:

* Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
* verbal consent to participate
* Able to communicate in French

Exclusion Criteria:

* representant of a patient \< 18 years old
* representant of a patient whose stay in ICU lasted less than 48 hours
* representant of a patient without social security
Amplification and Selection of Antimicrobial Resistance in the Intestine II

Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hemato-oncological disease in neutropenia or with expected neutropenia
* Need for treatment with meropenem or piperacillin-tazobactam

Exclusion Criteria:

* pregnancy
* HIV, HBV, HCV
Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).

This study is a randomized, double blind, placebo-controlled clinical trial. It aims to demonstrate that (1) Chinese medicine prescription "Wu Zhu Yu Tang" can prevent Acute Mountain Sickness(AMS) (2) "Wu Zhu Yu Tang" can prevent AMS especially for Yang-Xu body constitution.

We will randomize 240 unacclimatized healthy adults. They will be randomized after stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects will fill the "Body Constitution Questionnaire BCQ" in order to evaluate their body constitution. Before, during and after the two days hike we will measure their blood pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the Lake Louise Clinical Assessment score and Lake Louise Functional Score.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Chronic disease: cardiovascular disease, psychological disease, anemia, migraine.
* long-term use of the following materials: Chinese herbs, steroid, antibiotics.
* altitude acclimation: have been to mountain over 2000m in the past 1 month.
* Pregnancy.
Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia

This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmacological activity), in patients with co-morbid factors associated with erectile dysfunction (also called impotence). The duration of erection endpoint will be assessed by patient utilized stopwatch timings during each attempt at sexual intercourse. Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug Administration for the treatment of erectile dysfunction. While there is no intent to assess the effect vardenafil has on blood lipids, the study will provide prospective data on men diagnosed with both ED and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Males with ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
* Stable heterosexual relationship for more than 6 months
* Between 18 and \<65 years of age
* Diagnosed dyslipidemia and treated with a stable dose of a statin (or generic equivalent) \>/=3 months at Screening. In addition, the subject must have remained on this stable dose of statin (or its generic equivalent) throughout the study and no additional therapy to treat dyslipidemia was initiated
* InternationaI Index of Erectile Function - Erectile Function domain score of \<25, denoting mild to severe ED at Visit 2

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the US Product Information
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream

To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.

To compare the safety and efficacy profiles of 5-FU Cream with Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female 18 years of age and older.
2. Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study.
3. Subject must be generally healthy, based on medical records, and free from any clinically significant disease, other than AK, that in the opinion of the investigator might interfere with the study evaluations.
4. At least five (5) and no more than ten (10) clinically typical, visible or palpable, discrete AK lesions, each at least 4 mm in diameter on the face (excluding ears), forehead or bald scalp.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning a pregnancy within the period of study participation.
2. Subject suffers from excessive alcohol consumption, drug abuse or has a condition that could compromise the subject's ability to comply with study requirements.
3. Presence of Atopic Dermatitis, Basal Cell Carcinoma, Eczema, Psoriasis, Rosacea, Squamous Cell Carcinoma or other possible confounding skin conditions on the
Salt and HMB Study

Hypertension affects one-third of adults in the US. High salt diet is a key risk factor for elevated blood pressure (BP). The associations of gut microbiome with high salt diet and hypertension have been established in both animal and human studies. However, the underlying biological mechanisms linking sodium to BP elevation and gut microbiome alteration are not clear. Increasing evidence supports a pivotal role of leucine metabolism in hypertension. Leucine is initially catalyzed by the branched-chain amino acid aminotransferase enzyme (BCAT), producing α-ketoisocaproate (α-KIC), which can be further metabolized to β-hydroxy-β-methylbutyrate (HMB). Leucine/α-KIC/HMB metabolism pathway shows a promising involvement in the relationships among salt, gut microbiome, and elevated BP. Preliminary studies show that dietary sodium reduction increases circulating HMB, which is further associated with reduced BP, and that HMB treatment decreases Firmicutes/Bacteroidetes ratio, and increases α-diversity and gut microbiota-derived short-chain fatty acids (SCFAs). However, the leucine/α-KIC/HMB metabolism pathway has never been targeted in human studies. To establish causality, I propose a double-blind, two-stage randomized, placebo-controlled trial of sodium and HMB supplements for the following specific aims: Aim 1 will determine the effect of sodium supplement on leucine/α-KIC/HMB metabolism pathway. Aim 2 will determine the effect of HMB supplement on office BP and 24-hour ambulatory BP (Aim 2a), and α- and β-diversities and Firmicutes/Bacteroidetes ratio (Aim 2b). Secondary Aim will test the hypothesis that HMB supplement could partially block the detrimental effects of sodium intake on BP and gut microbiota. The proposed project would help to uncover the role of leucine/α-KIC/HMB metabolism pathway in salt-induced hypertension and the alteration in gut microbiome. Most importantly, the project will provide the training opportunities for me as a junior faculty, to study the new area of gut microbiome, acquire new experience and skills to conduct human trials. In addition, this project will generate rich preliminary data on the role of leucine/α-KIC/HMB metabolism pathway in salt-induced BP elevation, and test the feasibility for developing future NIH R01 project.


Eligibility Criteria:
Inclusion Criteria:

* normotensive \[SBP\<140 mmHg and diastolic BP (DBP)\<90 mmHg\];
* self-identified black or white; c. aged from 18 to 65 years.

Exclusion Criteria:

* taking medication that would affect BP or gut microbiome;
* being pregnant;
* with health conditions that would compromise sodium handling.
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.

Includes retrospective data collection and one prospective visit

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age at the time of the ESG procedure
* Subject with a BMI between 30 kg/m2 and 50 kg/m2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System
* Subject completed follow-up 1-year from the ESG procedure for weight loss management
* Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)
* Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.
* Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)
* Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study

Exclusion Criteria:

* None
Enhancing Care Study in Patients After CABG

Review the data of patients who underwent coronary artery bypass grafting (CABG) at the National Center for Cardiovascular Disease, Fuwai Hospital from January 2013 to June 2023 including medical history, head CT scan, and postoperative, including 30-day mortality, arrhythmia, cerebrovascular disease and intracerebral haemorrhage, etc. Case-control and retrospective cohort studies were conducted to explore the risk factors associated with early postoperative complications, examine their relationship with postoperative management, explore independent risk factors of compound complications, and build predictive models.


Eligibility Criteria:
Inclusion Criteria:

* patients accepted CABG enrolled from January 2013 to June 2023

Exclusion Criteria:

* patients discharged within 72 hours of admission
* patients with an admission diagnosis of atrial fibrillation
* patients underwent CABG as emergency surgery
* patients underwent concurrent surgical treatments
* patients with repeat admissions
Control Cohort CTRL COH

Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare disease that could be difficult to diagnose. So it necessary to obtain numerous sample from different disease to develop more specific diagnosis kit It could be possible through the characterisation of new genetic biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* patient with consent
* patient with following disease: Parkinson's disease, Amyotrophic lateral sclerosis, Glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis.

Exclusion Criteria:

* refusal consent
* patient with neurological disorder compatible with paraneoplastic neurological syndrome or auto-immune encephalitis
* patient under guardianship
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment

The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Participants have given written informed consent approved by the ethical review board (ERB) governing the site
* Female participants should be of non-childbearing potential
* Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m\^2)
* Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
* Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria:

* Has had esophagus variceal bleeding within 3 months of check-in
* Have the need to take medications that may interfere with how the liver removes the drug
* Have evidence of cancer in the liver
* Consumes excessively large amounts of drinks with caffeine or alcohol
Carpel Tunnel Syndrome and Physical Therapy Modalities

Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to continue postnatal. Conservative treatment is more recommended in these cases. There are many physical therapy modalities proposed to treat CTS without knowing which modality is better than the other. So the aim of this study to compare the effect of two modalities in treating CTS in postnatal females.

Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment disorders in the upper limb. CTS is common during pregnancy especially in the third trimester as well, a significant percentage of females postnatal may still have some complaints up to at least 3 years postnatal.

Purpose: To compare the effect of pulsed magnetic field (PEMF) versus ultrasound (US) in treating patients with CTS. Forty postnatal female patients with idiopathic CTS were assigned randomly into two equal groups. One group received PEMF with nerve and tendon gliding exercises for the wrist 3 times for week for 4 weeks. The other group received US plus the same exercises. Pain level, sensory and motor distal latencies of the median nerve (MSDL and MMDL), sensory and motor conduction velocities of the median nerve (MSCV and MMCV), functional status scale and hand grip strength were assessed pre and post treatment

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate CTS
* Positive electro diagnostic findings: prolonged median motor distal latency (MMDL) above 4 ms, and below 6ms.
* Prolonged median sensory distal latency above 3.5 ms .
* Positive Phalen and Tinel test.
* Subjects scored pain intensity more than 5 in visual analogue scale (VAS).

Exclusion Criteria:

* severe cases with delayed motor distal latency \> 6ms.
* Orthopedic or neurological disorders of neck or the upper limb as cervical radiculopathy.
* Pronator teres syndrome or double crush syndrome.
* Pre- existing CTS before their last pregnancy, current pregnancy.
* Diabetic neuropathy and Thoracic outlet syndrome.
* Wasting of thenar muscles, ulnar neuropathy.
* Rheumatoid arthritis, previous fractured carpal bone and previous surgery in the forearm especially transverse ligament release
Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon

The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed falciparum malaria. The study design was based on accepted WHO parasitological and clinical outcomes to determine the overall efficacy of Fansider and inform the Peruvian National Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line treatment for uncomplicated falciparum malaria in the Peruvian Amazon.


Eligibility Criteria:
Inclusion Criteria:

* Pf monoinfection with asexual forms
* Parasite density of greater than 500 per mcl and less than 200 parasites per oil immersion field (MINSA quantification of "4 plus")
* Age \> 6 months
* Temperature greater than 38C (101F)
* Available and willing to return for follow-up

Exclusion Criteria:

* Presence of any of the following "danger" signs or symptoms suggestive of severe malaria
* Not able to drink or breastfeed
* Repeated vomiting (unable to keep anything down)
* Convulsions during present illness
* Lethargic or unconscious state
* Unable to sit or stand up
* Respiratory distress
* Jaundice (observation) or dark urine (by history)
* Severe anemia (Hemoglobin \< 5 g/dl)
* Hypotension (systolic BP \< 80 mm Hg in adults and \< 50 mm Hg in children under the age of 5
* Presence of another significant illness or chronic disease
* Known pregnancy (by history)
* History of hypersensitivity to medication used in the test
Ultra-Violet Fluorescence Bronchial Cancer Location

Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.

The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Major Patient
* Patient who signed the informed consent document
* Patient with a known primary cancer in bronchial level

Exclusion Criteria:

* Pregnant woman
* Patient with a benign tumor histology
* Patient with an unknown tumor histology.
Utilizing Technology to Promote Cancer Prevention

The goal of the program is to develop an online module/a health application for cell phones which will share didactic information regarding cancer prevention and early detection measures. These module/application will be developed, and be tested among volunteers for feedback. In the future, these module/application will be disseminated widely to address cancer health disparity particularly in Arkansas.

The application or the online module will play a short didactic explanation video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures. It is currently unknown which method will be used, the online module or the application for the purpose. The study participants will be subjected to only one method (once the method have been finalized and created). The video content will engulf information about cervical, breast, colorectal and lung cancer prevention and early detection. After the video, the application or the module will capture information on gender, age, smoking status, body mass index and positive cancer history in family. Watching the video and answering the questions will take approximately 5 minutes. The study participants will download the application on their personal cell phones and the data collected will be linked to identifying information in case they choose to receive the compensation and opt for the 6-month follow-up. Based on the responses provided, and the age and the gender, the participants will be provided with a list of cancer prevention and early detection measure(s). A subset of the study participants from ARResearch (only those who have agreed for the 6-month follow-up) will be asked if they are willing to be contacted by the study staff after 6 ±1 months (from the date of enrollment in the study) to enquire if they received/adopted the screening measures(s) that were suggested based on their age, gender and family history. They will be asked whether it is OK to call and/or e-mail them for more information to better describe barriers to obtaining cancer prevention and screening measures.

Eligibility Criteria:
Inclusion Criteria:

* Any ARResearch volunteer
* 18 years or older in age
* Have access to a personal cell phone and/or computer

Exclusion Criteria:

* Unable to give an informed consent.