cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)

This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg) once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of MDD without psychotic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Have clinically significant depressive symptoms defined by a GRID Hamilton Depression Rating Scale 17 (HAMD17) Total Score ≥20 at screening
* Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m²)

Exclusion Criteria:

* Have a current or previous diagnosis of bipolar I or II disorder, MDD with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder
* Currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode
* Had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening
* Have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive \[as calculated by BMI = weight (kg)/ \[height (m)\]2
* This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the subject must be re-consented
* Men, ages 18 to 45 years, inclusive; women, ages 18-45, who are not of child-bearing potential
* Women must not be breastfeeding

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Women of child-bearing potential
* Current or recent (within 3 months of study drug administration) gastrointestinal disease which by the judgment of the Investigator may increase a subject's risk of gastrointestinal bleeding (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrectomy)
* Any major surgery within 12 weeks of study drug administration
* History of blood transfusion, clinically significant bleeding event(s), or documented genetic bleeding diathesis or thrombophilia
* For Aspirin Containing Arm Participants Only: Known allergy to non-steroidal anti-inflammatory drugs or history of intolerance or abnormal sensitivity to aspirin (e.g gastrointestinal intolerance, bruising or bleeding, aspirin induced breathing difficulties or nasal polyps)

Other protocol defined inclusion/exclusion criteria could apply
Exosomes Implication in PD1-PD-L1 Activation in OSAS

An increased occurrence of cancer associated mortality has been described in patients with Obstructive Sleep Apnea Syndrome (OSAS). This association might be partially explained by an impaired cellular immune response that has been described in OSAS. Is has been suggested that OSAS impact immune cells by upregulation of the PD-1/PD-L1 pathway. Exosomes are small membrane vesicles released by numerous cells in the bloodstream. Exosomes have been shown to be implicated in cancer cells proliferation via a PD-1/PD-L1 pathway activation.

This study will evaluate exosomal PD-1/PD-L1 expression in patients with OSAS as compared to controls and will further investigate their impact on immune cells function and proliferation capacities.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a sleep recording for suspected OSAS

Exclusion Criteria:

* Préviously treated OSAS
* Cancer past history
* Pregnant women
* Cognitif impairment
Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya

The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts.

Building on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-13 living in Moshi, Tanzania or Bungoma, Kenya who have had one or both parents die since they were 3 years old or older.
* Children must have scores on study measures indicating they have symptoms of traumatic grief and/or traumatic stress.
* Children must be living with an adult guardian who is willing to participate in 12 weekly group sessions.
* Adult guardians of eligible children.

Exclusion Criteria:

* Living in an institution (not with a guardian).
* Parent(s) died before child was 3 years old.
Home-exercise Program for Children and Adolescent Survivors of Acute Lymphoblastic Leukemia

* Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL) strengthens their physical fitness.
* Exercising improves muscular and functional mobility fitness after finalizing chemotherapy in children and teenagers diagnosed with ALL.
* Assess cardiological changes

Children and adolescents survivors of ALL will be randomly assigned to the intervention group and to the control group. A home-exercise program will be designed for 16 weeks with 55 sessions, combining aerobic, strength and flexibility exercises of light and moderate intensity. The following tests will be performed to evaluate the effects of the intervention program: Echocardiography, Tape treadmill test using a ramp protocol to assess cardiorespiratory fitness, hand grip test to assess muscular grip strength, Timed Up test And Go Test (TUG) and Timed Up and Down Stairs Test (TUDS) to assess functional mobility, the sit and reach test to assess flexibility and a questionnaire to assess levels of physical activity. The control group will perform their usual physical activity

Eligibility Criteria:
Inclusion Criteria:

* The study included of children and adolescents between 7 and 18 years old that were at time in complete remission for a minimum of one year of their neoplastic disease and had finalized their chemotherapy treatments by the time they began the physical exercise program.

Exclusion Criteria:

* Patients with structural cardiac anomalies, congenital cardiopathies, those in recurrence of their neoplastic diseases, signs of clinical or subclinical cardiac insufficiency and an echocardiography with alterations in systolic and/or diastolic function.
Change in Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Down Syndrome

To assess oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with down syndrome .

Dental treatment under GA provides a safe approach and has significant positive effects on quality of life for children with down syndrome who cannot accept normal treatment. Oral health related quality of life is measured in relation to how the mouth and teeth affect physical, psychological and social well-being and daily activities such as eating, chewing, swallowing, speaking, playing, learning, happiness, embarrassment, and social interactions (Jabarifar et al., 2009). Jankauskiene et al., 2010 conducted a systematic review concluded that "Oral rehabilitation under GA results in immediate improvement of the children's oral health and physical, emotional and social quality of life. It also has a positive impact on the family". Dental caries is a common condition amongst young children which negatively impacts on their quality of life. children with down syndrome who have an increased risk of developing caries due to various reasons: limited oral healthcare, difficultty in dental services,un stable diet, the high sugar contents in their medications and low salivary secretion(Peerbhay \& Titinchi, 2014).

Eligibility Criteria:
Inclusion Criteria:

- Inclusion Criteria Age range 1 to 15 years. Diagnosed with down syndrome Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.

Exclusion Criteria Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.

Children whose parents had no home or mobile phone to enable post-operative contact.

Parent that will not sign the consent.

Exclusion Criteria:

* Inclusion Criteria Age range 3 to 14 years. Diagnosed with down syndrome Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.

Exclusion Criteria Participation in any other concurrent clinical trials. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.

Children whose parents had no home or mobile phone to enable post-operative contact.

Parent that will not sign the consent.
Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population

Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology.

Purpose: The frequency of chronic renal failure is underestimated in patients with advanced liver disease and the difficulty to assess kidney failure justifies the investigator's study, which aims to describe, by means of a population pharmacokinetic model, the evolution of plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast agent which is used in radiographic procedures, in cirrhotic patients.

Cirrhosis is often complicated by kidney failure and the prognostic value of renal function (serum creatinine) during cirrhosis is included in the MELD model. In addition, chronic kidney disease (15%) after liver transplantation is also an independent mortality factor.

The most commonly used methods to estimate GFR are based on creatinine, but in patients suffering from advanced hepatic disease, such as cirrhosis, this parameter is incorrect, due to the low creatinine production and potentially to elevated serum bilirubin and decreased albumin levels. Furthermore, ascites can interfere with serum creatinine concentration. In this condition, all creatinine-based evaluations of GFR overestimate gold standard-measured GFR. Specific eGFR equations for liver disease or new approaches for estimating GFR may be necessary.

The plasma clearance of iohexol is a recognized technique for the measurement of the glomerular filtration rate (GFR).

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites :

  * No ascites: 3 patients.
  * Grade 1 (mild): ascites only detectable by ultrasound examination. 3 patients.
  * Grade 2 (moderate) and Grade 3 (wide): clinically significant ascites, causing moderate symmetrical distension of the abdomen, or causing severe abdominal distension. 3 patients.
* Patients will be over 18 years, affiliated to a social security scheme and give their informed consent.

Exclusion Criteria:

* Hypersensitivity to the active substance to the products of iodinated contrasts or to any of the excipients mentioned in Composition section
* History of major or cutaneous immediate reaction delayed injection of iodinated contrast medium (Omnipaque)
* Patients with thyrotoxicosis
* Asthmatic patients
* Patient with a history of dysthyroidism
* Patients with severe cardiovascular disease
* Patients with central nervous system disorders especially vascular
* Patients with pheochromocytoma
* Patients with myasthenia
* Patients with sickle cell disease
* Patients with autoimmune disease
* Patients treated with metformin
* Patients requiring anesthesia on the first day of levies
* Patients with an injection of iodine contrast during hospitalization and in both previous weeks. Gadolinium injections are not not contraindicated
* Patients under guardianship or curatorship or incapacitated give informed consent
Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms

Two unique proprietary formulations of adaptogens VL-G-E12 formulation and an herbal blend containing VL-G-A57 is one of the most well-known adaptogens that has been used for years to enhance positive mood states, deepen sleep, and improve memory. The product has been proven to have a role in improving depression, enhancing work performance, eliminating fatigue and treating symptoms of asthenia subsequent to intense physical and psychological stress. The extract was tested on antidepressant, adaptogenic, anxiolytic, nociceptive and locomotor activities at doses of 10, 15 and 20 mg/kg, using predictive behavioral tests and animal models. The results show that this product extract significantly, but not dose-dependently, induced antidepressant-like, adaptogenic, anxiolytic-like and stimulating effects in mice. Studies reveal that this shrub has antimicrobial (including antibacterial, antiviral, antifungal, antiprotozoal, antimalarial, anthelmintic), anti-inflammatory, anti-diabetic, anti-hypercholesterolemia, anti-hypertensive, anti-carcinogenic, and immunomodulatory effect.The aim of the current study is to assess the adaptogenic effects of two potential investigational products VL-G-A57 and VL-G-E12 Their adaptogenic effect shall be investigated by assessing several clinical symptoms of HPA axis dysfunction such as stress, anxiety, sleep quality, fatigue, mood etc.


Eligibility Criteria:
Inclusion Criteria

1. Male and female subjects ≥18 and ≤ 65 years' old with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
2. BMI: 18 to 29.9 kg/m2
3. RSQ-W (Restorative Sleep Questionnaire-weekly version) score less than or equal to 50
4. PSS scores ranging from 27-40
5. All participants will be encouraged to not make any major lifestyle changes during the study period.
6. They will be informed that any major changes may result in exclusion from the study.
7. Participants willing to provide written informed consent.

Exclusion Criteria

1. Subjects with a medical history of heart disease, respiratory disorders, metabolic or lifestyle disorders, seizure disorders, or other chronic health conditions requiring medication were excluded.
2. Individuals who currently, or in the past 6 months suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 5.0.01 ) or were taking apsychotropic medication or other herbal preparation were also excluded from participating in the study.
3. Subjects with a blood pressure range of systolic ≥ 140 mm Hg and diastolic ≥ 90 mm Hg.
4. Subjects on any sleep medication since last 3 months
5. Subjects with a history of severe intrinsic sleep related disorders.
6. Subjects who have taken Ashwagandha or any sleep or other supplements within the last three months,
7. People with a known hypersensitivity to Ashwagandha
8. Subjects who work on a night shift
9. Nursing or pregnant women
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (participant did receive previous treatment for hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participant has genotype 1 chronic hepatitis C with HCV RNA level \>1000 IU/mL
* Participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C, or participant is treatment-experienced who did not achieve sustained virologic response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy (null-responder, partial-responder or viral relapse)
* Participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan \> 2 years ago prior to screening
* A female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of RBV

Exclusion Criteria:

* Prior non-responder that is classified as a viral breakthrough participant
* Participant is infected or co-infected with HCV of another genotype than genotype 1
* Participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma
Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation

Study objectives:

1. Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation.
2. Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.

There are 2 clinically important and urgent questions to be explored in this study: 1. Who is more likely to benefit from guided drug reduction or discontinuation? How to design an individualized treatment plan which can balance the risk of relapse and side-effects from antipsychotics? 2. What are the predictors of functional remission in patients with schizophrenia after drug discontinuation? This will be the first related study to be conducted in China.

Eligibility Criteria:
Inclusion Criteria:

* Patients who met the diagnostic criteria of the International Classification of diseases, 10th edition (ICD-10) for a diagnosis of schizophrenia;
* Aged between 18 to 65 years old at time of investigation;
* Hospitalized in Shanghai Mental Health Center any time from the year 2013 to 2018;
* Informed consent.

Exclusion Criteria:

* Patients with neurological diseases, severe somatic diseases, psychoactive substance abuse, mental retardation, agitation, stupor, or risk of suicide, and female patients who are pregnant or breast-feeding, will be excluded from the study.
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years.
* Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
* Planned creation of a new AVF.

Exclusion Criteria:

* Patients for whom this is the only potential site for an AVF.
* By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
* Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
* Pregnancy, lactation or plans to become pregnant during the course of the study.