cyrilzakka/clinical-trials huggingface dataset:
CXCL9, CXCL10, CXCL11, and CXCR3 in Dry Eye Syndrome

The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome.

Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation between chemokine levels and tear film and ocular surface parameters was analyzed. Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells in the conjunctiva.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of dry eye syndrome

Exclusion Criteria:

* active ocular infection or inflammation not associated with dry eye
* drug toxicity
* contact lens wear
* ocular allergy
* ocular surgery within the last 3 months
* lid or lash abnormalities
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy

The GIMEMA FOUNDATION promotes an observational (retrospective) study on number and outcome of pregnancy in childbearing age female patients treated with chemotherapy for APL. These patients were enrolled in studies AIDA0493, AIDA2000 and were in CR.

Acute promielocitic leukaemia (APL) Among all the AML subtypes, APL has the distinction of being the most curable. The median age at diagnosis is 40 years, which is younger than with other AML subtypes. The fact that APL is more common in younger patients increases the likelihood that it may occur during fertile age. The introduction of ATRA and ATO has substantially modified the outcome of APL: in two successive studies 94% of patients achieved CR and the 6-yr OS rates (PETHEMA and GIMEMA) were about 80% 2,3,6.

ATRA is highly effective in APL patients, but adverse effects such as retinoic acid syndrome, arrhythmias, headache, rash, dizziness have been reported. Moreover, retinoids are known to be potent teratogens and increased rates of spontaneous abortion and major fetal abnormalities have been reported 10. Most of the cases reported suggest that ATRA is relatively safe for both mother and fetus when used in the second and third trimesters. By contrast, when it was used in the first trimester, a negative foetal outcome was reported. No data have yet been reported on the outcomes of pregnancies in young patients with APL, occurring during CCR following ATRA-including chemotherapy regimens.

APL therapy AIDA regimen: simultaneous Atra plus IDArubicin (AIDA) combination for induction treatment, followed by 3 courses of intensive chemotherapy as consolidation2.

Consolidation therapy in the AIDA-0493 trial consisted of 3 chemotherapy courses with Ara-C and idarubicin3.

Consolidation treatment in the AIDA-2000 was given according to a risk-adapted strategy as follows: patients with low-/intermediate-risk received the same 3 consolidation courses as in the AIDA-0493 but with omission of cytarabine; patients in the high-risk group received the identical 3 cycles as in the AIDA-0493.

Study rationale This is an observational (retrospective) study on number and outcome of pregnancy in childbearing age female patients treated with chemotherapy for APL. These patients were enrolled in studies studies AIDA0493, AIDA2000 and were in CR.

Eligibility Criteria:
Inclusion Criteria:

* Patients alive aged between 18 and 50 years
* Patients with unequivocal diagnosis of APL according to the FAB classification or WHO 2008 diagnostic criteria.

Female in childbearing age treated for APL, enrolled in the studies AIDA0493, AIDA2000 in CR after 2 years of maintenance with the exclusion of those randomized to observation in the AIDA2000, AIDA0493

Exclusion Criteria:

* Patients aged \< 18 and \> 50 years;
* Patients receiving chemotherapy;
* Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).


Eligibility Criteria:
Inclusion Criteria:

* DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation.
Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight or obesity

This phase 2 randomized, double-blind, placebo-controlled, multicenter study will assess the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight and obesity and without diabetes. Each subject will receive either semaglutide or tirzepatide, depending upon availability, and will maintain that course throughout the treatment period. In addition, all subjects will be randomized 1:1 to receive either apitegromab or placebo during the treatment period.

Eligibility Criteria:
Inclusion Criteria

* Able to comprehend the informed consent process and provide written informed consent prior to study enrollment and the conduct of any study-related assessments to study enrollment and the conduct of any study-related assessments
* Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent
* Stable body weight (±5 kg) within 90 days of Screening
* At Screening, a BMI of:

  1. ≥30.0 kg/m2 to ≤45.0 kg/m2 or
  2. ≥27.0 kg/m2 to \<30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See exclusion criteria for specific organ class disease parameters

Exclusion Criteria:

* History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease
* Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas
* History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening
* History of Type 1 diabetes or active Type 2 diabetes (T2D). If there was a history of T2D and it resolved, then the resolution must have occurred \>12 months prior to Screening. Prediabetes managed with nonpharmacologic approaches (exercise and diet) is not an exclusion
Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder

The investigators designed the Child-Caregiver Interaction Observation Scale（CCIOS）to assess social communication behaviors, stereotyped behaviors for children with autism spectrum disorder(ASD) via a 20-min video of interactions between a caregiver and a child. The original CCIOS coding scheme consists 23 items. The score range for each item is 0-4, with higher scores being indicative of more atypical behavior. The aim of the study is to determine items for inclusion in the final CCIOS coding scheme through exploration of item correlations, establish the cutoff score of CCIOS for ASD and evaluate the reliability and validity of CCIOS. The reliability evaluation include test-retest reliability and inter-rater reliability. DSM-5 criterion is used as the gold standard. Validity is assessed by determining the correlation and consistency between CCIOS and DSM-5 criterion.

The investigators designed the Child-Caregiver Interaction Observation Scale（CCIOS）to assess social communication behaviors, stereotyped behaviors for children with autism spectrum disorder(ASD) via a 20-min video of interactions between a caregiver and a child. The original CCIOS coding scheme consists 23 items. The score range for each item is 0-4, with higher scores being indicative of more atypical behavior. The investigators conduct this study to determine items for inclusion in the final CCIOS coding scheme through exploration of item correlations, establish the cutoff score of CCIOS for ASD and evaluate the reliability and validity of CCIOS.

It is of importance to accurately distinguish children with ASD from those with Global Developmental Delay (GDD) and Language Disorder (LD) without ASD, sometimes, it's very difficult in children with mental ages below 2 years. This differentiation has strong implications for treatment recommendations and may also inform long-term prognosis. In this study, The investigators planned to recruit 60 children with ASD and 60 children with GDD/LD aged from 18 months to 48 months. The reliability evaluation include test-retest reliability and inter-rater reliability. DSM-5 criterion is used as the gold standard. Validity is assessed by determining the correlation and consistency between CCIOS and DSM-5 criterion.

Eligibility Criteria:
Inclusion Criteria:

* The ASD/GDD/LD diagnosis is made based on the criteria of ASD/GDD/LD in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) ;
* Age 18 months - 48 months;

Exclusion Criteria:

* Visual, audi-tory and physical disabilities
Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects

The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.

Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/\[height(m)\]2

Exclusion Criteria:

1. Any significant acute or chronic medical illness
2. Current or recent (within 3 months of study drug administration) gastrointestinal disease
3. Any major surgery within 4 weeks of study drug administration
4. Any gastrointestinal surgery that could impact upon the absorption of study drug
5. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.

The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.

The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.

Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.

This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.

The patients will be administered with one tablet intravaginally daily for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman
* At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
* ≤ 5% superficial cells on vaginal smear cytology
* Vaginal pH \> 5.0

Exclusion Criteria:

* Consumption of estrogen alone or estrogen/progestin containing drug products.
* Allergy to estradiol or related products
* History of breast cancer and significant risk factors for endometrial cancer
* Abnormal genital bleeding
Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.

Context: Sport and physical activity during and after cancer treatment can improve fitness and social inclusion in adults. In children, although early studies show interesting results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children following a physical training program showed a significant improvement in endurance, muscle tone, overall self-esteem, sports skills and self-perceived strength. The investigators then want to evaluate the health of a group of children during treat cancer that physical activities adapted compared to children who did not practice.

Objective: Measuring the impact of physical activity program on health of children and adolescents with cancer with improved physical, psychological health, social reintegration and reduced time hospitalization.

Method and Design: The study plans to include 90 children from the pediatric hematology - oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18 months.

This is a randomized controlled open trial open with a stratified distribution. Children will be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits. - Arm B (Control - Delayed Program): the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months. Each child integrates the physical program for a period of one year.

Regardless of the randomization arm, the child performs the initial tests, the intermediate tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be performed at 3 and 9 months.

The physical activity program includes a minimum of 30 days of activities per 6 months (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.

The investigators aim at demonstrating a difference of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program.


Eligibility Criteria:
Inclusion Criteria:

* Patient with malignant disease
* Supported in service pediatric hematology-oncology child Timone hospital in Marseille.
* Age ≥ 5 years and ≤ 19 years
* No medical-cons to the practice of physical activity

Exclusion Criteria:

* Life expectancy less than 18 months.
* Inability to comply with follow-up study for geographical, social or psychological.
* Length of stay less than 18 months, for children living outside mainland
* Not understanding of the French language
* Prior Participation in physical activity program
Geriatric Thoracic Surgery Ambulation Challenge

This study is examining collecting data on steps walked (ambulation) per day by thoracic surgery patients over the age of 65 years-old before surgery.

The name(s) of the study device involved in this study is:

* Fitbit inspire

This research study is a Feasibility Study, which is the first-time investigators are examining the use of a Fitbit by thoracic surgery patients over the age of 65 years-old before surgery. The study is looking to see if patients can wear a wrist step-tracker and keep a log of their daily step counts for one week. The study is looking to see if people are willing to keep track of their daily steps, so in the future participants may be provided with step-goals to achieve and their steps prior to surgery can be accurately measured.

This research study involves using a Fitbit tracker to record daily steps over the course of 1 week prior to scheduled surgery. Participants will be given a step tracker in clinic and instructed on its use. During the 1 week period, participants will be called by a study team to check on progress.

After a week, participants will be asked to return the step-tracker and their log either at a scheduled pre-surgery clinic visit or in the pre-operative area which ever comes first.

It is expected that about 30 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Patients Aged ≥ 65 years

  * Who are preparing to undergo thoracic surgery at Brigham and Women's Hospital (BWH)

Exclusion Criteria:

* Patients who are completely non-ambulatory (i.e. wheelchair-bound-patients) \*
* Those who lack capacity to consent due to cognitive disease.
* Patient for which surgery is felt to be more urgent and therefore performed earlier then our required timeframe for intervention.
* Patients with cardiac disease or angina for which formal cardiac testing is required for clearance.

  * Our exclusion criteria do not include patients with gait disturbances or those who require assistance devices for ambulation.
Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly

In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly.

Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly susceptible to the 'inverse care law'. That is, those in greatest need for preventive assessment and surveillance have the highest potential benefit but are most likely to be missed. Hence, active case-finding and close follow-up might be an important strategy for maintaining the health, independence, and well-being of very elderly people who are at a particularly high risk.

In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Subjects in the intervention group will be visited by an occupational therapist who provides training and education about assistive devices that are already present and will give recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control subjects will not be visited by an occupational therapist.

The primary outcome measure of the trial will be the score on the Groningen Activity Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of loneliness.

Eligibility Criteria:
Inclusion Criteria:

* age 85 years
* living independently
* MMSE score \> 18 points

Exclusion Criteria:

* none
Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST or ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC.
3. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.

Exclusion Criteria:

1. Pregnancy or desire of pregnancy.
2. Breast-feeding.
3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis.
4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
6. Hepatotoxic drugs use before recruiting.
7. Fuzhenghuayu anaphylaxis.
A Study of Duloxetine in the Treatment of Fibromyalgia

This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists

Exclusion Criteria:

* Treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study.
* Any patients judged by their physicians to be at serious suicidal risk.
* Have uncontrolled narrow-angle glaucoma
Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity


Eligibility Criteria:
Inclusion Criteria:

* Medically stable poststroke patients with spastic muscles in the upper limb

Exclusion Criteria:

* Stroke within 6 months of study enrollment
* Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998
Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.

Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to improve liver function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Panax Ginseng C.A. Mey Extract on liver function in adults; the safety of the compound are also evaluate. The Investigators examine AST, ALT, GGT, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Panax Ginseng C.A. Mey Extract or a placebo each day for 8 weeks;

Eligibility Criteria:
Inclusion Criteria:

* ALT ranging from upper limit of reference to three times of upper limit

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks