cyrilzakka/clinical-trials huggingface dataset:
D-Serine Treatment For Tardive Dyskinesia

Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.

The hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-70;
2. diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;
3. history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
4. fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.

Exclusion Criteria:

1. meeting criteria for other DSM-IV Axis I diagnoses;
2. presence of a neurological disorder or history of significant head injury;
3. substance abuse or alcoholism during entire lifetime;
4. are judged clinically to be at suicidal or homicidal risk;
5. female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol. In addition, participants will be offered varenicline in the first pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with HIV
* Receive care at the Atlanta VA Healthcare System
* Are age 18 or over
* Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
* Have evidence of significant alcohol use: PEth \> 20ng/ml
* Currently smoking cigarettes
* Prescribed \>=5 medications
* Have cell phone or reliable contact number
* Can provide written informed consent

Exclusion Criteria:

* Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
* Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
* Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment
* Untreated moderate to severe opioid use disorder
* Residence out of state
* Inability to read or understand English
* History of serious hypersensitivity or adverse reaction to study medication
* Taking potentially interactive medication(s) (e.g. nicotine replacement therapy for varenicline pilot study)
* Already prescribed the pilot medication at the time of study recruitment
A Study to Evaluate Liver Stiffness With Shear Wave Elastography

The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis

This is a prospective, paired study. Study subjects who are scheduled to undergo EUS at Mayo Clinic will be identified through Epic. Chart review will be performed including review of prior imaging, medical history, and laboratory results as available in Epic to determine study eligibility. Subjects without history of chronic liver disease (screened by low FIB-4 score) and those with known advanced fibrosis/cirrhosis will be eligible for the study. Eligible study subjects will then be contacted either before, or at the time of their endoscopy procedure to discuss study participation. All subjects will then receive standard clinical care based on the indication for the EUS procedure. During the EUS procedure, study subjects with undergo shear wave measurements obtained in a non-invasive manner as part of the endosonographic evaluation of the liver. 10 measurements (including shear wave velocity (Vs), elastic modulus (E)) will be obtained for point SWE (pSWE). Measurements will be obtained from both left and right lobes of liver unless technically infeasible to do so. Study subjects will then undergo a paired MR elastography (same day or at later date) after completion of EUS and only if consistent and reliable shear wave measurements were obtained (e.g., VsN \> 70%(reliability index of each measurement expressed in percentages), IQR/M (interquartile range/ Median) is \<15% for Vs and \<30% for E). Enrolled study subjects who had undergone a previous MRE (within 6 months of enrollment) would be eligible for the study, without the need to undergo further research MRE. After completion of MR elastography, the subjects will then continue through their routine clinical care and will not be followed up by research staff. The expected duration of subject participation is anticipated to begin at the time of study enrollment and terminate after completion of MR elastography. There will be no additional follow up.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age who are undergoing EUS procedures.
* Subjects with history of chronic liver disease, advanced fibrosis or cirrhosis
* Subjects without any history of chronic liver disease
* Subjects who underwent MR elastography within six (6) months of enrollment will be eligible to participate in the study.
* Subjects able to give appropriate consent to the study or have an appropriate representative to do so.

Exclusion Criteria:

* Subjects who may have MRI-incompatible metal implants/devices.
* Subjects with severe claustrophobia who may not tolerate MR elastography.
Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries

Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.

This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Children ≤ 4 years old.
2. The presence of at least one carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II, Appendix 1, Table 1), detected by visual examination.
3. The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
4. Parental consent for children's participation in the study.

Exclusion Criteria:

1. Children reporting spontaneous or elicited pain from caries, or showing any signs of pulpal infection, swelling and/or abscess.
2. Children showing a definite negative behavior (Score 1 Frankel's classification) during clinical examination.
3. Allergy or sensitivity to silver or any of the materials included in the study.
Assessment of Different Equations to Accurately Calculate LDL Cholesterol

Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period.

New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state .

Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21_488) Hypothesis

To evaluate the most accurate equation in different conditions:

* Fasting and non-fasting state
* In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.


Eligibility Criteria:
Inclusion Criteria:

* lipid profile performed in the location 1 during the recruitment period

Exclusion Criteria:

* Results outside the first and 99th percentile for TG parameters
* Samples slightly opalescent
Towards a Health Promotion for Children Engaged in Sport Intensive Practice for a Healthy Adult

This project aims to elucidate the complexities of the preventive approach among young people involved in intensive sports activities, providing valuable recommendations to optimize their physical, mental, and social health both in the present and in the long term. The multidisciplinary skills of a team of researchers in sports science and health will contribute their recognized disciplinary expertise through international publications, as well as solid experience in the demands of elite sports, along with a commitment to transferring innovative knowledge toward a preventive approach to sports training.

The main objective is to determine whether a somatotype aligned with the discipline's expectations protects the athlete in terms of self-perception and, consequently, reduces health-risk behaviors. Secondary objectives will include linking somatotype, growth, psychological changes (self-perception), and the emergence of health-risk behaviors or injuries in these young athletes.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 to 15 years old
* Intensive athletes: that is to say they practice a competitive sporting activity with a number of hours of weekly training greater than their age in years.(For example, a 10 year old child will need to train more than 10 hours per week to be included.)
* Sport at an early age
* Obtaining written and signed informed consent from one of the two parents or the holder of parental authority
* Affiliation to a social security system

Exclusion Criteria: menstruation for more than a year at the time of inclusion

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Suicidal Risk Factors Associated With Opioid Analgesics Use

There is an increase in prescriptions for analgesics opioids and overdose mortality in France.

In the United States, the consumption of opioid analgesics is associated with excess mortality, especially suicide. In France, the investigator team showed retrospectively a link between history of suicide attempt (SA) and use of analgesics in general elderly population.

It is important to determine if there is a link between the prescription of opioid analgesics and suicide attempts, in a longitudinal study in general population.

The originality of the project lies in:

* the absence of a French epidemiological study on the link between opioid analgesics and suicide attempt / mortality despite the context of "opioid crisis",
* taking into account the terms of consumption of care

Main objective:

To estimate the relative risk (Odds ratio) of SA associated with exposure to opioid analgesics in a case-crossover design study

Secondary objectives:

1. To Compare the profile of subjects who attempted suicide versus subjects who had an accidental drug intoxication with opioids vs subjects who did not attempt suicide or did not have an accidental overdose with opioid analgesics (case-control design)
2. To Evaluate the dose-effect of opioid analgesics on the risk of SA (case-control and case-crossover design).
3. To Identify changes in care consumption (medical consultations, co-prescriptions, changes in analgesic doses) in the 3 months preceding a SA in patients who received at least one prescription for opioid analgesics in the same period.

The Database is retrospective (2012-2017) Two methods will be used

-case crossover study (reference period of 3 months preceding the SA versus 3 control periods of 3 months without SA.- Case control study (Age and gender matching) Case 1 = occurrence of a SA according to PMSI codes "X60 to X84" between the date of the first delivery of opioid analgesics recorded in the SNIIRAM database since 2012 and December 2017; Case 2 = subjects who had accidental drug intoxication with opioid analgesics according to PMSI code "T40"; Controls = absence of SA and accidental opioid overdose

Eligibility Criteria:
Inclusion criteria:

* adults \>18 years
* having received at least one reimbursed delivery of an opioid analgesic (morphine, oxycodone, fentanyl, tramadol, codeine, or lamaline) over the period 2012-2017 (SNIIRAM database).

Exclusion criteria:

- refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).
Risk Prediction Model of MACE in Patients With AMI Based on Multi-modal Machine Learning

A prospective, multicenter, observational study is adopted, with Jiangsu Provincial People's Hospital as the leading unit, and the other 13 Hospitals as cooperative units.

The deployment of an integrated cardiac rehabilitation management platform from the hospital to the outside of the hospital is uniformly arranged, and based on this platform, a study on the construction of a MACE prediction model and disease risk stratification for patients with acute myocardial infarction after PCI is carried out. It is planned to include 655 inpatients after PCI for acute myocardial infarction. Among them, the leading unit completes the enrollment and follow-up of 44 patients, and each cooperative unit completes the enrollment and follow-up of 47 patients, and competitive enrollment is allowed.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of AMI;

  * Ages 18 - 75 years old;

    * Meeting the indications for emergency PCI surgery, with informed consent and voluntarily undergoing PCI treatment; ④ Accurate and complete clinical relevant data; ⑤ First diagnosis and treatment; ⑥ All patients were given unified antiplatelet therapy after the operation; ⑦ All patients were followed up for 12 months after the operation.

Exclusion Criteria:

* With malignant tumors, infections and other diseases;

  * Blood diseases, immune system diseases, severe liver and kidney function disorders; ③ With other heart diseases such as heart failure; ④ Patients undergoing surgical treatment.
A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203

The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects


Eligibility Criteria:
* Inclusion Criteria:

  1. Healthy adults in the age between 19 and 50 years old
  2. Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
  3. After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
  4. Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
* Exclusion Criteria:

  1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  2. Subjects who judged ineligible by the investigator
SIL as Maintenance Therapy in Multiple Myeloma

The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.

The investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Documented response to ASCT (PR, VGPR, CR/stringent complete response \[sCR\]) according to IMWG criteria.

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women
Pain, Range of Motion, Edema, Sensibility, Strength (PRESS) & Self-reported Function Create a Comprehensive Score

The aim of this study is to examine the development of a conceptual framework and provide evidence for reliability of a comprehensive hand therapy evaluation score. This approach provides a new standardized tool for upper extremity (UE) evaluation. Components of Pain, Range of Motion (ROM), Edema, Sensibility, Strength (PRESS), and self-reported Function were combined to create a baseline. Each assessment tool used for the PRESS to Function Approach assists in determining appropriate interventions.

In this study, investigators used the innovative PRESS to Function Approach and Composite Score to describe the development and piloting of a systematic standard for upper extremity evaluation. Using existing instruments with substantial evidence of validity and reliability is more cost-effective than starting from scratch to develop and validate an instrument. This Approach and Score will provide occupational therapists an accurate measure to track the progression of a patient. The hypothesis for this study is Press to Function components will demonstrate utility for measuring clinical and patient-reported function when used as a comprehensive assessment tool.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of upper extremity disorder as the primary diagnosis
* Surgical and nonsurgical Diagnoses
* Age 21 years or older

Exclusion Criteria:

* Concomitant Diseases (i.e cerebralvascular accident, cerebral palsy, spinal cord injury)
* Full Body Lymphedema
* Individuals who did not complete at least one reassessment
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:

* echographic follicle rupture
* inhibition of follicle rupture
* luteal phase progesterone levels
* anovulatory progesterone levels


Eligibility Criteria:
Inclusion Criteria:

* Women of good general health aged 18 - 35 years
* Not at risk of pregnancy
* Regular menstrual cycles of 24-35 days duration
* Not pregnant
* Intact uterus and ovaries
* Haemoglobin ≥ 11 g/dl
* Normal laboratory tests and normal TSH
* Willing to abstain from any use of hormonal contraception until study completion
* No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
* Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
* Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles

Exclusion Criteria:

* Current participation in any other trial of an investigational medicine
* Known hypersensitivity to the ingredients of the test active substances or excipients
* Suspected hyperplasia or carcinoma of the endometrium
* Current pregnancy as confirmed by positive serum beta-hCG at screening
* Desire to get pregnant before the planned end of the study participation
* Currently breastfeeding
* Abnormal Pap smear
* Cancer (past history of any carcinoma or sarcoma)
* Known or suspected alcoholism or drug abuse
* Abnormal thyroid status
* Body mass index \> 32
* Current use of hormonal contraception
* Use of hormonal emergency contraception since last menstrual period
* Severe asthma insufficiently controlled by oral glucocorticoids
* Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption