cyrilzakka/clinical-trials huggingface dataset:
Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD

To explore the relationship of treatment-related changes in electrophysiology and those in metabolomics for identification of the underlying metabolic mechanisms for the electrophysiological effects of methylphenidate in children with ADHD.

Although the efficacy of methylphenidate in reducing the core symptoms of attentiondeficit/ hyperactivity disorder (ADHD) is well documented in clinical trials, no definite biomarker has been identified to differentiate responders from non-responders to methylphenidate treatment for children with ADHD. In addition, the neural and metabolic mechanisms underlying the therapeutic effects of methylphenidate remain to be elucidated. In this 4-year prospective project, the investigators will explore the effects of 12-week treatment with methylphenidate on the electrophysiology and metabolomics of children with ADHD to identify the biomarkers for predicting the clinical response to methylphenidate. In addition, the investigators will explore the metabolic mechanisms through which methylphenidate treatment may modulate the abnormality in the electrophysiology of children with ADHD.

Specific Aims:

1. To examine the differences in electrophysiology and metabolomics between children with ADHD and neurotypical controls.
2. To examine the differences in the change of electrophysiology and metabolomics after 12-week treatment with methylphenidate between responders and non-responders in children with ADHD.
3. To explore the relationship of treatment-related changes in electrophysiology and those in metabolomics for identification of the underlying metabolic mechanisms for the electrophysiological effects of methylphenidate in children with ADHD.

Eligibility Criteria:
1. Patients with ADHD

   1. Inclusion Criteria

      * Patients, aged 6 to 18 years, meet the DSM-5 diagnostic criteria for ADHD.
      * At baseline, patients have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score greater than 4.
      * Patients have a Full IQ (FIQ) score greater than 80.
   2. Exclusion Criteria

      * Patients have a major psychiatric disorder, such as autism spectrum disorder, schizophrenia, affective disorders, or substance use disorders.
      * Patients have a major disorder of central nervous system, such as epilepsy.
      * Patients have a major systemic disease, such as diabetes mellitus or cardiovascular diseases.
      * Patients have ever received any medication to treat the clinical symptoms of ADHD.
2. Neurotypical participants:

   1. Inclusion Criteria

      * aged 6 to 18 years
      * All of the neurotypical participants have no psychiatric disorder in lifetime according to the diagnostic criteria of DSM-5.
   2. Exclusion Criteria

      * participants have any disorder of central nervous system or major systemic disease
      * participants have ever taken any psychotropic drug, or who have FIQ scores less than 80, will be excluded from the present study.
GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?

This is a multicenter observational prospective study in smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years / pack) with respiratory symptoms and presenting a normal spirometry.

The patients who sign the corresponding informed consent, will undergo a DLCO and will be divided into two groups according to the result:

* Group I. Patients with DLCO \<80%.
* Group II Patients with DLCO≥80%.

Both groups will be followed for 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study.
* Female or male patients with age equal to or greater than 18 years.
* Smokers or ex-smokers with cumulative exposure ≥ 10 a / p
* Respiratory symptoms
* Normal spirometry.

Exclusion Criteria:

* Age under 18 years.
* Participation in another clinical study.
* Patients with a life expectancy of less than 2 years due to neoplasms or other serious systemic diseases.
* Refusal to sing informed consent.
Evaluating the Endometrial Receptivity of FET Patient by Ultrasounicelastography

Prospective clinical study ：observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate. In order to find a non-invasive, convenient and comprehensive evaluation method of evaluating the endometrial receptivity, and to provide effective means for the frozen embryo transplantation patients to improving pregnancy outcome.

Randomly selecting 20-40 years patients were prepared to accept frozen embryo transplant ; HRT cycle preparation of endometrium；choosing HRT plan to prepare the transplantation endometrium.Establishing a strict standard of exclusion and exclude standard to exclude endometrial lesions and underlying disease.The patients were given elastography for 5-7 days afterEndometrium transformation.Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate. In order to find a non-invasive, convenient and comprehensive evaluation method of evaluating the endometrial receptivity, and to provide effective means for the frozen embryo transplantation patients to improving pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

1. the volunteers voluntarily signed the informed consent.
2. female patients between 20-40 years old.
3. HRT cycle.
4. no uterine cavity operation was performed within 3 months.

Exclusion Criteria:

1. endometrial polyps, abnormal uterine cavity, intrauterine adhesions and dysplasia of uterus.
2. hydrosalpinx was not ligated.
3. patients with uterine myoma and uterine fibroids;
Phase III Study of Intramuscular TAK-816 in Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.

The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered TAK-816 IM.

The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Japanese infants.
2. Male or female infants aged 2-6 months (≥2 and \<7 months) at the time of the first dose of investigational product (excluding hospitalized infants).
3. Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
4. The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

1. Any serious acute illness.
2. Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
3. History of possible Haemophilus influenzae type b (Hib) infection.
4. Previously diagnosed immunodeficiency.
5. Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid).
6. A history of convulsions.
7. Previous administration of another Hib vaccine.
8. Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
9. Prior participation in any clinical study or post-marketing clinical study.
10. Previously receipt of blood transfusions, gamma globulin preparations (except monoclonal antibody products not containing any components of Hib as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period.
11. Presence of thrombocytopenia or coagulopathy.
12. Children considered ineligible for the study for other reasons by the investigator or subinvestigator.
Medication Adherence in Kidney Transplant

Aims and Objective: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.

Background: One of the most common problems encountered in transplant patients is incompatibility with immunosuppressive drugs, one of the most important reasons for graft rejection.

Design: A randomized controlled trial was conducted from January to October 2021 and conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.

Methods: This randomized controlled trial included a total of 100 patients receiving a kidney transplant, 50 in the intervention group and 50 in the control group. Patients in the intervention group were sent text message reminders four times a day during the 6th to 9th months after transplantation. Control patients received no such intervention. Tacrolimus concentrations in the bloodstream were monitored for all participants through measurements taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive Characteristics Form and Immunosuppressive Medication Adherence Scale.

Research hypotheses H1- Sending text message reminders improves immunosuppressive medication adherence in kidney transplant recipients.

H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood profiles in kidney transplant recipients.

H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence Scale and mean tacrolimus plasma levels in kidney transplant recipients.

H4- There is a correlation between the sociodemographic and descriptive characteristics of kidney transplant recipients and their mean scores from the Immunosuppressive Medication Adherence Scale.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Being a recipient of a kidney transplant for the first time
* Being a kidney transplant recipient at post-transplant month 6 with scheduled follow-up until month 9
* Ongoing immunosuppressive drug therapy
* Absence of any disability that hinders communication
* No diagnosis of psychological and mental problems
* Being an active cell phone user
* Ability to read and write
* Voluntary participation in the research.

Exclusion Criteria:

* Hospitalization for any reason during the research period
* History of combined or dual organ transplantation.
Effects of Herbal Supplements on Endurance Exercise Performance

Cordyceps and Rhodiola are two common herbal supplements marketed and consumed as adaptogens to athletes with regard to enhanced performance. The effects of these supplements has been well studied in animals but whether or not the same effects translate to humans is still unclear. Thus, the primary purpose of this study is to determine whether combined supplementation of Rhodiola and Cordyceps, compared to Rhodiola alone and placebo, will demonstrate a greater improvement in oxygen consumption (ie. VO2 max).

Herbal supplements are consumed worldwide with surveys approximating five billion dollars spent annually by consumers in the United States alone. Herbal supplements, such as Rhodiola and Cordyceps, both of which are considered to be adaptogens, remain popular among athletes. These adaptogens act as antioxidants, which have been speculated to confer endurance performance benefits by delaying muscle fatigue via the attenuation of muscle damage accumulation and its related by-products during prolonged or exhaustive exercise. Nevertheless, previous research investigating the individual effects of Rhodiola and Cordyceps on aerobic training performance remain equivocal. Moreover, literature elucidating the potential additive effects of Rhodiola and Cordyceps in human subjects are scarce. Therefore, the purpose of the present study is to determine the acute, additive influence of oral Rhodiola and Cordyceps supplementation on VO2 max, with secondary variables of interest being plasma glucose and lactate concentration, and measures of gastrointestinal distress.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18.5 and 35 kg/m\^2
* Non-smoking (assessed by Health History Questionnaire)
* English-speaking
* Regular participation in physical activity (\>4 hours per week)

Exclusion Criteria:

* Medical conditions that prohibit physical activity (assessed by Health History Questionnaire)
* Pregnant women or women expecting/trying to become pregnant
* BMI greater than or equal to 35 kg/m\^2
* Current smoker (assessed by Health History Questionnaire)
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
* Provision of signed Informed Consent
* Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.
* Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2
* Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
* Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the 4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 weeks.

Exclusion Criteria:

* Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1.
* Secondary or malignant hypertension
* Sitting SBP of 180 mmHg or more
* Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
* Angina pectoris requiring more treatment than short-acting nitrates
* Chronic use of NSAIDs
* Aortic or mitral valve stenosis
* Cardiac failure requiring treatment
* Cardiac arrhythmia requiring treatment
* Gout
* Renal artery stenosis or kidney transplantation
* Intravascular volume depletion
* Hypersensitivity to any component of the investigational products or to any sulphonamide derived drugs
* Concomitant disease which may interfere with the assessment of the patient
* Past or present alcohol or drug abuse, or any condition associated with poor compliance that in the opinion of the investigator might affect the patient's participation in the study
* Chronic liver disease
* Concomitant or previous treatment with any other investigational drug within 20 days of enrolment
* Previous enrolment in the present study
A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 4 years to 75 years.
5. Disease progresses but reserves reaction to recent treatments.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.

Exclusion Criteria:

1. HIV affected.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. Other situations we think improper for the research.
A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography

The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up to 48-72 hours after the administration of the contrast agent to evaluate renal function.


Eligibility Criteria:
Inclusion Criteria:

* Referred for cardiac angiography; with a documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2

Exclusion Criteria:

* Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing dialysis
Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure

Subjects will be consented to wear the AleriTM sensor prior to, during, and after an Electrophysiology Procedure. During this time, the system will measure the following parameters from subjects: HR, temperature, saline volume/rate, urine production volume, USG, BPO. Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor hydration levels of subjects compared to currently available methods.

Study subjects scheduled for an EP procedure who have signed an informed consent form (ICF) will be admitted to the study. Prior to the EP procedure (e.g. in a hospital room or operating room at NYU Medical Center), either an employee of NYU or Hydrostasis will place sensor on subject's bicep, forearm, or wrist, start the sensor and connect the sensor to mobile app to start data collection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiac arrhythmias or other cardiac conditions that are scheduled for EP procedures.
* Subject is over 18 years of age at the time of consenting
* Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study

Exclusion Criteria:

* Pregnant subjects
* Subjects who are participating in another clinical study that may affect the results of either study
* Subjects who are unwilling or unable to wear the sensor for a period of up to 14 hours
* Subjects who are considered by the principle investigator to be medically unsuitable for study participation
Comparison of Minimum Flow and Low Flow Desflurane Anesthesia in Robotic Assisted Laparoscopic Abdominal Surgery

This study aims to compare the use of low fresh gas flow (1 L/min) desflurane anesthesia with minimum fresh gas flow (0.5 L/min) desflurane anesthesia in patients undergoing robotic-assisted abdominal surgery. The comparison will be based on hemodynamic and respiratory parameters. The secondary aim of our study is to compare the two different fresh gas flow methods in terms of inhalation agent consumption and soda lime consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robotic-assisted abdominal surgery

Exclusion Criteria:

* serious cardiac, respiratory, hepatic, renal, or mental disorders;
* hearing problems;
* anxiety, depression, or other psychiatric conditions;
* patient's request to leave the study
The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

The purpose of this study is to determine the effect of penile vibratory stimulation on the muscle spasticity of men with chronic spinal cord injury.

Spinal cord injury can result in mild to severe muscle spasms that can both inhibit functional capability and increase the likelihood of injury due to fall. Anecdotal reports and a recent study suggest that triggering the ejaculatory reflex in men with vibratory stimulation can result in a significant decrease in spasm activity over a period of 2 to 42 hours. This study examines the effects of penile vibratory stimulation on spasticity when conducted daily in the home setting.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with a traumatic spinal cord injury

* Level of injury is at T6 or below
* Injured at least 6 months prior to study enrollment
* Male, aged 18 to 70 years
* Spasticity to a degree that either anti-spasticity medications have been or are being used or current spasticity is at 2 or greater on the Ashworth scale specifically for the quadriceps muscle group (knee flexion)

Exclusion Criteria:

* Medical instability
* Subjects may not use Cialis
* Use of Viagra, Levitra, Caverject, or vacuum constriction devices is restricted to no less than 8 hours prior to daily vibratory therapy
* Recent history of autonomic dysreflexia secondary to sexual stimulation
* Presence of intrathecal Baclofen pumps
* Inability or unwillingness to use the therapy daily