cyrilzakka/clinical-trials huggingface dataset:
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity

Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria.

A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.

The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling

Observational multicenter retrospective study from january 2011 to january 2021.

No supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient.

Patients will be included after their usual medical check-up.

Eligibility Criteria:
Inclusion criteria:

* Fetuses with prenatal colic hyperechogenicity
* Between January 2011 and January 2021
* Born without term limitation.

Exclusion criteria:

* Intestinal hyperechogenicity
* polymalformative syndrome
* Patients Age\<15 years
Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation

The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of major depressive disorder according to DSM-5
2. Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
3. Before treatment, patient have to stop antidepressant for at least 1 weeks.
4. Capable and willing to provide informed consent.

Exclusion Criteria:

1. Have a concomitant major, unstable medical or neurologic illness :

   * Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
   * Severe brian disease: Brain tumor, encephalitis, brian injury.
2. Intracranial implant and other ferromagnetic materials close to the head.
3. History of Seizures.
4. Cardiac pacemaker.
5. Pregnancy.
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.

This is a phase I, single center, randomized, double-blind and parallel group clinical trial.

The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.

At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and Xgeva®.

Subjects would receive a single 120mg（1.7mL）of MW032 or Xgeva® through subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years old (including 18 and 65 years old), healthy male subjects.
* Body mass index (BMI) within the range 19-28kg/m2.
* History, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant.
* Volunteered to participate in this clinical trial, capable of giving written informed consentan.
* The subject (including the subject's partner) takes effective contraceptive measures.

Exclusion Criteria:

* Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study.
* Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
* Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
* Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies.
* Those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement Treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (\>1000 IU/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.
Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation

Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying biochemical mechanisms for how folic acid affects health outcomes however are unknown. The naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as an adequate substitute to folic acid. This study aims to determine the effect of folic acid compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols will be used that allow determining the effect of folic acid on the dynamics of metabolic pathways in the human body.

Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key enzyme of the folate metabolism will aggravate the effect of folic acid on the metabolic pathways.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Body mass index of between 19-24 kg/m2
* Normal folate, vitamin B12, and B6 status

Exclusion Criteria:

* Unable to swallow tablets
* Unable to receive intravenous catheters
* Use of vitamin supplements, amino acid or protein supplements for more than six months before study participation
* Chronic consumption of a high-protein diet (e.g. Atkins Diet)
* Medical conditions such as diabetes, asthma, cancer, cardiovascular disease, a history of neural tube defect (such as spina bifida) affected pregnancy, have had gastrointestinal surgery, abnormal kidney, thyroid function, or psychiatric illness, or any other chronic disease
* Pregnancy or lactation
* Smoking, use of recreational drugs, and/or consumption of more than one alcohol drink per day or more than seven per week.
* Use of long-term prescription medication such as hormonal contraceptives, antidepressants, anticonvulsants, anticoagulants, or other chronic medication
* Blood donation in the last three months prior to study start
* Unable to provide informed consent, or unable to read and write English
* Low compliance to intervention as determined by early steady-state or reduction in blood folate concentrations
Natural History of SMA

This is an investigator initiated observational study with the aim to record several aspects of function, care and adverse events in a large cohort of SMA patients followed longitudinally by using a structured academic disease registry.

This is an observational multicenter retrospective and prospective study involving high quality data collected in 5 academic centers in Italy, the registry aims to

* better understand the natural history of the disease in untreated patients identifying factors that can influence disease progression by combining retrospective and prospective data.
* Describe the patterns of disease progression (in terms of functional measure, adverse events, levels of care, and hospitalization) in treated and untreated patients
* Identify all the patients treated with the available therapies in Italy, providing first line details on epidemiological data in a wider network including all centers recognized as centers for spinal muscular atrophy (SMA) in each region.

As part of the activity clinical evaluators, data manager and sub-investigators are also trained and use common manuals of operation to ensure reliability across the participating centers. The registry provides accurate and reliable information on natural history including results from currently used functional measures. The registry also includes information on supportive care, hospitalization and adverse events.

Details of the electronic clinical file record including data assembly and the platform used are available as part of a peer reviewed paper

Eligibility Criteria:
Inclusion Criteria:

all patients

Exclusion Criteria:

if enrolled in clinical trials
Alpha-1 Foundation DNA and Tissue Bank

This is a long-term follow-up banking protocol that collects medical information and tissue (blood, liver and lung) samples for future research; use of data and samples for research purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to further research on alpha-1 antitrypsin deficiency.

Subject participation includes completion of informed consent, medical questionnaire, and email authorization. Subjects may provide a blood sample for alpha-1 antitrypsin genotype, phenotype and level. Lung and liver tissue may also be provided if available. Subjects may be contacted no more often than annually for updated information.

This project has a certificate of confidentiality from NIH.

Eligibility Criteria:
Inclusion Criteria:

* all interested individuals may enroll

Exclusion Criteria:

* there are no exclusion criteria
Multicentre Observational Study on Community Acquired Intraabdominal Infections Management

Intraabdominal infection require rapid care management including antibiotic therapy and source control. Morbidity and mortality associated with Intraabdominal infections remain high. French recommendations have been edited in 2000 further updated in 2014. Delay in diagnosis and surgery can lead to worsened outcomes. However, little data are available on early community-acquired intraabdominal infections management to identify risk factors of inadequate management.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery

Exclusion Criteria:

* primary intraabdominal infection
* health-care associated intraabdominal infection
* abdominal trauma
* patient under guardianship
* opt out consent
* patient already enrolled in the present study
PET/CT Study in the Diagnosis of Coronary Plaque

This study is being done to determine if a picture taking test of the heart, positron emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in the heart arteries that lead to heart attacks when compared to the standard of heart catheterization.

Heart catheterization, in which a thin plastic tube, or catheter, is placed into an artery in the arm or leg and advanced into the heart arteries, is the procedure that you and your doctor have decided to pursue to look for heart artery blockages. It is being performed as part of your standard care and not for research purposes. The research procedure (cardiac PET/CT), which will be performed at a later date is a combination of heart CT (a test that involves the use of x-rays to identify heart artery blockages) and heart PET (an imaging test that uses a radioactive drug to look at how the heart uses fuel (sugar and fats) These tests will be combined (PET/CT) to look for the presence and type of blockage in your heart arteries.

It is important to develop a test that can determine if and what type of blockage you have in your heart arteries as the presence and type of heart artery blockage is a very important predictor of heart attack and death from heart attack.

Eligibility Criteria:
Inclusion Criteria:

* 18 years oof age or older
* referred for cardiac catheterization.
* coronary artery disease that does not need angioplasty.

Exclusion Criteria:

* history of cardiac stents
* bypass surgery
* bad kidney function
* unable to take beta blocker medication
* history of asthma
* allergies to egg containing products
* atrial fibrillation
* pregnancy
* breastfeeding
* overweight by definition of a BMI over 35.
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma

The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of PTCL can predict disease progression

In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in PTCL.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed PTCL
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.
Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting

The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.

This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.

Eligibility Criteria:
Summary of Key inclusion/exclusion criteria:

Inclusion Criteria:

* Age 21-65 years
* Type 1 diabetes mellitus for at least one year
* Using an insulin infusion pump for at least the past 6 months

Exclusion Criteria:

* Pregnancy
* History of diabetic ketoacidosis (DKA) in the past six months
* History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months

Other Inclusion/Exclusion criteria apply.

Please contact clinical study site for complete details.
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas

The aim of this pilot study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This pilot study will compare two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit 40 youth from 4-6 primary care clinics in the Dallas and Austin, Texas metropolitan areas. Each clinic will be randomly assigned to deliver one of the two study interventions.

This is a cluster randomized study focused on youth suicide prevention which will recruit 40 youth from four primary care clinics serving sexual and gender diverse young adults in the Dallas and Austin, TX metropolitan areas. Each clinic will recruit 10 youth. Two clinics will be randomly assigned to deliver each of the two study interventions. The interventions are adapted versions of two existing, brief suicide prevention interventions: 1) Suicidal Teens Accessing Treatment after an ED Visit (STAT-ED) is a brief intervention based on motivational interviewing that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management; and 2) Youth-Nominated Support Team for Suicidal Adolescents (YST-II) is a brief intervention developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation. The revised interventions will be called STAT-PC and YST-III. For YST III, participants will identify 1-2 supportive adults from their lives who agree to provide ongoing contact and support. The interventions will last two months. Primary and secondary outcome assessments will be done at baseline and/or at 2 months.

To be eligible, participants must report risk factors for suicide based on screening questions that will be implemented in our primary clinic sites.

Eligibility Criteria:
Inclusion Criteria:

* be aged 18-24 at the time of enrollment; and
* not have received mental health services in the past 90 days, excluding medication;
* English-speaking, and
* screen positive for suicidal ideation.

Exclusion Criteria:

* are actively suicidal
* have a developmental disability that would preclude them from participating in the study intervention or
* who are impaired due to psychosis, mania, or substance use that would prevent them from providing consent.
* Participants will also be excluded at YST-III sites if they are unable to identify a minimum of one support person to participate in the intervention with them.

Those who are excluded will be provided with referrals for treatment services.
An Observational Pilot Study to Characterize Relationships Between Self-reported Information, Game Performance, and Passive Physiology Measures Throughout a Daily Cycle

This study intends to collect self-reported information with multiple surveys about lifestyle habits, food and drink, state of mind (happy, sad, etc.) and traits (decision making, general personality, etc.) The purpose of this study is to understand relationships between self-reported information, game performance, and passive physiology measures throughout a daily cycle.


Eligibility Criteria:
Inclusion Criteria:

Must be \>=18 years old Must agree to participate via electronic consent Must agree to share e-mail and physical address (final dataset de-identified) Must own a computer and/or smartphone Must be a member of the survey panel and agree to take multiple surveys over 4-6 weeks Must complete the full surveys and not fail attention filters Must be able to access cognition games website and play the games Must be willing to wear a lifestyle assessment sensing device for 1 week

Exclusion Criteria:

Known skin reaction or allergy to metal Known skin reaction or allergy to medical adhesive Participation in another research study, behavior or new drug testing
Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease

Methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney disease (CKD) will be developed and implemented in real clinical practice. As a result of the project, new scientific data will be obtained on the relationship of hyperprolactinemia and impaired functioning of the pituitary-gonadal axis, changes in functioning of the renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid and parathyroid status in patients with CKD will be determined, including receiving renal replacement therapy (RRT) and after kidney transplantation, which will improve the efficiency of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce the direct financial costs of the diagnostic and treatment process primarily due to the optimization of hormonal studies and treatment of the revealed disorders, as well as will prevent the progression of CKD and the severity of the condition of this category of patients due to the development of hormonal dysfunctions.

1. Assessment of prevalence, clinical manifestations and pathological significance in a cohort of patients with CKD:

   * hyperprolactinemia, hormonal disorders of a pituitary -gonad axis ;
   * disorders of renin-angiotensin-aldosterone system;
   * pathology of the thyroid and parathyroid glands.
2. Analysis of CKD impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination.
3. Assessment of relationship of hormonal dysfunctions in patients with CKD and adipocytokines, markers of renal impairment.
4. To study the effect of renal replacement therapy on thyroid hormones clearance .
5. Investigate hormonal status in patients with CKD after kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* patients at CKD 1-5, including renal replacement therapy and renal transplantation

Exclusion Criteria:

* patients with impaired thyroid function before the onset of CKD;
* pregnant women;
* patients with acute diseases;
* patients in the acute phase of comorbid chronic diseases;
* patients in the acute period of myocardial infarction, after acute cerebrovascular accident;
* patients with mental illness;
* patients undergoing treatment for various cancer types.
The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1

The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written consent
* Genotyped in OCT1 for (M420del and R61C)

Exclusion Criteria:

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding