cyrilzakka/clinical-trials huggingface dataset:
Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth.

secondary outcomes:

1. To classify diabetes by gene detection in Chinese adolescent and youth.
2. To make the relationship between genotype and clinic phenotype in type 1 diabetes.
3. To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.

Phase 1: Baseline investigation Aims: To explore genetic susceptibility of diabetes in Chinese adolescent and youth.

Subjects and Methods: 500 patients under diabetic conditions and sex,age-matched NGR Healthy control(2:1) will be enrolled ,all aged from 14-30 years old. A comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. Diabetes should be diagnosed according to the WHO 1999 criteria,type 1 or type 2 diabetes diagnosed by clinical features recommended by International Society of Pediatric and Adolescent Diabetes ( ISPAD ).

Phase 2: Cohort follow-up Aims : To explore the association of genetic backgrounds and clinical characteristics in different types of diabetes in Chinese adolescent and youth.

Subjects and Methods: To recruit and follow up 200 newly diagnosed and genotyped patients for 3 years. Questionnaire, anthropometric measurements, biochemical analysis performed respectively at baseline,3,6,12,24,36 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 14- 30 years old
2. Gender: males and females
3. Race: han
4. Diabetes diagnosed by WHO cafeteria (WHO1999)
5. Living in east China area to minimize population stratification

Exclusion Criteria:

1. Secondary diabetes caused by other diseases or drugs
2. Moderate to severe liver, kidney dysfunction, i.e. ALT/AST \> 2.5 times the upper limit of normal range or Ccr \< 25ml/min;
3. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Holotranscobalamin Remains Unchanged During Pregnancy

Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.

Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues.

Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Eligibility Criteria:
Inclusion Criteria:

* Danish healthy Caucasian women \>18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy.

Exclusion Criteria:

* \>4 cigarettes smoked per day,
* Treatment with vitamin B12, folic acid or acetyl salicylic acid,
* Impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin \<6.4 mmol/L at first visit.
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for standard risk acute lymphoblastic leukemia in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following

  1. 1 year old ≤ Age \< 10 years old
  2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
  3. CNS 1 or 2
  4. No testis involvement
  5. Satisfaction of following organ functions

     A. Kidney function (satisfies i or ii)

     i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2

     ii. Creatinine value according to age/sec satisfies the following: 1 to \< 2 years: Male: 0.6 / Female: 0.6, 2 to \< 6 years: Male: 0.8 / Female: 0.8, 6 to \< 10 years: Male: 1 / Female: 1, 10 to \< 13 years: Male: 1.2 / Female: 1.2, 13 to \< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.

     B. Liver function i. Direct bilirubin \< 3.0mg/dL

     C. Cardiac function i. Shortening fraction ≥ 27% confirmed by cardiac echography ii. Ejection fraction ≥ 50% confirmed by cardiac echography

     Exclusion Criteria:
* Steroid administration within 2 weeks before the registration
* t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF
* One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
* Burkitt leukemia/lymphoma
* When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study

The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib).

A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant.

The specific objectives of the study are:

* To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data).
* To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data).
* To show that data obtained in clinical trials could be reproduced in non-screened patients.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccessible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).

Exclusion Criteria:

1. Patients without medical record available (lost, empty or unretrievable clinical information).
Telemedicine With Metabolic Syndrome

Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.

The patients are using mobile phone-based nutrition diary with heart rate monitoring watch (including activity meter) connected to a mobile phone with bluetooth technology worn on a wrist. These devices, and the weight scale, blood pressure monitor are connected with bluetooth to an IT system, that transmits and displays data from these devices. the patients are using the devices during 3 months, and get instructions about lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 years and 75 years
* Presence of at least three of the following five risk factors (Metabolic Syndrome ATP III Criteria):

  1. waist width above 102 cm in men and 88 cm in women
  2. treated diabetes or blood sugar above 5.6 mmol / l
  3. treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg
  4. fibrate treatment or triglyceride levels above 1.7 mmol / l
  5. blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women

Exclusion Criteria:

* Low level of physical activity (less than 30 minutes a day)
* IT proficiency at least for basic use of mobile phones (answering / making voice calls).
* For women with childbearing potential, by definition, all women who are able to conceive physiologically use dual contraception
* Signing an informed consent.
* The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.
Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic

HBV-related acute-on-chronic liver failure (HBV-ACLF) deteriorates rapidly with a high short-term mortality. Early identification and accurate prognostic prediction was critical to improve survival rate. This study was sought to determine the liver volumetry as predictor for short-term mortality in HBV-ACLF and develop a simpler prognostic model based on liver morphology. Liver volumetry were determined from CT at admission. Univariate and multivariate logistic regression were used to identify the optimum prognostic indicators and develop prognostic model. Additionally, receiver operating characteristic curves were analyzed to evaluate the predictive ability of the model.

HBV-ACLF deteriorates rapidly with a high short-term mortality and early identification and accurate prognostic prediction may be the key to make clinical decision and improve survival rate. Liver volume, non-invasively reflects the balance of structural collapse with hepatic regeneration, predicting the prognosis of liver diseases. However, there is no idea whether the liver volume is an indicator to predict the mortality of HBV-ACLF patients. The present study evaluated the difference of liver volume between 28-day survival group and non-survivals and developed a new prognostic model based on liver volume . This study highlighted the significance of liver morphology in predicting the outcome of HBV-ACLF for the first time.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-70 years, male or female.
2. Acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites, and/or encephalopathy in a patient with chronic HBV infection
3. Abdominal CT examination was performed within 3 days after admission
4. Biochemical examinations were available within 3 days before or after CT scan

Exclusion Criteria:

1. Patients with evidence of non-B hepatitis virus: alcohol abuse leads to liver failure, autoimmune leads to liver failure, oxic or other causes that might lead to liver failure
2. Past or current hepatocellular carcinoma
3. Serious diseases in other organ systems
4. Chronic liver failure
5. There was no CT imaging data or the interval between CT scan and diagnosis of liver failure \>3 days
HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs

This study will evaluate the safety of and immune responses to a dendritic cell vaccination for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).

Untreated HIV-1 infection is characterized by progressive immune dysfunction and the development of opportunistic infections and AIDS-associated malignancies. Highly active antiretroviral therapy (HAART) has been successful in suppressing HIV replication and restoring partial immune function. However, HIV-specific immunity remains poor, as evidenced by rapid rebound of HIV-1 RNA following HAART withdrawal. Studies of individuals with acute HIV-1 infection, as well as those who are long-term nonprogressors, have suggested that robust HIV-specific immune responses are associated with control of HIV-1 viremia. Dendritic cells (DCs) are potent antigen presenting cells that may increase HIV-specific immune responses. This protocol will evaluate the use of DCs to help control HIV infection.

Patients will be randomized to receive either intravenous or subcutaneous administration of HIV antigen expressing DCs. Each subject will receive two administrations of mature DCs given 3 weeks apart. Subjects will be followed weekly for 8 weeks, then at Weeks 12, 16, 24, 36, and 48. Two doses of DCs will be evaluated (low dose: 1-3 million cells; high dose: 5-10 million cells) for safety and immune system response.

Eligibility Criteria:
Inclusion Criteria

* HIV-1 infection
* Current CD4 count more than 400/mm3
* HIV RNA less than 400 copies/ml
* Stable combination antiretroviral therapy for at least 4 weeks prior to study entry
* HLA A2.1 (to be tested at screening)

Exclusion criteria

* Prior HIV vaccine
* Systemic steroids or immunosuppressive drugs within 30 days of study entry
* Pregnant or breastfeeding
Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy

The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.

Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor.

The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.

Eligibility Criteria:
Inclusion Criteria:

* Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission

Exclusion Criteria:

* Women who are undergoing a scheduled cesarean delivery
* Women with a contraindication to either of the 2 study interventions
* Multi-fetal gestations
* Current or planned tocolysis
* Women who are on magnesium prophylaxis
Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder

ADHD is generally associated with significant comorbidities including motor disorders in up to 96% of cases. Within these, disturbances of balance and motor coordination that interfere with school learning and daily activities are present in 47% of school children with ADHD. Therefore, the aim of this research is to determine whether Vojta therapy is beneficial for the improvement of balance, postural control, hand-eye coordination and manipulative motor skills in children with ADHD, hyperactive and/or combined, aged 6-12 years.


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) of the combined or hyperkinetic type.
2. Be between 6 and 12 years of age.
3. Be under treatment with methylphenidate.
4. IQ of 100 or higher.
5. Have a normal neurological examination.
6. Not dysmorphic.
7. Not have received specific physiotherapy treatment for the improvement of balance and postural control in the two months prior to inclusion in the study.

Exclusion Criteria:

1. Present a diagnosis of ADHD comorbid with other neuropsychiatric pathologies.
2. Have a history of neurological or musculoskeletal disorders that are linked to a deficit in balance and/or postural control.
3. Be under treatment with atomoxetine.
A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.

The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
2. Age range of 18-45 years old (including range), no limit to gender.
3. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).

Exclusion Criteria:

1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
3. History of acute cholecystitis attack within 3 months prior to screening.
4. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
9. Presence of clinically significant ECG results judged by the investigator at screening.
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management

The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.


Eligibility Criteria:
Inclusion Criteria:

* Aged:

  * 18-60 years:
  * 61-80 years who are never-smokers
* Evidence of asthma:

  * a diagnostic code for asthma, or
  * ≥2 prescriptions for asthma at different points in time during the prior year
* Baseline FP/SAL therapy:

  * ≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125).

Exclusion Criteria:

* Any chronic respiratory disease other than asthma
* Are receiving maintenance oral steroid therapy during baseline period.
A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients

We are interested in achieving an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative study phase.

We seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative study phase.

1. Positive affect induction: We will tests two types of positive affect induction. 1) sending patients a small gift, and 2) reminding patients of positive thoughts about themselves. Gift: Prior to a telephone call, patients in the positive affect condition will receive a small gift. The selection of gifts will be guided, in part, by data obtained from the qualitative study phase. Positive thoughts about themselves: Patients will be asked to describe a time when someone was helpful to them, and they felt good about it , and were nice to them in return.
2. Self affirmation: consists of a series of items reminding people of their core values.
3. Control: Control patients will have neither self affirmation nor gifts. After enrollment, patients will be randomized into four groups: control, the self affirmation, the positive affect gift group and the positive affect positive thought group. Thus, for the positive affect, we will test two different types of positive affect induction.

Follow-up: At two weeks after enrollment all patients will be called to ascertain impact of the pilot intervention.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment. Patients must be able to provide informed consent within the one week after the procedure.

Exclusion Criteria:

1. Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
2. Enrollment in other trials designed to modify post-procedure behaviors.
3. Patients who refuse to participate will be excluded.
4. If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.
Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)

Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc.

In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. Given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the DDD-related pathways and to screen promising treatments such as MSC-based therapies.

The primary aim of this study is to investigate the response of an inflamed organotypic spine unit model, intended as a 3D in vitro representation of an in vivo environment, to the treatment with mesenchymal stem cells (MSC)-derived secretome. In particular to investigate the ability of MSC-derived secretome to modulate genes found to be upregulated or downregulated by the inflammatory stimulation in the spine unit model and bring their expression back to a basal state.

Secondary aims of the study are:

* To identify specific degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating circulating features and tissue degeneration
* To develop an organotypic spine unit model using patient-derived cells to investigate the response of cells derived from nucleus pulposus (NP), annulus fibrosus (AF) and cartilaginous endplate (CEP) to inflammation

Eligibility Criteria:
DDD patients:

* Signature of the Informed Consent for the study
* Age 30-60 years (included)
* Pfirrmann grade III-V
* Need to undergo spinal surgery

Subjects for the isolation of adipose-derived MSCs:

* Signature of the Informed Consent for the study
* Age 18-50 (included)
* Need to undergo surgery that involves the removal of adipose tissue

Subjects for the isolation of placenta-derived MSCs:

* Signature of the Informed Consent for the study
* Age 18-50 (included)
* Women who are pregnant or who have not given birth from more than 6 hours

All enrolled subjects:

- Presence of HIV, HBV, HCV or TP infection