cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Autism Spectrum Conditions in Mainland China

The China SCORE study is a prevalence study of Autism Spectrum Conditions (ASC) in 14 regions in mainland China. It will include the following steps:

1. Large population-based screening This study will be conducted in urban areas but not rural areas across mainland China. One city of each region will participate, and in total there will be 14 cities for screening. Within each city, a number of 40 to 60 ordinary primary schools will be randomly selected from the defined region. All the students who are in 1st to 4th grade will asked to participate in order to form a sample of approximately 20,000 students.

   Screening questionnaires The screening pack includes the Chinese CAST, the AQ-Child, the AQ-Adult short version (10 items), and risk factors questionnaire. An information sheet and consent form will be included in the pack as well.
2. Further assessments We expect approximately 5% on the CAST will score positive in ordinary school population. Thus, for a 20,000 sample, we would expect 900 positives (90% response rate). All the screen-positives and a random selected 5% from borderline group will be invited for clinical assessment. The diagnosis of clinical assessment will be divided into three categories: definite ASC, suspected ASC, and non-ASC. Then all the children with clinical assessment results as definite ASC and suspected ASC and a randomly selected 10-20 non-ASC will be invited for research diagnostic assessment using the ADOS and ADI-R, as well as RPM as IQ test. After that, the consensus diagnosis between ADOS/ADI-R assessment and the clinical diagnosis will be the final diagnosis.
3. Case identification in special schools All the children in special schools or training institutes in study region will be asked to fill in the screening pack. The children who do not attend any ordinary or special schools will be identified according to their residential ID in the studied regions. All screen-positives in special education will be assessed using the ADOS and ADI-R. Then those who met the criteria of ASC on ADOS or/and ADI-R will be assessed by psychiatrists and the clinical diagnosis will be the final diagnosis.

If we combine the prevalence of ordinary schools and special schools together, we will get an estimate of the prevalence of ASC in school-population in China. If we combine all the cases identified from schools and from residential records, we will generate an estimate of the prevalence of ASC in the general population in mainland China.


Eligibility Criteria:
Inclusion Criteria:

* All children who are in study region will be recruited for this study.
* All children aged 6-11 years old.

Exclusion Criteria:

* Children who are not in the study region.
* Children who are not found from ordinary schools, private training centres, public special schools and community household with the help of local residence records will not be included for this study.
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly

There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.

Eligibility criteria are men and women over 60 years old and available to participate in the study for 3 months with blood pressure higher than 140/90.

Exclusion criteria are severe dementia, malignant hypertension, depression

Outcome measures are systolic and diastolic blood pressure after 3 months administration of structured education once a month.

Eligibility Criteria:
Inclusion Criteria:

* Subject with age more than 60 years
* Blood pressure higher than 140/90

Exclusion Criteria:

* Severe Dementia
* Depression
* Malignant Hypertension
Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Depression is a disorder that causes major harm to physical health and social life. It induces isolation, reduced physical and work capacity and increasing the risk of death. In contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive functions, stimulation of brain plasticity and resilience, in addition to promoting self-esteem and social interaction. The precise mechanisms by which exercise improves symptoms of depression are not fully clear, but it is probably multifactorial. In this project, the investigators aim to investigate variables that provide additional information about biomarkers involved in the pathophysiology of depression and therapeutic response to exercise. The investigators expect to find changes in biomarkers associated with potential mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived neurotrophic factor (BDNF), cortisol) after exercise program and the role in the therapeutics of depression. To evaluate functional assessment indices will be used ergospirometry, a test that determines the respiratory, cardiovascular and metabolic activity. Overall, this project will help to investigate alternative adjunctive treatments for depression and their associated biomarkers with response.


Eligibility Criteria:
Inclusion Criteria:

* Major Depression Disorder According Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
* Score higher or equal 18 in Hamilton Depression Rating Scale
* Age between 18 and 55 years old

Exclusion Criteria:

* Unstable Clinical Diseases
* Patients Unable to make Physical Exercises
* Present frequencies below 90% attendance in the program aerobic fitness
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple sclerosis (MS)
* Currently or recently pregnant
* Reside in a country where ozanimod is prescribed for treatment of MS

Exclusion Criteria:

* Diagnostic prenatal test results known prior to first contact with the Registry Coordination Center (RCC)
* Exposure to known teratogens and/or investigational medications during pregnancy

Other protocol-defined inclusion/exclusion criteria apply
Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes.

In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.

Goals that all participants will be instructed to target include: 1) weight loss \>=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to \<2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 24-hour ambulatory SBP 120-160 mmHg
* BMI ≥ 25 kg/m2
* Access to a telephone
* Access to a computer or smartphone with internet access
* Complete dietary data entry for at least 5 out of 7 days during run-in period
* Enter weight into the platform during run-in period

Exclusion Criteria:

* Inability to understand English
* Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months.
* Current treatment for malignancy
* Planned or previous bariatric surgery
* Pregnant, breast-feeding, or planned pregnancy prior to the end of participation
* Self-reported average consumption of \> 21 alcoholic beverages per week or binge drinking.
* Psychiatric hospitalization in past year
* Current symptoms of angina
* Planning to leave the area prior to end of the study
* Current participation in another clinical trial
* Principal investigator discretion (i.e. concerns about safety, compliance)
Cognitive Behavior Therapy for Patients With Psychoses.

Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.

Since patients in the early stage of the illness seem to benefit more from CBT than patients with chronic conditions the present research will focus on patients with psychosis at the early stages of their illness. Patients with first episode psychosis from the Northern Stockholm Psychiatry (Midhagen) and the South West Stockholm Psychiatry (TIPS) will be included.

Scores on Alcohol Use disorder identification Test (AUDIT) and Drug Use disorder Identification Test (DUDIT) will be used as a covariate in order to control for the patients' s drug and alcohol use habits.

The study is single blind randomized controlled trials of manualized Cognitive Behavior Group Therapy (CBGT) versus an active treatment condition of individual CBT for patients with first episode psychosis. A total of 16 patients are enrolled and randomly allocated to either CBGT or to individual CBT treatment. Then 18 structured CBGT or individual CBT sessions approximately once a week will be offered. Three experienced CBT trained therapists will perform the therapies. Two therapists will be allocated to each group composed by approximately 5 patients.

The group therapies are conducted according to the Acceptance and Commitment Therapy (ACT) for psychosis manual (an 18 Session Group Therapy Protocol by Pearson A. \& Tingey R.). The individual therapies are conducted according to non-manualized ordinary clinical procedure. The ACT manual is originally constructed for patients with chronic schizophrenia and has therefore been adapted by the therapists to be appropriate for patients with first episode psychosis. The therapists have taken a course in ACT and they receive ACT-supervision during the trial.

Assessments in both studies will be carried out at baseline, after therapy completion and 6 months later by an independent rater blind to group allocation and not involved in the treatment of the patients. The raters blindness will be measured.

Eligibility Criteria:
Inclusion criteria: Diagnostic and Statistical Manual 5 (DSM-5):

* schizophrenia spectrum disorders:
* schizophrenia,
* schizophreniform psychosis,
* schizoaffective disorder)
* delusional disorder,
* brief psychotic disorder
* psychosis not otherwise classified.

Exclusion Criteria:

* Patients with drug abuse diagnosis
* organic brain injury,
* patients with grave somatic illness with secondary psychotic symptoms.
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.

This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.

The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
2. Patients who are pregnant or having possibilities of being pregnant
Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot

APOLLO (Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal snapshot) is an international, multi-centre, prospective observational study which will address this need and aims to describe the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.

Primary aim: Describe the variation in the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.

Secondary aims:

* Identify risk factors for mortality (intraoperatively, at 30-days and at 90-days) and ostomy rates (at 30- and 90-days) in patients deemed for active management (i.e., not for palliative management) to develop a risk prediction model
* Validate risk criteria of large bowel obstruction in patients with previously known colorectal cancer undergoing neoadjuvant chemotherapy or awaiting elective surgery

Who?

* Patients aged 18 years and above presenting to the hospital acutely with colorectal cancer (CRC) for malignant large bowel obstruction (LBO), perforation, CRC-related haemorrhage or other reasons within the data collection periods. Both those managed with and without surgery will be included
* Patients with localised and metastatic disease will be included
* Patients with known colorectal cancer diagnoses will be included if they present acutely (e.g., with disease progression)
* Patients presenting acutely for the side effects of chemotherapy/radiotherapy of known cancers will be excluded

What? Data will be collected on patients' presenting status and symptoms, patient management strategies, and intraoperative and postoperative outcomes.

When? Prospectively over 2023 in consecutive 6-week data collection blocks between January and June with 90-day follow-up till September.

Eligibility Criteria:
Inclusion Criteria:

* Patient pathology: Patients admitted to the hospital acutely with primary colon AND/OR rectal adenocarcinoma and referred to general/colorectal surgical departments:
* Patients who are operated on for curative/palliative treatment of colorectal cancer
* Patients who are referred to general surgery for assessment (irrespective of if they proceed to surgery)
* New diagnoses of colorectal cancer
* Extent of cancer: All patients including extra-abdominal metastatic, intra-abdominal metastatic and non-metastatic disease
* Known cancer: Patients presenting for the first time with colorectal cancer AND/OR known colorectal cancer diagnosis with progression of disease. i.e. obstruction of known colorectal cancer
* Patient presentation: Symptomatic presentation of colorectal cancer i.e. large bowel obstruction, haemorrhage, perforation

Exclusion Criteria:

* Presenting for side effects of cancer treatment
* Patients with secondary cancers
* Previously included in the study
No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

This study evaluates the viability and safety of no drainage tube placement during transoral endoscopic thyroidectomy vestibular approach in treatment of patients with papillary thyroid carcinoma.

Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is widely used due to its excellent cosmetic effect without scars on the body surface. In prevention of postoperative hemorrhage, a postoperative drainage tube is routinely placed in the surgical area. However, current opinion suggest that under the circumstance of strict and effective intraoperative hemostasis, routine application of drainage tube is unnecessary in conventional open thyroidectomy(COT). The research about drainage placement decision during endoscopic thyroidectomy is scarce currently. This study evaluates the viability and safety of no drainage tube placement during TOETVA on papillary thyroid carcinoma.

Patients allocated to the intervention group will implace no drainage tube during TOETVA and those allocated in control group will implace one drainage tube routinely.

The incidence of postoperative complications will be evaluated. The time of postoperative hospital-stay and operation time will be evaluated as well. At the same time, blood test results like WBC and CRP will be evaluated 1 day after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing thyroid surgery for the first time
2. The surgical method is TOETVA
3. There is no lateral cervical lymph node metastasis assessed before surgery
4. Fine-needle aspiration revealed palpilary thyroid carcinoma
5. It meets the surgical indications and has no obvious surgical contraindications

Exclusion Criteria:

1. previous history of thyroid surgery;
2. conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach;
3. patients undergoing cervical lateral lymph node dissection;
4. past or current history of hyperthyroidism;
5. history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.
Improving CRT Outcome With Non-Invasive Cardiac Mapping

The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement.

The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation.

The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects.

The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply:

* Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm
* There is no trend or reason to believe statistical significance will be reached with a higher sample size.

Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.

The study is conducted at European sites as a Post-Market Clinical Follow-Up study of a CE marked device (Amycard 01C). Its aim is to strengthen clinical evidence by assessing whether the use of this device for CRT planning improves clinical outcome in a statistically significant number of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Appropriately signed and dated informed consent.
2. Age ≥18 years at time of consent.
3. Received optimal medical therapy for HF for at least 3 months before screening
4. Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteria per ESC CRT guidelines 2013 .
5. Patient is intended for placement of a CRT device with biventricular (BiV) pacing.

Exclusion Criteria:

1. Previous cardiac pacemaker/CRT/ICD implantation
2. Acute diseases or exacerbations of chronic diseases (as per the investigator's discretion)
3. Contraindications to CT scanning
4. Contraindications to body surface ECG mapping: (ongoing wound healing on the chest (e.g. recent surgery), skin diseases, allergic reactions to surface mapping electrodes and medical band-aid)
5. Pregnant, or subjects planning to become pregnant within 6 months after signing informed consent (a documented negative pregnancy test (serum or blood) is required for women of childbearing potential)
6. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population
Pioglitazone for Heroin and for Nicotine Dependence

The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.

Although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. Targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.

Eligibility Criteria:
Inclusion Criteria:

* 21-55 years of age
* Physically healthy
* Able to perform study procedures

Exclusion Criteria:

* Pregnancy
* Physical dependence on any other drugs besides caffeine, heroin and nicotine
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.


Eligibility Criteria:
Inclusion Criteria:

* Age: 3-17 years old
* Condition (medical or trauma) requiring opioid pain management per standard of care
* Need to establish an IV per standard of care
* Treating physician agrees to manage the patient's pain with morphine following randomization.

Exclusion Criteria:

* Trauma Team Activation
* Known allergy to ketamine
* Family member unable/unavailable to provide informed consent
* When appropriate, patient unwilling to provide assent
* High suspicion of injury related to child abuse
* Patient and/or family member is non-English speaking
* Patient is incarcerated
Microbiome Alterations in IL10RA-deficient Patients After HSCT

To elucidate the longitudinal development of intestinal microbiota in patients with IL10RA deficiency after hematopoietic stem cell transplantation (HSCT). The investigators planned to collect fecal samples from IL10RA-deficient patients who received HSCT. Samples were collected more than once every three days after engraftment in lamina flow ward and at least once a week before discharge. Microbial DNA was extracted from the fecal samples. And all analysis was based on the next generation sequencing data.

Hematopoietic stem cell transplantation is considered the only curative therapy for patients with interleukin-10 receptor-A(IL10RA) deficiency. The investigators aimed to collect the fecal samples of these patients throughout the conditioning, transplantation until discharge, providing a dense insight into the longitudinal development of intestinal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* IL10RA gene mutations;
* Eligible for hematopoietic stem cell transplantation.

Exclusion Criteria:

* Unwilling to participate.