cyrilzakka/clinical-trials huggingface dataset:
A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's Disease

In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤ 40) in a randomized, double-blind, controlled study in 2 centers (France and the Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n = 50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be evaluated by measurements of caudate volume using volumetric magnetic resonance imaging. Clinical improvement will be evaluated by brain energy metabolism quantification as evaluated by the ratio of inorganic phosphate/phosphocreatine, during visual stimulation, using 31P-MRS, UHDRS, TFC, and PBA-S scores as well as performance on the neuropsychological battery. Patient quality of life will be evaluated with the SF-36 questionnaire before and after treatment; biological tolerance and compliance will be evaluated by routine biochemical blood tests, plasma and urine measurements of triheptanoin oil derivatives and patient report.


Eligibility Criteria:
Inclusion Criteria:

* Positive genetic test with CAG repeat length ≥39 in HTT gene
* At least 18 years of age
* Signature of informed consent
* Covered by social security
* UHDRS score between 5 and 40
* Ability to undergo MRI scanning
* BMI between 18 and 30

Exclusion Criteria:

* Hypersensitivity to triheptanoin or to one of its excipients
* Additional major comorbidities
* History of severe head injury
* Participation in another therapeutic trial (3 month exclusion period)
* For women of childbearing age, the absence of two forms of effective contraception (with the exception of those who are abstinent)
* Pregnancy or breastfeeding
* Inability to understand information about the protocol
* Persons deprived of their liberty by judicial or administrative decision
* Adult subject under legal protection or unable to consent
* Treatment with tetrabenazine
The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass

The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of \> 110 mg/dL
* Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).

Exclusion Criteria:

* Subjects taking thiazolidinediones
* Subjects with active systemic illness
* Subjects with active microvascular or macrovascular complications of their diabetes
* For female subject: positive pregnancy test at the time of enrollment in study
MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.


Eligibility Criteria:
Inclusion Criteria:

* Patient who have received a kidney transplant during the "MMF era"
* Patients who have stable graft function indicated by a serum creatinine of \< 1.8 mg/dl, or a calculated creatinine clearance of \> 50 ml/minute

Exclusion Criteria:

* Patients who have had \> 1 rejection episode,
* Patients who have had a rejection episode within the past year;
* Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE
Impact of Exergaming on Adolescent Youth

The purpose of this study is to gather information on how much exercising with video games (ExerGaming) can increase the physical activity among overweight and youth. This study will try to see if participating in physical activity and exercising with video games at the same time can make overweight children move around more to better their own health. The hypothesis is that those in Exergaming arm will physiological changes and increase physical activity.


Eligibility Criteria:
Inclusion Criteria:

* male and female
* aged 12-14 years
* baseline BMI \> 25
* gender- and age-specific 85th percentile cutoff points from the CDC growth chart
* parental consent and subject assent

Exclusion Criteria:

* subjects not meeting the inclusion criteria or with physician-determined musculoskeletal, cardiopulmonary, metabolic, psychological, neuro-developmental or behavioral conditions that make mild-to-moderate physical activity potentially hazardous.
* Participants under the age of 12 are excluded from the study because Weingart YMCA has an age policy. Children under the age of 12 are not allowed to be at the facility alone. Therefore, the minimum age for the study is 12 years old so supervision is not a problem.
BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving 3 cm or greater average waist circumferential reduction in HFT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.

Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the HFT group of 64 subjects who are treated with the BTL-9000 HFT and the other arm is the Placebo group of 38 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 HFT treatment in achieving average post-treatment waist circumference reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area
* Body Mass Index (BMI) of 25 to 35 kg/m2.
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.

Exclusion Criteria:

* - Diabetics dependent on insulin or oral hypoglycemic medications
* Known cardiovascular disease such as arrhythmias, congestive heart failure
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
* Prior surgical interventions for body sculpting of abdomen such as liposuction
* Medical, physical or other contraindications for body sculpting/ weight loss
* Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
* Any medical condition known to affect weight levels and/or to cause bloating or swelling
* Active infection, wound or other external trauma to the area to be treated
* Pregnant, breast feeding, or planning pregnant before the end of the study
* Serious mental health illness
* Negative affection to heat
* Active or recurrent cancer or current chemotherapy and/or radiation treatment
Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.

Randomized, double-blind, placebo-controlled, dose-escalation Phase I safety study of inhaled N-IP-00001, to determine tolerability and safety in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤ 55 years.
2. Male or non-pregnant, non-lactating Female
3. Normally active and in good health as determined by the investigator or sub-investigator (who is a qualified physician)through physical examination, vital signs and laboratory parameters.
4. No current acute or chronic respiratory conditions.
5. FEV1 ≥ 80% predicted.
6. Ability to achieve reproducible FEV1 spirometry, as determined by 3 acceptable maneuvres within no more than 5 attempted maneuvres. The best two values should be within 5% or 150mL of each other, whichever is greater.
7. Ability to comply with study medication use, study visits, and study procedures as judged by the investigator.
8. Able to understand and sign an informed consent.
9. Non-smoker and has not smoked for at least 6 months.

Exclusion Criteria:

1. Bowel disease
2. Bariatric surgery
3. Evidence of biliary cirrhosis with portal hypertension
4. History of any drug or alcohol abuse in the past 1 year defined as \>21 units of alcohol per week for males and \>14 units of alcohol per week for females. Where 1 unit = 360ml of beer, 150ml of wine, or 45ml of spirits.
5. History of lung transplant.
6. History of asthma.
7. History of allergic reactions to fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut)
8. Antibiotic treatment within 4 weeks prior to screening
9. Recent (2 weeks) upper respiratory tract infection or COVID
10. Recurrent cough
11. Poor venous access
12. Unexplained, positive drugs of abuse or alcohol breath test results at the screening visit or positive alcohol breath test at check-in.
13. Not able and willing to refrain from alcohol from 24 hours before the first dose through study confinement
14. Unwilling to abstain from fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut) and strenuous exercise for 24 hours prior to dosing. Unwilling to abstain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) during confinement at the clinical unit'.
15. Participants who have received any investigational drug in a clinical research study within the previous 30 days prior to screening or 5 half-lives, whichever is longer.
16. Failure to satisfy the investigator of fitness to participate for any other reason.
17. Currently taking any medication by the inhaled route.
18. Those with commercial interest in the product or related products.
Comparison of the Needle Tip Location by the Position of the Operator During Ultrasound Guided LIJV Catheterization.

When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location.

When placing the central line catheter in the left internal jugular vein under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. (Above the midline of patient's head versus above the left extended axillary line)

Eligibility Criteria:
Inclusion Criteria:

* Central venous catheterization required on lt. IJV

Exclusion Criteria:

* History of cervical spine surgery
* Abnormal structure of cervical spine, carotid artery or jugular vein
* Disease of carotid artery
* Immobilization due to cervical spine fracture or other diseases.
Author-Wang Ping-- Research：Application of Ultrasonic Guided Puncture in Blood Collection in Patients With Severe Trauma

This study aimed to investigate the application of ultrasound guided puncture technique in blood collection in patients with severe trauma. The methods of this study is 93 patients with severe trauma were selected from the emergency room of the Second Affiliated Hospital of Zhejiang University from April 2020 to September 2,2020 and from October 2020 to March 2021, comparing the differences between nursing treatment efficiency and doctor satisfaction.

Standard process for blood collection using Ultrasonic Guided puncture.The control group used the traditional blood sample collection process, which was mainly based on personal clinical experience.

Statistical analysis using SPSS 25.0 statistical software. Observation index are time index of nursing treatment for patients with severe trauma: the time required for acquisition time, disposable puncture success rate, blood routine and blood type delivery time, rescue room stay time, etc and patient family and doctor satisfaction analysis: self-designed questionnaire, family satisfaction process, service time, service attitude, rescue technology, health education, including advice time, nursing quality, medical communication, teamwork, service attitude, evaluation levels: very satisfaction, satisfaction and dissatisfaction.

Eligibility Criteria:
Inclusion Criteria:

* ① airway obstruction, need tracheal intubation or intubation;② breathing stop, respiratory distress or significant slowing down;③ circulatory system shows various shock signs④GCS≤8;⑤ body table visible head, torso, chest open injury or yoke chest

Exclusion Criteria:

* All patients who stop the rescue room trauma evaluation and treatment midway through hospital transfer and automatic discharge
Peripheral Blood Stem Cell Combined With Mesenchymal Stem Cells for Treatment of Poor Graft Function

The purpose of this study is to evaluate the utility of treating patients experiencing poor graft function after allogeneic hematopoietic stem cell transplantation with Granulocyte Colony-Stimulating Factor (G-CSF) mobilized peripheral stem cell combined (PBSC) with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first objective was to evaluate the effect of such treatment on poor graft function, and second object was to investigate the safety of such treatment.

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) is the only cure for many hematologic diseases. However, poor graft function (PGF) is an important complication after allo-HSCT that occurs in 5-27% of patients, and is associated with considerable mortality related to infections or hemorrhagic complications. Treatment of PGF usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF), or second transplantation, but these methods are associated with dismal effect or even a significant risk of graft-versus-host disease (GVHD).

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs include improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. Some studies have shown that MSCs combined with PBSC or cord blood could be useful to improve engraftment after HSCT. Several reports suggested MSCs might be effective in the treatment of PGF.

However, the efficacy of MSCs as single-drug treatment for PGF is unsatisfactory in our previous study. Therefore, in the present study, G-CSF mobilized PBSC will be used combined with MSCs in the patients with PGF after allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* A patient age of 14-65 years
* Poor graft function developing after allo-HSCT
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Soluble Factors in the Serum of Severely Burned Patients

The present study investigates the levels of certain soluble factors in the blood of patients with severe burn injury. Serum levels of different soluble factors will be correlated with the clinical outcome, presence of sepsis, the area of burn, and other clinical parameters in order to make a statement regarding their use as biomarkers in the prediction and monitoring of burn patients.

Burn patients still represent a critical patient collective with a high mortality rate although treatment technologies have improved over the years. One problem healthcare professionals face is the fact that reliable biomarker which predict the clinical outcome, the onset of sepsis, and monitor the severity of disease in burn patients are still missing. These biomarkers would allow an early adoption of treatment modalities to improve the outcome and prevent life-threatening complications.

Blood samples from severely burned patients will be collected over a period of five days and different cytokines (for example the macrophage migration inhibitory factor protein family) will be measured in the serum. Clinical data of the patients (sepsis, total body surface area of burns, abbreviated burn severity index, sepsis-related organ failure assessment, etc.) will be documented and correlated to the levels of soluble factors.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* minimum of 10% total body surface area burn
* needing ICU treatment

Exclusion Criteria:

* younger than 18 years of age
* immunosuppression (e.g. HIV)
* undergone surgery 2 weeks prior to burn injury
* malignancies
* severe diseases (myocardial infarction, lung embolism)
* declining to participate in the study
Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis

Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion

Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.

The two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.

The patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.

   * patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.
   * pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
   * microscopic intraoperative findings suggestive of pleural malignancy.
2. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
3. Patients with rate of fluid accumulation less than 30 days.
4. Patient who signed informed consent about being involved in the study.

Exclusion Criteria:

1. Patients under the age of 18 years.
2. Female patients who are Pregnant or nursing.
3. Patients with rate of pleural effusion accumulation is more than 30 days.
4. Patients who didn't show clinical improvement post proper draining of the fluid
5. Patients who are hemodynamically or respiratory unstable.
6. Patients with Empyema.
7. Patients who are non functioning/ not active according to the Performance status.
8. The type of malignancy which cause the malignant pleural effusion is Lymphoma.
9. Patient who underwent pneumonectomy at the side of the fluid.
10. previous pleurodesis at the side of pleural effusion.
11. Chylothorax in the initial pleural tapping.
Substance Misuse To Psychosis for Ketamine (SToP-K)

Evidence suggests that repeated or chronic ketamine use, as compared to acute ketamine users, posed a higher clinical risk of developing psychotic disorders, potentially related to the underlying chronic N-methyl-D-aspartate receptor (NMDAR) dysfunction, and a higher risk of suffering from schizophrenia particularly in those genetically susceptible, or genetically predisposed ketamine abusers. With ketamine infusion rises as a emerging hope as an acute treatment for depression and suicidality under the shadow of unknown longer term psychotomimetic effects peculiarly amongst repeated or chronic use, the current case-control study aims to investigate: a) if repeated or chronic ketamine use is associated with an increased risk of psychosis by comparing those ketamine abusers with and without psychosis, and to those non-ketamine-using drug abusers with psychosis; and b) if genetic predisposition from single nucleotide polymorphisms are associated with risk of psychosis in ketamine abusers.


Eligibility Criteria:
Inclusion Criteria:

* Age: 12 - 65 years old
* Able to read and communicate in English and/or Chinese
* Able to give informed consent
* Self-reported to have psychoactive substance use continuously for ≥3 month
* At least one positive urine toxicology result showing the reported psychoactive substance being used

Exclusion Criteria:

* Age \<12 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10, F70-73)
* Had been diagnosed to have primary psychosis prior to the use of any psychoactive substances, including alcohol
* Had been diagnosed to have "bipolar and related disorder" prior to the use of any psychoactive substances, including alcohol
* Had been diagnosed to have "major depressive disorder with psychotic features" prior to the use of any psychoactive substances, including alcohol
* Had been diagnosed to have "psychotic disorder due to another medical condition" (DMS-5)
* Self-reported to have abstained from any psychoactive substance use continuously for ≥12 months AND with negative urine toxicology result at the time of recruitment/ intake at the psychiatric services as recorded on case notes
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells

The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
* Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
* Subject's modified Rankin scale (mRS) grades IV\~V.
* Ages between 20\~40 years.
* Estimated life expectancy must be greater than 2 months.
* Signed informed consent from the subject.

Exclusion Criteria:

* Pregnancy test positive.
* Subject infected with hepatitis C, HIV or syphilis.
* Subject not suitable for liposuction surgery.
* Subject not eligible for PET or MRI.
* Subject enrolled in any other cell therapy studies within the past 30 days.
* Subject deemed to be not suitable for the study by the investigator.