linjc16/ctgov huggingface dataset:
Evaluation of Compulsive Exercise Group Therapy for Eating Disorders

Study Overview
=================
Brief Summary
-----------------
The study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial.

Official Title
-----------------
A Randomized Control Trial Study Evaluating a Compulsive Exercise Group for Adolescent Inpatients With Eating Disorders

Conditions
-----------------
Eating Disorders in Adolescence

Intervention / Treatment
-----------------
* Behavioral: Newbridge Eating disorders Activity Treatment group
* Behavioral: Newbridge House treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients at Newbridge House Aged 11-18 Primary diagnosis of any form of eating disorder Females Exclusion Criteria: Previously received NEAT group at Newbridge House Aged under 10 years Severe learning disability Inpatients without compulsive exercise behaviours Day patients Co-morbid psychosis Males

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group. | Behavioral: Newbridge House treatment as usual<br>* Multi-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group).<br>|
| Experimental: Treatment as usual and NEAT group<br>Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group. | Behavioral: Newbridge Eating disorders Activity Treatment group<br>* A compulsive exercise cognitive-behavioural based group, for children and adolescents diagnosed with an eating disorder. It was devised for eating disorders including Anorexia Nervosa, Bulimia Nervosa and Other Specified Feeding or Eating Disorder. This treatment is semi-structured and problem-oriented, which focuses on tackling the factors and processes that maintain compulsive exercise behaviour.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Compulsive Exercise Test |  | Week 1 and week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eating Disorder Examination Questionnaire |  | Week 1 and week 7 |
Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel

Study Overview
=================
Brief Summary
-----------------
Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but also in many other tissues. It is part of balanced anesthesia in general anesthesiology as well as a sedastive agent in intensive care units, but also serves as a third-line agent in many psychiatric diseases including ADHD, schizophrenia and PTSD. The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The investigators will use a flowcytometric assay to determine activation of thrombozytes when they come into contact with clonidine in vitro as well as Multiplate analyses to determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or arachidonic acid-induced aggregation of thrombozytes.

Official Title
-----------------
The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study

Conditions
-----------------
Anticoagulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel Age above 18 years Exclusion Criteria: Additional anticoagulatoric treatment woth another inhibitor of platelet aggregation Surgery within the last two weeks Patients with long-term mediaction with omeprazole Patients under hemodialysis Patients with renal insufficiency (creatinine above 1.5mg/dl, urea above 80mg/dl) Patients with hepatic dysfunction (GOT above 30U/I, GPT above 30 U/I, GLDH above 10 U/I) Age under 18 yeary Non-responder to ASS and / or clopidogrel

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with an activated area under the curve in ASPI test | Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in ASPI test, i.e. an activated area under the curve in Multiplate analysis. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with an activated area under the curve in TRAP test and ADP test | Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in TRAP test and ADP test, i.e. an activated area under the curve in Multiplate analysis. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulation with ASS, anticoagulation with clopidogrel
Dosage Calculation for Vitamin D Treatment

Study Overview
=================
Brief Summary
-----------------
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis. We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.

Official Title
-----------------
The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D

Conditions
-----------------
Deficiency, Vitamin D, Obesity

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe hypovitaminosis D (25OH-vit.D <25 nmol/L) Exclusion Criteria: Malabsorption Renal disease Other treatment with vitamin D related products Patients with a recent travel history with suspected increased sun exposure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loading dose substitution<br>Substituted with a highdose of cholecalciferol at study start | Drug: Cholecalciferol<br> <br> * Other names: Dekristol capsules of 20.000 IU pr. capsule;|
| No Intervention: Historic controls<br>Control subjects from journal archive | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline value of [25-OH-vitamin-D] |  | 1 week, 3 weeks and 3 months |
NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will demonstrate improved sensitivity over that of standard urine cytology for patients with superficial transitional cell carcinoma at high risk of recurrence.

Detailed Description
-----------------
Patients who have been previously treated for bladder cancer and are at a high risk for recurrence are being monitored for recurrence every 3 months with urine cytology and cystoscopy as part of standard care.The NMP22 Bladder Cancer ® Test Kit has been designed to provide an alternative to regular urine cytology. A urine sample will be provided and divided with a portion being used to assess the NMP22 test kit and the remaining sample to be sent to the lab for regular urine cytology. Patient charts will be reviewed by a medical student to record age, clinical stage, pathologic stage, time to disease progression/recurrence, site of recurrence and survival data.

Official Title
-----------------
NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Device: Nuclear Matrix Protein 22 Urine sample kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · History of pTis, pT1, large (>2cm) pTa or multiple pTa bladder cancer tumours. Written Informed Consent prior to any study-related procedures. Exclusion Criteria: History of bladder cancer tumours other than those listed in inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with suerficial transitional cell carcinoma<br> | Device: Nuclear Matrix Protein 22 Urine sample kit<br>* Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Detection of Bladder Cancer using NMP22 Urine Test Kit
Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.

Detailed Description
-----------------
After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.

Official Title
-----------------
Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery

Conditions
-----------------
Fluid Responsiveness

Intervention / Treatment
-----------------
* Other: Ringer Lactate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old patients Will undergo elective laparoscopic gynecological surgery ASA I-II Exclusion Criteria: Obese patients (body mass index> 30 kg.m2) Patients who had arrhythmia Patients who had cardiac insufficiency.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before pneumoperitoneum<br>Fluid administration | Other: Ringer Lactate<br>* Fluids<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum | to evaluate reliability of stroke volume variation in evaluating the response to fluid administration | up to 10 months | 
| to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum | to evaluate reliability of pulse pressure variation in evaluating the response to fluid administration | up to 10 months |
Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels. Its role as capillary filtration control is important. In case of alteration of the glycocalyx, experimental models and some clinical studies show an increased capillary leak responsible for interstitial edema. The analysis of glycocalyx in routine care is important to guide volume expansion. Indeed, the literature provides evidence about the poor prognosis of excess water and its impact on organ. This analysis challenge is to justify filling solution of choice according to the characteristic of this capillary leakage.

Detailed Description
-----------------
Extra corporeal circulation and aortic clamp induce ischemia-reperfusion damages. Vascular damages are represented by first glycocalyx, a layer of endovascular vessel proteoglycans, responsible for fluid permeability and secondly by nitro oxygen liberation responsible for vascular tonus. The investigators suppose that both functions are impaired after cardiac surgery.

Official Title
-----------------
Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery

Conditions
-----------------
Capillary Leak Syndrome

Intervention / Treatment
-----------------
* Biological: plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery Exclusion Criteria: auricular fibrillation endocarditis aortic dissection end stage chronic renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| presence of a vascular dysfunction<br>plasma | Biological: plasma<br>* assesment of glycocalyx protein<br>|
| absence of vascular dysfunction<br>plasma | Biological: plasma<br>* assesment of glycocalyx protein<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycocalyx proteins 1 | proteoglycan in patient plasma is assayed. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycocalyx, capillary leak syndrome
Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Tiotropium


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients experiencing an exacerbation |  | 6 months | 
| Percentage of patients hospitalized for a COPD exacerbation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first COPD exacerbation |  | 6 months | 
| Time to first hospitalization associated with an COPD exacerbation |  | 6 months | 
| Total number of days of corticosteroids for an COPD exacerbation |  | 6 months | 
| Total number of antibiotics for an COPD exacerbation |  | 6 months | 
| Number of unscheduled out-patient visits |  | 6 months | 
| Total number of hospital admissions and total hospital days |  | 6 months | 
| Trough post-dose FEV1 and FVC |  | after 3 and 6 months | 
| 90 minute post-dose FEV1 and FVC |  | after 3 and 6 months | 
| Occurrence of serious adverse events |  | 6 months |
Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis

Official Title
-----------------
A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Vehicle
* Drug: M518101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who are able and willing to give signed informed consent Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator. Who have up to 20% of body surface area (BSA) afflicted with plaques Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. Exclusion Criteria: Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity. Who are pregnant or lactating. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study Whose serum calcium levels exceed the upper limit of reference range Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization. Who have been treated with systemic therapy within 30days of randomization. Who have treated with biologics within 5 half-lives of the biologics before the day of randomization Who have been treated with topical therapy within 14days before the day of randomization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Proper quantity twice a day | Drug: Vehicle<br> <br> |
| Experimental: M518101<br>Proper quantity twice a day | Drug: M518101<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment |  | 8 weeks after dosing |
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM

Study Overview
=================
Brief Summary
-----------------
The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.

Official Title
-----------------
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM: A Randomized, Cross-over, Prospective Study

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus; Age≥12 yr; Tanner sexual maturation rating 2-5; HbA1c levels: 7.5%-10%; MDI or CSII ≥6 months; Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least >1 month（dosage change<10%）. Exclusion Criteria: Serious acute and chronic complications associated with diabetes; Repeated and serious hypoglycemia episodes repeatedly; Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range); Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2); Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III IV; Female patients who have a sex life and are not willing to use contraceptive methods; Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metformin and Insulin<br>MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks | Drug: Metformin<br>* For arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks.<br>* Other names: Glucophage;|
| Other: Insulin<br>Accept insulin for 24 weeks | Drug: Insulin<br>* For arm 2, just accept insulin for 24 weeks<br>* Other names: CSII or MDI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | half one year |