linjc16/ctgov huggingface dataset:
Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF)

Study Overview
=================
Brief Summary
-----------------
The SOET project introduces a new strategy for routine follow-up of follicle growth during the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a learning instruction and demo, patients should be able to perform most of their vaginal echoes at home. The images can be sent to the medical center over the internet. These images are analyzed by the expert.

Official Title
-----------------
Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF).

Conditions
-----------------
IVF Treatment

Intervention / Treatment
-----------------
* Device: Perform Echo at home.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman, suffering from subfertility.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perform echo at home.<br>A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic. | Device: Perform Echo at home.<br>* A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.<br>* Other names: A home echo system will be used to perform an echo.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher efficacy by taking an echo at home. | During an IVF treatment, women are asked to perform the echo themselves, at home. This should create higher efficacy: patients are less stressed and can choose the moment of taking the echo themselves. Furthermore, this should result in a more cost effective and time saving way. | Every 2 days, up to a year. |
BLI801 Laxative in Constipated Adults

Study Overview
=================
Brief Summary
-----------------
A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.

Official Title
-----------------
A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: BLI801
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Constipated, defined by ROME III definition Subject has < 3 satisfactory BMs during the run-in period Exclusion Criteria: Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments. Subjects who are allergic to any BLI801 component Subjects taking narcotic analgesics or other medications known to cause constipation. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days Subjects with an active history of drug or alcohol abuse

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI801 laxative<br>BLI801 laxative - oral solution | Drug: BLI801<br>* BLI801 laxative - oral solution<br>|
| Placebo Comparator: Placebo<br>BLI801 placebo - oral solution | Drug: Placebo<br>* BLI801 placebo - oral solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose |  | 3 hours | 
| serum chemistry |  | 7 days |
Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

Study Overview
=================
Brief Summary
-----------------
In this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in AIS surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.

Official Title
-----------------
The Effect of the Alterations in Body Temperature to Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

Conditions
-----------------
Hypothermia; Anesthesia

Intervention / Treatment
-----------------
* Procedure: heating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents Exclusion Criteria: Patients with body weight <35kg, morbid obesity (BMI> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br> | Procedure: heating<br>* patients were aggressively warmed using multiple heating methods such as pressurized air heater and intravenous fluid heater<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss in the group of patients who are kept normothermic | to test that blood loss is reduced in the group of patients who are kept normothermic by applying aggressive multiple warming method compared to the patient group in which mild-moderate hypothermia was allowed by using a standard single heater in an operation that poses a high risk for bleeding and hypothermia, such as AIS deformity correction surgery. | surgery time (approximately 2 hours) |
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.

Detailed Description
-----------------
Taste assessment of new formulation. Subjects will not ingest the drug.

Official Title
-----------------
A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: crizotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive. Subjects must be trained sensory panelists. An informed consent document signed and dated by the subject or a legally acceptable representative. Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures. Exclusion Criteria: A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history. A history of hypersensitivity to any inactive ingredients employed in the formulation(s). Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study. Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API. Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: crizotinib<br> | Drug: crizotinib<br>* Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel). |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crizotinib
The Th9/IL-9 and Early Enteral Nutrition in Sepsis

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis. In addition, the investigators also aim to evaluate the effects of different proportions of target total enteral nutrition on the prognosis of sepsis.

Official Title
-----------------
The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis

Conditions
-----------------
Sepsis, Intestinal Mucosal Barrier, Th9 Cells, Enteral Nutrition

Intervention / Treatment
-----------------
* Other: Nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of sepsis Within 3 days of sepsis onset before ICU admission No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission Exclusion Criteria: Ileus Digestive tract hemorrhage Inflammatory bowel disease Abdominal hypertension (IAP >25mmHg) Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction) Malnutrition or immunodeficiency Long-term use of hormones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: 30% target total enteral nutrition<br> | Other: Nutrition<br>* Enteral nutrition<br>|
| Experimental: 60% target total enteral nutrition<br> | Other: Nutrition<br>* Enteral nutrition<br>|
| Active Comparator: 100% target total enteral nutrition<br> | Other: Nutrition<br>* Enteral nutrition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-d mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Th9 lymphocyte percentages | Serum Th9 lymphocyte percentages | 7 days | 
| Concentration of serum IL-9 | Concentration of serum IL-9 | 7 days | 
| Concentration of serum iFABP | Concentration of serum iFABP | 7 days | 
| Concentration of serum DAO | Concentration of serum DAO | 7 days |
LUPS-Lipids and Glucose Under Prospective Surveillance

Study Overview
=================
Brief Summary
-----------------
Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes

Detailed Description
-----------------
The LUPS-study is a collaboration between Asklepios Clinics Hamburg GmbH and University Clinic Hamburg Eppendorf, Germany. This study is assessing a multitude of serum biomarkers, anthropometrics, dietary habits, physical activity, perceived stress along with genetic information from healthy workers (25-60years) to better understand phenotype-genotype associations leading to MetS and type 2 diabetes.

Official Title
-----------------
Lipids and Glucose Under Prospective Surveillance

Conditions
-----------------
Metabolic Syndrome, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 25-60 years men and women willing to give consent Exclusion Criteria: diabetes (type 1 or 2)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Syndrome, Type 2 Diabetes | assessing risk factors, e.g. HDL, BMI, Blood Pressure, FPG | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Syndrome X, MetS,, Type 2 Diabetes
Adult Spinal Muscular Atrophy (SMA) China Registry

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) among adult Chinese participants with SMA linked to chromosome 5q (5q-SMA).

Official Title
-----------------
Adult Patients With Spinal Muscular Atrophy in China: A Nationwide Registry

Conditions
-----------------
Muscular Atrophy, Spinal

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: -Genetically confirmed 5q-SMA. Key Exclusion Criteria: -Other types of SMA (non 5q-SMA). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DMT Treated Participants<br>Participants with SMA who received prior treatment with DMTs including nusinersen will be followed prospectively for up to 60 months and the available data is collected retrospectively. | |
| Untreated Participants<br>Participants with SMA who received no treatment will be followed prospectively for up to 60 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Characterized by Natural History of 5q-SMA Observed Among Adult Chinese Participants | The natural history characteristics will include the categories of the evolution of the patient's condition over the time of data collection from the registry, to describe the natural history of the disease in a real-life situation. | Up to 60 Months | 
| Number of Participants Characterized by Utilization of Disease Modifying Therapies (DMTs) of 5q-SMA Observed Among Adult Chinese Participants | The DMT utilization characteristics will include the categories of the evolution of the DMT treated patient's condition over the time of data collection from the registry, to describe the utilization of DMTs of adult SMA patients in a real-life situation. | Up to 60 Months |
Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.

Detailed Description
-----------------
This is a Phase III, 6 month randomized, double-blind, placebo controlled multi-center study with a 6 month open-label extension. Patients will be randomized to the tacrolimus + methotrexate arm or the placebo + methotrexate arm in a ratio of 2:1. Patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study.

Official Title
-----------------
A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Tacrolimus (Prograf®)
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Willing to discontinue DMARDs, other than methotrexate Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration Have been receiving oral or parenteral methotrexate for at least 3 months Exclusion Criteria Has received tacrolimus for any indication Has moderate or severe liver disease Has a known history of HIV infection Has serum creatinine outside the normal range

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

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus (Prograf®)|nan|
|Drug: Methotrexate|nan|

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
-----------------
Tacrolimus, Prograf®, FK506
Latent Tuberculosis Infection in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.

Detailed Description
-----------------
We evaluate the usefulness of a newly-developed T cell-based assay prior to undergoing immunosuppression in renal transplant recipients. Among all renal transplant recipients, patients with negative tuberculin skin test and no other indications for latent tuberculosis infection will be enrolled in this study. We will exam T-SPOT.TB test in these patients, and observe the developement of tuberculosis within 1 to 2 years after the transplantation. The results of T-SPOT.TB will be blinded to the investigators.

Official Title
-----------------
A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Renal Transplant Recipients

Conditions
-----------------
Renal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16 or more Negative tuberculin skin test (induration less than 10 mm) Exclusion Criteria: Recent contact of patients with active pulmonary tuberculosis Suspected active tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| T-SPOT.TB positive<br>T-SPOT.TB positive patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of tuberculosis |  | within 2 years after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | within 2 years after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, transplantation