linjc16/ctgov huggingface dataset:
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin

Official Title
-----------------
Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus

Conditions
-----------------
Long Acting Insulin in Control of Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Long acting insulin
* Drug: multiple dose regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with gestational diabetes mellitus between 24-28 weeks gestation Exclusion Criteria: other endocrinological abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: long acting insulin<br> | Drug: Long acting insulin<br>* long acting insulin analogue once daily at bed time<br>|
| Active Comparator: multiple dose regimen<br> | Drug: multiple dose regimen<br>* intermediate and short acting insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time needed to achieve glycemic control | glycemic control assessed by fasting and postprandial blood sugar | 1 year |
Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented. Hyperalgesia is measured by von-Frey-Filaments.

Official Title
-----------------
Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy

Conditions
-----------------
Postoperative Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective nephrectomy Exclusion Criteria: contraindication against pregabalin creatinine > 2.0 mg/dl GGT >165, AST >105, ALT >135 peptic Ulcus haemorrhagic diathesis angina pectoris, myocardial infarction stroke bronchial asthma opioid abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>* Other names: Control;|
| Active Comparator: Pregabalin group<br>Receiving 300mg pregabalin preoperative | Drug: Pregabalin<br>* 300mg pregabalin orally 1 hour before operation<br>* Other names: Lyrica;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative opioid consumption |  | 48 hours |
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.

Official Title
-----------------
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant

Conditions
-----------------
Renal Insufficiency

Intervention / Treatment
-----------------
* Other: ESPAIR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with renal insufficiency on dialysis or not Registered on transplant list Exclusion Criteria: Patient with psychological disorder transplantation from living donor Patients with renal transplant antecedent

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPAIR<br>Patients with an educational therapy's program since registration in transplant list. | Other: ESPAIR<br>* ESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible<br>|
| No Intervention: normal care<br>Patients without educational therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Questionnaire | Quality of life 6 months after registration on transplant list. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Questionnaire | Quality of life one year after registration on transplant list. | One year | 
| Quality of life Questionnaire | Quality of life on the day of the transplantation | 1 day | 
| Composite measure of impact of educational therapy's program | Impact of educational therapy's program on anxiety, knowledge to prepare transplant, life hygiene, and patient compliance. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal insufficiency, kidney transplant, educational therapy
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).

Official Title
-----------------
An Open Label, Multicenter Phase Ib/II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

Conditions
-----------------
Anaplastic Thyroid Cancer, ATC

Intervention / Treatment
-----------------
* Drug: HLX208


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18Y; Good Organ Function; Expected survival time ≥ 3 months; Advanced BRAF V600 ATC that have been diagnosed histologically; At least one measurable lesion as per RECIST v1.1; ECOG score 0-1. Exclusion Criteria: Pregnant or lactating women; Previous treatment with BRAF inhibitors or MEK inhibitors; A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin; Severe active infections requiring systemic anti-infective therapy.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX208<br>Participants receive HLX208 450mg bid po | Drug: HLX208<br>* HLX208 450mg bid po<br>* Other names: BRAF V600E inhibitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 ) | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years | 
| OS | Overall survival | from the date of first dose until the date of death from any cause，assessed up to 2 years |
Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy

Official Title
-----------------
Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: biphasic human insulin 30
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c: 7.5-11.0% on current therapy OHA (oral hypoglycaemic agent) treatment for a minimum of two years BMI (body mass index): 25-32 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: repaglinide|nan|
|Drug: biphasic human insulin 30|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 20 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose (FBG) |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Adverse events |  |  |
International Lymphatic Disease and Lymphedema Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.

Detailed Description
-----------------
This project represents the inauguration of an International Patient Registry for Lymphatic Diseases. This project will be completed through an affiliation with the Lymphatic Education & Research Network, a non-profit organization whose mission is to promote research and the development of new therapies for patients with lymphatic diseases, including lymphedema. The registry will provide researchers with much-needed clinical data to study the impact of diseases of the lymphatic system, in order to develop improved treatments and find a cure for lymphatic diseases, lymphedema, and related disorders. The establishment of this initiative is a major step forward in research for direct study of groups of patients with lymphatic disease. In the future, this project will be able to be linked with a biorepository, in which tissue and blood samples derived from patients will be made available for research into human disease states. An international patient registry and tissue/cell bank program paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic disease in human subjects.

Official Title
-----------------
The International Lymphatic Disease and Lymphedema Patient Registry and Biorepository

Conditions
-----------------
Lymphedema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of lymphatic disease Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of lymphatic disease |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| socioeconomic impact of lymphatic disease | The data in the registry will be utilized to determine the financial impact of requisite diagnostic and treatment interventions and will be analyzed to consider the relative contribution of third-party payer participation in the cost of care. The financial impact of disease and treatment will be addressed through the financial data entered by registry participants. | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphatic disease, Lymphedema, Lymphangiomatosis, Lymphangiectasia, Protein-losing enteropathy, Vascular Anomalies
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.

Official Title
-----------------
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Conditions
-----------------
Hypertension, Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg Current treatment with at least 1 antihypertensive drug Exclusion Criteria: Age <18 and >65 years BMI ≥ 40 kg/m2 Heart failure, EF < 45%, acute myocardial infarction, stroke, significant valvular dysfunction Chronic renal failure (serum creatinine > 2 mg/dL) Use of cocaine, amphetamines, alcohol, illicit drugs Use of sympathomimetics (decongestants, appetite suppressants) Use of oral contraceptives and chronic use of NSAIDs Pregnancy Secondary causes of hypertension (other than sleep apnea)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous positive airway pressure<br>Continuous positive airway pressure therapy (CPAP) | Device: CPAP<br> <br> * Other names: Continuous positive airway pressure;|
| Placebo Comparator: Nasal strips<br>Nasal strips applied to the outside surface of the nose with adhesive. | Device: CPAP<br> <br> * Other names: Continuous positive airway pressure;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of OSA treatment with CPAP on target-organ damage |  | 6 months | 
| Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study) | Pulse wave velocity and carotid intima-media thickness | 6 months | 
| Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study) |  | 6 months | 
| Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous positive airway pressure, hypertension, sleep apnea
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

Detailed Description
-----------------
A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Official Title
-----------------
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects

Conditions
-----------------
Liver Carcinoma

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant Exclusion criteria: Patients less than 18 years of age

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus based immunosuppression<br>Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l | Drug: Sirolimus<br>* Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l<br>* Other names: Rapamune;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Surviving at One and Four Years After Liver Transplant | Percent of Patients Surviving at One & Four years after Liver Transplant was calculated | 1 & 4 years | 
| Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant | Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant | 1 and 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sirolimus Toxicity/Intolerance | Sirolimus toxicity/intolerance requiring discontinuation of sirolimus | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplant, hepatocellular carcinoma, sirolimus
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 60 - 85 years. Meet diagnostic criteria for amnestic mild cognitive impairment. Exclusion Criteria: Inability to provide informed consent. Concurrent medication likely to affect mental performance. Current substance use or dependence in last 3 months. Current active psychiatric or neurological condition

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial direct current stimulation<br>Transcranial direct current stimulation combined with cognitive training | Device: Transcranial direct current stimulation<br> <br> |
| Sham Comparator: Sham transcranial direct current stimulation<br>Sham transcranial direct current stimulation combined with cognitive training | Device: Transcranial direct current stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| California Verbal Learning Test II |  | Post treatment |