linjc16/ctgov huggingface dataset:
Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.

Detailed Description
-----------------
Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by availability of effective medicines. All of the existing oral hypoglycemic agents have secondary failure after long term administration. Thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. In diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. Numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical products are mixtures of multiple compounds. It is difficult to control their quality in the study or production. Up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of Coptis chinensis French, which was used for thousands of years in China in the treatment of human diseases including diabetes. Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.

Official Title
-----------------
Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 2 diabetes HbA1c > 7.0% or FBG > 7.0 mmol/L Stable or worsening glycemic control for at least 3 months Exclusion Criteria: Liver damage Kidney damage

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Berberine|nan|
|Drug: Metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 13 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose at 13 weeks |  |  | 
| Blood lipids at 13 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Berberine, Type 2 diabetes, Treatment
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges

Study Overview
=================
Brief Summary
-----------------
Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges

Official Title
-----------------
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges

Conditions
-----------------
Edentulous Alveolar Ridge

Intervention / Treatment
-----------------
* Device: piezoelectric


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are free from any systemic diseases. Participant have missing one or two premolars or molars with sufficient alveolar ridge height and insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL ridge width included in the study will be 3.5 mm to facilitate ridge splitting and expansion Exclusion Criteria: Patients with residual infections in the edentulous areas. Medically compromised groups. Smokers and patients with poor oral hygiene.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges<br>Piezoelectric split-crest technique in treatment of Maxillary Narrow Ridges | Device: piezoelectric<br>* Comparing Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges<br>|
| Active Comparator: Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges<br>Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges | Device: piezoelectric<br>* Comparing Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone width | bone width gain in millimeters | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | implant stability measured with periotest | 5 months |
Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.

Official Title
-----------------
Phase II Study of Sequential Therapy With Paclitaxel Plus Carboplatin Followed by Gemzar Plus Carboplatin in the Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages III-IV

Conditions
-----------------
Epithelial Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified epithelial ovarian cancer FIGO stage III-IV Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment. Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm. Exclusion Criteria: Ovarian tumors with low malignant potential (borderline tumors) Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors) Time between definitive surgery and enrollment into the study is greater than 6 weeks Patients who have received previous chemotherapy or radiotherapy

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

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

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

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: carboplatin|nan|
|Drug: paclitaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| 2-year survival |  |  | 
| Toxicity |  |  | 
| Dose intensity |  |  |
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Study Overview
=================
Brief Summary
-----------------
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.

Official Title
-----------------
To Compare the Immunogenicity & Safety of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: Hepatitis B adjuvanted vaccine
* Biological: Engerix-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female > = 15 years of age at the time of the first vaccination. Written informed consent obtained from the subject/ from the parents or guardians of the subject. Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg). If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. Pre-haemodialysis patient* or a patient on haemodialysis. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. Previous vaccination against hepatitis B. History of hepatitis B infection. Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female Clinically abnormal ALT/AST values (> 3 times normal values)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis B adjuvanted vaccine|nan|
|Biological: Engerix-B|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs seroprotection rates at Month 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited symptoms, unsolicited symptoms and serious adverse events |  |  |
Intensive Care Anxiety in SARS-CoV-2 Patients

Study Overview
=================
Brief Summary
-----------------
It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.

Official Title
-----------------
Intensive Care Anxiety in SARS-CoV-2 (COVID 19) Patients

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Hospital Anxiety Depression Measure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years old COVID PCR +, admitted to intensive care, conscious, cooperative patients Exclusion Criteria: Having hearing and speaking problems, Can't speak Turkish or English, who do not have the cognitive level to understand and answer the questions, Communication problems such as dementia and Alzheimer's, patients receiving sedation

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 |
| --- | --- |
| Hospital Anxiety Depression Measure<br>Hospital Anxiety Depression Measure | Behavioral: Hospital Anxiety Depression Measure<br>* Hospital Anxiety Depression Measure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensive care Anxiety | Hospital Anxiety Depression scale | 3 month |
A Long-term Study for the Outcome of Pompe Disease

Study Overview
=================
Brief Summary
-----------------
Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.

Official Title
-----------------
A Long-term Study for the Outcome of Pompe Disease

Conditions
-----------------
Pompe Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirm diagnosis with Pompe disease, is or is preparing receiving enzyme replacement therapy Exclusion Criteria: No
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 |
| --- | --- | --- |
| all cause morbidities |  | 10 years |
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray

Study Overview
=================
Brief Summary
-----------------
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.

Detailed Description
-----------------
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis. Secondary outcome: gambling expenditure.

Official Title
-----------------
Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray

Conditions
-----------------
Gambling, Opioid, Naloxone, Spray

Intervention / Treatment
-----------------
* Drug: Naloxone hydrochloride 20mg/ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years old South Oaks Gambling Scale (SOGS) 5 or over points possibility to keep a record with phone and send text messages fluent in Finnish Language Exclusion Criteria: active drug use (specially opioids) current use - drugs screen nasal abnormality or mucosal irritability hepatitis c virus, kidney insufficiency psychosis, unstable mental health, risk suicide (Beck Depression Inventory) pregnancy and/or breast feeding persons according to Finnish Medical Law 188/1999 §7-10
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A: max 8 mg/per day naloxone nasal spray Group B: max 16 mg/per day naloxone nasal spray
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>max 8 mg/per day naloxone nasal spray | Drug: Naloxone hydrochloride 20mg/ml<br>* Nasal spray<br>* Other names: Naloxone hyddochlodie;|
| Active Comparator: Group B<br>max 16 mg/per day naloxone nasal spray | Drug: Naloxone hydrochloride 20mg/ml<br>* Nasal spray<br>* Other names: Naloxone hyddochlodie;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Diary | 8 weeks | 
| Adherence | Case Report Form | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gambling expenditure | Money | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antagonist, nasal
Clinical Risk State for Bipolar Disorder in Adolescents

Study Overview
=================
Brief Summary
-----------------
Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development. Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia. Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.

Detailed Description
-----------------
Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.

Official Title
-----------------
Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents

Conditions
-----------------
Bipolar Disorder, Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 12-18 years; Sex: male or female; Race/ethnicity: no restrictions; Definite or suspected chart diagnosis of BP-II, BP-NOS, cyclothymia, MDD, depressive disorder NOS, dysthymia or mood disorder NOS, schizophrenifiorm disorder or psychotic disorder NOS; Subject and parent (if subject<18) willing and able to provide written, informed consent/assent. Exclusion Criteria: Estimated Premorbid IQ < 70; Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence; History of medical condition known to affect the brain; current group home affiliation.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| inpatients<br>Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with development of a bipolar or schizophrenia disorder | Diagnostic conversion | within 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychopathology | Psychopathology | within 60 months |
A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: MK633
* Drug: Comparator: Placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening Male or postmenopausal females 40 -75 years of age Exclusion Criteria: Impaired renal function History of chronic liver disease or persistent liver function test (LFT) abnormalities History of recent cardiovascular clinical event Evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0633 | Drug: MK633<br>* MK0633 100mg capsules qd for a 12-wk treatment period.<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo (unspecified)<br>* MK0633 100mg Pbo capsules for a 12-wk treatment period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test data |  | Measured over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score |  | Measured over 12 weeks of treatment |