linjc16/ctgov huggingface dataset:
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival. Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.

Official Title
-----------------
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Conditions
-----------------
Neoplasm Metastasis, Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Temsirolimus (CCI-779) for 34 months
* Drug: Letrozole for 34 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged greater than 18 years. Postmenopausal subjects Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria) Exclusion Criteria: Extensive visceral disease Subjects with bone as the only site of disease Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Temsirolimus (CCI-779) for 34 months|nan|
|Drug: Letrozole for 34 months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine overall progression free survival. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer
Nexium Capsules Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed Nexium for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, or Zollinger-Ellison syndrome

Detailed Description
-----------------
Nexium capsules Clinical Experience Investigation

Official Title
-----------------
Nexium Capsules Clinical Experience Investigation

Conditions
-----------------
Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,Non-erosive Reflux Disease, Zollinger-Ellison Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients treated with Nexium for the first time due to gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome. Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nexium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Drug Reactions |  | Patients with gastric ulcer, anastomotic ulcer or Zollinger-Ellison syndrome: 8 weeks | 
| Number of Adverse Drug Reactions |  | Patients with duodenal ulcer: 6 weeks | 
| Number of Adverse Drug Reactions |  | Patients with reflux oesophagitis: 8 weeks | 
| Number of Adverse Drug Reactions |  | Patients with non-erosive reflux disease: 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome, Nexium
Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated. The investigators evaluated parameters related with MGD including lid margin abnormalities, meibomian gland expressibility and meibography before and after surgery.

Conditions
-----------------
Meibomian Gland Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients scheduled for cataract surgery Exclusion Criteria: other comorbid ocular diseases such as ocular allergies. continuous use of topical ocular medications before surgery histories of ocular surgery, or ocular injury Already had severe obstructive MGD before surgery, abnormal findings on lid margin (> 3 positive findings), reduced meibum expression (> grade 2), and obstructed gland dropout (meibography score > 3)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 88 Years

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 |
| --- | --- | --- |
| Ocular parameters | Ocular symptom score, lid margin abnormalities, superficial punctuate keratopathy, tear film break-up time, Shirmer's test, lower tear meniscus height (TMH), depth (TMD), and area (TMA), meibum expressibility, and meibography score | change of Ocular parameters from 1 to 3 months after cataract surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, meibomian gland dysfunction, meibum expressibility, meibography
Artemether/Lumefantrine and Vivax Malaria

Study Overview
=================
Brief Summary
-----------------
The cure rate of artemether/lumefantrine in the treatment of vivax malaria.

Official Title
-----------------
Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan

Conditions
-----------------
Vivax Malaria

Intervention / Treatment
-----------------
* Drug: tablets artemether/lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vivax malaria Exclusion Criteria: severe malaria pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 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: artemether-lumefantrine<br>tablets (containing 20mg artemether and 120 mg lumefantrine) for three days | Drug: tablets artemether/lumefantrine<br>* six doses of oral tablets of artemether/lumefantrine<br>* Other names: Quartem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cure rate | The proportion of the cure patients | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever clearance time | The time for fever clearance | 28 days | 
| Parasite clearance time | The time for the parasite to clear | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malaria, vivax, artemether/lumefantrine, Sudan
Observational Study on Obese Patients During General Anesthesia

Study Overview
=================
Brief Summary
-----------------
There is increased frequency of asthma in obese patients. This study is trying to find out if there is a difference in the presence of bronchospasm during anesthesia in obese and non obese patients.

Detailed Description
-----------------
Obese patients come for surgery every day. In this specific population the frequency of asthma is high. Problems from the respiratory system increase the morbidity, as they are a significant part of perioperative complications. The frequency and the severity of bronchospasm have not been studied. Any data concerning the bronchospasm will lead to better perioperative management. In this study the investigators study any sign of bronchospasm during surgery in obese patients.

Official Title
-----------------
Bronchospasm During General Anesthesia in Obese Patients

Conditions
-----------------
Bronchospasm, Surgery, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AGE > 18 AND < 78 YEARS BMI < 35 Exclusion Criteria: MENTAL DISORDERS EMERGENCY SURGERIES

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- |
| OBESITY PATIENTS<br>PATIENTS WITH BMI >35 | |
| CONTROL TEAM BMI <35<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the presence of bronchospasm in obese and non obese patients | Recording the Peak pressure, plateau pressure, lung compliance, arterial blood gases and mean arterial blood pressure | 90 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of intraoperative bronchospasm on postoperative complications | Recording the vital signs, blood gases and postoperative pain scores for the first 24 postoperative hours | 1 day (24 postoperative hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchospasm, Laparoscopic Gastrectomy, Obesity
Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

Detailed Description
-----------------
The purpose of this study is to explore the efficacy of low energy (30J) cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.

Official Title
-----------------
Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure With or Without HTEA

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: HTEA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congestive heart failure accompanied by atrial fibrillation. Exclusion Criteria: Valvular heart diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| cardioversion+HTEA<br>Heart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion+HTEA. | Drug: HTEA<br>* usually high thoracic epidural anesthesia<br>* Other names: High thoracic epidural anesthesia;|
| only cardioversion<br>Heart failure patients accompanied by atrial fibrillation receive the treatment of cardioversion, but not with HTEA. | Drug: HTEA<br>* usually high thoracic epidural anesthesia<br>* Other names: High thoracic epidural anesthesia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of atrial fibrillation |  | 1 year |
Comparison of Suturing and Packing of Drained Abscesses

Study Overview
=================
Brief Summary
-----------------
The standard treatment for skin abscesses in drainage followed by packing to prevent premature closure and reaccumulation of pus. Studies from the 1950s and later conducted outside of the US suggest that when drained abscesses are drained and sutured closed they actually heal faster without complications. The current study compares the time to healing and scar formation when drained abscesses are packed or sutured.

Official Title
-----------------
Primary vs. Secondary Closure of Cutaneous Abscesses After I&D: A RCT

Conditions
-----------------
Cutanoeus Abscesses

Intervention / Treatment
-----------------
* Other: PRIMARY CLOSRE
* Other: SECONDARY CLOSURE
* Other: SPONTANEOUS HALING


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non complicated abscesses Exclusion Criteria: Fever, Immunocompromise, Cellulitis, Perianal and Pilonidal abscesses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: primary closure<br>suture after I&D | Other: PRIMARY CLOSRE<br>* SUTURE<br>|
| Placebo Comparator: SECONDARY CLOSURE<br>LEAVE TO HEAL BY SECONDARY INTENTIN AFTER I&D | Other: SECONDARY CLOSURE<br>* ALLOW TO HEAL SPONTANEOUSLY<br>Other: SPONTANEOUS HALING<br>* SECONDARY HEALING AFTER I&D<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to healing. |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for subsequent drainage, scar appearance. |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abscess, primary closure, secondary closure
Effects of a Clinical Pharmacist Service on Health-related Quality of Life

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.

Detailed Description
-----------------
A randomized controlled trial is performed in two internal medicine wards at Sahlgrenska University Hospital, Göteborg, Sweden.

Official Title
-----------------
Effects of a Clinical Pharmacist Service on Health-related Quality of Life

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: Pharmacist service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the wards during week days after decision of a ward physician or nurse if the medical condition allows inclusion Exclusion Criteria: Exclusion criteria are poor Swedish language and planned discharge before the intervention can be performed. Patients transferred to wards not belonging to the department of medicine or other hospitals during the hospital stay are also excluded.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacist service,<br>The pharmacist service consists of medication review, drug treatment discussion with the patient, and a medication report. | Other: Pharmacist service<br>* Medication Review, medication report<br>|
| No Intervention: Control<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescribing of drugs |  | Discharge from hospital |
Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Official Title
-----------------
Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 20-40 Blood glucose criteria must be met Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of significant diabetic complications Evidence of serious cardiovascular conditions Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply.

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: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 24 weeks for subset of Chinese patients |  |  | 
| Overall adverse event profile after 24 weeks of treatment |  |  | 
| Gastrointestinal side effect profiles after 24 weeks of treatment |  |  | 
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Patients with endpoint HbA1c <7% after 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Using Vegetable and Berry Products Can Improve Skin Conditions

Study Overview
=================
Brief Summary
-----------------
Hypothesis: vegetable and berry products for 8 weeks can improve skin condition

Detailed Description
-----------------
Hypothesis: Using vegetable and berry products for 8 weeks can improve skin condition

Official Title
-----------------
Using Vegetable and Berry Products Can Improve Skin Conditions

Conditions
-----------------
Skin Condition

Intervention / Treatment
-----------------
* Dietary Supplement: placebo
* Dietary Supplement: Vegetable and Berry Drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry skin Rough skin Large pores Dark yellow complexion Sagging skin Exclusion Criteria: Skin disorders Liver diseases Kidney diseases Allergy to cosmetics, drugs, or foods Pregnant and lactating women People who had any cosmetic procedures before 4 weeks of the study Area of facial spot over 3 cm2 Vegan People who took collagen supplements in the past 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Placebo Comparator: placebo group<br>subjects drank 50 ml , 1 bottle a day for 8 week | Dietary Supplement: placebo<br>* subjects drank 50 ml , 1 bottle a day for 8 week<br>|
| Experimental: Vegetable and Berry Drink<br>subjects drank 50 ml , 1 bottle a day for 8 week | Dietary Supplement: Vegetable and Berry Drink<br>* subjects drank 50 ml , 1 bottle a day for 8 week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin moisture | using corneometer CM825 to examine skin moisture (The higher the value, the more water content, C.U., corneometer units ).subjects drank 50 ml after meal | up to 8 week | 
| skin elasticity | using cutometer dual MPA580 to examine skin elasticity (The closer the R2 value is to 1, the better the elasticity and no unit) | up to 8 week | 
| skin gloss | using probe system GL2000 & MPA10 to examine skin gloss (The higher the value, the higher the gloss, no unit) | up to 8 week | 
| skin spot | usig VISIA-CR to examine skin spot (The higher the value, the larger the pore area, mm2) | up to 8 week | 
| skin wrinkle | using VISIOSCAN-VC20 to examine skin wrinkle (The higher the value, the more wrinkles, surface evaluation of wrinkles, SEW) | up to 8 week |