linjc16/ctgov huggingface dataset:
Comparing Liquid Versus Solid Forms of Sugars and Whey Protein

Study Overview
=================
Brief Summary
-----------------
To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its component mixtures and whey protein on subjective appetite and food intake in young men.

Detailed Description
-----------------
Three randomized cross-over design experiments were used to compare the effect of solid and liquid forms of gelatin (6 g) in experiment 1, sucrose (75 g) and a mixture of 50% glucose/ 50% fructose (G50:F50) in experiment 2, and acid and sweet whey protein (50 g) in experiment 3 on healthy normal weight males . The controls were water (experiment 1 and 3) and calorie-free sweetened water with gelatin (sweet gelatin, experiment 1) or without gelatin (sweet control, experiment 2). Subjective average appetite was measured by visual analogue scales frequently over 1 h and ad libitum food intake was measured 1 h after the treatment consumptions.

Official Title
-----------------
Effect of Drinking Liquid Compared to Eating Solid Treatment of Sugars or Whey Protein on Short-term Appetite and Food Intake

Conditions
-----------------
Obesity, Diabetes

Intervention / Treatment
-----------------
* Other: Compare the effect of solid vs. liquid forms of sugars on satiety and food intake
* Other: the effect of solid vs. liquid forms of gelatin on appetite and food intake
* Other: The effect of solid vs. liquid forms of whey protein on food intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy lean males with BMI between 18- 24.9 kg/m2 and an age range of 19 to 28 years were recruited for the three experiments. Exclusion Criteria: Diabetics (fasting blood glucose ≥ 7.0 mmol/L), smokers, breakfast skippers or dieters were excluded from the experiments. Individuals under medications or with a history of liver or kidney disease and major medical or surgical event within the last six months were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 28 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Compare the effect of solid vs. liquid forms of sugars on satiety and food intake|nan|
|Other: the effect of solid vs. liquid forms of gelatin on appetite and food intake|nan|
|Other: The effect of solid vs. liquid forms of whey protein on food intake|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective appetite and short term food intake |  | 60 min |
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

Study Overview
=================
Brief Summary
-----------------
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

Detailed Description
-----------------
The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Official Title
-----------------
Efficacy Study Comparing 0.9 g and 1.25 g EstroGelÂ® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause

Conditions
-----------------
Postmenopausal Symptoms

Intervention / Treatment
-----------------
* Drug: Estrogel
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 45-65 years naturally or surgically postmenopausal experiencing hot flushes Exclusion Criteria: hypersensitivity to estrogen replacement therapy pregnancy or lactating abnormal PAP smear history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EstroGel® Gel 0.9 grams 0.03%<br>0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks. | Drug: Estrogel<br> <br> |
| Experimental: EstroGel® Gel 1.25 grams 0.03%<br>1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks. | Drug: Estrogel<br> <br> |
| Placebo Comparator: Placebo Gel<br>0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks. | Other: Placebo<br> <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
-----------------
Post menopausal vasomotor symptoms
Human Phototoxicity Test

Study Overview
=================
Brief Summary
-----------------
To determine the phototoxic potential of a topically applied article in human subjects

Official Title
-----------------
Human Phototoxicity Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: Sunscreen Sport Lotion (BAY987516)
* Other: Untreated Skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product; have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>All subjects are patched. | Drug: Sunscreen Sport Lotion (BAY987516)<br>* 50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)<br>Other: Untreated Skin<br>* This site is patched without treatment as irradiated control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions will be evaluated using the 5 point grading scale |  | Up to 48 hours |
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).

Official Title
-----------------
Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Maintenance lenalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous induction treatment with bendamustine and rituximab 18 or more years of age chronic lymphocytic leukemia ECOG performance status less than or equal to 2 Absolute neutrophile count more than 1,000 Platelet count more than 70,000 Exclusion Criteria: Serious medical condition that would prevent treatment with lenalidomide Evidence of tumor lysis syndrome Any prior treatment with lenalidomide

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: lenalidomide<br>Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab. | Drug: Maintenance lenalidomide<br>* Daily maintenance treatment, oral lenalidomide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic lymphocytic leukemia, maintenance therapy
Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to choose the preferred treatment modality for solitary, small hepatocellular carcinoma.

Detailed Description
-----------------
To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group: Survival 5 year overall survival rate Disease free survival rate Recurrence Cumulative recurrence rate

Official Title
-----------------
Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Operation
* Procedure: Percutaneous ethanol injection therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The evidences of hepatitis B virus (HBV)&/or hepatitis C virus (HCV) infection or liver cirrhosis Single tumor nodule with Child-Pugh classification A (serum albumin ≥ 3.2 g/dL) The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm Only for the newly detected HCCs which were not treated before It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI) Without portal hypertension Exclusion Criteria: In case of hepatic vein or portal vein invasion radiologically (CT or MRI)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery<br> | Procedure: Operation<br>* No drug needed<br>* Other names: surgery;|
| Active Comparator: local therapy<br> | Procedure: Percutaneous ethanol injection therapy<br>* 99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week<br>* Other names: PEIT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival rate and recurrence rate |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, operation, percutaneous ethanol injection
Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).

Detailed Description
-----------------
Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.

Official Title
-----------------
Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer

Conditions
-----------------
Circulatory Function, Laparoscopic Radical Cystectomy for Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing laparoscopic radical cystectomy for bladder cancer ASA I-II Exclusion Criteria: Cardiac insufficiency Hepatic insufficiency Renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Brain Natriuretic Peptide(BNP) | To observe the change of BNP perioperatively. | before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively | 
| Central Venous Pressure(CVP) | To observe the change of CVP perioperatively. | before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively | 
| Stroke Volume Variation(SVV) | To observe the change of SVV perioperatively. | before induction (T1), at the end of operation (T2) | 
| Transthoracic Echocardiography | To observe the change of End-diastolic volume(EDV) perioperatively | before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain natriuretic peptide, pneumoperitoneum, Trendelenburg, circulatory function, laparoscopic radical cystectomy for bladder cancer, central venous pressure, stroke volume variation, transthoracic echocardiography
Clinical Use of Andante SmartStep System in Gait Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.

Detailed Description
-----------------
To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.

Official Title
-----------------
Clinical Use of Andante SmartStep System in Gait Rehabilitation

Conditions
-----------------
Ankle Injuries, Femoral Neck Fractures

Intervention / Treatment
-----------------
* Device: SmartStep(tm) biofeedback device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rehabilitation after operation Patient is allowed full weight bearing Patient is motivated and able to communicate and understands orders Patient is able to walk 10 meters Patient filled out agreement and consent form Exclusion Criteria: Activity limitation due to medical disorder, medications, or emotional status. Pain markedly obstructs gait ability Documented peripheral neuropathy Functional limitation prior to the current condition Premorbid, ongoing major depression or psychosis Multiple/pathological fractures Serious early complications Terminally ill patients Pregnant women Participation in current or recent (within 60 days prior to surgery) clinical trial

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SmartStep(tm) biofeedback device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| load bearing over the affected lower limb |  |  | 
| quality/symmetry of gait |  |  | 
| level of ambulation and physical independence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroscopy
Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relationship between body composition and knee osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.

Detailed Description
-----------------
Banked serum and urine specimens obtained from NIA Baltimore Longitudinal Study on Aging (BLSA) participants with and without knee OA will be used to determine inflammatory, metabolic, bone and joint biomarkers in an observational, case-control study. This study will be limited to BLSA data and samples that have already been acquired and stored. The specific aims of this study are to: Examine the association between prevalent radiographic osteoarthritis (OA), concurrently obtained inflammatory and metabolic mediator levels and change in bone density and bone markers over time subsequent to radiographic classification. Determine levels of inflammatory, metabolic and bone markers, and body composition when radiographic OA was absent, and examine their relationship to the development of radiographic knee OA. Adjustments will be made for age, gender, body mass index and level of physical activity.

Official Title
-----------------
Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of the BLSA who have had 1 or more DXA scans AND who were either classified as having radiographic knee OA (Kellgren & Lawrence 2 or higher) or as having no radiographic knee OA on two or more xrays (KL 0-1) Exclusion Criteria: Diagnosis of rheumatoid arthritis Diagnosis of malignancy Reported use of prednisone and other immunosuppressive medications or insulin

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Changes in inflammatory marker c-reactive protein |  | 3 to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other biomarkers: inflammatory, metabolic, bone, and joint |  | 3 to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory markers, bone markers, OA
A Prospective, Observational Study of COPD Patients in U.S. Hospitals

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the relationship between pulmonary function and the patient reported health-related quality of life (HRQoL) and chronic obstructive pulmonary disease (COPD) related admissions. Patients with COPD will be approached to participate in the study. Pulmonary function will be measured on consented, eligible patients. The pulmonary function measurement collected will be used for cohort assignment. The prospective follow up period will monitor the cohorts for evidence of readmission and to assess HRQoL.

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

Intervention / Treatment
-----------------
* Behavioral: HRQoL surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Fluent in English Current hospital admission is for COPD Diagnosis of COPD for at least 1 year prior to enrollment Exclusion Criteria: Unwilling or unable to provide informed consent

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 |
| --- | --- |
| Normal Pulmonary Function<br> | Behavioral: HRQoL surveys<br> <br> |
| Reduced Pulmonary Function<br> | Behavioral: HRQoL surveys<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD related readmissions |  | 6 months | 
| Health related quality of life (HRQoL) |  | 6 months |