linjc16/ctgov huggingface dataset:
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

Study Overview
=================
Brief Summary
-----------------
To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.

Official Title
-----------------
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

Conditions
-----------------
Papilloma, Cervix Lesion

Intervention / Treatment
-----------------
* Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HPV infections Occurrence of low-grade cervical lesions Exclusion Criteria: Diagnosis of malignancy or severe cervical lesions Concurrent uterine pathologies Pregnancy or intended to seek pregnancy in the next three months Cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-treatment with EGCG, FA, B12, and HA<br>One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. | Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid<br>* One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid.<br>|
| No Intervention: Control<br>Untreated women. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression of cervical lesions | The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none. | 12 weeks |
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment

Official Title
-----------------
A Pharmacokinetic Study of Brivanib (BMS-582664) in Subjects With Advanced Solid Tumor Malignancies and Normal Hepatic Function or Hepatocellular Carcinoma With Impaired Hepatic Function

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

Intervention / Treatment
-----------------
* Drug: Brivanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a biopsy proven advanced solid tumor Subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications A, B, or C

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Brivanib<br>* Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression<br>* Other names: BMS-582664;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine the effect of BMS-582664 on subjects with varying levels of hepatic impairment and guide prescribers with regards to dosing in specialized populations |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability of BMS-582664 in subjects with HCC with mild, moderate, and severe hepatic impairment and in subjects with advanced malignancies with normal hepatic function |  | by Day 1 and Day 28 Pharmacokinetics | 
| To assess efficacy of BMS-582664 in subjects with advanced solid tumor malignancies and subjects with HCC by CT or MRI |  | every 6 weeks until disease progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular cancer, Other advanced solid malignancies
Serotonin and the Upper Airway in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a certain medication, alone or combined with another medication, will increase muscle activity in the upper airway in people who do and people who do not have sleep apnea. The medications being studied are paroxetine, a commonly used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary supplement without a prescription. Because the effects of paroxetine in previous studies were not very large, we will also study it combined with 5HTP to see if the effect on the upper airway muscles is greater.

Official Title
-----------------
Serotonin and the Upper Airway in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Drug: Paroxetine
* Drug: 5HTP


Participation Criteria
=================
Eligibility Criteria
-----------------
Group A: 20 Adult patients with mild to severe sleep apnea. If patients are being treated with nasal CPAP, they will continue treatment except on study nights. Group B: 20 normal adult non-snoring subjects.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paroxetine|nan|
|Drug: 5HTP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serotonin, Sleep Apnea Syndrome, Pharyngeal Muscles
Cardiopulmonary Exercise Testing in Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom. Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.

Official Title
-----------------
Cardiopulmonary Exercise Testing in Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease

Intervention / Treatment
-----------------
* Other: cardiopulmonary exercise test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent provided ILD Exclusion Criteria: no informed consent no ILD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cardiopulmonary exercise test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar-arterial oxygen partial pressure difference (AaDO2) in cardipulmonary exercise testing in ILD |  | quarterly, three years |
Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers

Study Overview
=================
Brief Summary
-----------------
Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Detailed Description
-----------------
Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding

Official Title
-----------------
Efficacy of Low Dose of Proton Pumb Inhabitor in Treatment Upper Gastrointestinal Bleeding

Conditions
-----------------
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Drug: Omeprazole 40 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria: Inclusion Criteria: High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata, active bleeding was defined as a continuous blood spurting (Forrest IA) oozing (Forrest IB) from the ulcer base. A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA). An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB). Exclusion Criteria: ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Dose PPI<br>patients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily | Drug: Omeprazole 40 MG<br>* Omperazole 40 mg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morality | Determination of mortality rate from ulcer bleeding | within 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding | Determination of the percentage of the return of bleeding represented by recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment | within 1 week | 
| need for surgery | Determine the Surgery rate for treatment Bleeding ulcers within a week | within 1 week | 
| Length of hospital stay | Determining the length of stay in the hospital | within 1 month | 
| Blood transfusions | number of transfusion blood unites during admission | within 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

Study Overview
=================
Brief Summary
-----------------
Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease. The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial composition in a positive manner. The improved ecological system is believed to contribute to improved liver health and thereby counteract fatty liver disease.

Official Title
-----------------
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics and fruit fibre


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be able to participate in magnetic resonance imaging Exclusion Criteria: unable to understand oral and written information

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Probiotics and fruit fibre<br>Probiotics and fruit fibre | Dietary Supplement: Probiotics and fruit fibre<br>* probiotics and fruit fibre<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved and normalized liver status | normalized concentrations of liver enzymes in plasma. Magnetic resonanse imaging (compared to magnetic resonanse imaging before intervention) will also be used in the investigation of improved liver status. | after 12 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the gut bacterial flora | Changes and differences of the gut bacterial flora will be addressed in detail, e.g. changes in concentration of specific bacterial groups (e.g. Lactobacillus) before and after the intervention period. | after 12 weeks intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatty liver, probiotics, Lactobacillus, fruit, fibre, dietary intervention, obesity
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: BLI1100
* Drug: BLI1100 - modified formulation
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 12 to 45 years of age with facial acne vulgaris Qualifying Investigator's Global Assessment severity score Qualifying number of non-inflammatory lesions Qualifying number of inflammatory lesions Exclusion Criteria: Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade Using medications that are reported to exacerbate acne Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin Have a known hypersensitivity or previous allergic reaction to any of the components Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 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: BLI1100<br>BLI1100 topical cream | Drug: BLI1100<br>* BLI1100 topical cream<br>|
| Experimental: BLI1100 - modified formulation<br>BLI1100 topical cream | Drug: BLI1100 - modified formulation<br>* BLI1100 topical cream<br>|
| Placebo Comparator: Placebo<br>Topical cream | Drug: Placebo<br>* Placebo topical cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total lesion count |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in total lesion count |  | Baseline to Week 12 | 
| Investigator's Global Assessment | Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe) | 12 weeks | 
| Local Tolerability Score | Rating of facial symptoms on a 4 point scale (0=none, 3=severe) | 12 weeks |
Dietary Analysis for Caries Prevention in Children Using a Computer Software

Study Overview
=================
Brief Summary
-----------------
Children will be recruited from the pediatric dentistry clinic of Marquette University at their first or recall appointment and will be asked to fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, developed for this study and dietary instructions will be given to the children.

Official Title
-----------------
Dietary Analysis for Caries Prevention in Children Using a Computer Software

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Other: Software instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free medical history Informed Consent Exclusion Criteria: General disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sortware suggestions<br>Children will fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, and dietary instructions will be given to the children. | Other: Software instruction<br> <br> |
| Placebo Comparator: Traditional suggestions<br> | Other: Software instruction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in dietary habits at 3 months |  | 3 months |
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

Study Overview
=================
Brief Summary
-----------------
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler

Official Title
-----------------
Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

Conditions
-----------------
Nasolabial Folds

Intervention / Treatment
-----------------
* Device: Radiesse® Injectable Dermal Filler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 18 years of age. Has Fitzpatrick Skin Type IV, V, or VI. Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months. Exclusion Criteria: Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring. Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding. Has nasolabial folds that are too severe to be corrected in one treatment session. Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold. Is pregnant, lactating, or not using acceptable contraception.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiesse<br> | Device: Radiesse® Injectable Dermal Filler<br>* Calcium hydroxylapatite particles suspected in an aqueous based gel carrier<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely | 3 months | 
| Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate to severe wrinkles and folds such as nasolabial folds