linjc16/ctgov huggingface dataset:
Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds.

Official Title
-----------------
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds

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

Intervention / Treatment
-----------------
* Drug: TAT4 Gel
* Drug: Matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe, bilateral nasolabial folds Must understand and provide informed consent Exclusion Criteria: Pregnant or lactating women History of skin hypersensitivity of atopic dermatitis Any illness of disease that, in the investigator's opinion, would make trial participation inadvisable

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAT4 Gel<br>The participant will apply TAT4 Gel to the nasolabial fold area once daily. | Drug: TAT4 Gel<br> <br> |
| Placebo Comparator: Placebo<br>The participant will apply Placebo Gel to the nasolabial fold area once daily. | Drug: Matching placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasolabial Fold Severity Scale (Clinician-Reported) |  | Day 91 |
A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache

Study Overview
=================
Brief Summary
-----------------
Migraine headaches have previously been shown to be responsive to intranasal lidocaine in a small study. Using a nebulizer to administer the drug would improve the feasibility of using the treatment. It would also spare the patient narcotics with their attendant side effects. Because of the potential for placebo effect a placebo control is necessary in this study.

Official Title
-----------------
A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache

Conditions
-----------------
Migraine Headache

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets IHS criteria for migraine Exclusion Criteria: Pregnant Breast feeding Allergic to Lidocaine Worst or first Headache Abnormal neurological exam Substance abuse within 6 months Cardiac, liver or pulmonary disease Participation n another study within 30 days

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lidocaine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in 10 point pain score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Lidocaine, Headache
Ocular Allergy Treatment Practical Impact Trial

Study Overview
=================
Brief Summary
-----------------
To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.

Detailed Description
-----------------
To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)

Official Title
-----------------
To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)

Conditions
-----------------
Allergic Conjunctivitis, Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Alcaftadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more. have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment. Are willing/able to follow instructions from the study investigator and his/her study staff. Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee. - Exclusion Criteria: Active ocular infection; History of retinal detachment, diabetic neuropathy, or any progressive retinal disease; Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study. History of unstable, or uncontrolled disease of any nature. Pregnancy or lactation; Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcaftadine<br>subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks | Drug: Alcaftadine<br>* Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.<br>* Other names: Lastacaft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life- Eye Allergy Patient Impact Questionnaire |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index Pollen Count correlation of symptoms |  | 6 months |
Food Patterns, Inflammation Markers of Cardiovascular Disease Risk and Incidence of CVD

Study Overview
=================
Brief Summary
-----------------
Health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. To examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö, Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.

Conditions
-----------------
Cardiovascular Disease, Diet, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The cardiovascular sub-cohort is a random sample (i.e., 50 percent) of those who joined from November 1991 to February 1994. This group underwent additional examinations to assess carotid arteriosclerosis by ultrasound (n = 6103) and donated blood after fasting (n = 5533). Exclusion Criteria: Subjects were excluded, either because they were using medication for diabetes mellitus or had previously been diagnosed as having diabetes mellitus.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.

Official Title
-----------------
An Epidemiological, Postmarketing Observational Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease (GERD) on Patients' Daily Life

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastroesophageal reflux disease -GERD (disease duration ≤3 years or newly diagnosed) that are currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has previously decided to initiate or change the tre Patients should be treated for GERD according to current practice (National guideline for treatment of dyspepsia in GP setting)

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 |
| --- | --- |
| 1<br>Patients with GERD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Typical GERD symptoms (indicating frequency and severity of symptoms) and signs |  | 8 weeks | 
| Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data |  | 8 weeks | 
| Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Treatments for GERD and treatment changes |  | 8 weeks | 
| Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Patient's perspective of symptom control and impact on daily life assessed using a patient-questionnaire (GIS-GERD Impact Scale). |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the added value of a patient questionnaire (GIS-GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastroesophageal reflux disease (GERD)
Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.

Official Title
-----------------
Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

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

Intervention / Treatment
-----------------
* Other: culture ex vivo with exposure to different therapeutic agents alone or in combination.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged over 18 years Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses Surgery of any initial chemotherapy naive Patient information and signed informed consent Exclusion Criteria: A person deprived of liberty or under guardianship Insufficient tumor samples of ovarian cancer.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: culture ex vivo with exposure to different therapeutic agents alone or in combination.|When tumor resection, tumor specimens of ovarian cancer will be made towards a culture ex vivo with exposure to different therapeutic agents alone or in combination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of apoptotic cells |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Ovarian, chemotherapy, BH3-mimetic, platin, ex-vivo
Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding

Study Overview
=================
Brief Summary
-----------------
In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives: To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy

Detailed Description
-----------------
11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.

Official Title
-----------------
A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study Female Age ≥18 Negative serum pregnancy test for women of child bearing potential Signed study-specific informed consent Exclusion Criteria: Unable to perform breath-holding of adequate duration. Unable to lie prone for approximately one hour during the study procedure Breast implants Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc. Positive serum pregnancy test Mastectomy

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

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

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 |
| --- | --- | --- |
| The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing. | Subjects will be evaluated holding their breath and during normal breathing. | During MRI approx 1 hour | 
| Feasibility as measured by a BOLD contrast signal in at least 30% of subjects | The imaging technique will be considered feasible if for any of the proposed imaging sequences, breath-holding induces a measurable (≥3× standard deviation of background) BOLD contrast signal in at least 30% of the subjects. Contrast will be measured by comparing breath hold sequences to normal breathing. | During MRI approx one hour |
Reproductive Medicine Network Biologic Specimen Repository

Study Overview
=================
Brief Summary
-----------------
The Reproductive Medicine Network (RMN) is a nationwide cooperative network of 7 clinical sites and a data coordination center, and is sponsored in 5 year increments by The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD). The RMN is charged with designing, implementing and publishing high quality clinical research in reproductive medicine. It has been in existence for over 15 years and has performed several seminal clinical trials that have fundamentally changed clinical practice in this field. In addition, many worthy ancillary protocols have been generated and published. It is this latter fact, as well as the continued interest by investigators both inside and outside the RMN for access to DNA or serum samples from the previously performed trials, that has motivated the present investigators to proactively begin a biologic samples repository from the ongoing and pending RMN clinical trials. Ideally, this repository would allow investigators to seamlessly access trial samples for many years into the future, and thus greatly amplify the use of resources and the impact of the RMN.

Official Title
-----------------
Reproductive Medicine Network Biologic Specimen Repository

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject of an RMN clinical trial and consents to participate in the repository is eligible for inclusion. Exclusion Criteria: N/A
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 |
| --- | --- | --- |
| Proportion of subject who accepted participation |  | 4.2 years |
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).

Conditions
-----------------
Hyperlipoproteinemia Type III

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: atorvastatin
* Drug: fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia) Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|
|Drug: fenofibrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C and non-HDL-C levels. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid and biomarker variable levels. |  |  |
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.

Official Title
-----------------
Oxygen Supply and Ventilation During Physical Exercise in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Hypoxia

Intervention / Treatment
-----------------
* Drug: Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic obstructive pulmonary disease Exclusion Criteria: No exacerbation No active heart disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 95 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplementary oxygen<br>Study subjects receive, in randomized order, either supplementary 30% oxygen or air (21% Oxygen) from a gas tight bag | Drug: Oxygen<br>* supplementary oxygen during exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary ventilation |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnoea |  | 1 hour | 
| Heart rate |  | 1 hour | 
| Blood pressure |  | 1 hour |