linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.

Official Title
-----------------
A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: KAI-1678
* Drug: Ketorolac Tromethamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) classification 1, 2, or 3 total hip or total knee replacement pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS) Exclusion Criteria: presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment recent history of angina or myocardial infarction (MI) clinically significant abnormality on laboratory tests or electrocardiogram (ECG)

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1: Placebo<br>Placebo | Drug: Placebo<br>* Subcutaneous infusion-once over 4 hours<br>|
| Active Comparator: A2: KAI-1678<br>Test Drug | Drug: KAI-1678<br>* Subcutaneous infusion-once over 4 hours<br>* Other names: Active drug;|
| Active Comparator: A3: Ketorolac<br>Active Comparator | Drug: Ketorolac Tromethamine<br>* Active comparator, IV infusion, once<br>* Other names: Ketorolac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4). |  | Post operative Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4) |  | Post operative Day 1 | 
| The effect of KAI-1678 on pain intensity difference (PID) at 4 hours |  | Post-operative Day 1 | 
| The effect of KAI-1678 on total quality analgesia |  | Post-operative Day 1 | 
| The effect of KAI-1678 on time to meaningful pain relief |  | Post-operative Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ketorolac / therapeutic use, Analgesics. Non-narcotic / therapeutic use, Arthroplasty, replacement hip, Arthroplasty, replacement knee, Pain measurement / drug effect, Pain postoperative / drug therapy
Evaluation of Attitudes About Fertility

Study Overview
=================
Brief Summary
-----------------
Assess the attitudes and feelings of premenopausal Latin American women towards the risk of loss their fertility by adjuvant chemotherapy. Correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual cycle.

Detailed Description
-----------------
Eligibility criteria: Latin American women with evidence of cancer diagnosis at premenopausal status Over 18 years Agree to sign the informed consent No evidence of infertility.

Official Title
-----------------
Evaluation of Attitudes of Premenopausal Latin American Patients With Breast Cancer Towards the Risk of Loss Their Fertility by Chemotherapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with breast cancer diagnosis in premenopausal over 18 years signed informed consent Exclusion Criteria: Evidence of infertility at diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pre menopausal, fertility, chemotherapy, breast cancer, latin american women
Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma

Study Overview
=================
Brief Summary
-----------------
In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication respectively and we came to this point that; T+MMC and AGI are comparable in terms of success rate and complications in pediatric aphakic glaucoma.

Conditions
-----------------
Pediatric Aphakic Glaucoma

Intervention / Treatment
-----------------
* Procedure: trabeculectomy with mitomycin-C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital cataract history of cataract surgery under 16 years old Ocular pressure more than 21 mmHg Exclusion Criteria: interruption of the follow up before 6 month Anterior segment dysgenesis

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 16 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

| Intervention/Treatment |
| --- |
|Procedure: trabeculectomy with mitomycin-C|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
-----------------
Aphakic Glaucoma, trabeculectomy with mitomycin- C, Ahmed glaucoma implant
RLIP76 in Human Serum in Adults With Rheumatologic Diseases

Study Overview
=================
Brief Summary
-----------------
It is the investigators aim to determine the feasibility of directly detecting anti-RLIP76 auto-antibodies in human serum using prepared RLIP76 antigen peptides in persons with rheumatologic disease and persons without rheumatologic diesease (healthy subjects).

Detailed Description
-----------------
This is an exploratory study conducted to see the feasibility of measuring the anti-RLIP76 antibody and to standardize the methods for its measurement. We will perform these studies on blood samples obtained from human subjects after informed concent for blood draw for research purposes is obtained by the Clinical Research Co-ordinator (CRC).

Official Title
-----------------
Measurement Of RLIP76 Auto Antibodies in Human Serum In Adults With Rheumatologic Diseases.

Conditions
-----------------
Carotid Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study. Exclusion Criteria: Children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera. |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLIP76 Auto Antibodies
Comparison Between RTX (Biphasic Cuirass Ventilator) and Physiotherapy in Cystic Fibrosis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of different mucous clearance techniques in cystic fibrosis patients

Detailed Description
-----------------
Cystic fibrosis (CF) is associated with chronic progressive lung disease that may lead to respiratory failure.Bi-Phasic Cuirass Ventilation (BPCV) is a form of non-invasive respiratory support, which can provide negative pressure ventilation as well as high frequency chest wall oscillations and cough mode.The standard therapy for CF patients to release mucous is treatment by a physiotherapist. In this study we will compare the effect of BPCV with regular physiotherapy by full pulmonary function testing prior and post treatment.

Official Title
-----------------
Comparison Between bi-Phasic Negative Pressure Ventilator Therapy and Physiotherapy in Cystic Fibrosis Patients

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Procedure: physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF patients over 7 years old Exclusion Criteria: Hemoptysis Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physiotherapy<br> | Procedure: physiotherapy<br>* physiotherapy either by biphasic cuirass ventilator or physiotherapist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic fibrosis, physiotherapy, pulmonary function test
Effect of Tetrabenazine on Stroop Interference in HD

Study Overview
=================
Brief Summary
-----------------
Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in Huntington disease (HD) patients as measured by computerized dynamic posturography testing. This study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the Stroop interference test.

Official Title
-----------------
Effect of Tetrabenazine on Stroop Interference in Huntington Disease

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Drug: Tetrabenazine withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of Huntington disease by movement disorders expert Patients currently taking tetrabenazine. Patients should not have taken dopamine receptor blocking medication for at least three days Exclusion Criteria: -

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: Tetrabenazine withdrawal<br>Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication. | Drug: Tetrabenazine withdrawal<br>* Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stroop Interference Score | Participants will have Stroop Visual Interference Scores measured while OFF tetrabenazine for at least 3 days. Two doses of 12.5 mg tetrabenazine will be subsequently administered: first dose just after the Stroop test and second dose 3 hours later. Stroop Visual Interference Scores will be measured again in the ON state, 6 hours after the initial OFF measurement. | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Huntington disease, HD, tetrabenazine, Stroop
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients who have undergone exstrophy closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This study is a descriptive analysis of the study cohort's gait patterns and pelvic structure. Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent closure demonstrate gait abnormalities. Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) demonstrate gait abnormalities compared with a reference population. Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) will have below normal functional survey scores.

Official Title
-----------------
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy

Conditions
-----------------
Bladder Exstrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was seen at CCMC for bladder exstrophy between January 2002 and December 2010. Subject is four years of age or older at time of enrollment. Subject has the ability to walk. Subject has not had gait testing performed. Subject provides Informed Consent and HIPAA Authorization. Exclusion Criteria: Subject was not seen at CCMC for bladder exstrophy between January 2002 and December 2010. Subject under four years of age at time of enrollment. Subject does not have the ability to walk. Subject had prior gait testing performed. Subject not willing to provide Informed Consent and HIPAA Authorization.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 65 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 |
| --- | --- |
| Bladder Exstrophy Patients<br>Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Testing and Analysis |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age |  | 2 weeks | 
| Pediatric Outcomes Data Collection Instrument (PODCI) |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder exstrophy, Abnormal gait, anatomy, urinary bladder disease, urogenital abnormalities
A Registered Cohort Study on Cerebellar Ataxia in the Organization in South-East China for Cerebellar Ataxia Research (OSCCAR)

Study Overview
=================
Brief Summary
-----------------
Cerebellar ataxia is a form of ataxia originating in the cerebellum. Cerebellar ataxia can occur as a result of many diseases and may present with symptoms of an inability to coordinate balance, gait, extremity and eye movements. To understand the clinical and genetic characteristics of cerebellar ataxia, we establish a registered cohort to follow up Chinese patients with cerebellar ataxia.

Official Title
-----------------
A Registered Cohort Study on Cerebellar Ataxia

Conditions
-----------------
Cerebellar Ataxia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cerebellar ataxia based on the diagnoses of tow neurologists Relatives of patients with cerebellar ataxia Unrelated healthy controls Participants or legal guardian(s) willing and able to complete the informed consent process Exclusion Criteria: Participants are unable to comply with trial procedures and visit schedule
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hereditary cerebellar ataxia | Look for the causative gene in the patient with cerebellar ataxia | Up to 20years |
Enhanced Critical Care Air Transport Team Training for Mitigation of Task Saturation

Study Overview
=================
Brief Summary
-----------------
This study involves two tasks. The first involves observation of patient care during simulated aeroevacuation missions in order to gauge task saturation. The second involves review of records from actual evacuation flights in order to determine the effects of task saturation on patient care.

Official Title
-----------------
Enhanced Critical Care Air Transport Team Training for Mitigation of Task Saturation

Conditions
-----------------
Task Saturation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in a US Air Force CCATT Advanced Class at University Hospital, Cincinnati

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| CCATT Team<br>Measurements will be taken on groups of 3 people each. There will be a total of 16 such teams, with total membership of 48 individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of task saturation | Task saturation is defined as the point at which the volume or complexity of events exceeds the capability of the individual or team to maintain a standard of care. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Task saturation
Comparison Of Two Tablet Formulations Of SB-568859

Study Overview
=================
Brief Summary
-----------------
SB-568859 is a medication that is being developed for the treatment of atherosclerosis (hardening of the arteries). The purpose of this study is to see if there is a difference in how the human body takes up the study drug depending on how the study drug is made. This study will compare SB-568859 tablets that are made in 2 different ways. This is not a treatment study.

Official Title
-----------------
A Randomised, Single Blind, 2 Period, Crossover Study to Compare the Single Dose Pharmacokinetics and Tolerability of Formulations Containing Unmilled and Micronised SB-568859 in Healthy Adults

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: SB-568859


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and sterile women between 18 and 50 years old Body weight greater than 50 pounds and a body mass index between 19 and 31 Normal electrocardiogram Exclusion criteria: No history of asthma or severe allergic reactions No history of or current drug use No Hepatitis or HIV/AIDS No excessive alcohol use No smoking or tobacco use No use of prescription drugs, over-the-counter drugs or vitamins within 7 days No use of herbal supplements within 14 days No treatment with an investigational drug within 30 days. No treatment with 4 or more investigational drugs in the last 12 months No grapefruit or grapefruit juice in the last 7 days No donation of blood in the last 8 weeks No history of allergy to heparin No history of liver or gall bladder disease Unwillingness to use contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB-568859|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the amount of SB-568859 found in the blood over a period of 6 days after a single dose of each of the two types of tablets |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety and tolerability of SB-568859 after a single dose of each of the two types of tablets based on blood and urine tests, vital signs, electrocardiograms and reporting of side effects over a period of 6 days after each dose. |  | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unmilled formulation,, micronised formulation, relative bioavailability,