linjc16/ctgov huggingface dataset:
Pupillary Response After Glaucoma Medication

Study Overview
=================
Brief Summary
-----------------
Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.

Official Title
-----------------
Effect of Topical Anti-glaucoma Medications on Late Pupillary Light Reflex, as Evaluated by Pupillometry

Conditions
-----------------
Drug Effect (Glaucoma Drugs)

Intervention / Treatment
-----------------
* Drug: Latanoprost
* Drug: Timolol
* Drug: Dorzolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: ophthalmological diseases systemic disease smoking refractive error >= 6 diopters

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Latanoprost<br>solution, 1 drop of 50ug/ml latanoprost, was given to study eye after washout period of 1 week between drugs | Drug: Latanoprost<br>* 1 drop of latanoprost was given to study eye after washout period of 1 week between drugs<br>|
| Experimental: Timolol<br>solution, 1 drop of 5mg/ml timolol , was given to study eye after washout period of 1 week between drugs | Drug: Timolol<br>* 1 drop of timolol was given to study eye after washout period of 1 week between drugs<br>* Other names: Optimol;|
| Experimental: dorzolamide<br>solution, 1 drop of 20 mg/ml dorzolamide, was given to study eye after washout period of 1 week between drugs | Drug: Dorzolamide<br>* 1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs<br>|
| No Intervention: Other<br>no drug given and pupil measurements were performed before and at 30 and 180 min at equivalent hours as drugs measurements | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupillary constriction measured as the post-illimination pupillay response (PIPR) | The pupillary diameter 0 to 10 seconds after light stimulation, the diameter is measured relative to the initial dark adapted pupil diameter | 1 day |
Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.

Official Title
-----------------
A Comparison Between Povidone-iodine and Normal Saline in Vaginal Cleansing Before Office Hysterosocpy: a Randomized Controlled Trial

Conditions
-----------------
Postoperative Infection

Intervention / Treatment
-----------------
* Drug: povidone-iodine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 - All women who will subject to office Hysterosocpy for gynecological problems Exclusion Criteria: All patients have current vaginitis or urinary tract infection before the hysteroscopy Diabetic women. Women with body mass index > 25 kg/m2.
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Active Comparator: Group A<br>povidone-iodine group | Drug: povidone-iodine<br>* The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy<br>|
| Active Comparator: Group B<br>Normal saline group | Drug: normal saline<br>* The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of postoperative vaginal irritation symptoms |  | 24 hours |
Treatment of Male Pattern Baldness With Botulinum Toxin

Study Overview
=================
Brief Summary
-----------------
This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe and effective method for treating this form of hair loss.

Official Title
-----------------
A Prospective, Single Center, Open Label, Proof of Principle Study to Assess the Efficacy and Safety of 150 Units of Botulinum Toxin-A Intra-Muscular Injection in the Prevention of Hair Loss in Men With Androgenetic Alopecia

Conditions
-----------------
Male Pattern Baldness

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin - A injections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male pattern baldness Norwood II-VI Exclusion Criteria: Treatment with Botulinum toxins or other hair growth interventions with past year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum Toxin - A injections|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Growth |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Loss |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male pattern baldness, androgenetic alopecia, hair loss
Prebiotic Effect on Metabolites in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the influence of the prebiotic oligofructose enriched inulin on the metabolite pattern in Crohn's disease patients.

Official Title
-----------------
Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Oligofructose enriched inulin
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: crohn's disease Exclusion Criteria: severe crohn's disease (harvey bradshaw index >12) pregnancy history of colectomy use of antibiotics 4-wks before start of the study use of sulfapyridine use of commercially available prebiotics and probiotics

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prebiotic<br> | Dietary Supplement: Oligofructose enriched inulin<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Maltodextrin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A First In Human Study Of PF-00184562 In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.

Official Title
-----------------
An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: PF-00184562
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects of non-childbearing potential Exclusion Criteria: Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: PF-00184562|nan|
|Drug: Olanzapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs). |  |  | 
| Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax) |  |  | 
| Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2). |  |  | 
| Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine. |  |  | 
| All measurements to be assessed over single doses. |  |  |
Testicular Tissue Viability After Cryopreservation

Study Overview
=================
Brief Summary
-----------------
we will use testicular tissue from patient who underwent orchidectomy due to medical reasons and test the viability of the tissue after cryopreservation and de-freezing.

Conditions
-----------------
Fertility

Intervention / Treatment
-----------------
* Other: cryopreservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patient undergo orchidectomy - Exclusion Criteria: non viable testicular tissue -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: orchidectomy<br>as specified in the summary | Other: cryopreservation<br>* cryopreservation of testicular tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| viable tissue after cryopreservation |  | 1/1/2011 - 30/12/2012 |
The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. After two years follow-up, we observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.

Official Title
-----------------
The Impact of Frailty on Thrombosis of Elderly Patients With Non-valvular Atrial Fibrillation (NVAF).

Conditions
-----------------
Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis

Intervention / Treatment
-----------------
* Other: Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥65yr Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale patients agreed and provided informed consent Exclusion Criteria: valvular atrial fibrillation cardiac surgery related atrial fibrillation acute disease related atrial fibrillation patients not fulfilled all the exam and text，or not accept the follow-up

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Participates<br>This is an observational study | Other: Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.<br>* This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke | Cerebral infarction, Transient ischemic attack, Cerebral embolism. | 24 months | 
| Massive hemorrhage | Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc. | 24 months | 
| All-cause death | All-cause death during the 2-year observation | 24 months |
The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort)

Study Overview
=================
Brief Summary
-----------------
Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

Detailed Description
-----------------
The study is aimed to evaluate if optimized antiplatelet treatment using a test and treat algorithm (with whole blood aggregometry) is able to improve clinical outcome of patients compared to standard treatment without platelet function testing.

Official Title
-----------------
Optimized Antiplatelet Therapy With Aspirin and Clopidogrel Improves Mortality Compared to Standard Treatment.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary stent implantation Exclusion Criteria: no consent

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 |
| --- | --- |
| Standard therapy<br>Antiplatelet therapy following coronary stenting without platelet function testing | |
| Optimized antiplatelet therapy<br>Platelet function testing and according to a test and treat strategy improve the antiplatelet therapy in low-responder. Treatment adjustments were done as published before - see BOCLA-Plan manuscript. (Reference: Tailored antiplatelet therapy can overcome clopidogrel and aspirin resistance--the BOchum CLopidogrel and Aspirin Plan (BOCLA-Plan) to improve antiplatelet therapy. BMC Med. 2011 Jan 12;9:3.) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction) | MACE-rate | Follow up for up to 12 months (retrospective analysis) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clopidogrel, aspirin, low response, platelet aggregation, Acute Coronary Syndrome, Coronary Stent Implantation
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

Detailed Description
-----------------
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.

Official Title
-----------------
A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: AMG 827


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was randomized into Study 20090062 and completed the week 16 evaluation. Exclusion Criteria: Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP. Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.

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: AMG 827<br>AMG 827 | Drug: AMG 827<br>* 210 mg SC or 140 mg SC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) | 264 weeks | 
| Percent Change in Psoriasis Area and Severity Index (PASI) | Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement. | 264 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home

Study Overview
=================
Brief Summary
-----------------
The investigators seek to construct a novel, multimodal, distributed system that facilitates a new paradigm of home-based medical surveillance and treatment for frail older adults centered on timely diagnosis of movement system impairments and personalized intervention. Measurements from a heterogeneous set of complementary sensors will be combined with clinically-informed and data-learned dynamic models of human motion to enable real-time activity recognition (e.g., sitting, standing, walking) and movement assessments (e.g., speed, repetition, quality). As the study progresses, the system will be integrated with wearable assistive technology to provide smart, activity-specific assistance of movement deficits or the activation of caregivers if a decline in function is detected. Finally, the investigators will test the combined assessment and intervention system in the clinic and the home, identifying challenges and solutions for the scaling up to unconstrained real-world settings.

Official Title
-----------------
Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home

Conditions
-----------------
Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Capacity to consent Community dwelling Ability to follow 3-step commands Lives within 15 miles of Boston Exclusion Criteria: Undomiciled Active substance use disorder Active psychosis Domestic violence or neglect Inability to communicate with investigators Other comorbidities that prevent full participation in the research

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video and inertial motion unit capture | Successfully capture video and inertial motion unit capture of subjects as they perform various movement assessments. | 1 recording episode, approximately 3 hours |
Oral Versus Parental Progesterone in the Management of Preterm Labor

Study Overview
=================
Brief Summary
-----------------
Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately 12% of pregnancies in the United States Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)

Official Title
-----------------
Oral Versus Parental Progesterone in the Management of Preterm Labor

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: oral progesterone
* Drug: intramuscular progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Past history of one or more spontaneous preterm labor. Singleton pregnancy. Pregnancy of less than 20 weeks of gestation Exclusion Criteria: Women on tocolytic drugs . Underwent cervical cerclage in this pregnancy . Multiple gestations . Major fetal congenital malformations . Pregnancy 0f more than 20 weeks gestation .
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group 1<br>oral progesterone | Drug: oral progesterone<br>* daily<br>|
| Active Comparator: study group 2<br>intramuscular progesterone | Drug: intramuscular progesterone<br>* every week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of preterm labor | number of women delivered before 37 weeks | 10 weeks |