linjc16/ctgov huggingface dataset:
Study of Long-term Use of Forlax® in Elderly Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.

Official Title
-----------------
Tolerance of Long Term Administration of Forlax® 10g in Elderly Ambulatory or Institutionalized Patients Suffering From Chronic Constipation. Single Blind Randomised Lactulose-controlled Study With Individual Expected Benefit.

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: PEG 4000 (Forlax ®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Institutionalized patients (in a medical care ward) for at least 3 months, or ambulatory patients Suffering from chronic constipation defined as: either less than 3 stools per week for at least 3 months and no or partial efficacy of dietary advices, OR patient treated with laxative medication/s for at least 3 months before inclusion, because of chronic constipation corresponding to less than 3 stools per week in case of no laxative treatment patient has less than 3 stools during 7 consecutive days of the screening wash-out period Exclusion Criteria: known organic intestinal disease having had intestinal surgery abdominal or pelvic radiation, carcinoma, obstructive disease, malabsorption disease fecal mass in the rectum which cannot be completely evacuated during the screening wash-out period

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PEG 4000 (Forlax ®)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and biological tolerance with special attention to digestive and nutritional status. Clinical tolerance will be assessed by digestive symptomatology collected on a daily basis |  |  | 
| Digestive examination assessed at screening wash-out period and each month |  |  | 
| Nutritional status assessed at screening wash-out period, month 3 and month 6 |  |  | 
| Vital signs assessed at screening wash-out period, month 3 and month 6. Biological tolerance will be assessed by nutritional markers, malabsorption markers and routine laboratory tests assessed at screening wash-out period and month 3 and 6. |  |  | 
| Drug interaction assessment assessed at screening wash-out period and month 3 and 6. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy based on daily nurse diary |  |  | 
| Healthcare cost analysis. |  |  |
Cold Plasma to Treat Hair Loss

Study Overview
=================
Brief Summary
-----------------
Self applied cold plasma activated medium used for androgenetic alopecia

Official Title
-----------------
Using Indirect Cold Atmospheric Pressure Plasma (Plasma Activate Liquid) for the Treatment of Hair Loss

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Device: Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of mild-to moderate androgenetic alopecia ability of applying treatment regularly ability to keep in-person follow-up appointments Exclusion Criteria: any inflammatory scalp condition starting or discontinuing any hair loss treatments within 6 months of start date allergy to any components of the carrier solution

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: Cold-atmospeheric pressure plasma activated solution<br>Treatment arm subjects receive the trial intervention | Device: Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment<br>* Cold plasma is generated and applied to carrier liquid. Subjects are provided with the liquid to apply to the treated area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of detectable hair growth | Presence of hair growth is observed clinically. Evaluation may include photo comparison, hair count, trichoscopy | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects related to the treatment | Patients are monitored for adverse effects, including but not limited to irritation, itch, inflammation, scaling, redness, rash, peeling, blistering | throughout study completeion, 6 months |
TVT Worldwide Registry

Study Overview
=================
Brief Summary
-----------------
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.

Detailed Description
-----------------
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System

Official Title
-----------------
TVT-World Wide Observational Registry for Long-Term Data

Conditions
-----------------
Stress Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).

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 |
| --- | --- | --- |
| Standing cough stress test |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I-QOL score |  | 3, 6, 12 and 24 months |
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

Study Overview
=================
Brief Summary
-----------------
The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.

Detailed Description
-----------------
The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.

Official Title
-----------------
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Total joint arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Eaton type 2+3 TMC osteoarthritis Exclusion Criteria: Patients with Eaton type 4 TMC osteoarthritis

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
Interventional Model Description: Implantation of TMC total joint arthroplasty in a patient cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient cohort<br>TMC total joint arthroplasty | Procedure: Total joint arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Revision with removal of implant | 10 year survival | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total joint arthroplasty, thumb, trapeziometacarpal joint, osteoarthritis
A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Study Overview
=================
Brief Summary
-----------------
After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

Official Title
-----------------
An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with at least 65 years-old Patients with essential hypertension Exclusion Criteria Severe hypertension History or evidence of a secondary form of hypertension History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Ages Eligible for Study
-----------------
Minimum Age: 65 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks |  |  | 
| Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks |  |  | 
| Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks |  |  | 
| Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks |  |  | 
| Blood pressure control target of < 140/90 mmHg after 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, aliskiren, age
Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children

Study Overview
=================
Brief Summary
-----------------
Visual development during early childhood is a vital process. Examining the visual acuity of children is essential for the early detection of visual abnormality, but performing such an assessment in children is challenging. Here, the investigators developed a human-in-the-loop artificial intelligence (AI) paradigm that combines traditional vision examination and AI with integrated software and hardware, thus making the vision examination easy to perform. The investigator also establish a entity intelligent visual acuity diagnostic system based on the paradigm, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.

Official Title
-----------------
Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children: Using a Human-in-the-loop Artificial Intelligence Paradigm

Conditions
-----------------
Ophthalmopathy, Artificial Intelligence

Intervention / Treatment
-----------------
* Device: An intelligent visual acuity diagnostic system for children


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric patients from eye clinic written informed consents provided

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eligible patients for AI test.<br>Device: An intelligent visual acuity diagnostic system for children. An artificial intelligence to evaluate children's vision. | Device: An intelligent visual acuity diagnostic system for children<br>* An artificial intelligence to make evaluation and of children's vision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system. |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vision Disorders
Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis. II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients will be stratified according to sex (male vs female) and osteoporosis disease severity (mild vs severe). Patients are randomized to one of two treatment arms. Patients undergo bioavailability assessment to confirm the ability to absorb alendronate. Arm I: Patients receive calcium and vitamin D supplements with a placebo daily for one month. Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for one month. Treatment continues if differences are seen in bone mineral density between the treatment arms. Patients are followed for biochemical response at week 6, 12, and 52. Bone mineral density is measured at 1 year and 2 years. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Osteoporosis, Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: alendronate sodium
* Drug: calcium carbonate
* Drug: cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of cystic fibrosis Mild to moderate lung disease At least one site specific (spine or femur) bone mineral density representing low bone mass or osteopenia (greater than 1 standard deviation below peak bone mass) --Prior/Concurrent Therapy-- Endocrine therapy: At least 3 months since prior corticosteroids --Patient Characteristics-- Performance status: Ambulatory Renal: Creatinine no greater than 3 mg/dL No renal failure Other: No history of esophagitis No allergies to alendronate Not pregnant Fertile female patients must use effective barrier contraception or progestin only oral contraceptives (e.g., norethindrone) Ability to comply with treatment No intestinal problems other than cystic fibrosis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alendronate sodium|nan|
|Drug: calcium carbonate|nan|
|Drug: cholecalciferol|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, osteoporosis, rare disease
Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Study Overview
=================
Brief Summary
-----------------
Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.

Official Title
-----------------
Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Conditions
-----------------
Cervical Stenosis, Disk, Herniated, Spondylosis

Intervention / Treatment
-----------------
* Device: epidural electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized. Exclusion Criteria: none

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: Electrical Stimulation group<br>Epidural Electrical Stimulation of the Cervical Spinal Cord | Device: epidural electrical stimulation<br>* Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in respiratory frequency | Increase or decrease in respiratory frequency of 20% during or after stimulation | During intraoperative surgery during stimulation and within 2 minutes after stimulation | 
| Change in respiratory tidal volume | Increase or decrease in respiratory tidal volume of 20% during or after stimulation | During intraoperative surgery during stimulation and within 2 minutes after stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Increase or decrease in heart rate of 20% during or after stimulation | During intraoperative surgery during stimulation and within 2 minutes after stimulation | 
| Change in blood pressure | Increase or decrease in blood pressure of 20% during or after stimulation | During intraoperative surgery during stimulation and within 2 minutes after stimulation |
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

Study Overview
=================
Brief Summary
-----------------
Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine. Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.

Official Title
-----------------
Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.

Conditions
-----------------
Typical Facial Pain, Atypical Facial Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Triamcinolone
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block. Exclusion Criteria: Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine | Drug: Bupivacaine<br>* 4 mL of 0.25% bupivacaine<br>Drug: Dexamethasone<br>* 4 mg of Dexamethasone<br>|
| Active Comparator: Triamcinolone<br>40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine | Drug: Bupivacaine<br>* 4 mL of 0.25% bupivacaine<br>Drug: Triamcinolone<br>* 40 mg of Triamcinolone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects Reporting at Least 50% Overall Pain Relief | The number of subjects reporting a minimum of 50% pain relief after receiving the injection. | 2 weeks |