linjc16/ctgov huggingface dataset:
Polarstem Cementless Hip Stem

Study Overview
=================
Brief Summary
-----------------
Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

Detailed Description
-----------------
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™. Efficacy evaluations: Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: Intra- and perioperative device-related adverse events (AE) and complications up to discharge Postoperative AE up to 10 years

Official Title
-----------------
Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM

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

Intervention / Treatment
-----------------
* Device: Osteoarthritis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has no general medical contraindication to surgery Informed consent to participate in the MCO signed by the patient Routine radiographic assessment is possible Patient is likely to comply with study follow-up requirements Primary total hip replacement (THR) to the affected side, unilateral or bilateral Exclusion Criteria: Previously failed endoprosthesis and /or THR components in relevant hip History of infection in the affected joint; systemic infections Grossly insufficient femoral or acetabular bone stock in the involved hip Charcot joint disease or other severe neurosensory deficit Severe spinal disorders Age of patient at date of surgery > 75 years High comorbidity Cemented acetabular cup

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Osteoarthritis|Total Hip Arthroplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term survivorship of Polarstem | Long-term survivorship will be calculated according to Kaplan-Meier with stem revision due to any reason as endpoint | 10 years Follow Up after surgery |
OneShot Renal Denervation Registry

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

Official Title
-----------------
Renal Denervation Using the OneShot Ablation System

Conditions
-----------------
Hypertension, Heart Failure, Diabetes Mellitus, Sleep Apnea

Intervention / Treatment
-----------------
* Device: OneShot Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is an acceptable candidate for renal denervation based upon the Instructions for Use. Patient is ≥ 18 years old. Patient provided written informed consent. Exclusion Criteria: Patients who are pregnant, nursing, or planning to become pregnant. Patients who have only one functioning kidney. Allergy to contrast or known hypersensitivity to device materials Patients with renal arteries < 4 mm in diameter. Patients whose life expectancy is less than the planned period of study involvement.

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 |
| --- | --- |
| Other: Renal denervation<br>Patients will be treated with the OneShot ablation system | Device: OneShot Ablation System<br>* Renal denervation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office systolic blood pressure (SBP) from baseline to 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention. |  | One Week | 
| Change in office diastolic blood pressure (DBP) |  | 6 and 12 months post procedure | 
| Change in office SBP |  | 6 and 12 months post procedure |
Prevalence and Recognition of Geriatric Syndrome in Outpatient Clinic at Srinagarind Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect the prevalence of geriatric syndrome, which is recognized by an internist, and to compare the data based on the comprehensive geriatric assessment by a geriatrician. The secondary outcome is to develop a practical collected form for the internist.

Official Title
-----------------
Prevalence and Recognition of Geriatric Syndrome in Outpatient Clinic at Srinagarind Hospital

Conditions
-----------------
Dementia, Cognitive Impairment, Depression, Urinary Incontinence, Constipation, Falls

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who are over than 60 years old who visit internal medicine outpatient clinic

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Comparing the prevalence of geriatric syndrome between internist and geriatrician |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of a practical form to collect patient's data |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geriatric syndrome, immobility
Effect of Ocular Hygiene on Scleral Lens Wear

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the performance of Lid Scrubs when added to the daily regimen of scleral lens wear. Lid Scrubs contain surfactants and chemically developed Ringer's solution with microbial attributes. Lid Scrubs are typically used in the treatment of blepharitis. This study is geared towards showing added benefits to scleral lens patients when adding Lid Scrubs to their daily regimens. This study will also show if Lid Scrubs are capable of antimicrobial properties on scleral lens accessories.

Official Title
-----------------
Effect of Ocular Hygiene on Scleral Lens Wear

Conditions
-----------------
Scleral Contact Lenses

Intervention / Treatment
-----------------
* Drug: Ringers Solution
* Drug: Placebo - Concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age: 18 years old to - 85 years old Scleral Lens Correction criteria: Patients should be habitual scleral lens wearers. Patients should use scleral lenses for at least 8 hours a day and for at least 5 days of the week Exclusion Criteria: Exclusions to participate in the study include: adults unable to consent, age restrictions, pregnant women, prisoners, non-english speaking patients (as consent forms are only available in the English language), current optometry students and faculty as these patients may be biased to which products they are using.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Drug: Ringers Solution<br>* Treatment vs Placebo<br>|
| Placebo Comparator: Placebo Group<br> | Drug: Placebo - Concentrate<br>* treatment vs placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of scleral lens wear |  | one month |
Risedronate Sodium in Post Menopausal Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women. The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].

Official Title
-----------------
A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: risedronate sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria. Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel. Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator. Exclusion criteria : Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion criteria if the subject has been in remission for at least 6 months prior to enrollment. Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: risedronate sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks. |  |  | 
| Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline. |  |  |
Profermin® in Active Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.

Official Title
-----------------
Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Profermin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of UC based on clinical, endoscopic and histological features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI) (Table 1) score above 4 and below 12. - Exclusion Criteria: Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Profermin<br>Daily oral intake of a food for special medical purposes (Profermin) | Other: Profermin<br>* Medical Food (food for special medical purposes)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%. | Daily report of SCCAI symptoms on the Internet | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5 | Daily report of SCCAI symptoms on the Internet | 24 weeks |
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease

Study Overview
=================
Brief Summary
-----------------
WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.

Official Title
-----------------
A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease

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

Intervention / Treatment
-----------------
* Drug: WVE-120102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient successfully completed the Phase 1b/2a study with WVE-120102, WVE-HDSNP2-001. Exclusion Criteria: Received an investigational drug other than WVE-120102, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer. Inability to undergo brain MRI (with or without sedation). Clinically significant medical finding on the physical examination other than HD that, in the judgment of the Investigator, will make the patient unsuitable for participation in and/or completion of the study procedures.
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: WVE-120102 (Dose A)<br> | Drug: WVE-120102<br>* WVE-120102 is a stereopure antisense oligonucleotide. It is administered monthly via intrathecal injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) |  | Day 1 to Study Termination (maximum of 12 monthly doses) | 
| Safety: Number of Patients With a Severe TEAE |  | Day 1 to Study Termination (maximum of 12 monthly doses) | 
| Safety: Number of Patients With Serious TEAEs |  | Day 1 to Study Termination (maximum of 12 monthly doses) | 
| Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs |  | Day 1 to Study Termination (maximum of 12 monthly doses) |
Januvia Re-examination Study (MK-0431-181)

Study Overview
=================
Brief Summary
-----------------
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Sitagliptin
* Drug: Sulfonylurea
* Biological: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus Treated With Januvia within local label for the first time Exclusion Criteria: Contraindication to Januvia according to the local label Treated with Januvia before contract and out of enrollment period Inclusion criteria for long-term surveillance Treated with Januvia for more than or equal to 24 weeks
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years) | Drug: Sitagliptin<br>* Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label<br>* Other names: Januvia;Drug: Sulfonylurea<br>* Sulfonylurea administered in general use according to the local label<br>Biological: Insulin<br>* Insulin administered in general use according to the local label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with any adverse experience |  | up to 14 days following cessation of treatment | 
| Mean change in Hemoglobin A1c (HbA1c) |  | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment | 
| Mean change in fasting plasma glucose (FPG) |  | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment | 
| Mean change in 2hr-postprandial glucose (PPG) |  | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment |
Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for renal injury due to the toxic effect of contrast agents. Patients developing renal dysfunction after primary angioplasty have worse outcome. To investigate the role of the antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized 352 consecutive patients undergoing primary angioplasty into three groups: the first group received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty, followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily for 48 hours; n=118), and the last group received placebo (controls; n=119).

Conditions
-----------------
Contrast-Induced Nephropathy, Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: intravenous and oral N-acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Consecutive patients admitted to the Coronary Care Unit for ST-segment elevation acute myocardial infarction undergoing primary angioplasty. Patients were included if they presented within 12 hours (18 hours for acute myocardial infarction complicated by cardiogenic shock) from the onset of symptoms. - Exclusion Criteria:Patients in chronic peritoneal or hemodialytic treatment and those with known allergy to N-acetylcysteine. -

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

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

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

| Intervention/Treatment |
| --- |
|Drug: intravenous and oral N-acetylcysteine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of contrast-induced nephropathy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital major clinical adverse events including death |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast-induced nephropathy, Acute myocardial infarction, Primary coronary angioplasty