linjc16/ctgov huggingface dataset:
Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH. Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of SL77.0499-10 Once Daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH)

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: SL77.0499-10 (alfuzosin hydrochloride)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suffering from LUTS related to BPH for at least 6 months; having an IPSS >13; having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL; having a residual urine volume < or = 200 mL.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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: SL77.0499-10 (alfuzosin hydrochloride)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit. |  |  | 
| Safety: adverse events, vital signs, laboratory tests. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary tract
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Study Overview
=================
Brief Summary
-----------------
Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.

Official Title
-----------------
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Conditions
-----------------
Revision Total Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used Cases with at least 2 year follow-up Cases with regular follow-up visits completed Exclusion Criteria: Cemented sleeves Patients with less than two year follow-up completed Cases lost to follow-up

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survivorship 2 years following revision TKA |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score |  |  | 
| KOOS score |  |  | 
| Radiographic assessment 1 and 2 years following revision surgery |  |  |
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.

Official Title
-----------------
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

Conditions
-----------------
Breast Cancer, Arthralgia

Intervention / Treatment
-----------------
* Behavioral: Exercising block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month. Patients must complain of mild to moderate arthralgia. Ability to understand and sign informed consent. Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines. Exclusion Criteria: Inability to comply with study requirements. Metastatic breast cancer. Patients with orthopedic or neuromuscular disorders that preclude participation in exercise. Rheumatoid arthritis. History of MI, angina or congestive heart failure. Pregnant or lactating females. Patients that are high risk for moderate exercise based on ACSM risk classification. Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week. Morbidly obese with BMI ≥ 40

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Subjects will be participating in a home-based flexibility and exercise program | Behavioral: Exercising block<br>* Exercising for 8 weeks using an elastic band<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of exercise | To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors. | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Multi-institutional study | To perform a pilot to access the feasibility of a multi-institutional approach | Length of the study |
Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Parallel Pilot Clinical Trial to Study the Efficay of a Treatment of Lactulose + Vitamin D + Calcium 0.5 g Concurrently Controlled With a Standard Treatment (Vit D + Calcium) in Bone Mass Preservation Among Postmenopausal Women

Conditions
-----------------
Osteopenia

Intervention / Treatment
-----------------
* Drug: Lactulose, Vitamin D, Calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged between 55 and 65 years old; postmenopausal who have amenorrhea for 5 or more years; women with the diagnosis of osteopenia defined DMO -1,5 to -2,5 Exclusion Criteria: Any disease causing osteopenia (hyperthyroidism, hyperparathyroidism, hypercortisolism, osteogenesis imperfecta, rheumatoid arthritis, homocystinuria, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactulose, Vitamin D, Calcium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mass preservation by bone densitometry values in 1 year period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evolution of bone remodelling parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lactulose; randomised clinical trial; osteopenia; postmenopause
Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.

Official Title
-----------------
Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)

Conditions
-----------------
Primary Brain Tumor, Epilepsy

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years suspected primary brain tumor by imaging planned bioptical or cytoreductive surgery of the tumor symptomatic epilepsy Karnofsky performance score ≥ 70% women with child bearing potential must perform sufficient contraception sufficient haematologic, hepatic and renal function by laboratory testing Exclusion Criteria: treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery known allergic reaction to levetiracetam or other serious side effects known, not tumor-induced, epilepsy previous brain surgery dementia participation in another clinical trial addiction to drugs or alcohol pregnant or breast feeding women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: levetiracetam<br>* oral and intravenous dosing 2000-3000 mg per day<br>* Other names: Keppra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention. |  | 1 year |
Ocular Manifestations of Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Ocular damage is found in the 3rd rank of extra intestinal manifestations (MEI) Potentially serious functional complications (see uveitis and risk of blindness) requiring rapid management Rare uveitis in the literature (0.5% -3%), study on a large sample to assess their prevalence in patients with IBD at the Nancy CHRU and describe all the ocular manifestations that can be found.

Official Title
-----------------
Ocular Manifestations of Chronic Inflammatory Bowel Disease (IBD): Retrospective Study in the Hepato-gastroenterology Department of the Nancy CHRU

Conditions
-----------------
Inflammatory Bowel Diseases, Ophthalmopathy

Intervention / Treatment
-----------------
* Other: reason for consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department Exclusion Criteria: Minor patients patients without IBD patients for whom there is no ophthalmology consultation

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 |
| --- | --- |
| patients with chronic inflammatory bowel disease who consulted in ophthalmology<br> | Other: reason for consultation<br>* search in medical files for reasons for ophthalmology consultation, functional signs, clinical signs, treatment, characteristics of IBD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency | frequency of ocular manifestations in inflammatory bowel disease | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number | Number of uveitis, scleritis and episcleritis; prevalence calculation | baseline |
Evaluation of a Food Supplement on Sleep Quality

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: cyclamax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer aged between 25 to 65 years Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale) Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale) Patient affiliated to the French Social Security Patient who gave written informed consent Exclusion Criteria: Secondary insomnia History of severe psychiatric disorder, assessed by the MINI test Resistance to Hypnotic drugs Anxiety, depression, suicide, detected by the Beck Depression Inventory Acute Pathology during the precedent three years Breast feeding and pregnancy women Non compliant volunteer Hypersensibility to treatment composant

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal |  |  | 
| Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants |  |  | 
| Sleep efficiency measured by ambulatory actigraphy (2 period) |  |  | 
| Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment) |  |  | 
| Clinical General Impression of the clinician, before and after treatment. |  |  | 
| Safety of the treatment (adverse event reporting) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
actigraphy, Sleep quality, food supplement, randomized controlled trial, Leeds, Volunteers presenting moderate primary insomnia
Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.

Official Title
-----------------
Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants

Conditions
-----------------
Non-Valvular Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date Patients 18 years old or older as of the index date At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim At least 12 months of baseline period prior to index date with continuous enrollment Exclusion Criteria: Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date Evidence of pregnancy during the study period Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period Had more than 1 oral anticoagulant claim on the index date

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 |
| --- | --- |
| NVAF patients on Warfarin<br>NVAF patients newly initiated with Warfarin. Non-Interventional. | |
| NVAF patients on Apixaban<br>NVAF patients newly initiated on Apixaban. Non-Interventional. | |
| NVAF patients on Dabigatran<br>NVAF patients newly initiated with Dabigatran. Non-Interventional. | |
| NVAF patients on Rivaroxaban<br>NVAF patients newly initiated with Rivaroxaban. Non-Interventional. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first major bleeding event |  | Up to 33 months | 
| Time to first stroke/systemic embolism (SE) event |  | Up to 33 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding-related medical costs |  | Up to 33 months | 
| Stroke/SE-related medical costs |  | Up to 33 months | 
| All-cause Healthcare costs |  | Up to 33 months |
Validation of a Smartphone App for Anemia Screening Among General Population

Study Overview
=================
Brief Summary
-----------------
The current standard for anemia screening, complete blood count, presents invasiveness, infrastructure requirements and high costs, leading to serious underestimation of anemia prevalence and insufficient care for anemia patients. Here, the investigators established and validated an artificial intelligence system to achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. This system has been integrated into a smartphone app to be further validated through hospital-based and population-based clinical trials.

Official Title
-----------------
Validation of a Smartphone App for Anemia Screening Among General Population: A Clinical Trial

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Device: A smartphone app for anemia screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be aware of the contents and signed for the informed consent. Exclusion Criteria: Patients who underwent ophthalmic or fingernail surgery in the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 87 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 |
| --- | --- |
| Experimental: Eligible patients for app-based anemia screening<br>Device: A smartphone app for anemia screening This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. | Device: A smartphone app for anemia screening<br>* This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and missed detection of this smartphone app. |  | 27 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smartphone app, Artificial intelligence, Public health