linjc16/ctgov huggingface dataset:
Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %. Another purpose is to investigate whether patients with diabetes have a worse and more painful frozen shoulder than patients without diabetes, and whether the diabetes have an influence on the prognosis.

Detailed Description
-----------------
Patients who are not diagnosed with diabetes would be ask to give a blood sample to investigate if they have an unknown diabetes. All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder Score) to clarify how bad their frozen shoulder is. All patients will receive the questionnaire 6 and 24 month following the date on inclusion.

Official Title
-----------------
Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

Conditions
-----------------
Diabetes Mellitus, Frozen Shoulder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newly referred patients who is being diagnosed with frozen shoulder - Exclusion Criteria: age below 25 or above 75, pt. who don't read or understand danish, not danish citizen, patients with mental illness, pt. with a abuse of alcohol or substances, pregnancy, pt. who within 4 months have been injected with adrenocortical hormone, arthrosis in the glenohumeral joint, avascular necrosis of caput humeri, rotator cuff lesion. -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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 |
| --- | --- |
| Patient with diabetes<br>Patients who have been diagnoses with diabetes. | |
| Patients without diabetes<br>Patients who have not previous been diagnosed with diabetes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of known and unknown diabetes diabetes |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes influence on the prognosis of frozen shoulder | how the status of diabetes influence the prognosis of frozen shoulder. The patient will be asked to fill out oxford shoulder score at the time of inclusion and at 6 and 24 months follow-up. The two groups (patients with and without diabetes) will be compared using the oxford shoulder score. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, frozen shoulder, adhesive capsulitis
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

Detailed Description
-----------------
This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: Clomipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent for subjects and partdners Men 20-65 stable monogamous relation at least for 6 mn PEDT more than 9 at least 6 Mn of premature ejaculation Hx IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period Exclusion Criteria: Hx of medical or psychiartric illness erectile dysfunction (<21 IIEF EF domain score) or other forms of sexual dysfunction Partner sexual dysfunction known hypersensitivity to clomipramine and contraindications for clomipramine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PED 0<br>placebo | Drug: Clomipramine<br>* 15mg and 30mg on demand<br>* Other names: PED-2;|
| Experimental: PED 1<br>PED-1 (clomipramine 15mg) | Drug: Clomipramine<br>* 15mg and 30mg on demand<br>* Other names: PED-2;|
| Experimental: PED-2<br>PED-2 (Clomipramine 30mg) | Drug: Clomipramine<br>* 15mg and 30mg on demand<br>* Other names: PED-2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fold cahnges of Intraviginal ejaculation latency time (IELT) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug coitus interval time |  | 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PE, IELT, DCIT
A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.

Detailed Description
-----------------
There is no consensus about management of acute traumatic primary patellar dislocations in young physically active adults. Acute lateral patellar dislocation is a relatively common injury among young adults. Proper treatment for this condition has been researched for decades. However, there is a lack of prospective randomized studies to evaluate the different treatment options for traumatic primary patellar dislocations. Therefore a prospective, randomized study was designed with the aim to compare the outcome of operative versus nonoperative treatment of primary traumatic patellar dislocations in young adults.

Official Title
-----------------
A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation in Young Adults With a Median 7-Year Follow-Up

Conditions
-----------------
Patellar Dislocation

Intervention / Treatment
-----------------
* Procedure: proximal patellar surgery
* Procedure: Nonoperative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An acute primary traumatic patellar dislocation Exclusion Criteria: Previous dislocation or subluxation of the patella Pre-existing ipsilateral or contralateral knee pathology Previous knee trauma or patellar fracture.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Operative | Procedure: proximal patellar surgery<br>* Initial proximal patellar surgery<br>|
| Experimental: 2<br>Nonoperative | Procedure: Nonoperative<br>* Nonoperative without surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of redislocations |  | 7 years |
BacLite Rapid MRSA Clinical Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.

Official Title
-----------------
BacLite Rapid MRSA Clinical Performance

Conditions
-----------------
Methicillin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 years or older Subjects willing to document demographic characteristics Subjects willing to have their nose swabbed Subjects (or legal representative) willing to sign consent and authorization forms Exclusion Criteria: Subjects who use Vicks Sinex Nasal spray or other nasal sprays Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares Investigator believes that subject is unsuitable for inclusion.

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 |
| --- | --- | --- |
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

Study Overview
=================
Brief Summary
-----------------
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Official Title
-----------------
A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis

Conditions
-----------------
Lice Infestations

Intervention / Treatment
-----------------
* Drug: MALG
* Drug: Ovide (malathion) lotion 0.05%
* Drug: Permethrin 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed active head lice infestation Patient, parent or guardian must be able to apply the treatment Entire household must be screened All infested persons must agree to participate Exclusion Criteria: Allergy to pediculicides, hair care products or chrysanthemums Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Female patients who are pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 2 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MALG | Drug: MALG<br>* 30 minute application<br>|
| Active Comparator: 2<br>Ovide | Drug: Ovide (malathion) lotion 0.05%<br>* 8-12 hour application<br>|
| Active Comparator: 3<br>Permethrin 1% | Drug: Permethrin 1%<br>* 10 minute application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure of Head Lice |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of treatments |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head Lice, Pediculosis capitis
Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD

Study Overview
=================
Brief Summary
-----------------
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF.

Detailed Description
-----------------
Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, SaO2 measurement. Serum Iron and Ferritin levels will be measured before procedure and at follow ups. From 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation. Study endpoints: 9 months post implant or the following: 1)Patients are subjected for surgical repair of CHD; 2)Death before surgical repair; 3)Unplanned re-intervention with additional stenting procedure.

Official Title
-----------------
Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD

Conditions
-----------------
Patent Ductus Arteriosus, Duct-dependent Cyanotic Congenital Heart Disease

Intervention / Treatment
-----------------
* Device: Iron biocorrodable coronary scaffold system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight >3.0 kg Age <3 months Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight Exclusion Criteria: Weight <3 kg, age >3 months Angiographic criteria-tortuous PDA Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis Other severe congenital anomalies with life expectancy <12 months

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBS implantation<br>Implantation of IBS in PDA in duct-dependent cyanotic CHD | Device: Iron biocorrodable coronary scaffold system<br>* Implantation of Iron biocorrodable coronary scaffold system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants for surgical repair of CHD | Patients are subjected for surgical repair of CHD | 9 months | 
| Number of Unplanned re-intervention | Unplanned re-intervention with additional stenting procedure | 9 months | 
| Death | Death before surgical repair | 9 months |
Pharmacovigilance and Patient Compliance in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.

Official Title
-----------------
Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study

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

Intervention / Treatment
-----------------
* Drug: Telmisartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic) Exclusion Criteria: - corresponding to the contraindications listed in the summary of product characteristics of the drug

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 non-secondary, essential hypertension<br> | Drug: Telmisartan<br> <br> * Other names: Micardis®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in heart rate |  | Baseline, up to 8 weeks after start of treatment | 
| Assessment for patients with changes in laboratory values |  | Baseline, up to 8 weeks after start of treatment | 
| Number of patients with adverse events |  | Up to 8 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean systolic and diastolic blood pressure values | Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours | Baseline, up to 8 weeks after start of treatment | 
| Changes in mean systolic and diastolic blood pressure values | Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer | Baseline, up to 8 weeks after start of treatment | 
| Evaluation of treatment compliance as percentage of tablets planned | (number of tablets taken / total number of days) x 100 | Up to 8 weeks after start of treatment |
Epidemiology of Patients Consulting for Original LBP Spinal Adult Emergency

Study Overview
=================
Brief Summary
-----------------
Lumbar pain is an extremely common complaint in general population. The direct and indirect costs incurred in are a real public health problem. Cohort studies show that improving symptoms after consultation for lumbar pain is insufficient, but there are few data on emergency medical and surgical services in France. In order to reflect on areas for improvement the investigators to carry out an inventory of consultations for lumbar pain emergencies of Hautepierre Hospital.

Official Title
-----------------
Epidemiology of Patients Consulting for Original LBP Spinal Adult Emergency Hautepierre and 3 Months Course of Care

Conditions
-----------------
Lumbar Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to adult emergencies in Hautepierre for lumbago pain, with or without sciatica, Age greater than or equal to 18 years Having signed non-opposition to participation in the study Having completed the initial questionnaire Exclusion criteria: Spinal trauma in the month before the consultation Pain of non-spinal origin (pyelonephritis, colic Nephritic, aortic dissection ...) Non-Francophone Patients Patient under tutorship or under curatorship Patient under safeguard of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| current clinical condition, lumbar antecedent and patient care questionnaires | The initial questionnaire focuses on the current clinical condition of the patient and his or her lumbar antecedent. The 3-month follow-up questionnaire focuses on the patient care during this period. | At the time of consultation in the adult emergency department, 3 months after consultation in the adult emergency department |
Role of PET/MRI in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.

Detailed Description
-----------------
This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.

Official Title
-----------------
PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology

Conditions
-----------------
Head and Neck Cancer, Benign Neoplasm, Malignant Neoplasm

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proved Head and neck cancer Underwent PET/CT and PET/MRI Lymph nodes due to primary Head and neck cancer. For healthy subject: No previous history of malignancy. no inflammation or infection in the neck region. lymph node size <10mm. Exclusion Criteria: patients treated before by radiotherapy / chemoradiotherapy patients underwent surgery artifacts

Ages Eligible for Study
-----------------
Minimum Age: 41 Years
Maximum Age: 88 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients underwent PET/CT & PET/MRI<br>Patients with head and neck cancer were underwent PET/CT and PET/MRI for staging, assessment and follow up | Radiation: Radiotherapy<br>* Patients have received radiotherapy as a treatment modality for Head and neck cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Apparent diffusion coefficient value between benign and malignant lesions | Apparent diffusion coefficient (ADC) was measured from benign and malignant lymph nodes by drawing region of interest (ROI) on the most homogeneous and most solid part in the target lymph node. Higher ADC value in Benign lymph node means that there are more water molecules movement inside the lymph node, more water molecules movement resulting in higher Apparent diffusion coefficient value. in malignant nodes and due to more tumor tissue, the result is to have lower water molecules motion so, lower ADC value. | Baseline |