linjc16/ctgov huggingface dataset:
Functional Outcome After Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Bipolar hemiarthroplasty (BA) has long been the preferred treatment and is performed in most fracture neck of femur (FNF) cases. It is justified by the reasonable operative time, low blood loss and acceptable functional outcomes. The dual mobility cup total hip replacement (DMTHA) has emerged as a relevant alternative to BA. Since then, there is an on-going debate on the best implant to use. Age, co-morbidities, patient independence and potential surgical complications must be considered when deciding between implants. The risk of dislocation is a crucial factor because of its important consequences. The investigators evaluated the functional and mechanical outcomes of BA versus DMTHA in FNF in active elderly patients.

Official Title
-----------------
Functional Outcome After Dual Mobility Cups Total Hip Replacement Versus Bipolar Hemiarthroplasty in Fracture Neck of Femur in Active Elderly Patients

Conditions
-----------------
Fracture Neck of Femur

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active patients displaced fracture neck of femur age from 60 to 80 Exclusion Criteria: ipsilateral previous hip surgery grade 3 hip osteoarthritis according to tonnis classifiction dysplastic acetabulum

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bipolar hemiarthroplasty group<br> | Procedure: arthroplasty<br>* arthroplasty for fracture neck of femur<br>|
| Active Comparator: Dual mobility cups total hip replacement group<br> | Procedure: arthroplasty<br>* arthroplasty for fracture neck of femur<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome using the Harris hip score | hip joint range of motion and activities of daily living | 2 years | 
| rate of dislocation | postoperative prosthesis dislocation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time in minutes | the time needed to perform the procedure | 45 minutes to 2 hours | 
| blood loss in cc | the amount of blood loss during the procedure | during the procedure |
A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

Study Overview
=================
Brief Summary
-----------------
To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

Official Title
-----------------
A 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients who are eligible and able to participate in the study 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: 18 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 diastolic blood pressure after 26 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 26 weeks |  |  | 
| Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks |  |  | 
| Change from baseline in systolic blood pressure after 6 weeks and 12 weeks |  |  | 
| Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Official Title
-----------------
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

Conditions
-----------------
Small-cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: HLX07
* Drug: HLX10
* Drug: carboplatin and etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system) No prior systemic therapy for ES-SCLC Major organs are functioning well Participant must keep contraception Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC Known history of severe allergy to any monoclonal antibody Known hypersensitivity to carboplatin or etoposide Pregnant or breastfeeding females Patients with a known history of psychotropic drug abuse or drug addiction Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment

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: HLX07+HLX10+Chemotherapy<br>HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide) | Drug: HLX07<br>* HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.<br>Drug: HLX10<br>* HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.<br>Drug: carboplatin and etoposide<br>* chemotherapeutics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate by investigator assessment per RECIST 1.1 | up to 2 years | 
| PFS | Progression-free survival by investigator assessment per RECIST v1.1 | Up to 2 years |
Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Although there is no evidence that individuals with type 1 diabetes have a different approach to alcohol compared to the background population, nevertheless, its use does have implications for patients mainly because of the risk of hypoglycaemia unawareness. However, binge drinking has been implicated as a factor in the development of ketoacidosis and is probably under-recognised. The aim of this study is to examine the effect of binge drinking on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type 1 diabetes. It is hoped that data from this project will be used to develop a larger study comparing different treatment regimens for patients using alcohol to reduce the risks of hyperglycaemia as well as hypoglycaemia.

Detailed Description
-----------------
This is a randomised trial involving Type I diabetics who have had Type I diabetes >5 years. They will be using multiple daily injections of a basal insulin and a rapid acting component.Apart from insulin and oral contraceptive, none will be on regular medication. All will be regular consumers of modest amount of alcohol (Female - less than or equal to 14 units, males - less than or equal to 21 units). Each will participate in 2 studies. Subjects will be randomised either to white wine or an equivalent volume of alcohol-free wine.Outcome measures are the results of the effect of acute ingestion of alcohol on glucose levels and intermediate metabolites in subjects with Type I diabetes.

Official Title
-----------------
Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study

Conditions
-----------------
Diabetes Mellitus, Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for > 5 years Use of multiple daily injections of a basal insulin and a rapid acting component Regular consumption of modest amounts of alcohol Exclusion Criteria: Type 2 diabetes Type I diabetes < 5 years Excessive alcohol consumption Unstable diabetes

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 |
| --- | --- | --- |
Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.

Official Title
-----------------
A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: CP-675,206
* Drug: SU011248
* Drug: CP-675,206
* Drug: SU011248


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven renal cell carcinoma with metastases Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 Exclusion Criteria: Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: CP-675,206<br>* CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.<br>Drug: SU011248<br>* SU011248 administered at a dose of 37.5mg/day every day.<br>|
| Experimental: Arm B<br> | Drug: CP-675,206<br>* CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.<br>Drug: SU011248<br>* SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug |  | 6 weeks after first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported |  | 18 months | 
| To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination |  | up to 18 months | 
| To monitor for an antibody response to CP-675,206 |  | up to 18 months | 
| To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled |  | 6-18 months after last subject enrolled |
Laparoscopic Surgical Management of Endometriosis on Fertility

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.

Official Title
-----------------
Study of the Impact of Laparoscopic Surgical Management of Endometriosis on Fertility

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014. Exclusion Criteria: Patients under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: retrospective study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| benefit of endometriosis surgery on fertility : occurrence of pregnancy or live birth, spontaneous or after use of a MPA technical |  | after surgery, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, fertility, endometriosis surgery
Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to test the feasibility of a protocol of enhanced recovery after surgery for reducing the total length of hospital stay in a large scale setting

Detailed Description
-----------------
This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac.

Official Title
-----------------
Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: ERAS (Enhanced recovery after surgery)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese patients undergoing a sleeve gastrectomy Patients having signed the informed consent Patients over 18 year old ASA 1-3 Obesity with indication for surgery according the guidelines of the French High Authority for Health BMI < 50 kg/m2 No contra-indication for general anesthésia Exclusion Criteria: contra-indication for general anesthésia Age under 18 years ASA 4 BMI > 50 kg/m2 Patients having other serious comorbidities: cardiac, pulmonary, diabete, immunodepression, coagulopathy ou anticoagulant therapy Pregnancy Patients living alone

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERAS (Enhanced recovery after surgery)<br>This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac | Procedure: ERAS (Enhanced recovery after surgery)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | Posoperative day when the patients satisfies the criteria of discharge | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enhanced recovery,, sleeve gastrectomy,
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G Coronary Stent to reduce restenosis in the coronary artery.

Official Title
-----------------
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

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

Intervention / Treatment
-----------------
* Device: Coronary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery. Patient must be an acceptable candidate for coronary artery bypass surgery. Patient must have given signed informed consent. Patient agrees to return at one month for an office visit to assess cardiovascular status and at 4-6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram. Exclusion Criteria: Patient is less than 18 years old. Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. The patient is simultaneously participating in another investigative interventional cardiovascular device or drug study. Patient has known hypersensitivity or contraindication to aspirin, Clopidogrel, or stainless steel, or a sensitivity to contrast dye that. Patient is pregnant. Patient has other medical condition that may cause the patient to be non-compliant with the protocol, confound the results or is associated with limited life expectancy.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coronary stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-stent % diameter at follow-up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events |  |  | 
| Total lesion revascularization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery, stenosis, drug eluting stent, stent
Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea

Study Overview
=================
Brief Summary
-----------------
Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact. This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: COPD
* Other: COPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD with dyspnoea with Medical Research Council scale (MRC) >1, No exacerbation for 6 weeks No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility. Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit Having given a written consent Exclusion Criteria: Patient Under 18 Other respiratory illness Clinically significant left cardiac failure Obesity with BMI > 35 kg / m2) Unable to perform respiratory evaluations Contraindication to the salbutamol or to the ipratropium bromide or to one of its components Pregnant or breast-feeding woman Unable to agree No social security scheme

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD<br> | Other: COPD<br>* Plethysmography<br>Other: COPD<br>* Forced oscillations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of obstruction reversibility |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance, Forced oscillations, Dyspnea