linjc16/ctgov huggingface dataset:
Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by: Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines. Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI

Official Title
-----------------
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.

Conditions
-----------------
Patients Suitable for THA

Intervention / Treatment
-----------------
* Device: ASR hip prosthesis
* Device: ReCap hip prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II,DEXA-scanning: lower limit for a 55 years old women, MRI normal vitality in caput willing to return for follow-up evaluations. Exclusion Criteria: collum femoris < 2 cm large cysts in caput (> 1 cm) mismatch between caput and acetabulum caput necrosis treatment with medicine which affects bone metabolism impaired kidney function.

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 |
| --- | --- |
| Active Comparator: ASR hip prosthesis<br>DuPuy ASR hip prosthesis | Device: ASR hip prosthesis<br>* Implantation of resurfacing prosthesis<br>* Other names: DuPuy ASR hip prosthesis;Device: ReCap hip prosthesis<br>* Implantation of resurfacing prosthesis<br>* Other names: Biomet ReCap hip prosthesis;|
| Active Comparator: ReCap hip prosthesis<br>Biomet ReCap hip prosthesis | Device: ReCap hip prosthesis<br>* Implantation of resurfacing prosthesis<br>* Other names: Biomet ReCap hip prosthesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up. | follow with intervals of 1 to 3 years for determination of function and prosthesis survival | 10 year follow up |
Effects of Increased Muscle Mass on Resting Metabolic Rate

Study Overview
=================
Brief Summary
-----------------
Healthy males are randomized to isometric exercise for three months with either extra protein or extra calories in the form of a fast food meal/day in order to study if increase in muscle mass increases resting metabolic rate and if this is affected by presumed increased caloric intake as compared with only proteins. Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured by registration of CO2 production and O2 consumption.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Procedure: Isometric exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males Exclusion Criteria: significant disease inability to exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: extra protein supplement<br>isometric training with addition of extra protein | Procedure: Isometric exercise<br>* Isometric exercise several times/week for three months<br>|
| Active Comparator: extra food supplement<br>isometric exercise with addition of extra food and calories: one fast food meal/day | Procedure: Isometric exercise<br>* Isometric exercise several times/week for three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in resting metabolic rate | measurement of resting metabolic rate at baseline and at the end of the three month trial period | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle mass | measurement of muscle mass with DEXA at baseline and at the end of the three month trial period | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resting metabolic rate
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Inflammatory reaction in different compartments of the body may have a negative effect on outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.

Official Title
-----------------
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective lobectomy elective segmentectomy 20-90 years informed consent given Exclusion Criteria: emergency operations pneumonectomy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| 1<br>lobectomy / segmentectomy in patients with lung cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels in blood, bronchial lavage fluid and pleural fluid |  | 2 years | 
| Correlation between cytokine levels and pulmonary morbidity |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265) |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lobectomy, inflammatory reaction, intrapulmonary, intrapleural
Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

Study Overview
=================
Brief Summary
-----------------
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.

Detailed Description
-----------------
Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient. The therapeutic support and monitoring are standard.

Official Title
-----------------
Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Patient with breast cancer proved by histology and treated surgically 2. Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age ≥ 18 years 4- Information and no opposition to the patient Exclusion Criteria: - Metastatic disease - Patient having another severe disease or uncontrolled which could jeopardize the trial participation - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute and tardive toxicity according to NCI-CTCAE v4.0 | according to NCI-CTCAE v4.0 | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life according to QLQC-30 | Quality of life according to QLQC-30 | up to 24 months | 
| Quality of life according to BR-23 module | Quality of life according to BR-23 module | up to 24 months | 
| Disease free survival | according to RECIST 1.1 | up to 5 years | 
| esthetic results | by physician and patient according to a scale (good, excellent, moderate and poor) | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, radiotherapy, intensity modulation, toxicity
Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. lidocaine gel alone in the management of pain during endouterine manual aspiration.

Official Title
-----------------
Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration

Conditions
-----------------
Pain, Abortion, Spontaneous

Intervention / Treatment
-----------------
* Drug: Lidocain topical + paracervical blockade
* Drug: Lidocaine topical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding). Exclusion Criteria: Allergy to lidocain
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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine + paracervical blockade<br>5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade. | Drug: Lidocain topical + paracervical blockade<br>* 5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade<br>|
| Experimental: Lidocaine<br>5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied. | Drug: Lidocaine topical<br>* 5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global evaluation of pain | Visible scale of pain evaluation | 5 minutes post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reaction | Presence of adverse effects to the drug used (lidocaine gel) | 5 minutes post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.

Official Title
-----------------
A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy

Conditions
-----------------
Prostatic Neoplasms, Prostatectomy

Intervention / Treatment
-----------------
* Drug: tamsulosin 0.4mg
* Other: No medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have localized or locally advanced prostate cancer Patients must receive robot assisted laparoscopic radical prostatectomy Patients must be able to provide written informed consent Exclusion Criteria: Patients must not have a history of treatment with alpha blockers within 4 weeks Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate Patients must not have previously been diagnosed with neurogenic bladder Patients must not have hypersensitivity to trial drug or other alpha-blockers Patients must not have the participation of other clinical trial within the past 3 months
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin 0.4mg<br>Perioperative tamsulosin 0.4mg daily | Drug: tamsulosin 0.4mg<br>* perioperative tamsulosin 0.4mg daily for three weeks<br>|
| Placebo Comparator: Control<br>No medication | Other: No medication<br>* No medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute urinary retention |  | within the 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes |  | 20 days after surgery (plus or minus 3 days) |
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects

Study Overview
=================
Brief Summary
-----------------
In order to evaluate the effect of CYP3A5*3 allele on the pharmacokinetics of sildenafil, udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined.

Detailed Description
-----------------
The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokinetics(PK) of sildenafil, udenafil, and vardenafil in healthy male subjects. Twenty one healthy male subjects with CYP3A5*1/*1, *1/*3, or *3/*3 were enrolled. An open-label 3-way crossover study was performed with a week washout. A single oral dose of PDE5I (100 mg sildenafil; 200 mg udenafil; 20 mg vardenafil) was administered, respectively. After a single oral dose of phosphodiesterase type 5 inhibitor (PDE5I), plasma levels of the parent and the major metabolite were measured up to 24 or 48 h.

Official Title
-----------------
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects

Conditions
-----------------
Pharmacokinetics of Three PDE5Is, Healthy Subjects, Genetic Polymorphic CYP3A5

Intervention / Treatment
-----------------
* Drug: phosphodiesterase type 5 inhibitor
* Drug: phosphodiesterase type 5 inhibitor
* Drug: phosphodiesterase type 5 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject whose CYP3A5 genotype was determined Exclusion Criteria: Subject whose CYP3A5 genotype was not determined

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Vardenafil | Drug: phosphodiesterase type 5 inhibitor<br>* single oral administration of 20mg vardenafil<br>* Other names: vardenafil;|
| Active Comparator: B<br>Sildenafil | Drug: phosphodiesterase type 5 inhibitor<br>* single oral administration of 100mg sildenafil<br>* Other names: sildenafil;|
| Active Comparator: C<br>Udenafil | Drug: phosphodiesterase type 5 inhibitor<br>* single oral administration of 200mg udenafil<br>* Other names: udenafil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUC |  | upto 24hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP3A5, sildenafil, udenafil, vardenafil
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Official Title
-----------------
Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Lanreotide (Autogel formulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documentation of a diagnosis of active acromegaly based on either of the following definitions: the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a) Exclusion Criteria: receipt of radiotherapy for acromegaly within 3 years pituitary surgery within 3 months prior to visit 1 prior receipt of lanreotide autogel or GH antagonist anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period known hypersensitivity to any of the test materials or related compounds clinically significant renal or hepatic abnormalities

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: Lanreotide (Autogel formulation)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal |  |  |