linjc16/ctgov huggingface dataset:
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.

Official Title
-----------------
A Placebo-Controlled, Randomized, Two-Way Cross-Over, Double-Blind, Flexible Dose, Multicenter Study to Evaluate the Efficacy and Safety of Viagra in Male Patients With Traumatic Spinal Cord Injury and Erectile Dysfunction

Conditions
-----------------
Spinal Cord Injury, Erectile Dysfunction, Spinal Cord Trauma, Injuries, Spinal Cord, Impotence

Intervention / Treatment
-----------------
* Drug: sildenafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients were men with spinal cord injury and erectile dysfunction Exclusion Criteria: -N/A

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: sildenafil<br>* sildenafil 50 mg tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks; after 2 weeks on treatment, doses could be escalated to 100 mg or reduced to 25 mg<br>|
| Placebo Comparator: Arm 2<br> | Drug: placebo<br>* placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections |  | Weeks 6 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to the International Index of Erectile Function (IIEF) |  | Weeks 0, 6, 8, and 14 | 
| Responses to the Global Efficacy Assessment (GEA) Question |  | Weeks 0, 6, 8, and 14 | 
| Responses to questions on the Quality of Life (QoL) Questionnaire |  | Weeks 0, 6, 8, and 14 | 
| Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions |  | Weeks 0, 6, 8, and 14 | 
| Intercourse success rate derived from patient event log |  | Weeks 0, 6, 8, and 14 |
S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues

Study Overview
=================
Brief Summary
-----------------
Surgical site infections (SSI) are a significant clinical issue that requires the use of a great amount of resources. In particular, periprosthetic joint infections (PJIs) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. National surveillance estimates may under-report the true incidence and when considering the large number of total hip (THA) and total knee arthroplasty (TKA) procedures performed each year. Patients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. The association between a patient's nasal carriage of S. aureus, specifically MRSA, and PJI has been demonstrated in a systematic review and confirmed in recent cohort studies. While this association seems to be well accepted, no mechanistic explanation has been provided for this association.

Official Title
-----------------
Staphylococcus Aureus Translocation From Skin and Nose to Periprosthetic Tissues

Conditions
-----------------
Staphylococcus Aureus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible Exclusion Criteria: Patients included in other prospective studies

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 |
| --- | --- | --- |
| S. aureus Culture and Next Generation Sequencing | Diagnostic performance of molecular and culture techniques for S. aureus screening using nasal and groin swabs to determine whether the S. aureus retrieved on the skin and nares of patients who develop a joint infection is identical to the bacteria found in the wound of the PJI | 1 day |
Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus

Study Overview
=================
Brief Summary
-----------------
In the proposed pilot project, MRI data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. Patients will be selected from those undergoing GPi DBS placement. This pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3T targeting study to improve outcomes and decrease complications in GPi DBS placement. Improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.

Official Title
-----------------
Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus: Functional Segmentation Based on Probabilistic Tractography

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: DBS Programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)

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: GPi DBS<br>Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue. | Device: DBS Programming<br>* DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III) | Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, Deep Brain Stimulation, Diffusion Tensor Imaging
Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation

Study Overview
=================
Brief Summary
-----------------
A systematic evaluation of predictors of health related quality of life (HRQoL) leads to multiple level of data analysis. The aim of the herein described observational project is to create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally predictors of HRQoL after different types of solid organ transplantation in the long-term. A sample size of 700 participants consisting of all solid organ types is envisioned. Data will be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may guide development of tailored interventions to reduce complications and to further improve outcomes.

Official Title
-----------------
Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study

Conditions
-----------------
Organ Transplantation, Anxiety, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Follow-up at our outpatient clinics Written informed consent Sufficient German language skills to read and answer a battery of questionnaires Min 18 years Exclusion Criteria: Illiteracy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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>Kidney-Tx-recipients | |
| 2<br>Liver-Tx-recipients | |
| 3<br>Heart-Tx-recipients | |
| 4<br>Lung-Tx-recipients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQoL after transplantation |  | 5 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social re-integration |  | 5 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, adverse effects
A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil

Study Overview
=================
Brief Summary
-----------------
In the present study, it is planned to observe a population of 100 ED patients treated previously with udenafil and for whom their physician decided to switch them to sildenafil because of poor udenafil tolerance and/or poor efficacy.

Official Title
-----------------
Non-Interventional, Prospective Study Of the Evaluation Of Patients Population With ED, Treated With Sildenafil

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged ≥ 18 years. Clinical diagnosis of erectile dysfunction supported by a total score of less than or equal to 21 according to Sexual Health Inventory-Male (SHI-M). Patients having a sexual partner throughout the study. Patients having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks. Exclusion Criteria: The patients for whom sildenafil is contraindicated according to the Local Product Document (LPD). (See appendix D) The patients for whom sexual activity is not indicated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with erectile dysfunction (ED)<br>100 ED patients in the study that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated | Drug: sildenafil<br>* tables, 25,50,100 mg, on demand, 1 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe the treatment satisfaction of ED patients (sum of questions 13-14 IIEF) that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction udenafil sildenafil treatment satisfaction
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Detailed Description
-----------------
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal. Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Official Title
-----------------
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Conditions
-----------------
Postpartum Hemorrhage, Blood Loss

Intervention / Treatment
-----------------
* Drug: carbetocin
* Drug: Syntometrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants are at 37 - 40 weeks of gestational age Noncomplicated pregnancy. Exclusion Criteria: Participants with placenta previa Patients with coagulopathy preeclamptic women known sensitivity to oxytocin or methergine were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carbetocin<br>single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal. | Drug: carbetocin<br>* Oxycontin analogue<br>* Other names: Pabal;|
| Active Comparator: Syntometrine<br>Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal. | Drug: Syntometrine<br>* Uterotonins<br>* Other names: Oxytocin methergine combination;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of post partum hemorrhage after CS | Number of participants experienced postpartum hemorrhage | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects of drugs used | Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbetocin, syntometrine, postpartum hemorrhage, cesarean section
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod

Official Title
-----------------
An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: imiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have one superficial BCC - primary tumour Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm. If female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception. Exclusion Criteria: Evidence of clinically significant, unstable medical conditions. Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site. Have received defined treatments in tumour site or surrounding area. Any dermatological disease in the target tumour site or surrounding area. Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and cosmetic outcome of once daily 5 days per week dosing for 6 weeks with imiquimod 5% cream in the treatment of sBCC |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aldara, Superficial Basal Cell Carcinoma, Long-Term Study
Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities

Study Overview
=================
Brief Summary
-----------------
This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have foot-drop. The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.

Official Title
-----------------
Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: Ankle-bot
* Other: Conventional focused ankle therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of MS EDSS level between 3.5 - 6.0 Unilateral foot-drop Able to ambulate 25 ft. with no more than a unilateral assistive device Exclusion Criteria: Lower extremity injuries that limit range of motion or function Unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment Unable to fit safely and properly into the Ankle-Bot device

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Ankle-Bot Training<br>Subjects in this group receive focused ankle training using the ankle-bot device. | Device: Ankle-bot<br>* The Ankle-bot is a piece of robotic therapy equipment for the ankle. In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion.<br>|
| Active Comparator: Conventional Therapy<br>Subjects in this group will receive conventional focused ankle physical therapy. | Other: Conventional focused ankle therapy<br>* Conventional focused ankle therapy will be performed by a physical therapist.<br>|
| No Intervention: Control<br>Subjects in this group will not receive treatment; they will continue their usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Parameters |  | Baseline, throughout study enrollment, and at 1 month and 3 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Gait, foot-drop, Ankle-Bot, Physical Therapy, Gait Abnormalities