linjc16/ctgov huggingface dataset:
Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.

Official Title
-----------------
Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice

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

Intervention / Treatment
-----------------
* Drug: Vardenafil (Levitra, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization. Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history. No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry. Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation. Exclusion Criteria: Do not follow the contraindications and warnings of the Summary of Product Characteristics.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Group 1<br> | Drug: Vardenafil (Levitra, BAY38-9456)<br>* Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF) |  | After approx 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks |  | After approx. 12 weeks | 
| Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks |  | After approx. 12 weeks | 
| Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks |  | After approx. 12 weeks | 
| Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale |  | After approx. 12 weeks |
ESBL in Patients Returning to Sweden With Traveller's Diarrhoea

Study Overview
=================
Brief Summary
-----------------
Patients with traveller's diarrhoea frequently harbour Extended Spectrum Betalactamase (ESBL)-producing Enterobacteriaceae (EPE) returning from EPE-endemic areas. This study investigates to what extent travellers returning to Sweden with traveller's diarrhoea carry ESBL in their stool. The isolates are examined further according to species, phenotype, antibiogram and whole genome sequencing.

Detailed Description
-----------------
Samples sent to the department of clinical microbiology in Lund, Sweden for culture of salmonella, shigella, yersinia or campylobacter are also cultured selectively for ESBL. All patients are contacted by mail with the results. ESBL-positive patients are invited to submit further faecal cultures and blood samples during one year follow up time, to investigate how long the patient is colonized with ESBL.

Official Title
-----------------
ESBL-producing Enterobacteriaceae in Patients With Traveller's Diarrhoea- a Prospective Cohort Study.

Conditions
-----------------
Antibiotic Resistant Infection, Antibiotic Resistant Strain, Traveler's Diarrhea

Intervention / Treatment
-----------------
* Other: No intervention, observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Travellers diarrhoea foreign traveller Exclusion Criteria: foreign traveller but no symptoms
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESBL carrier<br>This cohort is followed for a year with additional selective ESBL cultures after 1, 3, 6 and 12 months. In the end of the year a questionnaire is handed in to the study group. Sera is donated after 4-6 weeks and in year. | Other: No intervention, observational<br>* See above<br>|
| Non ESBL-carrier<br>No further rectal cultures. In the end of the year a questionnaire is handed in to the study group. Sera is donated after 4-6 weeks and in year. | Other: No intervention, observational<br>* See above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion ESBL-colonized after one year. | Defined as a Positive ESBL-culture obtained 12 months after travel | 1 year |
The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.

Official Title
-----------------
An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch ExperieNCE)

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue Subjects with type 1 diabetes should have been treated with insulin for at least 12 months Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IDet users<br> | Drug: insulin detemir<br>* Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS) |  | Baseline, month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ) |  | Baseline, month 6 | 
| Change in HbA1c (glycosylated haemoglobin) |  | Baseline, month 6 | 
| Change in Fasting blood glucose (FBG) |  | Baseline, month 6 | 
| Change in body weight |  | Baseline, month 6 | 
| Hypoglycaemic episodes |  | Month 6 | 
| Adverse events |  | Month 6 |
Healthcare Access and Utilization Among Living Kidney Donors

Study Overview
=================
Brief Summary
-----------------
This is a mailed survey to persons who served as living kidney donors at Saint Barnabas Medical Center. The experimental component of this study (the clinical trial) is a randomized trial of two monetary incentives for the living kidney donors invited to participate in the study. Kidney donors will be randomized to receive one of two incentives in the mailed survey packet: $2 cash vs. $5 cash. The main outcome measure is the response rate to the survey.

Official Title
-----------------
Randomized Trial of Financial Incentives to Increase Response Rates to a Mailed Survey of Healthcare Access and Utilization Among Living Kidney Donors

Conditions
-----------------
Organ Donor

Intervention / Treatment
-----------------
* Other: $2 cash
* Other: $5 cash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who donated a living donor kidney at Saint Barnabas Medical Center between January 2000 and December 2006 are eligible to participate Exclusion Criteria: Current address outside the continental United States Persons who donated a living donor kidney prior to January 2000 or after December 2006 Persons who indicated they no longer wished to be contacted by Saint Barnabas Medical Center

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: $2 cash incentive<br> | Other: $2 cash<br>* $2 cash incentive will be included in the mailed survey<br>|
| Experimental: $5 cash incentive<br> | Other: $5 cash<br>* $5 cash incentive will be included in the mailed survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey response rate |  | 2 weeks, 2 months (primary), 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
questionnaires, health care surveys/methods, motivation, living donors, living kidney donation
A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer

Study Overview
=================
Brief Summary
-----------------
PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to determine whether treatment with pembrolizumab is effective in patients with advanced clear cell gynaecological cancer.

Official Title
-----------------
A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer

Conditions
-----------------
Clear Cell Tumor, Gynecologic Cancer, Advanced Cancer

Intervention / Treatment
-----------------
* Drug: Pembrolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer. Have measurable disease based on RECIST 1.1. Evidence of radiological disease progression. Patient is willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression. ECOG Performance Status 0 or 1. Patient has a life expectancy of at least 3 months from consent. Received ≥ 1 line of prior chemotherapy . Main Exclusion Criteria: Has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses > 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Has a known history of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive), Hepatitis C or a known history of Human Immunodeficiency Virus (HIV). Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose >10mg predisolone daily or equivalent) or immunosuppressive drugs). Has known history or evidence of active, non-infectious pneumonitis. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Has received a live vaccine within 30 days prior to the planned start of trial treatment.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pembrolizumab<br> | Drug: Pembrolizumab<br>* 3 weekly cycles of Pembrolizumab administered by IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival at 12 weeks |  | 12 weeks |
Effects of Chewing Gum Against Postoperative Ileus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy

Detailed Description
-----------------
Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer. This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Official Title
-----------------
The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection

Conditions
-----------------
Pancreas Neoplasm

Intervention / Treatment
-----------------
* Other: gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy. Exclusion Criteria: 2. Ongoing treatment for mental disease 3. Diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function 4. Ongoing abuse of alcohol or other drugs 5. Previously known allergies to the content of chewing gum 6. Additional surgery after primary surgery.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: normal<br>people will not use chewing gums after whipple operation | Other: gum<br>* Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First flatus after surgery | From day of surgery until first postoperative flatus | (with in the first 21 days) | 
| Length of hospital stay | Time Frame: From day of surgery until discharge from surgical ward | (with in the first 21 days) ] |
Effects and Safety of Metronidazole in Patients With Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Recent study showed that SIBO is common among postgastrectomy patients and It appears to be associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO could be a new therapeutic target for managing intestinal symptoms in postgastrectomy patients.The purpose of this study is to determine whether antiboitic (metronidazole) is effective in patients with postgasrectomy syndrome

Conditions
-----------------
Post Gastrectomy State

Intervention / Treatment
-----------------
* Drug: metronidazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 70 gastrectomy for early gastric cancer with complete resection no reccurrence after follow up more than 6 months identified small bowel bacterial overgrowth by hydrogen breath test symptoms of postgastrectomy syndrome Exclusion Criteria: hypersensive to metronidazole systemic chemotherapy history other organic gastrointestinal disease (inflammatory bowel disease, carcinoid syndrome, amyloidosis, intestinal obstruction) other gastrointestinal operation history except appendectomy, cholecystectomy) recent colonoscopic examination (within 30 days) uncontrolled psychopathy drug or alcohol abuser pregnant or breast feeding woman recent history of antibiotics treatment (within 90 days) recent history of PPI or H2 blocker treatment (within 30 dyas) recent history of probiotics treatment (within 30 dyas) recent history of prokinetics or antispasmotic treatment (within 15 days) severe systemic illness

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole<br>active drug: metronidazole 500mg three time per day for 10 days | Drug: metronidazole<br> <br> |
| Placebo Comparator: Placebo<br>Placebo three times per day for 10days | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Assessment of abdominal symptom |  | 4 week |
Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

Study Overview
=================
Brief Summary
-----------------
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.

Detailed Description
-----------------
Nasal septum operation cause agitation because of nasal package. This research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.

Official Title
-----------------
The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation

Conditions
-----------------
Agitation

Intervention / Treatment
-----------------
* Drug: deksmedetomidine
* Drug: Remifentanil
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Exclusion Criteria: patients with any sensitivity each drug

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deksmedetomidine infusion<br>To prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale. | Drug: deksmedetomidine<br>* deksmedetomidine infused during operation 0.2 mcg/kg/hour<br>* Other names: Precedex;|
| Experimental: Remifentanil infusion<br>To prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale. | Drug: Remifentanil<br>* Remifentanil infused during operation 0.2 mcg/kg/min<br>* Other names: Ultiva;|
| Placebo Comparator: Saline infusion<br>Saline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale. | Drug: Saline<br>* During operation saline infused equal volüme of deksmedetomidine and remifentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses postoperative agitation score by Riker sedation agitation scale |  | Postoperative first hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yo asses postoperative side effects emesis, vomitting or pain |  | Postoperative first hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal septum operation, agitation