linjc16/ctgov huggingface dataset:
Pharmaceutical Care in Ambulatory Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.

Official Title
-----------------
Effectiveness of Pharmaceutical Care in Ambulatory Hemodialysis Patients: a Randomized Controlled Pilot Study

Conditions
-----------------
Medication Adherence, Chronic Renal Diseases, Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
-----------------
* Other: Pharmaceutical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or more Chronic renal patients undergoing regular hemodialysis Receiving their scheduled medications (at least one drug) Exclusion Criteria: Unable to answer the questionnaire or to sign the informed consent form Inability to obtain prescription drugs

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Pharmaceutical care with educational intervention provided by a pharmacist to ambulatory hemodialysis patients | Other: Pharmaceutical care<br>* Pharmacist-provided education on medication adherence in hemodialysis patients.<br>|
| No Intervention: Usual Care<br>Usual Care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | High adherence according to the Brief Medication Questionnaire | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life will be evaluated with EQ-5D questionnaire | one month |
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of CG8020 and CG2505.

Detailed Description
-----------------
To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Official Title
-----------------
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Conditions
-----------------
Metastatic Pancreatic Cancer, Nonresectable Pancreatic Cancer

Intervention / Treatment
-----------------
* Biological: CG 8020 and CG 2505


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma Chemotherapy naïve or chemotherapy experienced pancreatic cancer Exclusion Criteria: Prior cancer vaccines or gene therapy History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis) History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor

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

| Intervention/Treatment |
| --- |
|Biological: CG 8020 and CG 2505|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Efficacy measured by clinical benefit response |  |  | 
| Progression-free survivial |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer vaccine, pancreatic cancer, metastatic pancreatic cancer, unresectable pancreatic cancer, immunotherapy
Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection

Study Overview
=================
Brief Summary
-----------------
Postoperative anastomotic leakage is a serious complication in patients with oesophageal or cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present study is to investigate the clinical use of mediastinal microdialysis and whether is able to detect anastomotic leakage prior to the development of clinical symptoms.

Detailed Description
-----------------
Patients undergoing oesophageal or cardia resection for cancer are monitored by mediastinal microdialysis during the postoperative period. Subcutaneous microdialysis serves as a control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. A total of 30 patients will be included in this pilot study. The results of the mediastinal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in mediastinal microdialysis. This will be compared to results from patients with various complications.

Official Title
-----------------
Mediastinal Microdialysis in Early Diagnosis of Anastomotic Leakage After Resection for Esophageal Cancer: Preliminary Results

Conditions
-----------------
Anastomotic Leakage, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological verified oesophageal or cardia cancer Exclusion Criteria: Lack of consent, otherwise none
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 |
| --- | --- | --- |
| Early detection of postoperative complications |  | 30 days postoperative |
Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.

Official Title
-----------------
Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: prostate biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 Patients with a PSA value between 3 et 20 ng/ml Obtained informed consent Patients able to comply with the study protocol Patients covered by a social insurance Exclusion Criteria: None

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 20 cores<br> | Procedure: prostate biopsy<br>* prostate cores - 12 or 20<br>|
| Active Comparator: arm 12 cores<br> | Procedure: prostate biopsy<br>* prostate cores - 12 or 20<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).

Official Title
-----------------
Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®

Conditions
-----------------
Menopause, Healthy

Intervention / Treatment
-----------------
* Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women At least 3 months on Trisekvens® before screening period Ability to understand and comply with the protocol requirements Exclusion Criteria: Less than 12 months or more than 36 months postmenopausal judged by the Investigator Known, suspected, or past history of hormone dependent tumor/cancers Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions Ischemic heart disease or myocardial infarction within 6 months prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: estradiol / norethisterone acetate<br> | Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)<br>* After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postmenopausal women's acceptance of bleeding |  | After 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding profile in postmenopausal women |  | After 24 weeks of treatment | 
| Acceptance of hot flushes and breast tenderness |  | After 24 weeks of treatment |
Patients' Willingness-to-pay of Endodontic Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the monetary value of endodontic treatment (primary root canal treatment) compared to the alternative treatment options, such as extraction with or without subsequent insertion of a dental implant or placement of a fixed dental prosthesis.

Detailed Description
-----------------
Endodontic treatment of teeth with irreversibly damaged pulp aim at the long-term preservation of the affected tooth. If contraindications are present and / or a patient refuse endodontic treatment, the extraction of the affected tooth is often necessary. The resulting tooth gap might be closed by inserting a dental implant or by placing a fixed dental prosthesis. Prior studies have shown that patients' decisions in alternative treatment options depend on a variety of factors. Studies on the willingness-to-pay (WTP) are used to compare the monetary value of different therapy procedures.

Official Title
-----------------
Patients' Willingness-to-pay of Endodontic Treatment

Conditions
-----------------
Patient Preference

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants are selected by consecutive patient sampling (total n = 200). Inclusion Criteria: Patients who are in need of an primary root canal treatment and who are able to give written consent Exclusion Criteria: Non-fulfillment of the inclusion criteria Lack of capacity to consent No German language skills in written and spoken language Age <18 years

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 in need of endodontic treatment<br>n = 200 | Other: Questionnaire<br>* Patients are given a questionnaire with items related to personality and their willingness-to-pay for different treatment options.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of a questionnaire |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
WTP, willingness topay, health economic, preference-based measures
Colchicine for Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which their 24 hour urine protein and renal function tests will be monitored. The investigators' hypothesis is that colchicine will diminish proteinuria and might also help slow down the development of end stage renal failure in the long run.

Official Title
-----------------
Colchicine for Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with DM aging 18+, able to sign an informed consent. 24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment. Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±) Creatinine lower than 1.5 mg/dL. Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months. Treated with ACE & ARB, unless contraindicated Exclusion criteria: Malignancy or significant heart, lung or liver disease. Any GI disease, IBD, malnutrition ( BMI under 18 ) Psychiatric disease Any muscle disease, history of rhabdomyelysis, myopathy or myositis. Any disease causing renal injury/proteinuria apart from DM Any inflammatory or autoimmune disease Any infection during the last month. Use of potentially nephrotoxic drugs. Woman in child bearing age that do not use at least one contraceptive device. Pregnant or lactating woman. Participation in another study during the last 3 months. Alcohol or drug abusers Anyone whom the investigators conclude are not appropriate Any patient receiving steroids. Any patient with Colchicine allergy, or treated with the drug during the last two weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: colchicine<br>patients will receive 2 mg of colchicine daily | Drug: colchicine<br>* 2mg, per-os, once daily for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hr urine protein collection |  | every 2 months |
Patient Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS)

Study Overview
=================
Brief Summary
-----------------
This is a multi-centre, multi-national, prospective, observational study of Friedreich's Ataxia (FRDA) with a control group to: obtain natural history data on individuals affected by FRDA relate clinical assessments and results from proteomic analyses expedite identification and recruitment of participants for clinical trials develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of FRDA which may also be potential outcome measures for use in future clinical trials and clinical care plan for future research studies

Detailed Description
-----------------
The EFACTS patient registry integrates prospectively and systematically collected clinical research data (e.g. clinical tests, demographical characteristics) with access to biological specimens (e.g. blood, urine) obtained from individuals with genetically confirmed FRDA and unrelated control research participants. The EFACTS patient registry started out as a 4-year study and is currently running without a set end date. Eligible subjects are assessed at annual study visits on the clinical symptoms and signs of the disease. At each study visit, general clinical, motor function, cognitive, and Quality of Life assessments are administered. In addition, participants are providing bio samples for the purposes of genetic testing and for research to identify valuable biomarkers of FRDA. Biological specimens and clinical data are made available to qualified scientists within the EFACTS network whose projects are reviewed and approved by the EFACTS Steering Committee. Research projects should aim to advance scientific knowledge towards establishing clinically effective treatments that delay onset and/or slow the progression of the disease.

Official Title
-----------------
Patient Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS)

Conditions
-----------------
Friedreich's Ataxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic diagnosis of FRDA For control research participants: genetically confirmed absence of FRDA
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 |
| --- | --- |
| Control research participants<br>diagnosis of FRDA genetically excluded | |
| FRDA patients<br>with genetically confirmed diagnosis of FRDA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression as assessed by clinical examination |  | Participants are followed with annual assessments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Friedreich's Ataxia, EFACTS, FRDA
Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study seasonal inter-individual and intra-individual variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy Swedish adults.

Detailed Description
-----------------
Serum was collected during 12 months and analysed for 25(OH)D in 540 healthy blood donors. The blood donors answered questionnaires concerning vitamin D supplements, smoking, physical activity, sunbed use and holidays in sunny locations. Repeated serum samples were also collected from thrombocyte donors to study the intra-individual variations in S-25(OH)D.

Official Title
-----------------
Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort

Conditions
-----------------
Vitamin-D Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy at the time of donating blood Exclusion Criteria: unhealthy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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 |
| --- | --- |
| Blood donors<br>N=540 | |
| Thrombocyte donors<br>N=75 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-individual and intra-individual varations in serum 25-hydroxy vitamin-D during different seasons. |  | Group1:Blood donors, single test, 25(OH)vit D at inclusion . Group 2: thrombocyte donors: multiple tests, serum 25(OH)vit D during 8 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, vitamin D deficiency, parathyroid hormone
HD12 for Advanced Stages

Study Overview
=================
Brief Summary
-----------------
This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

Conditions
-----------------
Hodgkin´s Lymphoma

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide
* Drug: Adriamycin
* Drug: Etoposide
* Drug: Procarbazine
* Drug: Prednisone
* Drug: Vincristine
* Drug: Bleomycin
* Procedure: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS(PS) IIB with one or both of the risk factors: bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter) extranodal involvement CS(PS) III, IV written informaed consent Exclusion Criteria: Leukocytes <3000/microl Platelets <100000/microl Hodgkin´s Disease as composite lymphoma Activity index (WHO) < grade 2

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclophosphamide|nan|
|Drug: Adriamycin|nan|
|Drug: Etoposide|nan|
|Drug: Procarbazine|nan|
|Drug: Prednisone|nan|
|Drug: Vincristine|nan|
|Drug: Bleomycin|nan|
|Procedure: radiation therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin´s Lymphoma, advanced stages