louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01542567: Efficacy of Diclofenac BCG Irrigations
Official title: Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Diclofenac
BCG
BLADDER IRRIGATIONS
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.

Detailed description: This study is designed as a double blind placebo controlled randomized study to evaluate the effectiveness of diclofenac suppositories in the prevention of side effects of BCG bladder irrigation in bladder cancer patients. After signing an informed consent, the patients will be randomized to either receive an unmarked suppository of Diclofenac or a placebo suppository. The effectiveness of the drug will be tested weekly by quality of life questionnaires and bladder symptom questionnaire. Another questionnaire is designed to monitor the time in minutes that the BCG is retained in the bladder before the patients urinates.

Eligibility criteria: Inclusion Criteria:

1. Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre
2. Male and female
3. Age 20-80.
4. Patients capable of understanding reading and signing the informed consent form in Hebrew.

Exclusion Criteria:

1. Diclofenac hypersensitivity
2. Pregnancy, Lactation
3. Elevated creatinine at baseline (male \> 1.2 mg/% female 1.0 mg/%)
4. Peptic gastric or duodenal ulcer
5. Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding)
6. Gross hematuria (which is per se a contraindication for BCG irrigation)

Primary outcomes:
measure: Change in weekly COOP Questionnaire 1
timeFrame: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
measure: Change in weekly COOP Questionnaire 2
timeFrame: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
measure: Change in weekly COOP Questionnaire 3
timeFrame: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
measure: Change in weekly Bladder symptoms Questionnaire
timeFrame: The questionnaires will be completed every week for the bladder symptoms of the passing week. The complete time frame of all questionnaires will be 7 weeks
measure: Change in weekly time schedule questionnaire
timeFrame: every week for 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00909467: Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
Official title: Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Disorder
Myelodysplastic Syndromes
Pulmonary Hypertension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with known myeloproliferative or myelodysplastic disease as a risk factor for pulmonary hypertension

Brief summary: Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. The effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. This exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.

Detailed description: For early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. Patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. The described work-up of patients allows precise and objective hemodynamic and clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* myelodysplastic disease or myeloproliferative diseases

Exclusion Criteria:

* known pulmonary hypertension
* relevant pulmonary disease
* relevant left cardiac or valvular disease
* recent major operations
* recent changes in medications
* relevant anaemia
* inability to exercise

Primary outcomes:
measure: mean pulmonary arterial pressure at rest and during exercise
timeFrame: at baseline and after 1 year
Secondary outcomes:
measure: exercise capacity
timeFrame: at baseline and after 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Pulmonology
Study officials:
affiliation: Medical University of Graz, Pulmonology
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01915667: Oral Bioavailability of Two Solid Formulations of GLPG0634
Official title: Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 12
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.

Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 40-60 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets
timeFrame: From predose (before first study drug administration) up to 144 hours post last study drug administration
Secondary outcomes:
measure: The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets
timeFrame: Between screening and 7-10 days after the last dose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Pille Harrison, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02756767: Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology
Official title: Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Lung, Breast, Head and Neck, or Pelvic Malignancies
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.

Brief summary: The goals of this study are to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform and to explore the correlation between patient reported outcomes as well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies


Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.
* Must be ≥ 18 years of age
* Able to read, write, and speak English in order to complete patient reported outcomes.

Patients will be approached about the study at the time of consultation or at the time of simulation by their treating physicians or by a research coordinator. All patients must sign a study-specific informed consent to participate. All patients, including those who do not choose to consent to the study, will be provided with a short survey to assess health literacy using the eHealth Literacy Scale (eHEALS).

For those not consenting to the study, the survey will be de-identified and will also ask for basic demographic information including age grouping, race, education level, and type of cancer.

Primary outcomes:
measure: Number of Surveys completed
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lilie Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912067: Ocular Graft Versus Host Disease After Hematopoietic Stem Cell Transplantation in Adults
Official title: Ocular Graft Versus Host Disease After Hematopoietic Stem Cell Transplantation in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graft Versus Host Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults after hematopoietic stem cell transplantation done at sheba medical center Israel during the last 3 years

Brief summary: The purpose of this study is to evaluate the presence and manifestations of ocular graft versus host disease in adults that had hematopoietic stem cell transplantation in the past 3 years at the sheba medical center, Israel. As well as correlate the degree of the presentation to the therapeutic protocol (chemotherapy and irradiation).


Eligibility criteria: Inclusion Criteria:

* after hematopoietic stem cell transplantation done at sheba medical center Israel
* 3 month have past from transplantation but no more then 3 years

Exclusion Criteria:

* transplantation done in the last 3 month or more than 3 years have past since

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: irina barequet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SK. Update on ocular graft versus host disease. Curr Opin Ophthalmol. 2006 Aug;17(4):344-8. doi: 10.1097/01.icu.0000233952.09595.d8.
citation: Anderson NG, Regillo C. Ocular manifestations of graft versus host disease. Curr Opin Ophthalmol. 2004 Dec;15(6):503-7. doi: 10.1097/01.icu.0000143684.22362.46.
Clinical trial NCT01413867: Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids
Official title: Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: III Degree Hemorrhoids
Keywords: hemorrhoids
circular staplers
mucosal resection
hemostatic suture
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
First posted: 2011-08-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.

This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.


Eligibility criteria: Inclusion Criteria:

* III degree Hemorrhoids
* written informed consent
* mental ability to understand the procedure

Exclusion Criteria:

* Previous treatments for hemorrhoids or other proctological diseases
* Fecal Incontinence
* Chronic inflammatory bowel disease
* Anal sphincter lesions
* coagulative defects
* obstructed defecation

Primary outcomes:
measure: quantity of anorectal mucosa resected using two different circular staplers
timeFrame: 1 hour following the end of the operation
Secondary outcomes:
measure: Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers
timeFrame: 1 hour after each operation
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept of Emergency and Organ transplantation
Study officials:
References:
Clinical trial NCT01588067: Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease
Official title: Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-04-30
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with PAD

Brief summary: This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD) patients undergoing lower extremity revascularization to describe the population and assess comparative effectiveness of endovascular therapy versus surgery. In addition, this study will conduct a prospective cohort study of patients treated medically or undergoing lower extremity revascularization at the VA and Kaiser Colorado to compare changes in health status.

Detailed description: Using electronic medical records, a registry of patients undergoing lower extremity revascularization therapy will be identified. Chart reviews with be done by an expert panel.

The prospective cohort study will ask participants to complete health status surveys before they begin therapy for PAD and again 6 months later.

Eligibility criteria: Inclusion Criteria:

* presents with PAD,
* \> 18 years of age,
* can complete a questionnaire, and
* has either had a change in PAD lower extremity intervention or start of a new intervention (surgical, endovascular, or medical therapy (cilostazol or exercise regimen)

Exclusion Criteria:

* dementia,
* inability to consent,
* pregnancy,
* limited life expectancy (\< 6 months),
* previous endovascular or surgical revascularization within the previous 12 months,
* non English speaking

Primary outcomes:
measure: Change from baseline in Health Status at 6 months
timeFrame: Baseline (pre procedure), 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: David Magid, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01226667: Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Official title: Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: fibromyalgia
lyrica
pregabalin
Lead sponsor: Osteoporosis Medical Center, Beverly Hills, CA
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-10-22
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.


Eligibility criteria: Inclusion Criteria:

* diagnosis of fibromyalgia by ACR criteria
* ambulatory patients
* complete of 5 pain diaries during 1 week evaluation
* other inclusion criteria may apply

Exclusion Criteria:

* pregnant or of childbearing potential not using contraceptives
* use of pregabalin in the past
* concomitant use of opioids or gabapentin
* estimated creatinine clearance less than 60
* other criteria may apply

Primary outcomes:
measure: Pain score evaluation by NRS
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: At weeks 4 and 8
measure: Discontinuation rate
timeFrame: 9 weeks
measure: Improvements in Wolfe Symptom Severity Score
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: David Silver MD Inc
state: California
city: Beverly Hills
country: United States
facility: Stuart L Silverman MD Inc.
state: California
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: Tucson
country: United States
facility: Catalina Pointe Clinial Research
state: California
city: West Hills
country: United States
facility: Affilaites in Medical Specialty
state: California
Study officials:
affiliation: Osteoporosis Medical Center
name: Keaton Nasser
role: STUDY_DIRECTOR
affiliation: Osteoporosis Medical Center
name: Stuart L Silverman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.
Clinical trial NCT02838667: Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
Official title: Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Injury
Preventive Measures
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nephrology participation in care of patients undergoing CABG could reduce AKI through correction of modifiable risk factors and early detection and intervention of post-op AKI.


Eligibility criteria: Inclusion Criteria:

* Adult patients (Age \>18 years)
* Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017

Exclusion Criteria:

* Non-elective CABG
* Renal failure on dialysis
* Renal transplantation

Primary outcomes:
measure: Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg
timeFrame: baseline to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Qi Qian, MD
role: PRINCIPAL_INVESTIGATOR
References: