louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01579552: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Official title: EMPOWER Study: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cancer
Keywords: Questionnaires
telephone counseling session
10-104
Childhood Cancer Survivor Women Post Chest Radiation
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
name: University of Colorado, Denver
name: Dana-Farber Cancer Institute
name: University of Chicago
First posted: 2012-04-18
Enrollment: 360
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy.

The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.


Eligibility criteria: Inclusion Criteria:

* Participant in the CCSS cohort
* Diagnosed with a childhood cancer prior to 21 years of age
* Treated with \> 20 Gy of chest radiation (mantle, mediastinal, lung, or chest)
* Age 25-49 years at time of enrollment into the study
* Interval from chest radiation to the time of enrollment of \> 8 years
* No mammogram or other breast imaging study in the 24 months prior to enrollment
* English-speaking - The University of Colorado AMC Denver and MSKCC group are not capable of or equipped for conducting a brief motivational interviews by telephone in another language.

Exclusion Criteria:

* Diagnosed with breast cancer
* Participated in the Project VISION feasibility study (exposed to part of the intervention)

Primary outcomes:
measure: efficacy
timeFrame: 12 months
Secondary outcomes:
measure: Moderating factors
timeFrame: 12 months
measure: Mediating factors
timeFrame: 12 months
measure: Economic analysis
timeFrame: 12 months
measure: Breast MRI completed by 12-month questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chaya Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oeffinger KC, Ford JS, Moskowitz CS, Chou JF, Henderson TO, Hudson MM, Diller L, McDonald A, Ford J, Mubdi NZ, Rinehart D, Vukadinovich C, Gibson TM, Anderson N, Elkin EB, Garrett K, Rebull M, Leisenring W, Robison LL, Armstrong GT. Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2019 Aug 20;37(24):2131-2140. doi: 10.1200/JCO.19.00547. Epub 2019 Jul 1.
Clinical trial NCT00361452: Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Official title: Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rsv Bronchiolitis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.

Detailed description: Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers.

Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.

Eligibility criteria: Inclusion Criteria:

* Under one year of age
* first episode of wheezing and dyspnea
* RSV antigen detected by ELISA
* parents signed informed consent.

Exclusion Criteria:

* infants with chronic lung disease
* cardiac disease
* other chronic conditions.

Primary outcomes:
measure: respiratory clinical score
measure: computerized quantification of wheezing and crackles
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Pediatric Ward, Rambam Medical Centre
Study officials:
affiliation: Rambam medical centre, pediatric pulmonary unit, HAIFA
name: LEA BENTUR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck R, Elias N, Shoval S, Tov N, Talmon G, Godfrey S, Bentur L. Computerized acoustic assessment of treatment efficacy of nebulized epinephrine and albuterol in RSV bronchiolitis. BMC Pediatr. 2007 Jun 2;7:22. doi: 10.1186/1471-2431-7-22.
Clinical trial NCT02254252: Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
Official title: Nicorandil Versus Nitroglycerin for Symptomatic Relief of Angina in Patients With Slow Coronary Flow Phenomenon Visited in Imam Reza Hospital, Mashhad, Iran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Slow Coronary Flow
Normal, or Near Normal Coronary Angiography
Stable Angina
Keywords: Slow coronary flow phenomenon
Angina pectoris
chest pain
nicroandil
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed opacification of epicardial arteries in the absence of significant arterial narrowing and blockade. Endothelial dysfunction at the level of microarteries have been proposed as the main pathological mechanism in this regard. Available evidence suggest that standard anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is hypothesized that anti-angina medications which exert vasodilatory effects in large coronary arteries as well as small dividing branches might be superior to nitroglycerin in amelioration of angina symptoms. The present randomized clinical trial was thus designed and conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina medication with effects on both large and small coronary vessels) with nitroglycerin in a group of patients with slow coronary flow presented with frequent angina episodes.


Eligibility criteria: Inclusion Criteria:

* on coronary angiographic studies, arterial narrowing did not exceed 50% in any of the three main coronary arteries; (
* a delayed opacification in at least one of the main coronary arteries was documented. Delayed opacification was defines as corrected TIMI frame count \> 23 fps

Exclusion Criteria:

* comorbid cardiovascular condition other than mild coronary atherosclerosis and coronary slow flow
* refusal to participate
* discontinuation of treatment
* not returning for the follow up visit

Primary outcomes:
measure: Angina Episode Frequnecy
timeFrame: 1 month
measure: Angina Episode Intensity
timeFrame: 1 month
measure: Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
timeFrame: 1 month
Secondary outcomes:
measure: Side-effects
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05474352: Use of Water Warming/Cooling Garment to Maintain a Constant Intraoperative Core Target Temperature in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Proof-of-Concept Study
Official title: Use of Water Warming/Cooling Garment to Maintain a Constant Intraoperative Core Target Temperature in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hyperthermic Intraperitoneal
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To look at the feasibility of using a water warming/cooling garment (called the ALLON system) to maintain a target body temperature during surgery and chemotherapy perfusion (a method of pouring chemotherapy throughout your abdominal cavity) without overheating or overcooling your body.

Detailed description: Objectives:

Primary Objectives:

To evaluate the feasibility of using a water warming/cooling garment (Allon system) to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core (esophageal) hyperthermia (≥39.5°C).

Secondary Objective:

To evaluate the safety for all study participants when using of the Allon system strategy in achieving and maintaining a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core hyperthermia (≥39°C)

Eligibility criteria: Inclusion Criteria:

* Adults patients (\>18 years old)
* Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy with an expected duration of perfusion longer than 60 minutes
* Signed informed consent

Exclusion criteria:

* America Society of Anesthesiology (ASA)physical status \>4
* Patient undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for recurrent disease.
* Patients with open wounds
* Patients with a history of thermoregulatory diseases such as spinal cord injury, thyroid disease, and malignant hyperthermia.

Primary outcomes:
measure: Number of Patients to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer.
timeFrame: through HIPEC surgery (up to 4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Maria F Ramirez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044432: Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial
Official title: Treatment of Patients With Chronic Osteoarthritis (Gonarthrosis) With Ginger Kidney Compress - a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the respective control group (waitlist).


Eligibility criteria: Inclusion Criteria:

* Chronic osteoarthritis, mainly osteoarthritis of the knee
* osteoarthritis symptoms for at least six months
* written consent to participate in the study
* Age: 30 years and more

Exclusion Criteria:

* Rheumatoid Arthritis
* Fibromyalgia
* Oncological or other serious diseases
* Use of corticosteroids
* Nephropathy
* Non-intact skin conditions in the area of application
* Hypersensitivity / allergy to ginger
* Simultaneous participation in another clinical trial

Primary outcomes:
measure: Total Sum Score (WOMAC)
timeFrame: Change from baseline at 5 weeks of treatment and 5 weeks follow up
Secondary outcomes:
measure: Change in medication
timeFrame: After 5 weeks of treatment and 5 weeks follow up
Other outcomes:
measure: Sum Score of "Short Arthritis Assessment Scale" questionnaire
timeFrame: After 5 weeks of treatment and 5 weeks follow up
measure: Parameters of a warmth questionnaire
timeFrame: After 5 weeks of treatment and 5 weeks follow up
measure: Range of knee movement
timeFrame: After 5 weeks of treatment and 5 weeks follow up
measure: Thermography (body heat distribution)
timeFrame: After 5 weeks of treatment and 5 weeks follow up
Locations:
Study officials:
References:
Clinical trial NCT01533532: A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Gonadotropin-Releasing Hormone (GnRH) antagonist
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: The severity score of the pelvic pain
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
Clinical trial NCT00910832: Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia
Official title: Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyschesia
Keywords: Dyschesia treatment
Rehabilitation
Dyschesia
Lead sponsor: Laboratoires Techni Pharma
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years
* Patients with dyschesia
* Prescription of rehabilitation for dyschesia

Exclusion Criteria:

* Rectal diseases
* Pain killers
* Pregnant women
* Breast feeding patients
* Non-compliant patients

Primary outcomes:
measure: To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms
timeFrame: Day -7, 0, 3, 7, 10, 14, 17, and 21
Secondary outcomes:
measure: To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation
timeFrame: Day 0 and 21
Other outcomes:
Locations:
city: Paris
country: France
facility: Diaconesses Hospital
Study officials:
affiliation: Diaconesses hospital
name: Odile Cotelle, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cotelle O, Cargill G, Marty MM, Bueno L, Cappelletti MC, Colangeli-Hagege H, Savarieau B, Ducrotte P. A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2014 Jun;57(6):781-9. doi: 10.1097/DCR.0000000000000098.
Clinical trial NCT02669732: An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Adult
Developmental Phase II
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 20 years at the time of informed consent
* Japanese patients with type 2 diabetes
* Patients who have HbA1c ≥ 7.0% and \< 9.0%

Exclusion Criteria:

* Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR\] of \< 45 mL/min per 1.73 m2) or clinically significant renal disease
* Patients with fasting plasma glucose ≥ 240 mg/dL

Primary outcomes:
measure: First-phase and Second-phase secretion Insulin
timeFrame: Baseline to Day 28 (Period 1 and 2)
measure: First-phase and Second-phase secretion C-peptide
timeFrame: Baseline to Day 28 (Period 1 and 2)
Secondary outcomes:
measure: M value
timeFrame: Baseline to Day 28 (Period 1 and 2)
measure: M/I value
timeFrame: Baseline to Day 28 (Period 1 and 2)
measure: Disposition Index
timeFrame: Baseline to Day 28 (Period 1 and 2)
measure: Number and severity of Adverse Events
timeFrame: Day 28 (Period 1 and 2)
measure: plasma concentration of DS-8500a
timeFrame: Day 28 (Period 1 and 2)
Other outcomes:
Locations:
city: Hakata-ku
country: Japan
facility: SOUSEIKAI Hakata Clinic
state: Fukuoka
Study officials:
affiliation: Juntendo University
name: Hirotaka Watada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01493232: Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
Official title: Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous
Keywords: Lingualized occlusion
Complete denture occlusion
Fully bilateral balanced occlusion
Patient satisfaction of complete denture
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. For each participant, it will be made 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participants can leave it. Each set will be inserted for 1month in 5 participant randomly. The participants will be examined in two stages, after a day and after a week. At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors. Then the second and third denture will be inserted simultaneously.


Eligibility criteria: Inclusion Criteria:

* edentulous patients
* at least 3 month ago the latest teeth was extracted
* ideal jaw relation
* signing the informed consent

Exclusion Criteria:

* uncontrolled systemic disease
* mentally problem
* dissatisfaction for keeping on the study

Primary outcomes:
measure: Patients' Satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Patients' Dissatisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Isfehan
country: Iran, Islamic Republic of
facility: Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan
Study officials:
affiliation: Medical University of Isfahan
name: Ramin Mosharraf, Prosthodontics Specialist
role: STUDY_CHAIR
References:
citation: Shirani M, Mosharraf R, Shirany M. Comparisons of patient satisfaction levels with complete dentures of different occlusions: a randomized clinical trial. J Prosthodont. 2014 Jun;23(4):259-66. doi: 10.1111/jopr.12101. Epub 2013 Oct 19.