louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01096394: Collection of Tissue Samples From Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Official title: Orthotopic Propagation of Primary Human Ovarian Tumors for Preclinical Investigation of Novel Anti-Tumor Agents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Celgene Corporation
First posted: 2010-03-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females age 18-80 with a diagnosis of Stage III-IV ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma and scheduled treatment for epithelial ovarian malignancies.

Brief summary: RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to test in the laboratory may help the study of cancer.

PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial cancer.

Detailed description: OBJECTIVES:

* To generate a translational ovarian cancer model using tumor tissue and cells from patients with stage III-IV ovarian/primary peritoneal/fallopian tube epithelial cancer for drug response and development.

OUTLINE: Tissue and fluid samples are collected at the time of surgery or paracentesis and used in laboratory experiments and in animal models. Health data is collected from patient medical records before, during, and after surgery.

After surgery, patients are followed up for 5 years.

Eligibility criteria: INCLUSION:

• Females age 18-80 with a diagnosis of Stage III-IV ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma and scheduled treatment for epithelial ovarian malignancies.

EXCLUSION:

* Patients with less than Stage III epithelial ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma
* Patients who have received prior chemotherapy
* Patients who have nonepithelial ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma
* Patients who have malignancy other than ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma

Primary outcomes:
measure: Establishment of a "live" library of primary ovarian epithelial tumors
timeFrame: 5 year follow up of outcome.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Dineo Khabele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000294: Effects of Carvedilol on Cocaine Use in Humans - 11
Official title: Effects of Carvedilol on Cocaine Use in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine carvedilol effects in response to cocaine.

Detailed description: The purpose of this study was to determine whether carvedilol, and alpha and beta adrenergic blocker, would inhibit the priming effect of cocaine in a laboratory model. A total of 12 subjects were enrolled in this double blind, placebo controlled, outpatient study. After an adaptation session, three experimental sessions were held, 2-9 days apart. On each of 3 experimental sessions, a single oral dose of low (25mg) or high dose of carvedilol (50mg) or placebo were administered. Two hours following carvedilol or placebo treatment, subjects received a priming dose of smoked cocaine, 0.4 mg/kg. during the second part of the session, subjects had the option to earn up to 2 tokens by working on a computer task that could later be exchanged for money or deliveries of cocaine. We proposed that blockage of adrenergic receptors by carvedilol would significantly alter the subjective and physiological effects of cocaine.

Eligibility criteria: Inclusion Criteria:

Male/Female between 20 and 55. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breast feeding, using acceptable birth control methods (e.g. birth control pills diaphragm, condoms plus foam)

Exclusion Criteria:

Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency withing the past 6 months.

Primary outcomes:
measure: Behavioral
measure: Subjective
measure: Physiologic measures
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797094: BOTOX® in the Treatment of Upper Facial Lines in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Facial Rhytides
Crow's Feet Lines
Glabellar Lines
Frown Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).


Eligibility criteria: Inclusion Criteria:

-Moderate to severe Crow's Feet Lines and Frown Lines

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
* Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
* Medium-depth or deep facial peels within 5 years
* Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)

Primary outcomes:
measure: Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL)
timeFrame: Day 30
measure: Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
timeFrame: Baseline, Day 30
measure: Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
timeFrame: Baseline, Day 30
measure: Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire
timeFrame: Day 30
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03775694: Diffusion MRI-1 Imaging Database
Official title: Diffusion MRI-1 Imaging Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Tumor
Healthy
Other
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have previously received a dMRI scan.

Brief summary: The purpose of the dMRI-1 data collection study is to establish a database of clinical images and limited medical history information from patients that have previously received a dMRI scan. All data collected will be de-identified. No safety or effectiveness assessments will be completed.


Eligibility criteria: Inclusion Criteria:

1. Patient is either ≥ 18 years and has previously received an acceptable dMRI scan(s) with at least 30 unique gradient directions or \< 18 years who has previously received an acceptable dMRI scan of any number of unique gradient directions and who is allowed to participate in this type of research project (e.g., IRB/EC approval with waiver of consent) per IRB/EC
2. Acceptable dMRI scan was completed prior to site activation in the study

Exclusion Criteria:

None

Primary outcomes:
measure: Image assessment
timeFrame: Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Sherbrooke
country: Canada
facility: University of Sherbrooke
state: Quebec
Study officials:
References:
Clinical trial NCT02021994: BPM Cuff： 15-24cm, 20-34cm, 30-44cm, 40-48cm, 22-42cm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resident of a community

Brief summary: The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood pressure monitor device.

The cuff range is as follows:

15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm


Eligibility criteria: Inclusion Criteria:

1. Normal adult or adults with Hypertension

   Exclusion Criteria:

   ⎯1) people with serious arrhythmia
2. Patients with Takayasu arteritis
3. people wit adverse vascular peripheral circulation
4. people with upper limbs vein thrombosis
5. people who is weak

Primary outcomes:
measure: All the test results of the electronic blood pressure monitor with 5 cuffs is within the accuracy creteria, with the mercury sphygmomanometer as control
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03011294: Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea
Official title: Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.


Eligibility criteria: Inclusion Criteria:

* Bed partners of patients with moderate to severe OSA

Exclusion Criteria:

* Bed partners with OSA using specific treatment.

Primary outcomes:
measure: Endothelial function (forearm dilation, FMD - %)
timeFrame: 3 months
Secondary outcomes:
measure: Sleep quantity (measured by actigraphy - hours/night)
timeFrame: 3 months
measure: Sleep quality (Pittsburgh Questionnaire)
timeFrame: 3 months
measure: Ambulatory blood pressure monitoring (ABPM)
timeFrame: 3 months
measure: Frequency of OSA
timeFrame: Baseline only
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Luciano Drager
Study officials:
References:
Clinical trial NCT01544894: Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
Official title: Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Compliance
Keywords: Postmenopausal osteoporosis
Compliance
Bone mineral density
Bonemarkers
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.

Detailed description: OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis.

DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year.

MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with densitometric osteoporosis

Exclusion Criteria:

* Secondary osteoporosis

Primary outcomes:
measure: Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
timeFrame: One year
Secondary outcomes:
measure: Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
timeFrame: One year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario Dr Peset
Study officials:
affiliation: University of Valencia
name: Antonio Cano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05049694: Success of Zirconia and Stainless Steel Crowns for Permanent Molars
Official title: Clinical and Radiographic Performance of Preformed Zirconia Crowns and Stainless-Steel Crowns in Permanent First Molars: 18-Month Results of a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries Active
Dentin, Carious
Keywords: zirconia crowns
stainless steel crowns
dental caries
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and stainless steel crowns on permanent molar

Detailed description: Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.

Group 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

Eligibility criteria: Inclusion Criteria:

* Patients and parent of the patients who accept to participate and sign the informed consent
* Patients who have at least two permanent molars with caries that require crown restoration
* Patients that have good cooperation to the procedure

Exclusion Criteria:

* Patients and parent of the patients who don't accept to participate and sign the informed consent
* Teeth that doesn't have opposing permanent molars
* Patients who have bruxism or deep-bite
* Patient who are allergic to nickel

Primary outcomes:
measure: Number of zirconia and stainless steel crowns that showed successful retention over two years
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01347294: Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Official title: Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Venous Malformation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 135
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

Detailed description: Patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. Compression therapy (elastic stockings), pain medication and good counseling is adequate for many. Patients with significant symptoms, however, may require more invasive treatment. Previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. Today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. This type of therapy almost always requires repeated treatment sequences, sometimes over several months. Treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. Recurrence occurs frequently and there are many who are not completely free from symptoms. Many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. Predicting the performance of a specific type of treatment can be very difficult.

Until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (China) and ethanol in the treatment of vascular malformations. To our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of VM.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Venous malformation
* Must be able to fill in questionary form
* Must be able to sign informed consent form

Exclusion Criteria:

* Kidney disease
* Lung disease
* Pregnancy or not willing to safe contraception
* Allergy to Bleomycin or Fibrovein

Primary outcomes:
measure: Intesity, frequency and type of pain.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Rikshospitalet
Study officials:
affiliation: Oslo Universitetssykehus, Rikshospitalet
name: Andreas Abildgaard, Phd
role: STUDY_DIRECTOR
References: