louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03136068: Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
Official title: Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: FPA Women's Health
name: Society of Family Planning
name: Oregon Health and Science University
First posted: 2017-05-02
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D\&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D\&E procedure, but doctors want to clarify how digoxin effects D\&E procedure time, if at all.


Eligibility criteria: Inclusion Criteria:

* 20 weeks 0 days-24 weeks 0 days gestation
* English or Spanish speaking
* 18 years or older

Exclusion Criteria:

* Under 18
* Contraindications to digoxin

Primary outcomes:
measure: Procedure Duration
timeFrame: Beginning to end of procedure (between 5 minutes and 1 hour)
Secondary outcomes:
measure: Total Procedure Duration
timeFrame: done on Day 2 during the procedure
measure: Measured Blood Loss
timeFrame: Day 2, during the procedure
measure: Number of Patients With Reported Fetal Death Prior to Procedure
timeFrame: Day 2, before procedure
measure: Complications
timeFrame: Day 2
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: FPA Women's Health
state: California
city: San Francisco
country: United States
facility: SFGH Women's Options Center
state: California
city: Portland
country: United States
facility: Lovejoy Surgicenter
state: Oregon
Study officials:
References:
Clinical trial NCT02036268: Different Levels of Patient Education for Care of Ostomy Site
Official title: A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ostomy
Keywords: Ostomy education
Education
care of ostomy site
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized study of standard versus extra ostomy education.

Detailed description: The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.

Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years of age at the time of consent.
* Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.
* Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.
* Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.
* Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.
* Subjects who do NOT have any history of prior colostomy or ileostomy.

Exclusion Criteria:

* Subjects not meeting any of the above eligibility criteria.

Primary outcomes:
measure: Stoma Quality of Life Scale (SQOLS)
timeFrame: Six weeks
Secondary outcomes:
measure: Skin integrity at the ostomy site by lesion type
timeFrame: Six weeks
measure: Skin integrity at the ostomy site by location
timeFrame: Six weeks
measure: Number of appliance changes
timeFrame: Six weeks
measure: Stoma Care Self-Efficacy Scale (SCSES)
timeFrame: Six weeks
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana University Health North Hospital
state: Indiana
Study officials:
affiliation: Indiana University, Department of Surgery
name: Bruce W Robb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04315168: FRED and FRED JR Devices for Intracranial Aneurysm Treatment
Official title: Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: aneurysm
endovascular
flow-diverter
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an intracranial aneurysm treated with the FRED or FRED JR Device

Brief summary: A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

Detailed description: Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.

Sample Size: 138 patients.

Eligibility criteria: Inclusion Criteria:

* Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
* Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data

Exclusion Criteria:

* None

Primary outcomes:
measure: Mortality Rate
timeFrame: 1 year
measure: Morbidity Rate
timeFrame: 1 year
Secondary outcomes:
measure: modified Rankin Score
timeFrame: 1 year
measure: Complete aneurysm occlusion rate
timeFrame: 1 year
measure: Retreatment Rate
timeFrame: 1 year
measure: Patient description
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: Hôpital Maison Blanche, Reims, France
name: Laurent Pierot, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623968: A 39-year Follow-up Study on the World´s First Single Dental Implants
Official title: A 39-year Follow-up Study on the World´s First Single Dental Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulism
Keywords: dental implants
edentulism
Lead sponsor: Branemarkkliniken
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All living patient included in the original prospective study

Brief summary: This is a comprehensive, long-term follow-up study of single-implant treatments. At the Brånemark Clinic in Gothenburg, Sweden, during the period of 1982-1985, 16 patients received single-tooth implants. This study evaluates the survival rate of the implants after nearly four decades, focusing on the biological and technical complications.

Of the original 16 patients with a total of 23 implants, 14 patients with 19 implants were available for the follow-up and were included in the study. Clinical and radiographic examinations were performed on these patients.


Eligibility criteria: Inclusion Criteria:

Patient with diagnosis singel-tooth gap Patient with singel-tooth implants

Exclusion Criteria:

patient with bridge constructions

Primary outcomes:
measure: Biological and technical complications
timeFrame: From enrollment in 1982 - today
measure: Marginal bone level
timeFrame: from 1982 to today
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06301568: Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
Official title: Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cochlear Hearing Loss
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH)

Brief summary: This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.


Eligibility criteria: Inclusion Criteria:

* Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ
* Being a user of the "acoustic earhook" system
* Having provided informed consent regarding use of his/her data for research.

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Freiburger monosyllabic word recognition score in quiet
timeFrame: 12 months after device activation
Secondary outcomes:
measure: HSM sentence score or OlSa recognition score in quiet
timeFrame: 12 months after device activation
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
affiliation: Hannover Medical School
name: Andreas Büchner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415568: Effects of MCDG Oil on Postprandial Lipid Metabolism
Official title: The Effects of Functional Edible Oil (MCDG) on Reducing Body Fat of Overweight or Obesity Subjects (Part.2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Triglycerides High
Keywords: Postprandial lipid metabolism
Medium-chain triglycerides
Diacylglycerols
Serum triglycerides
Chylomicron triglycerides
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism compared to long-chain triglycerides (TGs).

Detailed description: A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of MCDGs. Twenty-eight healthy male and female subjects aged 21-29 years with normal body weight \[18.5 kg/m\^2 ≤ body mass index (BMI) \< 25 kg/m\^2\] were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the first visit, the participants were randomly assigned to consume a test or placebo product \[test product: muffins containing MCDG oil (MCDG muffin); placebo product: muffins containing LCT oil (LCT muffin)\] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 6-hr meal tolerance test was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (2, 3, 4, and 6 hr) of the products.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects with normal body weight (18.5 kg/m\^2 ≤ body mass index (BMI) \< 25 kg/m\^2)

Exclusion Criteria:

* history/presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease, liver disease, gastrointestinal disease, thyroid disease, or any other acute or chronic diseases requiring treatment
* Use of any medication affecting body weight or energy expenditure for 1 month before screening

Primary outcomes:
measure: Triglyceride levels
timeFrame: 6 hours
Secondary outcomes:
measure: The areas under the curve (AUC) of triglycerides
timeFrame: 1 day of second visit (after finishing cross-over trial)
measure: Triglyceride maximum concentration time
timeFrame: 1 day of second visit (after finishing cross-over trial)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117468: Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Official title: A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: luteal phase replacement
oocyte donation
infertility
progesterone
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.

Detailed description: This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months.

Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.

Eligibility criteria: Inclusion Criteria:

* Not pregnant
* Clinically or medically-induced non-functioning or surgically removed ovaries
* Clinical investigator believes patient would be eligible for oocyte donation

Exclusion Criteria:

* Any contraindication to progesterone or estrogen therapy
* Undiagnosed vaginal bleeding
* History of uterine fibroids or any other conditions that could adversely affect pregnancy success
* Hysterectomy
* Any contraindication to vaginal drug delivery systems

Primary outcomes:
measure: Adequate endometrial transformation
timeFrame: Cycle Day 25 or 26
Secondary outcomes:
measure: Hormone levels
timeFrame: Duration of study
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
Study officials:
affiliation: Duramed Research, Inc,
name: Duramed Protocol Chair
role: STUDY_CHAIR
References:
Clinical trial NCT02075268: Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers
Official title: An Open Label, Single Dose Study to Characterize the Pharmacokinetics and Pharmacodynamics of Prasugrel in Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Korean
Healthy
Male
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 8
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects

Detailed description: 1. Screening
2. Enrollment and treatment randomization
3. Confinement to Research Unit from day - 1 to day 2
4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)
5. Drug administration : Overnight Fasting
6. Blood sampling for PK, PD and genotyping

   1. PK: up to 24 hours after dosing
   2. PD: up to 72 hours after dosing

Eligibility criteria: Inclusion Criteria:

* male aged 19 to 45 years
* weigh over 60 kg
* body mass index 18 to 30 kg/m2

Exclusion Criteria:

* any history or state of clinically significant disease
* any gastrointestinal disease may interfere absorption of drug
* any history of hypersensitivity to prasugrel or other drug
* any history of taking herbal medication within 30 days before dosing or taking prescription medication within 14 days before dosing or taking over the counter drug within 7 days before dosing
* taking investigational drug within 60 days before dosing
* transfused within 30 days or donated blood within 60 days before dosing
* Positive serology test ( Hepatitis B surface antigen (HBs Ag), HIV, HCV)
* Clinically significant finding in laboratory result or electrocardiogram result

Primary outcomes:
measure: plasma R-138727 and R-95913 concentrations
timeFrame: predose, 10 min, 15 min, 25 min, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 4 h, 6 h, 8 h, 12 h and 24 h after dosing
Secondary outcomes:
measure: Maximal platelet aggregation
timeFrame: predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Jeon HS, Kim MJ, Choi HY, Kim YH, Kim EH, Kim AR, Park HJ, Bae KS, Lim HS. Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel in healthy male Korean volunteers. Clin Ther. 2015 Mar 1;37(3):563-73. doi: 10.1016/j.clinthera.2015.01.010. Epub 2015 Feb 16.
Clinical trial NCT05135468: A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
Official title: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: AGA
Lead sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 270
Sex: MALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.


Eligibility criteria: Inclusion Criteria:

1. Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
2. Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
3. Males aged 18 to 41 years (inclusive);
4. Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details);
5. Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -

Exclusion Criteria:

1. A history of scalp skin abnormalities or scalp skin diseases at the time of screening
2. Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
3. Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
4. Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
5. Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
6. A history of depression, anxiety, personality disorder or other mental disorders;
7. A history of varicocele or infertility ;
8. A history of malignant tumor;

Primary outcomes:
measure: The Rate of TAHC
timeFrame: 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People Hosptial
state: Beijing
Study officials:
References:
Clinical trial NCT03324568: Helping Young Children Improve Eating
Official title: Helping Young Children Improve Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding and Eating Disorders of Childhood
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 156
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.


Eligibility criteria: Inclusion Criteria:

* Parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; English-speaking parents; parent has the technology to access the videos and REDCap survey.

Exclusion Criteria:

* Parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.

Primary outcomes:
measure: Behavioral Pediatrics Feeding Assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Food Frequency Questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: