louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01063023: Drug Interaction Oral Contraceptive Pill (OCP)
Official title: Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug

Exclusion Criteria:

* Abnormal pap smear within 1 year prior to day 1
* Any significant or chronic uncontrolled medical illness

Primary outcomes:
measure: Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
timeFrame: 24 hours of dosing
Secondary outcomes:
measure: To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered
timeFrame: Safety will be assessed through day 78
measure: To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination
timeFrame: PK assessments will be done on Day 49, 50, 77 and 78
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pra International
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03596723: KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
Official title: Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ocular Inflammation
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 2
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.


Eligibility criteria: Inclusion Criteria:

* Be a candidate for routine, uncomplicated cataract surgery

Exclusion Criteria:

* Have a post-traumatic cataract.
* Have suspected permanent low vision or blindness in the fellow non-study eye.
* Have active uveitis in either eye.
* Have an ocular neoplasm in either eye.
* Have the presence of viral, bacterial, or fungal disease in either eye.
* Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP

Primary outcomes:
measure: Anterior Chamber Cell Grade
timeFrame: Day 15
Secondary outcomes:
measure: Modified Global Overall Assessment of Postoperative Inflammation
timeFrame: Day 15
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Detroit
country: United States
facility: Children's Eye Care, PC
state: Michigan
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie, Inc.
state: Pennsylvania
city: The Woodlands
country: United States
facility: Houston Eye Associates
state: Texas
Study officials:
References:
Clinical trial NCT04514523: QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events
Official title: QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Trinity Health Of New England
name: National Institute on Aging (NIA)
First posted: 2020-08-17
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to co-develop a toolkit (known as the QBSAfe toolkit) with patients, family caregivers, and clinicians that focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety for patients with diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

-Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician

Exclusion Criteria:

* Do not speak English
* Severe vision/hearing impairment
* Unable to give informed consent for any reason

Primary outcomes:
measure: Acceptability - Patients
timeFrame: Baseline [Post Clinical Encounter]
measure: Acceptability - Clinicians
timeFrame: Baseline [Post Clinical Encounter]
Secondary outcomes:
measure: Feasibility 1
timeFrame: Baseline [Post Clinical Encounter]
measure: Feasibility 2
timeFrame: Baseline [Post Clinical Encounter]
measure: Feasibility 3
timeFrame: Baseline [Post Clinical Encounter]
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Waterbury
country: United States
facility: Trinity Health of New England
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Victor Montori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark JE, Boehmer KR, Breslin M, Haider S, Pasciak W, Gravholt D, Sanchez BB, Hartasanchez SA, El Kawkgi OM, Montori V, Lipska KJ. Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care. Pilot Feasibility Stud. 2021 Nov 8;7(1):196. doi: 10.1186/s40814-021-00935-8.
Clinical trial NCT04363723: The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in COPD Patients Awaiting Lung Transplantation
Official title: The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease Awaiting Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Exacerbation COPD
pulmonary rehabilitation
lung transplantation
acute exacerbation
waiting list
end-stage lung disease
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Schön Klinik Berchtesgadener Land
First posted: 2020-04-27
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: data will be collected from the internal database of the reference Center

Brief summary: Data from chronic obstructive pulmonary disease patients awaiting lung transplantation which performed a pulmonary rehabilitation program will be analyzed retrospectively. Acute exacerbations occur frequently in these patients and have a major impact on the course of the disease. This study investigates the prevalence and the impact of acute exacerbations during pulmonary Rehabilitation in patients with severe chronic obstructive pulmonary disease patients awaiting lung Transplantation that continued the Rehabilitation program despite an acute exacerbation. Data will be taken from the internal database of the reference center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where these data were collected during clinical routine.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of chronic obstructive pulmonary disease including patients with alpha-1 antitrypsin deficiency
* listed for lung Transplantation or in the Evaluation process for lung transplantation
* performed a pulmonary rehabilitation program at the reference center

Exclusion Criteria:

* patients that discontinued the pulmonary Rehabilitation program due to any reason and could therefore not perform assessement tests at the end of regular Rehabilitation program

Primary outcomes:
measure: Change in 6-minute walk distance
timeFrame: day 1 and last day of pulmonary rehabilitation
measure: Change in Quality of life
timeFrame: day 1 and last day of pulmonary rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
Study officials:
affiliation: Schoen Klinik Berchtesgadener Land
name: Rembert A Koczulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gloeckl R, Jarosch I, Leitl D, Schneeberger T, Nell C, Langer D, Koczulla AR, Kenn K. Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease Awaiting Lung Transplantation. J Cardiopulm Rehabil Prev. 2021 Jul 1;41(4):267-270. doi: 10.1097/HCR.0000000000000613.
Clinical trial NCT00084123: Healing Touch and Relaxation Therapies in Cervical Cancer Patients
Official title: Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervix Neoplasms
Keywords: Relaxation Techniques
Radiation
Drug Therapy
Healing Touch
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-06-08
Enrollment: 60
Sex: FEMALE
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 evaluate the effects of healing touch and relaxation therapy on cervical cancer patients undergoing chemotherapy and radiation treatment.

Detailed description: The side effects of chemotherapy and radiation treatment are often severe and can have devastating effects on the mental and physical well-being of cancer patients. This study will determine whether healing touch and relaxation therapy are effective in minimizing the side effects of chemotherapy and radiation treatment in cervical cancer patients.

Participants in this study will receive weekly chemotherapy and daily radiation treatments for 6 weeks. Participants will be randomly assigned to receive either standard care (SC), SC plus relaxation therapy, or SC plus healing touch therapy. The relaxation therapy consists of progressive muscle relaxation and guided imagery. The healing touch therapy involves an energy-based modality in which health care practitioners stimulate the energy fields surrounding the patient. A physician-completed assessment and measures of immune function will be used to assess the well-being and overall quality of life of participants.

Eligibility criteria: Inclusion Criteria:

* Stage Ib1-IVa cervical cancer
* Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics

Exclusion Criteria:

* Immunosuppressive disorders
* Use of immunosuppressive medications
* Transplant recipient
* Metastatic or recurrent cervical cancer
* History of any other type of cancer

Primary outcomes:
measure: natural killer cell cytotoxicity
timeFrame: Baseline to week 6
measure: T-cell counts
timeFrame: Baseline to week 6
measure: side effects
timeFrame: Baseline to week 6
Secondary outcomes:
measure: distress
timeFrame: Baseline to week 6
measure: WBC and RBC
timeFrame: Baseline to week 6
measure: days of treatment delay
timeFrame: Baseline to week 6
measure: salivary cortisol
timeFrame: Baseline to post-treatment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Susan K Lutgendorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00796523: An Intervention to Decrease Infant Crying
Official title: A Randomized, Controlled Trial to Decrease Infant Crying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colic
Keywords: colic
crying
clinical trial
Lead sponsor: Riverside Methodist Hospital
Sponsor class: OTHER
Collaborators: name: Prevent Child Abuse America
First posted: 2008-11-24
Enrollment: 51
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study looking at the Happiest Baby on the Block technique. The investigators hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers given a 30 minute videotape on general newborn care. The investigators also hypothesized that mothers given the Happiest Baby on the Block videotape would have lower levels of stress.

Detailed description: Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.

Eligibility criteria: Inclusion Criteria:

Mothers of singleton newborns

* 37 to 41 week gestation
* healthy (no ICU admission)

Exclusion Criteria:

* not able to view videotape at home
* not able to speak English

Primary outcomes:
measure: Hours Per Day of Fuss/Cry
timeFrame: week 8
measure: Hours Per Day of Sleep
timeFrame: week 8
Secondary outcomes:
measure: Parenting Stress Index
timeFrame: week 6
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
Study officials:
affiliation: University of Toledo
name: Jonna M. McRury, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04271423: Ridge Preservation Comparing a Flap Versus Flapless Technique
Official title: Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 24
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: To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.

Detailed description: Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Eligibility criteria: Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
2. Study subjects at least 18 years old
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.

Exclusion Criteria:

1. Patients with debilitating systemic disease, or a disease affects the periodontium
2. Have an allergy to any material or medication used in the study
3. Require prophylactic antibiotics
4. Previous head and neck radiation therapy
5. Chemotherapy in the previous 12 months
6. Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
7. Smoked more than one pack of cigarettes per day

Primary outcomes:
measure: Crestal Horizontal Ridge Width
timeFrame: 4 months after surgery
Secondary outcomes:
measure: Percent osseous tissue
timeFrame: 4 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229423: Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.


Eligibility criteria: Inclusion Criteria:

* Eyelash prominence assessment of minimal or moderate
* Of Korean ethnicity

Exclusion Criteria:

* Any eye disease or abnormality
* Any ocular surgery or use of any eyelash extension or eyelash growth products within 3 months
* Any permanent eyeliner within 5 years
* Eyelash implants of any kind
* Eyelash tint or dye application within 2 months
* Use of any treatment that may affect hair growth within 6 months

Primary outcomes:
measure: Change From Baseline in Eyelash Length at Week 20
timeFrame: Baseline, Week 20
Secondary outcomes:
measure: Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20
timeFrame: Week 20
measure: Change From Baseline in Eyelash Thickness at Week 20
timeFrame: Baseline, Week 20
measure: Change From Baseline in Eyelash Intensity (Darkness) at Week 20
timeFrame: Baseline, Week 20
measure: Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20
timeFrame: Week 20
measure: Percentage of Subjects Satisfied With Treatment at Week 20
timeFrame: Week 20
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kwon O, Kim JY, Paik SH, Jeon HC, Jung YJ, Lee Y, Baek JH, Chun JH, Lee WS, Lee JY, Rogers JD, Halstead M, Eun HC. Long-term utility and durability of the therapeutic effects of bimatoprost 0.03% for eyelash augmentation in healthy Asian subjects. Dermatology. 2014;229(3):222-9. doi: 10.1159/000363379. Epub 2014 Sep 6.
Clinical trial NCT06487923: Knowledge and Awareness of Pelvic Floor Health
Official title: The Effects of Knowledge and Awareness of Pelvic Floor Health on Dyspareunia in Postpartum Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Awareness
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 298
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primiparous women who have given birth within the past year aged 18 and older

Brief summary: The aim of this study is to investigate the relationship between knowledge and awareness of pelvic floor health and dyspareunia, pelvic floor dysfunctions, and quality of life in postpartum women.


Eligibility criteria: Inclusion Criteria:

* Being a native speaker of Turkish
* Being in the first year of postpartum
* Women who had a vaginal delivery
* Primiparous women
* Women aged 18 and over

Exclusion Criteria:

* Women who have not given birth
* Multiparous women
* Women who had a cesarean delivery
* Having difficulty to understanding evaluations

Primary outcomes:
measure: Pelvic Floor Health Knowledge Quiz
timeFrame: Baseline
measure: Carol Postpartum Sexual Function And Dyspareunia Assessment Scale
timeFrame: Baseline
measure: Sociodemographic Information Form
timeFrame: Baseline
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: Baseline
measure: Prolapse and Incontinence Knowledge Questionnaire
timeFrame: Baseline
measure: Global Pelvic Floor Symptom Bother Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
Study officials:
References:
Clinical trial NCT01783223: Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services
Official title: Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Intoxication
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 668
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: Patients in the emergency department for alcohol intoxication

Brief summary: This study is intended to evaluate the prevalence of chronically inebriated patients in the Emergeny Department (ED). Patients will be identified prospectively by screening all patients (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be kept. Of these patients, any patient that is noted to have alcohol intoxication will be identified. The chart of that patient will be reviewed for details about the patient's alcohol use and for the patient's suitability for a sobering house, which is a place where intoxicated patients can go to await sobriety. The chart will also be reviewed for the number of previous visits for alcohol use to our hospital ever and in the last year.

Detailed description: For this cross-sectional study, all patients presenting to the ED of an urban, Level 1 trauma center for one month were prospectively screened by trained research associates. When an intoxicated patient was identified, study information including patient demographics, diagnoses, vital signs, blood alcohol concentration (BAC), GCS on arrival, ability to ambulate independently on arrival, use of physical or chemical restraint, previous ED visits, length of stay, and health insurance was collected. Data was analyzed using descriptive statistics.

Eligibility criteria: Inclusion Criteria:

* Patients in the emergency department for alcohol intoxication

Exclusion Criteria:

* Under 18
* Prisoners
* Pregnancy

Primary outcomes:
measure: Intoxicated Patients Eligible for a Sobering House
timeFrame: Eligibility for a sobering house is assessed during the current ED admission. The study ends when patient is discharged from the ED, an expected average time of 9 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: James Miner, MD
role: PRINCIPAL_INVESTIGATOR
References: