louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05005546: The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers
Official title: The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers With Their Babies in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stress
Anxiety
Psychological Resilience
Keywords: Psychological Resilience
Depression
Stress
Anxiety
Nursing
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: The study will carried out in a randomized controlled trial to determine the effect of yoga and laughter yoga on increasing the psychological resilience of mothers with their babies in the Neonatal Intensive Care Unit

Method: The research will be carried out with mothers whose babies are treated in the neonatal intensive care unit. Mothers will be divided into three groups as yoga (n=20), laughter yoga (n=20) and control (n=20) by block randomization method. Research findings; Data Form will obtained by using "Introductory Characteristics Form", "Depression, Anxiety, Stress Scale (DASS-21)" and "Psychological Resilience Scale".

Detailed description: Starting from the 1st week (5-7 days) after the birth, mothers will be given 10 sessions of laughter yoga (laughter group) and yoga (yoga group) twice a week for 45 minutes.DASS-21 and Resilience Scale will be administered to mothers in all groups at 1st, 3rd and 5th weeks.

Eligibility criteria: Inclusion Criteria:

* Mothers who are older than 18 years of age,
* whose gestational week is less than 32 weeks,
* whose baby has been treated in the neonatal intensive care unit for at least one week,
* who have internet access

Exclusion Criteria:

* Mothers with a genetic disease or congenital anomaly in their baby

Primary outcomes:
measure: Depression, Anxiety, Stress Scale (DASS-21)
timeFrame: 0-3 point each item, min 0-max 21 total point each subscale
measure: Psychological Resilience Scale
timeFrame: min 0-max 40 point
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
Clinical trial NCT04031469: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gut Microbiome
Gastrointestinal Microbiome
Keywords: Microbiome
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and minors of any age

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records.

Eligibility criteria: Inclusion Criteria:

* 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
* 2. Male or female patients of any age (interest is given to children to compare with mothers).

Exclusion Criteria:

* 1. Refusal to sign informed consent form
* 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
* 3. Postoperative stoma, ostomy, or ileoanal pouch
* 4. Participation in any experimental drug protocol within the past 12 weeks
* 5. Treatment with total parenteral nutrition
* 6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
* 7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Sabine Hazan
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: STUDY_DIRECTOR
References:
citation: Hazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. BMJ Open Gastroenterol. 2022 Apr;9(1):e000871. doi: 10.1136/bmjgast-2022-000871.
Clinical trial NCT01184469: Prospective Observational Study of Peri-implantation Serum hCG Levels
Official title: Prospective Observational Study of Peri-implantation Serum hCG Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Fertility Center of Las Vegas
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 451
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF patients

Brief summary: The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed embryos, and to compare and contrast these models. This may reveal insights into differences between these types of IVF cycles.

Detailed description: The current study seeks to examine the effect of the timing of implantation (as indicated by the first increase in serum hCG level) on the viability of pregnancies and to determine if such effect of timing differs between fresh embryo transfers and frozen-thawed embryos transfers. In this case, the timing of implantation will be measured through serum hCG analysis on days 3, 4, 5, and 7 after blastocyst transfer.

Eligibility criteria: Inclusion Criteria:

* IVF patients (adults) who received blastocyst transfer

Exclusion Criteria:

* Those patients using different laboratories

Primary outcomes:
measure: Ongoing pregnancy
timeFrame: 10 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Fertility Center of Las Vegas
state: Nevada
Study officials:
References:
Clinical trial NCT00947869: Contrast Sensitivity in Glaucoma
Official title: Glaucoma Including Pseudoexfoliation Syndrome (SFB 539)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Secondary Open Angle Glaucoma Due to PEX
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The primary aim of the Erlangen´s Glaucoma Contrast Sensitivity-Study (EGCS-Study) is the evaluation of the diagnostic and prognostic validity of a diagnostic procedure, measuring contrast sensitivity. No therapeutic studies are performed.


Eligibility criteria: * Patients: Primary open angle glaucoma, secondary open angle glaucoma due to PEX
* Healthy volunteers (for reliability analysis)

Inclusion Criteria:

* Age \> 18
* Best corrected visual acuity 0.8 or better
* European

Exclusion Criteria:

* eye diseases: Infantile glaucoma, angle glaucoma, secondary open angle glaucoma, wich are not due to PEX, diseases involving retina, condition after ophthalmological operations or trauma, cataract, diseases concerning the refractive system, age-related macular degeneration, diabetic retinopathy, optic neuropathy (MS, neuritis), amblyopia
* Any neurological diseases
* Systemic diseases with potentially ocular involvement (e.g., diabetes mellitus)
* Systemic drugs with potentially ocular involvement
* ocular drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Eye Hospital
state: Bavaria
Study officials:
affiliation: University Erlangen-Nuremberg
name: Anselm G Juenemann, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03382769: Hearing Loss in Older Adults Study
Official title: Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: CogState Ltd.
name: Syneos Health
First posted: 2017-12-26
Enrollment: 1
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling
* Proficient in English
* Oral communicator
* PTA (500, 1000 \& 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
* Active daily hearing aid users
* HHIE-S score greater than or equal to 24
* MoCA score greater than or equal to 20
* Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation
* Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol

Exclusion Criteria:

* Prelingual or perilingual severe-to-profound hearing loss
* Previous cochlear implantation in either ear
* Hearing loss of neural or central origin
* Permanent conductive hearing impairment (e.g. otosclerosis)
* Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
* Self reported disability in 2 or more activities of daily living
* Vision impairment worse than 20/40 on a near vision card

Primary outcomes:
measure: Hearing Handicap
timeFrame: 6 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Center for Neurosciences
state: Arizona
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary of Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Health
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Cochlear
name: David N Cade, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT06736769: Ketamine Effects on Learning In Eating Disorders
Official title: "KETTLE" Trial: Ketamine Effects on Learning In Eating Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Anorexia Nervosa
Atypical Anorexia Nervosa
Keywords: Anxiety
Depression
Anorexia
Psychotropic Drugs
Feeding and Eating Disorders
Physiological Effects of Drugs
Cognitive Flexibility
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.


Eligibility criteria: Inclusion Criteria:

1. Age 16-26 years old
2. Meets diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (atypical AN) per DSM-5 criteria on admission
3. Admitted to the medical hospital for malnutrition
4. No changes to psychiatric medications for month prior to trial enrollment
5. Agree to use a highly effective form of contraception for at least two weeks following ketamine administration
6. Have an outpatient primary care provider, medical provider, or behavioral health provider or psychiatrist who is actively managing or coordinating care

Exclusion Criteria:

1. Lifetime history of any psychotic disorder
2. Moderate or severe substance use disorder
3. Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial
4. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment
5. Intellectual or developmental disability
6. High risk for self-harm/suicide
7. Active laxative misuse or abuse
8. Biochemical refeeding syndrome or electrolyte abnormality
9. Cardiac abnormalities identified on admission
10. Taking medications that would be unsafe to administer with ketamine
11. Other medical condition or diagnosis, physical exam finding, laboratory abnormality, or health risk that would increase the risk of adverse events, at the discretion of the investigators

Primary outcomes:
measure: Mean Change From Baseline in Reversal Learning
timeFrame: Day 2, Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amanda E. Downey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084069: Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Valve Diseases
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.


Eligibility criteria: Inclusion Criteria:

* Greater than 25 y/o
* No occurrence of intra- or post-operative cardiopulmonary arrest
* Not consuming drugs affecting atrial rhythm
* Having sinus rhythm before surgery
* Lack of paroxysmal atrial fibrillation history
* Only undergo heart valve surgery
* Lack of considerable heart ischemia needed atorvastatin use
* Routine cares in ward, post-operative ward, and intensive care unit were done

Exclusion Criteria:

* Lesser than 25 y/o
* History of atrial fibrillation
* History of taking anti-arrhythmic drugs
* History of implementing pacemakers
* Severe heart failure
* Renal failure
* Hepatic failure
* Severe pulmonary diseases
* Heart block or bradyarrhythmia
* Routine cares in ward, post-operative ward, and intensive care unit were not done
* Performing concomitant cardiac surgery except valve repair
* Having considerable heart ischemia needed atorvastatin use

Primary outcomes:
measure: Atrial Fibrillation Incidence After Open Cardiac Valve Repair
timeFrame: Within 5 days after open cardiac valve repair
Secondary outcomes:
Other outcomes:
Locations:
city: Urmia
country: Iran, Islamic Republic of
facility: Seyyed-al-Shohada Heart Center
state: West-Azerbaijan
Study officials:
affiliation: Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
name: Yousef Rezaei, M.D
role: STUDY_DIRECTOR
References:
citation: Dehghani MR, Kasianzadeh M, Rezaei Y, Sepehrvand N. Atorvastatin Reduces the Incidence of Postoperative Atrial Fibrillation in Statin-Naive Patients Undergoing Isolated Heart Valve Surgery: A Double-Blind, Placebo-Controlled Randomized Trial. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):465-72. doi: 10.1177/1074248414564869. Epub 2014 Dec 24.
Clinical trial NCT03261869: EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY
Official title: EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Ice pack therapy, third molar surgery, swelling, pain, trismus
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: this study evaluates the effect of cold application after impacted third molar extractions. Patients have bilateral impacted third molar tooth included in this study. Patients do not applied cold after extraction of third molar on one side and applied cold cold after extraction of third molar on the other side.

Detailed description: Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some postoperative symptoms may occur such as edema, pain, limitations in mouth opening and dysfunction as a consequence of the wisdom tooth extraction surgery.

Local cold application reduces the magnitude of postoperative symptoms. The physiological effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy also induces muscle constriction which reduces muscle stress, pain and inflammation.

Eligibility criteria: Inclusion Criteria:

* Bilateral bony mandibular third molar impactions
* Has no systemic disease

Exclusion Criteria:

* Different Pell-Gregory classification of impacted teeth
* Previous or current gastric ulcer
* Allergies or hypersensitivities to any common medications
* pregnant or breastfeeding patients

Primary outcomes:
measure: Post operative Visual Analogue Scale Scores
timeFrame: pre-operative-postoperative 7th day
measure: Post operative facial swelling
timeFrame: pre-operative-postoperative 7th day
measure: Post-operative mouth opening
timeFrame: pre-operative-postoperative 7th day
Secondary outcomes:
measure: Complications after impacted third molar removal
timeFrame: pre-operative-postoperative 7th day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05232669: COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance
Official title: COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fall
Physical Performance
Fracture
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 21442
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improve musculoskeletal health and prevent falls and declining physical performance in the increasing number of older adults in the U.S. with potential for clinical and public health benefits.


Eligibility criteria: Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

1. Participants who reported an injurious fall resulting in healthcare utilization (visit to a healthcare provider or hospital)
2. Participants who reported recurrent falls (2 or more falls per year)

Primary outcomes:
measure: Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)
timeFrame: 5 years
measure: Recurrent falls (2 or more falls per year)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Meryl S LeBoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Carolyn Crandall, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBoff MS, Chou SH, Ratliff KA, Cook NR, Clar A, Holman B, Copeland T, Smith DC, Rist PM, Manson JE, Sesso HD, Crandall CJ. Rationale and design of an ancillary study evaluating the effects of the cocoa flavanol and/or multivitamin interventions on falls and physical performance outcomes in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). Contemp Clin Trials. 2023 Feb;125:107078. doi: 10.1016/j.cct.2023.107078. Epub 2023 Jan 6.