louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02501785: Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population
Official title: Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver Burden
Keywords: Quality of Life
Patient care givers
15-145
Ambulatory Extended Recovery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 47
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: Patients and caregivers will be recruited prior to the patient's scheduled surgery during a clinic visit within the four target services. (Breast, Gynecology, Head and Neck, and Urology

Brief summary: The purpose of this study is to understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. As the caregiver they are providing care to a family member, friend, or neighbor. Even when not formally trained, the care they provide is important to the patient's recovery. Providing care in this manner can be stressful. This study will help us understand what aspects of the patient's recovery are most difficult for the caregiver.


Eligibility criteria: Inclusion Criteria:

* Caregiver/patient pairs undergoing surgery for an indication tracked within the Breast, Gynecology, Head and Neck, and Urology AXR program
* English speaking
* Patients willing to provide demographic, surgical, and outcome information
* Caregivers willing to provide demographic, socioeconomic, and caregiver experience information
* Caregivers willing to complete the caregiver burden measurement scales

Exclusion Criteria:

* Patients undergoing surgery within the AXR pathway that do not have a caregiver
* Non-English speaking patients or caregivers
* Patients unwilling to provide demographic and surgical information
* Caregivers unwilling to provide demographic, socioeconomic, or caregiver experience information or unwilling to complete the caregiver burden measurement scales

Primary outcomes:
measure: Caregiver Reaction Assessment (CRA) score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mindy Sovel, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162485: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
Official title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained
* Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed
* Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
* Pregnant or lactating females

Primary outcomes:
measure: Cmax of plasma salmeterol and fluticasone propionate
timeFrame: within 34 h
measure: AUCt of plasma salmeterol and fluticasone propionate
timeFrame: 34 h
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma Pharmacology Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Merja Mäkitalo
role: STUDY_DIRECTOR
affiliation: Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
name: Leena Mattila, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05833685: Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning
Official title: Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Sexual Dysfunction
Keywords: Core Muscles, machine learning,female sexual dysfunction, KNN
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients were distributed randomly into two groups. Female sexual dysfunction group and another group is normal females. Two group will be measure Transverses muscle ratio, Multifidus muscle ratio ,diaphragm excursion and force of contraction of pelvic floor muscles by ultrasound imaging, VLQ and FSFI questionnaires for female sexual function VLQ and FSFI questionnaires for female sexual dysfunction and normal females. Patients will be examined by radiologist with medical ultrasound imaging

Brief summary: The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages. It is characterized by a range of symptoms, including decreased libido, difficulty achieving orgasm, and pain during intercourse. One potential cause of FSD is muscular weakness or changes in the core muscles. These muscles play an important role in sexual function, and changes in their strength or activation patterns can lead to FSD. Additionally, the development of a machine learning model for this purpose could pave the way for future studies exploring the use of artificial intelligence in the diagnosis and treatment of other musculoskeletal disorder and female health issues.


Eligibility criteria: Inclusion Criteria:

* a number of parities ≤ three
* normal vaginal deliveries

Exclusion Criteria:

* History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection,
* diabetes,
* intrauterine device
* sexual disorder

Primary outcomes:
measure: Diaphragm excursion
timeFrame: 2 months
Secondary outcomes:
measure: Force of contraction of pelvic floor muscles
timeFrame: 2 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Deraya university
state: Minia
Study officials:
References:
Clinical trial NCT01908985: Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
Official title: Ocular Fluorophotometry to Assess the Aqueous Humor Production for Patients With Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Refractory Open Angle Glaucoma
Keywords: glaucoma
high intensity focused ultrasound
aqueous humor
fluorophotometry
Lead sponsor: EyeTechCare
Sponsor class: INDUSTRY
First posted: 2013-07-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound.

Population selected:

- Patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma.

The purpose of our study is:

- To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry.

Planning:

* First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase.
* Second phase: 6 patients

Detailed description: Main outcome criteria:

Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.

Eligibility criteria: Inclusion Criteria:

* refractory primary open-angle glaucoma (POAG)
* IOP\> 21 mm Hg and \<32 mm Hg with an optimal treatment.
* Lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...)
* Lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of HIFU treatment.
* Male or female age (s) of at least 18 and able to give informed consent
* Patient who signed the informed consent form
* Patient affiliated to a social security scheme

Exclusion Criteria:

* History of glaucoma by placing a drainage implant (valves, pipes ...)
* previous refractive procedures preventing accurate measurement of intraocular pressure (PRK, LASIK)
* General treatment which may alter IOP began in the month before the HIFU procedure
* Patient monophthalmus
* thyroid orbitopathy
* History of ocular or retrobulbar tumor
* Cyclodialysis
* choroidal hematoma or uprising choroidal
* Anatomy of the eyeball inadequate treatment or medical device (eye too small or too large)
* Pregnancy, breastfeeding, lack of contraceptive use among women at risk of having a child
* Participation in another clinical investigation of a medical or surgical treatment can affect the intraocular pressure in the three months preceding the HIFU
* Patient minor or major protected by law

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05144685: A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic
Official title: A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Suicide, Attempted
Suicidal Ideation
Lead sponsor: Oui Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-12-03
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.

Detailed description: This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.

Eligibility criteria: Inclusion Criteria:

1. Ages ≥18 years old
2. Patients recently hospitalized.
3. Owns a smartphone.
4. Willing and able to complete enrollment procedures.
5. Able to understand the nature of the study.
6. Able and willing to provide at least two verifiable contacts.

Exclusion Criteria:

1. Patients who have untreated psychosis or active psychosis
2. Patients who appear to be impaired by the use of alcohol or other substance(s)
3. Patients who sign, or have signed, an informed consent form to participate in any clinical research
4. Patients who upon clinical examination are cognitively impaired
5. Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale(C-SSRS)
timeFrame: Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: UCDDenver / Denver Health
state: Colorado
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Omaha
country: United States
facility: Common Spirit
state: Nebraska
city: Glen Oaks
country: United States
facility: Northwell Health
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Harding Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00114985: Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
Official title: A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Total Androgen Suppression
Simulation
3-D Conformal External Beam Radiation Therapy
Intra-rectal immobilization device
Quality of Life Assessment Questionnaire
Rectal Bleeding
Late effects
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-06-21
Enrollment: 100
Sex: MALE
Minimum age (years): 31
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

Detailed description: * MRI using an endorectal coil done prior to treatment for staging.
* Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
* Total androgen suppression is initiated and will continue for at least 6 months.
* Prostate Immobilization Device (PID) placed during the planning session.
* PID will be placed daily for the first 15 3D external beam radiation treatments.
* QOL assessment and follow-up will take place every 6 months for 3 years.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven prostate cancer
* Clinical Stage T1 - T4
* Negative bone scan
* PSA and routine blood work
* \>30 years of age
* ECOG Performance 0,1, or 2
* No prior pelvic radiation
* No pacemaker

Exclusion Criteria:

* Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
* Prostatic rectal fistula
* Stricture of anal canal

Primary outcomes:
measure: Rectal toxicity at six month intervals
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life
timeFrame: 2 years
measure: urinary symptoms
timeFrame: 2 years
measure: sexual dysfunction at six month intervals
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Anthony V. D'Amico, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woel R, Beard C, Chen MH, Hurwitz M, Loffredo M, McMahon E, Ching J, Lopes L, D'Amico AV. Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):392-6. doi: 10.1016/j.ijrobp.2004.10.003.
Clinical trial NCT03453385: Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
Official title: Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Use
Keywords: Smoking
Nicotine
Tobacco
Electronic Cigarette
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-03-05
Enrollment: 638
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.

Detailed description: Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.

Eligibility criteria: Inclusion Criteria:

* age 21+,
* current smoker
* regular use of email OR capacity to receive SMS text and internet access
* additional smoking and health criteria determined at screening

Primary outcomes:
measure: E-cig Use at End of Sampling Period
timeFrame: at week 4
Secondary outcomes:
measure: Conversion
timeFrame: Study enrollment through end of 6-month follow up
measure: Smoking Cessation
timeFrame: at 6-month follow-up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT05777785: A Novel Device for the Management of ADHD
Official title: A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Peripheral Retinal Stimulation
non-pharmacological
Lead sponsor: VIZO Specs Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-21
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.

Detailed description: This study was designed as a pilot single-center, open-label study of 2 months treatment. Following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of VIZO Glasses. The participants will be instructed to wear the glasses throughout the day for two months. A follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of VIZO Glasses on managing ADHD symptoms, using the Conners Continuous Performance Test-3, the Adult ADHD Self-Report Scale (ASRS), Behavior Rating Inventory of Executive Function Adults (BRIEF-A), and Clinical Global Impression-Improvement (CGI-I) .

Eligibility criteria: Inclusion Criteria:

* Documented history of primary ADHD diagnosis by certified clinicians
* Age 18-40 y
* Written informed consent
* Able and willing to complete all required ratings and assessments

Exclusion criteria:

* Any current psychiatric / neurological comorbidity (e.g., epilepsy, Autism, depression, TBI, etc), other than ADHD
* ADHD Medications (stimulants, non-stimulants, other)
* Neurofeedback, cognitive training

Primary outcomes:
measure: Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up
timeFrame: Baseline, 2 months
measure: Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up
timeFrame: 2 months
measure: Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up
timeFrame: Baseline, 2 months
measure: Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Max Stern Academic College of Emek Yezreel
Study officials:
affiliation: Max Stern Academic College of Emek Yezreel
name: Zohar Elyoseph, PhD
role: PRINCIPAL_INVESTIGATOR
References: