louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00978835: Tailored Case Management for Diabetes and Hypertension
Official title: Tailored Case Management for Diabetes and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Keywords: Diabetes
Hypertension
Physical Activity
Diet
Medication Adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-09-17
Enrollment: 377
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes and hypertension co-exist in approximately 10 million people in the USA and constitute severe risk factors for the development of such complications as heart and kidney disease. The investigators propose a randomized controlled trial in patients of community primary care practices to study a tailored telephone-administered behavioral intervention to improve control of blood pressure and blood sugar in patients with both hypertension and diabetes. The investigators hypothesize that 20% more patients talking to a nurse every other month about ways to improve blood pressure and blood sugar control will bring their blood pressure under control when compared to patients who talk with the nurse only about general health issues. If successful in improving control of these diseases this intervention can easily be adopted in other community primary care practices to lessen the burden of diabetes and hypertension in the USA.


Eligibility criteria: Inclusion Criteria:

* Enrolled and receiving primary care at one of 9 participating clinics in North Carolina
* Diagnosis of diabetes as determined by billing data
* Taking medication for diabetes
* Diagnosis of hypertension as determined by billing data
* Taking medication for hypertension
* Most recent (within one year) Hemoglobin A1c \>= 7.5%

Exclusion Criteria:

* Active psychosis
* Hospitalization for stroke, myocardial infarction (MI), or coronary artery revascularization in the past 6 months
* Type I diabetes
* Does not speak English
* No access to a telephone
* Institution-dwelling or receiving comprehensive professional home health care
* Hearing or speech inadequate for long interactive phone conversations
* Terminal illness or active treatment for cancer
* Cognitive impairment too severe to understand instructions

Primary outcomes:
measure: Blood Pressure
timeFrame: 2 years
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 2 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT03088735: Transfer Strategy in an Oocyte Donation Programme
Official title: Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oocyte Donation
Infertility, Female
Embryo Transfer
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.


Eligibility criteria: Inclusion Criteria:

* Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.

Exclusion Criteria:

* Preimplantation genetic screening or diagnosis cycles.
* Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Secondary outcomes:
measure: Cumulative pregnancy rate
timeFrame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department Obstetric, Gynecologic and Reproductive Medicine
state: Barcelons
Study officials:
References:
Clinical trial NCT01176435: Trial of L-DOPA as a Treatment to Improve Vision in Albinism
Official title: Clinical Trial to Evaluate Levodopa as Treatment to Improve Vision in Individuals With Albinism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Albinism
Keywords: Levodopa
Albinism
Vision
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized, placebo-controlled, double-masked clinical trial to see if vision can be improved in individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these individuals may increase melanin pigment production. Increased melanin has previously been shown to be associated with improved vision.

Detailed description: A group of 45 individuals with the clinical findings of oculocutaneous albinism (OCA) will be randomly assigned to one of 3 treatment groups: treatment with 0.76 mg/kg/d with 25% carbidopa, 0.51 mg/kg/d levodopa with 25% carbidopa \[divided into 3 doses/d), or placebo. Subjects will be between ages 3 and 60 years. Blood will be drawn to determine the mutation(s) in the genes that causes OCA. Primary outcome will be binocular best-corrected visual acuity measured with the EVA. Enrollment and 20 week examination will be complete eye exam with fundus photos. At weeks 5, 10, and 15, exams will include just vital signs and BCVA. At all visits, a review of potential side effects will be conducted. Between visits, subjects will be contacted to determine if any side effects have occurred. The study will remain double masked until the last study examination on the last subject has been performed. At that time, the data will be statistically analyzed and subjects will be informed re: treatment assignment, mutations found, and the study results.

Eligibility criteria: Inclusion Criteria:

* Age 3 to 60 years with albinism

Exclusion Criteria:

* Glaucoma or at increased risk of glaucoma
* History of dystonia
* History of melanoma
* Planning to undergo eye muscle surgery during study time frame
* Undergoing vision therapy
* Taking iron supplements or vitamins with iron
* Taking medication for ADHD
* Known liver or gastrointestinal disease
* Previous treatment with levodopa
* Psychological problems
* Ocular abnormalities other than those associated with albinism
* Pregnant, nursing or planning to become pregnant during study
* Known allergy to levodopa/carbidopa

Primary outcomes:
measure: Improved Vision
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Eye Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Gail Summers, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06956235: Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-05-04
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).

Detailed description: This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.

Eligibility criteria: Inclusion Criteria:

* Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months and a clinical diagnosis of HS at screening
* Has moderate or severe HS
* Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
* Has ≤20 draining tunnel count at Screening and Randomization

Exclusion Criteria:

* Has other active skin conditions that may interfere with the assessment of HS
* Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
* Has a transplanted organ and requires continued systemic immunosuppression
* Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Primary outcomes:
measure: Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of participants achieving HiSCR75 at Week 16
timeFrame: Week 16
measure: Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to ~130 weeks
measure: Percentage of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to ~116 weeks
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03946735: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
Official title: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety
Perfectionism
Rumination
Cognitive Behavioural Therapy
Lead sponsor: Alzahra University
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, controlled trial study was designed to examine the efficacy of Cognitive Behavioural Therapy (CBT) on social anxiety, perfectionism, and rumination among individuals diagnosed with social anxiety in Tehran, Iran.

Detailed description: A total of 52 individuals with Social Anxiety Disorder (SAD) (68% female, mean age = 35.67) were allocated to a CBT group or to a control group. The intervention group was given one session of therapy per week over a duration of 8 weeks, while the control group did not receive any intervention and was placed on a waiting list. Self-reported social anxiety, perfectionism, and rumination were measured before the CBT intervention, after the intervention, and two months after the intervention for both groups.

Eligibility criteria: Inclusion Criteria:

* Participants formally diagnosed with SAD by psychologists who determined the individual meet criteria outlined by the Diagnostic and Statistics Manual for Mental Disorders (DSM-5)

Exclusion Criteria:

* If participants report a history of psychiatric disorders within the past 12 months such as schizophrenia, dementia, depression, alcohol and other drug addiction.
* Participants could not partake if they were pregnant
* Participants enroll in another psychological treatment program.

Primary outcomes:
measure: Change: Social anxiety
timeFrame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
Secondary outcomes:
measure: Change: Rumination and Reflection
timeFrame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months))
Other outcomes:
measure: Change:Perfectionism
timeFrame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
Locations:
Study officials:
References:
Clinical trial NCT02828735: Respiration Patterns With Impedance in LINQ
Official title: REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing Exercises
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.


Eligibility criteria: Inclusion Criteria:

* Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.
* Chronic Kidney Disease (CKD) in Stage 5 (GFR = \<15 mL/min).
* Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).
* Willing to sign the informed consent form.
* Greater than 18 years of age.

Exclusion Criteria:

* Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
* Significant respiratory diseases such as COPD or pulmonary hypertension.
* Frequent arrhythmias, including PVC's.
* Known systolic heart failure.
* Recent infection.
* Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method.
* Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc).
* Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
* Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest.
* Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes.
* Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.

Primary outcomes:
measure: feasibility of respiration detection
timeFrame: up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
Study officials:
affiliation: Groote Schuur Hospital, Cape Town, South Africa
name: Mpiko Ntsekhe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04947735: CYPRESS Efficacy and Safety Study Extension
Official title: Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Juvenile Myopia
Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.


Eligibility criteria: Inclusion Criteria:

* Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
* Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
* Willingness to participate in the trial for up to 3 years without contact lens wear;
* The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

* Known allergy to proparacaine, tetracaine, or tropicamide.

Primary outcomes:
measure: Axial length
timeFrame: 72 months
measure: Spherical equivalent refraction (SER)
timeFrame: 72 months
Secondary outcomes:
measure: Axial length
timeFrame: 42 months
measure: SER
timeFrame: 60 months
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Longwood
country: United States
facility: Omega Vision Center, PA
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: West Monroe
country: United States
facility: Haik Humble
state: Louisiana
city: Raytown
country: United States
facility: Advanced Eyecare PC
state: Missouri
city: New York
country: United States
facility: SUNY School of Optometry
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Dakota Dunes
country: United States
facility: Dunes Eye Consultants
state: South Dakota
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Houston
country: United States
facility: Dr. Bridgitte Shen Lee (PI)
state: Texas
city: Salt Lake City
country: United States
facility: William J Bogus, OD, FAAO
state: Utah
city: Waterloo
country: Canada
facility: Centre for Ocular Research and Education
state: Ontario
Study officials:
References:
Clinical trial NCT00750035: Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Keywords: Total hysterectomy
subtotal hysterectomy
urinary function
bowel function
sexual function
Quality of life
Psychological function
Lead sponsor: St George's Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 279
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background

It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy.

Methods

The investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. The main outcomes were measures of bladder, bowel, and sexual function at 12 months. The investigators also evaluated postoperative complications.


Eligibility criteria: Inclusion Criteria:

* Women having abdominal hysterectomy for benign conditions of the uterus

Exclusion Criteria:

* Suspected cancer
* A body weight that exceeded 100 kg
* Previous pelvic surgery
* Known endometriosis
* Abnormal cervical smears,
* Symptomatic uterine prolapse
* Symptomatic urinary incontinence

Primary outcomes:
measure: Main outcome measure was stress incontinence
timeFrame: Completed
Secondary outcomes:
measure: Quality of life
timeFrame: Completed
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
Study officials:
References:
citation: Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002 Oct 24;347(17):1318-25. doi: 10.1056/NEJMoa013336.
citation: Thakar R, Ayers S, Georgakapolou A, Clarkson P, Stanton S, Manyonda I. Hysterectomy improves quality of life and decreases psychiatric symptoms: a prospective and randomised comparison of total versus subtotal hysterectomy. BJOG. 2004 Oct;111(10):1115-20. doi: 10.1111/j.1471-0528.2004.00242.x.
citation: Thakar R, Ayers S, Srivastava R, Manyonda I. Removing the cervix at hysterectomy: an unnecessary intervention? Obstet Gynecol. 2008 Dec;112(6):1262-1269. doi: 10.1097/AOG.0b013e31818f3bf5.