louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02095613: Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care
Official title: A Randomized Trial of Ready-to-use-supplementary Food Compared to Corn-soy-blend+ as Food Rations for HIV-infected Adults on Antiretroviral Therapy in Rural Haiti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Food Insecurity
Malnutrition
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Partners in Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-03-26
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.


Eligibility criteria: Inclusion Criteria:

* documented to have HIV infection by standard laboratory procedures
* live in the geographic catchment area of PIH services where study is taking place
* 18 years of age or older
* started antiretroviral therapy for HIV in the 24 months prior to study enrollment

Exclusion Criteria:

* if another household member is also eligible for food assistance
* if subject is pregnant at the time of enrollment
* if unable to give informed consent

Primary outcomes:
measure: Change in Body Mass Index over time
timeFrame: 6-month, 12-month
Secondary outcomes:
measure: Change in Quality of Life over time
timeFrame: 6-month, 12-month
Other outcomes:
measure: Change in CD4 cell count over time
timeFrame: 6-month, 12-month
Locations:
city: Marc
country: Haiti
facility: Zanmi Lasante
Study officials:
affiliation: Brigham and Women's Hospital
name: Louise Ivers, MB, BCh, BAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04829513: Exercise and Two Different Kinesiotape Applications in Patients With Sacroiliac Joint Dysfunction
Official title: Exercise and Two Different Kinesiotape Applications in Addition to Exercise in Patients With Sacroiliac Joint Dysfunction: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled study. 99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study.

Detailed description: 33 patients will be given a home exercise program that strengthens the waist and hip girdle (to be shown once in the hospital by a physiotherapist and the form of the exercises will be given), 33 patients will be given kinesiotaping (KT) with ligament correction technique with the exercise program, and 33 patients will be given kinesiotaping with lymphatic correction technique with the exercise program. Patients will do the exercises once a day for 1 month. KT will be repeated once a week for 3 weeks. When taping is performed, it will be kept for 5 days.The patients' pain at rest and during movement will be measured using the Visuel Analog Scale (VAS). Patient Global Assessment and Oswestry Disability Index (ODI) will be questioned. Evaluations will be performed before, 4th week and 1 month after treatment (8th week).

Eligibility criteria: Inclusion Criteria:

* Patients with sacroiliac joint dysfunction between the ages of 18-65

Exclusion Criteria:

* Patients with rheumatological inflammatory disease
* Inflamatory sacroiliitis
* Patients with polyarthrosis, herniated disc, severe symptomatic disc degeneration, spinal stenosis and spondyloarthrosis.
* Patients with a history of pelvic trauma
* Patients with metabolic bone disease, infection, malignancy, pregnancy
* Patients with open wounds in the lumbar and sacral area

Primary outcomes:
measure: Pain at rest
timeFrame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
measure: Pain at movement
timeFrame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
Secondary outcomes:
measure: Patient Global Assessment
timeFrame: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
measure: Oswestry Disability Index
timeFrame: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
affiliation: Ufuk University
name: saime ay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354413: Outcomes of Concomitant Bypass Surgery in Septal Myectomy
Official title: Establishing a Database of Patients Undergoing Surgery for Hypertrophic Cardiomyopathy (Concomitant Bypass Surgery)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Coronary Artery Disease
Myocardial Bridging
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 320
Sex: ALL
Minimum age (years): 8
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting(due to atherosclerosis coronary artery diseases or myocardial bridge) during septal myectomy.

Brief summary: To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy.

Detailed description: Surgical septal myectomy (SM) is an effective approach for treating patients with drug-refractory obstructive hypertrophic cardiomyopathy (HCM).However, numerous patients with HCM exhibit concurrent ischemic heart disease, including atherosclerotic coronary artery disease (CAD) and myocardial bridging (MB). Although patients with HCM have been known to possess diminished coronary flow reserve,additional CAD can worsen myocardial ischemia, contributing to an unfavorable prognosis.MB, although infrequent, may affect diastolic heart perfusion, leading to angina and even sudden death.Current guidelines recommend revascularization for ischemic heart disease caused by CAD and MB.However, the impact of concomitant coronary revascularization during HCM management remains unclear. In this study, we analyzed the clinical characteristics and surgical scenarios of patients who underwent concomitant coronary artery bypass grafting (CABG) during ventricular SM and investigated their prognosis.

Patient clinical and survival data from 2009-2020 were retrospectively reviewed. The median follow-up period was 5.1 years. All-cause mortality was the primary endpoint.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of obstructive hypertrophic cardiomyopathy.
2. Undergo ventricular septal resection and cardiac bypass surgery at the same time.

Exclusion Criteria:

Incomplete surgical and follow-up data

Primary outcomes:
measure: all-cause mortality
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: cardiac-related deaths and readmission
timeFrame: through study completion, an average of 5 year
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Tao Lu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05733013: A Study to Collect Information About the Use of Redifferentiating Medications as a Standard Treatment for Thyroid Cancer
Official title: Outcomes of Patients With Thyroid Carcinoma Treated With Redifferentiating Agents as Part of Routine Clinical Care: A Prospective Data Collection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Thyroid
Refractory Thyroid Cancer
Keywords: RAI refractory thyroid cancer
thyroid cancer
thyroid
Refractory Thyroid Cancer
Radio-iodine refractory thyroid cancer
22-320
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 100
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: All patients eligible to receive a redifferentiating agent in the adjuvant setting or in the treatment of structural metastatic disease not enrolled in a clinical trial will be approached for recruitment. All eligible patients will enroll in the study and will be followed indefinitely after enrollment.

Brief summary: The purpose of this study to learn more about the use of redifferentiating medications as a standard treatment for radioactive iodine/RAI-refractory thyroid cancer. This study is a registry study.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old at time of consent

Inclusion Criteria:

* Patients diagnosed with RAI refractory thyroid cancer or unlikely to respond to RAI.
* Patients who will receive redifferentiation agents prior to planned diagnostic and/or therapeutic use of radioactive iodine as part of routine clinical care.
* Patients who have never received redifferentiation agents outside of a clinical trial or have received redifferentiation agents in the context of a clinical trial will be enrolled after the clinical team has decided to proceed with a redifferentiation agent as part of routine clinical care prior to diagnostic and/or therapeutic radioactive iodine administration.
* Patients previously treated with redifferentiation agents as part of clinical care prior to diagnostic and/or therapeutic radioactive iodine administration who are willing to provide retrospectively collected data surrounding the time of the previous treatment and will provide prospective data from the time of consent.

Exclusion Criteria:

* RAI refractory thyroid cancer patients that will receive redifferentiation agents prior to diagnostic and/or therapeutic use of radioactive iodine as part of a prospective clinical trial.

Primary outcomes:
measure: Adverse events will be collected in every visit
timeFrame: 2 years
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: Laura Boucai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04451213: Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis
Official title: Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Cardiff University
First posted: 2020-06-30
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.

Detailed description: Patients with CF have several potential risk factors which may predispose them to memory problems. Because the CF population has historically only been young, this is not something that has been focused on. No research has currently identified whether patients with CF have a much earlier risk of developing cognitive impairment or how CF impacts on the brain.

There has not previously been work in this area of CF and the investigators are in a unique position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on patients with CF for the first time.

Eligibility criteria: Inclusion Criteria:

* Male or Female, aged greater or equal to 30 years

  * A diagnosis of CF
  * Primary school education or above
  * Able to provide informed consent

Exclusion Criteria:

* Contraindications to MRI as found on the CUBRIC screening form (including presence of indwelling metal devices/clips)

  * Existing neurological disease affecting cognition (including stroke and traumatic brain injury)
  * Existing diagnosis of dementia documented in medical notes
  * Vascular complications of diabetes
  * Requiring supplemental oxygen -long term or overnight
  * Hepatic failure
  * Overt psychiatric disorders
  * Past or present alcohol or recreational drug misuse
  * Pregnancy
  * Current infection Smoker

Primary outcomes:
measure: Objective memory scores
timeFrame: up to one year
Secondary outcomes:
measure: MRI head
timeFrame: up to one year
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff and VAle University Health Board
Study officials:
References:
Clinical trial NCT06770413: Diagnostic Value of Modified Cough Reflex Test With Staged Water Swallow Test in Post-Stroke Patients Showing Dysphagia
Official title: Diagnostic Value of Modified Cough Reflex Test With Staged Water Swallow Test in Post-Stroke Patients Showing Dysphagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Pneumonia
Aspiration
Deglutition Disorders
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 328
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients who were admittied to a single tertiary hospital and demonstrating signs of dysphagia. Dysphagia was documented when any of the following criteria were met: impaired sensory or motor function of oral cavity structures (jaw, lip, tongue, palate, and cheeks), impaired cranial nerve functions (trigeminal, facial, glossopharyngeal, and hypoglossal nerves), voice change (wet or gurgly voice) after swallowing, drooling, or buccofacial apraxia.

Brief summary: The investigators conducted staged water swallow test (sWST) and modified cough reflex test (mCRT) on stroke patients referred for videofluoroscopic swallowing studies (VFSS) due to dysphagia. The patients were followed for up to four weeks to examine the incidence and timing of aspiration pneumonia, the relationship between these tests and VFSS results, and the diagnostic value of these tests as screening tools. Descriptive statistics will be presented for the incidence and timing of pneumonia, as well as the results of the SWST and MCRT. Regression analysis will be conducted to determine the explanatory power of each aspiration indicator (sWST and mCRT) in predicting aspiration or aspiration pneumonia. Additionally, using the VFSS results and the diagnosis of aspiration pneumonia as gold standards, the validity, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), odds ratio (OR), and relative risk (RR) for sWST, mCRT, and their combination will be calculated to evaluate their diagnostic value.


Eligibility criteria: Inclusion Criteria:

* either ischemic or hemorrhagic stroke confirmed by a computed topography or magnetic resonance imaging
* aged 20 years or older
* signs or symptoms of dysphagia.

Exclusion Criteria:

* inability to maintain sitting posture with support
* dyspnea requiring oxygen supplementation
* diagnosed with aspiration pneumonia at enrollment
* diagnosed with co-existing major neuromuscular disorders affecting swallowing
* diagnosed with infectious diseases requiring isolation
* refusal to participate

Primary outcomes:
measure: Incidence of pnuemonia
timeFrame: within 4 weeks after initial evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT03811613: Photobiomodulation and Parkinson
Official title: Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: movement disorders
light therapy
motor aspects
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD).

Detailed description: Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17, \[mean±SD\] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking ability (ten-meter walk test \[TMWT\]) and functional mobility (timed up and go \[TUG\] test).

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with idiopathic PD.
* Stage 1-2 on the Hoehn and Yahr Scale.
* Having no neurological condition other than PD.
* Being able to stand for 2 minutes and walk 10 meters without assistance.
* Having no severe dyskinesias or "ON-OFF" phases.

Exclusion Criteria:

- Do not follow inclusion criteria.

Primary outcomes:
measure: The motor portion of the MDS-UPDRS.
timeFrame: 9 weeks
Secondary outcomes:
measure: Motor function
timeFrame: 9 weeks
measure: Static posturography
timeFrame: 9 weeks
measure: Walking speed
timeFrame: 9 weeks
measure: TUG
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University School of Sports Medicine, University of Oviedo, Spain.
state: Asturias
city: León
country: Spain
facility: Department of Physical Education and Sport, University of León
state: Castilla y León
Study officials:
affiliation: Department of Physical Education and Sport (University of León, Spain)
name: Luis Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santos L, Olmo-Aguado SD, Valenzuela PL, Winge K, Iglesias-Soler E, Arguelles-Luis J, Alvarez-Valle S, Parcero-Iglesias GJ, Fernandez-Martinez A, Lucia A. Photobiomodulation in Parkinson's disease: A randomized controlled trial. Brain Stimul. 2019 May-Jun;12(3):810-812. doi: 10.1016/j.brs.2019.02.009. Epub 2019 Feb 20. No abstract available.
Clinical trial NCT01833013: Infertility and Endometriosis Cohort
Official title: Infertility and Endometriosis : a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Infertility
Keywords: Endometriosis
Cohort study
fertility
pregnancy
assisted reproductive technics
laparoscopy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Nowadays, one in six couples consults for fertility problems. If the standard examination and tests do not reveal any cause of infertility, the woman may undergo a laparoscopic exploration which reveals endometriosis in more than 50% of cases.

Endometriosis is an inflammatory disease defined as the presence of endometrial tissue out of the uterine cavity. It is frequent (1 in 10 women) and associated with a high economic burden (22 billion dollars in 2002 in the USA) and important decrease in quality of life. Physiopathological mechanisms and risk factors for endometriosis are not well identified.

A woman with endometriosis is 20 times more at risk of infertility. Fecundity rate of a 25-year-old couple is about 15 to 20% in the general population and only 2 to 10% in case of endometriosis.

There are many manifestations of this disease (infertility, pelvic pain) and the anatomo-clinical correlation is not good. The presently used international classification (American Fertility Society revised in 1985, AFSr) does not predict the chance of pregnancy. New scores such as the Endometriosis Fertility Index (EFI) have been proposed to do so, but need to be validated. Treatment for endometriosis-related infertility is not consensual.

A prospective cohort study would give access to clinical data of patients followed in our center, so as to identify clinical factors predicting pregnancy and to help treatment decision for women with endometriosis suffering from infertility.


Eligibility criteria: Inclusion criteria:

* Woman from 18 to 41 years old.
* Dealing with infertility,
* With a normal pelvic echography and hysterosalpingography, a normal hormonal status and a partner with a normal sperm.
* For whom a laparoscopic exploration finds endometriosis.
* Consenting to participate to the study.

Exclusion criteria:

* Any contraindication for general anesthesia or for laparoscopy.
* Any contraindication for pregnancy.
* Follow-up is impossible.
* Consent is impossible.

Primary outcomes:
measure: live birth date
timeFrame: 3 years
Secondary outcomes:
measure: Quality of life
timeFrame: 3 years
measure: pain symptoms
timeFrame: 3 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Montpellier
state: Herault
Study officials:
affiliation: University Hospital, Montpellier
name: Herve Dechaud, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02484313: The Effect of Snacks on Glycaemic Regulation in Children
Official title: The Effect of Dairy and Non-Dairy Products on Blood Glucose Regulation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Energy Intake
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: IWK Health Centre
First posted: 2015-06-29
Enrollment: 18
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Dairy products have a potential to be healthy snack foods for children. The purpose of this project is to investigate the short-term effects of Greek yogurt, a new popular dairy product on the regulation of glucose homeostasis, satiety and energy intake in normal weight and overweight/obese children.


Eligibility criteria: Inclusion Criteria:

* The children must be born at full-term within the normal weight range

Exclusion Criteria:

* food sensitivities or allergies, dietary restrictions, health, learning, emotional or behavioural problems, of if children are receiving medication

Primary outcomes:
measure: blood glucose
timeFrame: 120 min
measure: insulin
timeFrame: 120 min
measure: C-peptide
timeFrame: 120 min
Secondary outcomes:
measure: Food intake (grams and kcal)
timeFrame: 120 min
measure: Subjective appetite
timeFrame: 0-120 min
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: