louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02210234: Wheat Bioactives and Immune Function
Official title: Wheat Bioactives and Immune Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocrine, Nutritional, Metabolic and Immunity Disorders
Keywords: wheat bran
healthy immunity
T cells
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Kellogg's Corporate Citizens Fund
First posted: 2014-08-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research was to understand the effects of bioactive compounds found in wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function assays were performed at both sampling times. It was predicted that eating wheat bran would benefit immune function.

Detailed description: Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of mouth on the University of Florida campus and in the surrounding area, in May of 2010. Eligible subjects were randomly assigned to one of two experimental groups, to consume either 50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from fasting subjects before consumption (baseline) and after three weeks of cereal consumption. Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow cytometry and analyzed. Overall compliance was assessed using self-reported data and by counting left-over bags of cereal.

Eligibility criteria: Inclusion Criteria:

* generally healthy
* aged 18-65

Exclusion Criteria:

* chronic health problems
* high blood pressure
* BMI greater than 25
* vegan

Primary outcomes:
measure: γδ-T cell proliferation
timeFrame: Change in Baseline and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Department of Food Science & Human Nutrition, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Susan S Percival, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05872334: The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
Official title: Exploratory Clinical Trial for Evaluating the Safety and Efficacy of MONOFIX® on Fascial Closure of Mid-line Wound for Patients With Colon Cancer Underwent Minimally Invasive Surgery: Single-center, Non-blinded, and Single-arm Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Colon Adenocarcinoma
Rectal Adenocarcinoma
Keywords: minimally invasive surgery
Barbed suture
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Colorectal adenocarcinoma
* Elective (or planned) curative surgery
* Laparoscopic surgery
* Midline incision less than 10 cm

Exclusion Criteria:

* Previous laparotomy with midline incision more than 10cm.
* Systemic chemotherapy for any cause within the last 6 months.

Primary outcomes:
measure: Incisional hernia
timeFrame: 18 months from surgery
Secondary outcomes:
measure: Wound infection
timeFrame: 1 month from surgery
measure: Wound bleeding
timeFrame: 1 month from surgery
measure: Wound dehiscence
timeFrame: 1 month from surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam
Study officials:
References:
Clinical trial NCT06427434: Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain
Official title: Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.

Detailed description: In fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. Women who experience LBP or pelvic girdle pain (PGP) at 3 months postpartum were found to be at higher risk for persistent or chronic LBP. Of these women, only 6% recover within 6-18 months after giving birth.

A modified lumbar Sustained Natural Apophyseal Glide (SNAG) is an existing Mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. The glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise.

Few studies have been concerned with the effects of modified "SNAGS" on the lumbar spine . So, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment.

Eligibility criteria: Inclusion Criteria:

1. All participants will be diagnosed as chronic postnatal low back pain.
2. Their ages will be ranged from 20 to 35 years old.
3. Their body mass index (BMI) will not exceed 30 kg/m2.
4. All participants have the same social level.
5. All participants have the same lifestyle.
6. Their number of parity will be ranged from 2-4 children.

Exclusion Criteria:

1. Spinal fracture or any other neurological disorders.
2. Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
3. Women with BMI \> 30 kg/m2.
4. Participants who had pelvic pathology.
5. Skin disease interferes with mobilization application.
6. Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).

Primary outcomes:
measure: Pain intenesity
timeFrame: within 4 weeks
measure: Lumbar flexion range of motion
timeFrame: within 4 weeks
measure: Lumbar extension range of motion
timeFrame: within 4 weeks
measure: Lumbar lateral flexion range of motion
timeFrame: within 4 weeks
Secondary outcomes:
measure: Functional disability
timeFrame: within 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mina Nageb Soliman
Study officials:
affiliation: Cairo University
name: Azza Kassab, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05575934: Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
Official title: Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Unconscious State
Keywords: transient loss of consciousness
syncope
emergency department
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 250
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 adult patients presenting to the emergency room of the CHU de Clermont-Ferrand with a transient loss of consciousness of syncopal or undifferentiated origin will be included once the non-objection has been collected.

Brief summary: The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC)

The main questions it aims to answer are:

* prevalence of TLOC
* prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file

Detailed description: Patients over the age of 18 presenting to the University Hospital of Clermont-Ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. Their non-opposition will be sought.

Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file.

No visit is planned after the passage to the emergency room.

Eligibility criteria: Inclusion Criteria:

* patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin

Exclusion Criteria:

* N/A

Primary outcomes:
measure: prevalence of transient loss of consciousness in emergency department
timeFrame: through the study duration, an average of 6 months
measure: prevalence of different diagnoses leading to transient loss of consciousness
timeFrame: through the study duration, an average of 6 months
Secondary outcomes:
measure: prevalence of different clinical presentations of loss of consciousness
timeFrame: through the study duration, an average of 6 months
measure: Prevalence of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness
timeFrame: through the study duration, an average of 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Fares Moustafa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05561634: Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
Official title: Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Basal Cell Carcinoma
Radiotherapy; Complications
Keywords: Locally advanced basal cell carcinoma
Sonic Hedgehog inhibitors
Consideration radiotherapy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2022-09-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years
* Locally advanced non-recurrent BCC in complete response after first course of SHHi
* Complete response has to be confirmed histologically
* Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor

Exclusion Criteria:

* Patients with distant metastasis
* Patients with Gorlin's syndrome
* Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
* Pregnant women
* Life expectancy less than 1 year
* Inability to receive informed consent
* Inability to participate in the entire study
* Lack of social security coverage
* Refusal to sign consent

Primary outcomes:
measure: Occurrence of a local relapse at 2 years in both groups.
timeFrame: At 2 years
Secondary outcomes:
measure: Occurrence of local relapse at 1 and 3 years.
timeFrame: at 1 year and at 3 years
measure: Occurrence of adverse effects in the radiotherapy group.
timeFrame: at 1 year, at 2 years and at 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Laurent Mortier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04074434: Study Watch Atrial Fibrillation (AF) Detection Investigation
Official title: Study Watch Atrial Fibrillation (AF) Detection Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2019-08-30
Enrollment: 160
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: Subjects with a known history of AF (including persistent or paroxysmal AF)

Brief summary: This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Able to read and speak English
* Able and willing to sign written Informed Consent
* Interest in participating in the study
* Subjects with a known history of AF (including persistent or paroxysmal AF)
* Without significant limitation in ability to participate in the study, in the opinion of the investigator.

Exclusion Criteria:

* Currently in a paced rhythm
* Known severe allergy to nickel or metal jewelry
* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies

Primary outcomes:
measure: Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
timeFrame: At least 60 minutes
measure: PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data.
timeFrame: 14 days
Secondary outcomes:
measure: Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
timeFrame: At least 60 minutes
measure: Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population.
timeFrame: 14 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
Study officials:
References:
Clinical trial NCT01188434: Integrating Interventions for Maternal Substance Abuse
Official title: Integrating Interventions for Maternal Substance Abuse and Child Neglect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Abuse
Child Neglect
Keywords: Methamphetamine
Substance Abuse
Child Neglect
Child Welfare
Evidence Based Practice
Lead sponsor: Oregon Social Learning Center
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 31
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). This project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the Department of Child Welfare.


Eligibility criteria: Inclusion Criteria:

* Maternal Substance Abuse
* Child Welfare involvement
* Child Neglect
* English Speaking
* Child either remaining in the home or reunification plan in place
* Living in the county

Exclusion Criteria:

* Current involvement in other substance abuse treatment
* Current involvement in other parenting skills training
* parental rights terminated
* active psychosis

Primary outcomes:
measure: Addiction Severity Index
timeFrame: Baseline, 6 months, 12 months
measure: Service Utilization Survey
timeFrame: monthly
measure: Parenting Measures
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Urinalysis
timeFrame: monthly
measure: Archival data from the Child Welfare system
timeFrame: annually
Other outcomes:
Locations:
city: Eugene
country: United States
facility: OSLC
state: Oregon
Study officials:
affiliation: OSLC Community Programs
name: Lisa Saldana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05087134: Characterizing LAM With 11C-Choline PET/CT
Official title: Characterizing Lymphangioleiomyomatosis (LAM) With 11C-Choline PET/CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Lymphangioleiomyomatosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It was reported that TSC2-deficient cells enhance phosphatidylcholine synthesis via the Kennedy pathway. 11C-Choline can reflect the metabolic process of choline in vivo by intravenous injection. The purpose of this study is the ability of 11C-Choline PET/CT to evaluate the baseline condition of LAM patients and the efficacy of rapamycin after treatment.

Detailed description: Tuberous Sclerosis Complex (TSC) is an autosomal dominant disorder caused by inactivating mutations of the TSC1 or TSC2 gene, characterized by neurocognitive impairment and benign tumors of the brain, skin, heart, and kidneys. Lymphangioleiomyomatosis (LAM) is a diffuse proliferation of α-smooth muscle actin-positive cells associated with cystic destruction of the lung. LAM occurs almost exclusively in women, as a TSC manifestation or a sporadic disorder (TSC1/TSC2 somatic mutations). Biomarkers of whole-body tumor burden/activity and response to rapalogs or other therapies remain needed in TSC/LAM. It was reported that TSC2-deficient cells enhance phosphatidylcholine synthesis via the Kennedy pathway. 11C-Choline can reflect the metabolic process of choline in vivo by intravenous injection. The purpose of this study is the ability of 11C-Choline PET/CT to evaluate the baseline condition of LAM patients and the efficacy of rapamycin after treatment.

Eligibility criteria: Inclusion Criteria:

- provide a written informed consent; Diagnostic CT or MRI suggesting a diagnosis of lymphangioleiomyomatosis.

Exclusion Criteria:

- Females planning to bear a child recently or with childbearing potential; Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time.

Primary outcomes:
measure: Standardized uptake value of 11C-Choline in LAM lesions
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Dongcheng
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fang Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379934: Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
Official title: Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Ischemia Reperfusion Injury
Mitochondrial Pathology
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.

Detailed description: Ketone bodies are high energy molecules which are naturally occurring in the body during fasting or stress.

Recently, ketone bodies have been shown to improve cardiac function in patients with heart failure(1) through a mechanism, which has yet to be elaborated.

We wish to evaluate the effects of ketone body administration on cardiac tissue subjected to ischemia reperfusion injury. We will evaluate contractile force of the and the mitochondrial performance. Cardiac atrial tissue will be obtained from patients undergoing coronary artery bypass grafting (CABG) or valve replacement surgery. Patients will be recruited after signing an informed consent and allocated in heart failure / non-heart failure groups based on a clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* EF \< / \> 45%, hospitalized for elective CABG or heart valve surgery

Exclusion Criteria:

* Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.

Primary outcomes:
measure: Contractile force recovery
timeFrame: Outcome will be assessed within a year when the inclusion of patients is complete
Secondary outcomes:
measure: Mitochondrial respiratory capacity
timeFrame: Outcome will be assessed within a year when the inclusion of patients is complete
measure: Mitochondrial Reactive Oxygen Species production
timeFrame: Outcome will be assessed within a year when the inclusion of patients is complete
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Hans Erik Bøtker, M.D., Prof.
role: STUDY_DIRECTOR
References:
citation: Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.