louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06260228: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)
Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Cognitive Dysfunction
Memory Disorders
Keywords: Parkinson Disease
Memory
Cognitive Training
Self-Management
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)

The main questions it aims to answer are:

1. Can the current HOBSCOTCH program be adapted for people with PD?
2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?

Participants will be asked to:

* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach
* complete a brief clinical questionnaire about their diagnosis of PD
* complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes
* keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program
* complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program


Eligibility criteria: Inclusion Criteria:

* Age 30 - 75 years
* Diagnosis of Parkinson's Disease per participant's provider
* Literate, English-speaking with grade 12 or equivalent in education
* Self-reported cognitive/memory difficulties
* Telephone and internet access

Exclusion Criteria:

* Cognitive dysfunction that precludes participation in giving informed consent
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access

Primary outcomes:
measure: Change in quality of life as measured by comparing PDQ-39 (Parkinson's Disease Questionnaire) scores pre- and post-HOBSCOTCH-PD intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.
measure: Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PD intervention.
timeFrame: Baseline (pre-HOBSCOTCH-PD) and post-HOBSCOTCH-PD, approximately 9 weeks later.
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock, Dartmouth College
name: Elaine T Kiriakopoulos, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01255228: Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women
Official title: Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity
body composition
adipocyte-derived cytokine
low glycemic index
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Excessive body weight and obesity have reached epidemic proportions over the last few decades, which may cause many chronic diseases. Maintaining a healthy life style could decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body composition and the mechanism of obese women. The pilot study will recruit twenty healthy subjects, and served test food to determine low GI food. In the experiment period, twenty women age from 20-50 years will be recruited. To be included in the study, subjects should have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline \> 80 cm). Before dietary intervention, participants will receive food choice table and dietary questionnaires to record their dietary intake.

The study will be a randomized, crossover, controlled clinical trails. The experiment period have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6 week, subjects will measurement their body composition (body weight, body mass, waist and hip circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical analysis will be performed by paired t-test. The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women.


Eligibility criteria: Inclusion Criteria:

* BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline \> 80 cm )

Exclusion Criteria:

* Cardiovascular disease
* type 2 diabetes mellitus or impaired glucose tolerance
* serious liver or renal disease, gastro-intestinal disease
* proceed serious diet control for formerly three months
* take any supplemental food products or medications known to influence lipid or carbohydrate metabolism

Primary outcomes:
measure: the effect of body composition ( body weight,body mass,waist and hip circumferences )
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Jen-Fang Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748628: Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: AME Study
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]EDP-305 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive)
* able to comprehend and willing to sign an Informed Consent Form
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
* Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Primary outcomes:
measure: Cmax of EDP-305 in plasma
timeFrame: Up to 9 days
measure: AUC of EDP-305 in plasma
timeFrame: Up to 9 days
measure: AUC-inf in plasma
timeFrame: Up to 9 days
Secondary outcomes:
measure: Amount excreted in urine (Aeu)
timeFrame: Up to 9 days
measure: Amount excreted in feces (Aef)
timeFrame: Up to 9 days
measure: Safety measured by adverse events
timeFrame: Up to 9 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01122628: Long Term Follow up of the DVR-A Locking Plate
Official title: Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radial Fractures Treated With a DVR-A Locking Plate
Keywords: Distal Radial Fracture
Volar Locking Plate
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: DePuy International
name: Global Diagnostics UK
First posted: 2010-05-13
Enrollment: 136
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be taken from a population consisting of all patients who have undergone distal radial fracture treatement with a DVR-A locking plate at the norfolk and Norwich University hospitals NHS Foundation Trust

Brief summary: The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement.

This type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with this type of plate. The investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.


Eligibility criteria: Inclusion Criteria:

* Treatment between Jan 2005 and March 2009

Exclusion Criteria:

* Under 16
* Unable to consent
* Pregnant

Primary outcomes:
measure: DASH score
timeFrame: One year or more post surgery
measure: Pain
timeFrame: One year or more post surgery
Secondary outcomes:
measure: Complications
timeFrame: One year or more post surgery
measure: Radiographic appearance
timeFrame: One year or more post surgery
measure: EQ 5D
timeFrame: More than one year post surgery
measure: Grip Strength
timeFrame: One year or more post surgery
measure: Range of motion
timeFrame: One year or more post surgery
measure: Pain
timeFrame: One year or more post surgery
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Adrian J Chojnowski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03686228: Treatment of No-option CLI by G-CSF-mobilized PB-MNC
Official title: Treatment of No-option CLI Patients by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PAD
Critical Limb Ischemia
Atherosclerotic Ischemic Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months.

Detailed description: This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion Criteria:

* Recent myocardial infarction
* Severe valvular heart disease
* After organ transplantation
* Cardiomyopthy( EF\< 25%)
* Liver failure
* Coagulopathy
* HIV

Primary outcomes:
measure: Amputation free survival
timeFrame: 3 month
Secondary outcomes:
measure: Amputation free survival
timeFrame: 1,6,12 month
measure: Ankle brachial index (ABI)
timeFrame: 1,3,6,12 month
measure: Toe brachial index (TBI)
timeFrame: 1,3,6,12 month
measure: Transcutaneous oxygen measurement (TCOM)
timeFrame: 1,3,6,12 month
measure: 36-Item Short Form Health Survey (SF36)
timeFrame: 1,3,6,12 month
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Vascular Surgery, Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nuttawut SERMSATHANASAWADI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018328: The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
Official title: The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Positivity for Helicobacter Pylori
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Aims

* H.pylori is a common human pathogen by which almost 50% of the world population is infected. According to the accepted guidelines, once H.pylori infection has been diagnosed,first line therapy with three drugs should be given. The triple treatment includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is only 70-80%.
* Curcumin has many beneficial merits and it was also been demonstrated to be efficient in inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether addition of Curcumin to the standard triple therapy will increase the eradication rate of H.pylori infection.

Methods

* 150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology department and will be positive for H.pylori according to urease test and then by gastric biopsy, will be included. The patients will be randomized to two different treatments, according to binomial distribution. 75 patients will be treated with the standard triple therapy for 10 days and the other 75, will be treated for 10 days, with triple therapy combined with Curcumin that will be given three times a day.
* During the treatment the patients will complete an adverse effect's questionnaires. 6 weeks after the completion of the treatment the patients will undergo urea breath test to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds or proton-pump-inhibitor until the second urea-breath-test.
* We will compare the eradication rate and the adverse effects between the two groups by using SPSS


Eligibility criteria: Inclusion Criteria:

* positivity for Helicobacter pylori by urease test and gastric biopsy

Exclusion Criteria:

* prior treatment for H. pylori
* allergy to penicillin
* gastric outlet obstruction
* pregnancy or breast feeding
* inability to understand the informed consent

Primary outcomes:
measure: Urea breath test
timeFrame: 6 weeks after the completion of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
citation: Foryst-Ludwig A, Neumann M, Schneider-Brachert W, Naumann M. Curcumin blocks NF-kappaB and the motogenic response in Helicobacter pylori-infected epithelial cells. Biochem Biophys Res Commun. 2004 Apr 16;316(4):1065-72. doi: 10.1016/j.bbrc.2004.02.158.
Clinical trial NCT05392361: Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
Official title: Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis With Nocturnal Calf Cramps
Keywords: baclofen
spinal stenosis
nocturnal calf cramps
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of baclofen in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability and patient satisfaction between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).


Eligibility criteria: Inclusion Criteria:

1. diagnosed lumbar spinal stenosis with MRI finding
2. nocturnal calf cramps symptoms at least once per week

Exclusion Criteria:

1. electrolyte disorder
2. congenital muscle disease
3. muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
4. cognitive impairments

Primary outcomes:
measure: Pain score
timeFrame: follow up 4 weeks
Secondary outcomes:
measure: Frequency and severity of nocturnal calf cramps
timeFrame: follow up 4 weeks, 12 weeks
measure: Insomnia severity index
timeFrame: follow up 4 weeks, 12 weeks
measure: Oswestry Disability Index
timeFrame: follow up 4 weeks, 12 weeks
measure: Patient satisfaction (PGIC)
timeFrame: follow up 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Shin Hyung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520961: Functional Recovery After Partial Hip Arthroplasty: Anterior or Posterolateral Approach?
Official title: Approach Your Neck Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthroplasty
Femoral Neck Fractures
Keywords: Partial Hip Arthroplasty
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Partial Hip Arthroplasty for Femoral Neck Fracture

Brief summary: Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.

The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.


Eligibility criteria: Inclusion Criteria:

* Femoral Neck Fracture
* Partial Hip Arthroplasty

Exclusion Criteria:

* Total Hip Arthroplasty
* Osteosynthesis
* Pathologic fracture

Primary outcomes:
measure: Measurement of mobility
timeFrame: Timed Get Up and Go Test at six weeks
Secondary outcomes:
measure: Measurement of mobility
timeFrame: Using 2 cruches or walker at 6 weeks after surgery
measure: Dislocation rate
timeFrame: At 6 weeks postoperatively
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré Hospital. Orthopaedic surgery department
state: Ile de France
Study officials:
References:
Clinical trial NCT02014961: Worm Study: Modifier Genes in Sudden Cardiac Death
Official title: Worm Study: Identification of Modifier Genes in a Unique Founder Population With Sudden Cardiac Death
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brugada Syndrome
Long QT Syndrome 3
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2013-12-19
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Quest for modifier genes associated with ventricular arrhythmias in presence of a cardiac sodium channel gene (SCN5A-delPhe1617) mutation.

Detailed description: In a large Dutch SCN5A founder population with malignant ventricular arrhythmias, the investigators aim to identify genetic modifiers by means of whole-exome sequencing and to establish a comprehensive genotype-phenotype correlation, focussing on clinical and cellular electrophysiological characteristics and neurocardiac modulation.

Eligibility criteria: Inclusion Criteria (mutation carrier group):

* Age ≥ 18 years.
* Heterozygous or homozygous carriership of SCN5A-delPhe1617.
* Confirmed kinship to the founder population by haplotype analysis using predefined microsatellite markers.
* Written informed consent.

Inclusion Criteria (non-mutation carrier group):

* Age ≥ 18 years.
* Non SCN5A-delPhe1617 genotype.
* Confirmed kinship to the Founder Group by haplotype analysis using predefined microsatellite marker.
* Written informed consent.

Inclusion criteria Spouse Group

* Age ≥ 18 years.
* Biological parent of SCN5A-delPhe1617 positive subject participating to the Worm Study, and not belonging to study group 1 or 2.
* Written informed consent.

Exclusion Criteria:

* Age ≥ 18 years.
* Biological parent of SCN5A-delPhe1617 positive subject participating to the Worm Study, and not belonging to study group 1 or 2.
* Written informed consent.

Primary outcomes:
measure: Difference in genetic profile (e.g. modifier genes) between mutation carriers expressing different phenotypes and non-mutation carriers.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Paul Volders, M.D., Ph.D.
role: STUDY_DIRECTOR
References: