louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01768130: Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy
Official title: Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Pain After Open Inguinal Herniotomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent pain after open inguinal herniotomy

Brief summary: The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. In this area and in a contralateral area as a control, 5 sites were outlined, including the point of maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were repeated after a 4-6 weeks interval.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent pain after open inguinal herniotomy
* Age \> 18 years

Exclusion Criteria:

* Cognitive impairment
* Drug or alcohol abuse
* Bilateral inguinal hernia operation
* Nerve injury from other causes

Primary outcomes:
measure: Test- retest variability of thermal thresholds.
timeFrame: At baseline and retest 4-6 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT02715830: Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.
Official title: Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis of Artery
Keywords: angioplasty
infrapopliteal arteries
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, there is no use of other drugs, biological vaccine or combination product, but it was used two different approaches to the same problem: the renalization of the tibial arteries in patients with tissue loss. The angioplasty, that is the usual method of treatment, is done for one or more than one artery after randomization. It is phase 4 because it is an usual method of treatment (gold standard) for this disease.
Primary purpose: TREATMENT

Brief summary: It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in which 40 procedures to treat one artery (standart) or more than one artery in the same procedure.

The aim of this study is to know if this strategy increase healing velocity and limb salvage.


Eligibility criteria: Inclusion Criteria:

* Occlusion of the three arteries bellow the knee previously
* Rutherford 5 - ischemic lesion of the foot
* Informative Term
* At least one patente vessel in pedal arch

Exclusion Criteria:

* allergy to aspirin, clopidogrel or contrast media
* renal impairment
* Tasc D lesion in femoral or popliteal arteries
* no undersatnting patients

Primary outcomes:
measure: Time of wound healing
timeFrame: 1 year
measure: Limb Salvage
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Santa Marcelina Hospital
Study officials:
References:
Clinical trial NCT04019730: The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Official title: The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: comparing the exercise induced immune response after two weeks on a low carbohydrate (ketogenic) diet with the response after two weeks on a high carbohydrate diet.

Detailed description: A cross-over intervention study, with a total duration of 6 weeks. An athlete follows a high, or low carbohydrate (ketogenic) diet. After 2 days a test day takes place where the athlete performs an exercise test and blood samples are taken at different time points. After that, the athlete continues following the diet for another 12 days, after which he comes back again for another identical test day. Then a 2 weeks wash-out period. After that, the athlete follows the same protocol but then with either the low (ketogenic), or high carbohydrate diet.

Eligibility criteria: Inclusion Criteria:

* Male
* Age: 18 - 45 y
* BMI: 18.5 - 25 kg/m2
* Hb ≥ 8.5 mmol/L, determined with blood sample from finger tip
* Minimal of 3 hours of training per week, and a maximum of 10 hours
* DKTP (diphtheria, pertussis, tetanus and polio) vaccinated (for stimulation of isolated cells (PBMC's) with tetanus toxoid)
* No asthma medication and/or anti-inflammatory medication
* No use of immunosuppressive medication
* No flu and/or travel vaccinations in the 4 months before and during the study
* Able to be present and participate at all test days
* Willing and able to follow prescribed 2 times a diet for 2 weeks in a row

Exclusion Criteria:

* Chronic illness
* Food allergies (e.g. nuts, gluten, avocado)
* Vegetarian diet
* Blood donations during study or in the 2 months prior to the study
* Use of immunosuppressive medication
* Flu and/or travel vaccination 4 months before and during the study
* Hb \< 8.5 mmol/L
* Working at "Human Nutrition" - Wageningen University

Primary outcomes:
measure: PBMC cell differentiation changes in %
timeFrame: after 2 days and 2 weeks of adapted diet
Secondary outcomes:
measure: stress hormone Cortisol
timeFrame: after 2 days and 2 weeks of adapted diet
measure: ketone bodies
timeFrame: after 2 days and 2 weeks of adapted diet
measure: Free fatty acids
timeFrame: after 2 days and 2 weeks of adapted diet
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Division of Human Nutrition, Wageningen University
state: Gelderland
city: Wageningen
country: Netherlands
facility: Wageningen University and research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Marco Mensink, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06670430: Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy
Official title: Digital Heath Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Neuropathies
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.

Detailed description: Experimental Group:

This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment.

Control Group:

This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment.

Eligibility criteria: Inclusion Criteria:

* 1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI\> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.

  5. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.

  8. exhibiting moderately controlled blood pressure

Exclusion Criteria:

* 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.

  2. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.

  4. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy

Primary outcomes:
measure: nerve conduction velocity
timeFrame: 10 weeks
measure: Electromyography
timeFrame: 10 weeks
Secondary outcomes:
measure: Google Fit
timeFrame: 10 weeks
measure: Manage My Pain
timeFrame: 10 weeks
measure: PEDIS Score Diabetes App
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: professor
name: nesreen elnahas, phd
role: STUDY_CHAIR
References:
Clinical trial NCT00535730: ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
Official title: A Phase III Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With PNEUMOVAX™ 23 in Subjects 60 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 473
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.


Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* Stable underlying conditions
* Postmenopausal if female
* Afebrile

Exclusion Criteria:

* Previously vaccinated with either vaccine
* Immune deficiency
* History of allergy to components in either vaccine
* Concomitant antiviral therapy

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
timeFrame: 4 weeks postvaccination
measure: Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.
timeFrame: Four weeks postvaccination
measure: Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.
timeFrame: Four weeks postvaccination
measure: Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.
timeFrame: Four weeks postvaccination
measure: Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.
timeFrame: Four weeks postvaccination
measure: Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.
timeFrame: Four weeks postvaccination
Secondary outcomes:
measure: Safety and Tolerability of Both Vaccines When Administered Concomitantly.
timeFrame: Eight weeks postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: MacIntyre CR, Egerton T, McCaughey M, Parrino J, Campbell BV, Su SC, Pagnoni MF, Stek JE, Xu J, Annunziato PW, Chan IS, Silber JL. Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1.
Clinical trial NCT02910830: Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "
Official title: Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthrosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 848
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with osteoarthritis of the hip and patients with knee osteoarthritis

Brief summary: The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It guarantees its methodology great representativeness and therefore an interesting material for the study of risk factors in the population. In addition, it should have little here Radiographs of hands for all its patients. It therefore has the opportunity to study a possible relationship between tobacco and hip osteoarthritis , knee and hand but also to study the relationship between tobacco and structural evolution of hip osteoarthritis and / or symptomatic knee.


Eligibility criteria: Inclusion Criteria:

* Men or women aged between 40 and 75 years
* hip osteoarthritis and / or knee ( stifle ) , unilateral or bilateral , symptomatic with a confirmed diagnosis and meeting the ACR criteria , representative of prevalent cases in France during the constitution of the cohort
* Affiliation to social security

Exclusion Criteria:

* Presence of a hip or knee prosthesis of the painful joint at baseline ;
* Antecedent osteotomy ;
* severe comorbidity likely to affect significantly the quality of life or induce a major healthcare consumption regardless of osteoarthritis ;
* Knee pain with patellofemoral osteoarthritis isolated , that is to say without tibiofemoral osteoarthritis associated ;
* Other pathologies of these joints
* adults subject to a legal protection measure or unable to express their opposition not to participate in the study

Primary outcomes:
measure: relationship between smoking and severity of functional impairment in patients with osteoarthritis of hip and knee osteoarthritis using datas from cohort KOHALA
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01473030: Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Official title: Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostate Tissue
Keywords: Benign prostate
serum DHT
Dutasteride
PSA
Avodart
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-11-17
Enrollment: 80
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cross-sectional comparison of biomarkers in prostate biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial

Brief summary: The overall goal of this project is to quantify the long-term effects of dutasteride on the architectural and nuclear features of benign prostate tissue, using state-of-the art digital image analysis techniques. The ultimate result will be a multivariable morphological "signature" that could provide a useful indicator of an individual's degree of drug response.


Eligibility criteria: Inclusion Criteria:

* completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)
* compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline
* subgroup: Year 2 biopsy blocks and HE slides available for Aim 4a

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Architectural Features
timeFrame: Year 4
measure: Morphometric features
timeFrame: Year 4
measure: Independent changes in architecture and morphometry
timeFrame: Year 4
Secondary outcomes:
measure: Changes in cytomorphology
timeFrame: Year 2 & Year 4
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Peter H Gann, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03946930: Cognitive Decline in AD
Official title: A Cohort Study of Cognitive Decline in Alzheimer Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 92
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from the geriatric outpatient clinics or memory clinic.

Brief summary: There is lack of information on the risk factors of accelerated cognitive decline in older people with Alzheimer disease (AD). The extent of neurodegeneration and white matter disease has been reported to be important factors. In addition there may be biomarkers e.g. inflammatory cytokines that can contribute to cognitive decline. The impact of care arrangement and physical activity may also be important. Insulin signaling is impaired in Alzheimer disease (AD).

We therefore propose to perform a cohort study of older people with AD. This will be based on an on-going AD registry which was designed to identify genetic biomarkers for AD. Detailed neurocognitive tests and lifestyle information are available. In addition, volumetric MRI brain scans were performed in all AD subjects. The hypothesis is that MRI brain volumes, serum biomarkers, physical activity, physical functioning are independently associated with cognitive decline in older people with AD. The objective is to identify risk factors of accelerated cognitive decline so that preventive measures can be designed to delay dependency in AD.


Eligibility criteria: Inclusion Criteria:

* Sufficient Cantonese competency for cognitive test
* Clinical diagnosis of AD
* FAST test staging 3-5

Exclusion Criteria:

* Subjects who refuse blood taking procedure
* No reliable family caregiver informant (person contact at least once a month)

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG
timeFrame: 24-Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT03316430: Podocyturia as Predictive Factor for Pre-eclampsia
Official title: Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 1000
Sex: FEMALE
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: Patients coming before 16 weeks of gestation at their first planned prenatal visit at the Hôpital Femme Mère Enfant, who planned to deliver at the Hôpital Femme Mère Enfant

Brief summary: Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.


Eligibility criteria: Inclusion Criteria:

* women aged 18 years or more
* single pregnancy
* first planned prenatal visit before 16 weeks of gestation
* planned delivery at Hôpital Femme Mère Enfant in Lyon, France
* patient receiving information and non opposition to participate

Exclusion Criteria:

* multiple pregnancy
* pregnancy stopped
* antecedent of nephropathy
* inability to understand information provided
* prisoner or under administrative supervision
* fetal malformation, chromosomal anomalies
* preterm delivery for other reason that any hypertensive disorder of pregnancy or Intrauterine growth restriction

Primary outcomes:
measure: Occurrence of pre-eclampsia
timeFrame: At childbirth (around 8 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Study officials:
References: