louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01752868: Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?
Official title: Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2012-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.


Eligibility criteria: Inclusion Criteria:

* age 40-60 yr
* body mass index of 21 - 30 kg/m2
* sedentary to moderately active
* eating a typical US diet

Exclusion Criteria:

* history of any chronic disease other than mild osteoarthritis
* use of medications other than occasional use of non-steroidal anti-inflammatory drugs, antihistamines, antacids or laxatives
* use of nutritional supplements
* smoking
* alcohol intake greater than two drinks per day for women and three drinks per day for men

Primary outcomes:
measure: Carotid-femoral pulse wave velocity
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Luigi Fontana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231268: Observational Study to Assess a 6-months Treatment With Gladem
Official title: Observational Study Via Internet to Assess a 6-months Treatment With GLADEM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Study population: out-patients

Brief summary: * Evaluation of a 6-months treatment with Gladem
* Experiences with the internet for performing a postmarketing study (PMS) trial


Eligibility criteria: Inclusion Criteria:

* Men and women at least 18 years old
* De novo prescription of Gladem
* Treatment with Gladem intended for at least 6 months
* Depressive disorders

Exclusion Criteria:

* Known hypersensitivity against sertraline
* Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
* Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
* Instable epilepsy

According to product information (October 1998) Gladem prescription was possible with precautions in the following cases:

* Patients with stable epilepsy
* Patients with restricted liver functions
* Suicidal patients
* Patients in emotional state and marked sleeping disorders

According to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.

Primary outcomes:
measure: Change in Hamilton Depression Scale (HAMD-6)
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Global assessment of efficacy on a 4-point scale
timeFrame: up to 6 months
measure: Global assessment of compliance on a 4-point scale
timeFrame: up to 6 months
measure: Global assessment of tolerability on a 4-point scale
timeFrame: up to 6 months
measure: Clinical global impression score
timeFrame: up to 6 months
measure: Number of responders
timeFrame: up to 6 months
measure: Change in HAMD subscores
timeFrame: baseline, 6 months
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00398268: Dislocated Unstable Distal Both-Bone Forearm Fractures in Children
Official title: Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Forearm
Distal
Child
Treatment
Keywords: Fracture
Forearm
Distal
Child
Treatment
Lead sponsor: Colaris, Joost, M.D.
Sponsor class: INDIV
First posted: 2006-11-10
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal both-bone forearm fracture.

Detailed description: children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial.

After an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility criteria: Inclusion Criteria:

* both-bone forearm fracture
* distal
* dislocated
* unstable after reposition
* age \< 16 years

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
* both fractures of type torus

Primary outcomes:
measure: pronation and supination
Secondary outcomes:
measure: complications, function, esthetics, complains in daily living, X-rays
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HAGA, location Juliana Children's Hospital
state: Zuid Holland
Study officials:
name: joost w colaris, drs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04185168: Isoflavones and Peritoneal Dialysis
Official title: Effects of Isoflavones on Hypertension, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing


Eligibility criteria: Inclusion Criteria:

Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35

Exclusion Criteria:

infections inflammatory diseases liver diseases Clinical diagnosis of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet

Primary outcomes:
measure: glucose
timeFrame: 8 weeks
measure: fructoseamine
timeFrame: 8 weeks
measure: carboxymethyl lysine
timeFrame: 8 weeks
measure: pentosidine
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
measure: Diastolic blood pressure
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Iran (the Islamic Republic Of)
Study officials:
References:
Clinical trial NCT02561468: The Preemptive Analgesic Efficacy of Nefopam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 94
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with breast cancer
* Lumpectomy with axillary lymph node dissection or Lumpectomy with sentinel lymph node biopsy
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* Refusal
* Seizure
* Cardiac disease
* Monoamine oxidase inhibitor user
* Urologic disease
* Glucoma
* Preoperative analgesic drug medication
* Pregnancy
* Recurred breast cancer patient

Primary outcomes:
measure: The change of pain numerical rating score from postoperative 30 min until postoperative 3 month
timeFrame: Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month
Secondary outcomes:
measure: The dose of ketorolac administered to the patient.
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT05115968: Single Cell Sequencing of Tonsillar Tissue in Children With OSA
Official title: Single Cell Sequencing to Examine the Pathogenesis of Adenotonsillar Hypertrophy in Children With Obstructive Sleep Apnoea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea of Child
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Case: Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (obstructive apnoea hypopnoea index (OAHI) of ≥1/hour), with adenotonsillar hypertrophy and clinical indications for adenotonsillectomy will be recruited as cases.

Control: Non-OSA subjects (with PSG OAHI \<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.

Brief summary: Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder, and is characterised by repetitive complete or partial upper airway obstruction during sleep. It is an important disease as it is associated with a large spectrum of end-organ morbidities.

Adenotonsillar hypertrophy is the commonest cause of OSA in children, however, the cause of the lymphoid tissue hypertrophy in some individuals but not the others remains unknown. To address the cellular heterogeneity and immune cell involvement in adenotonsillar hypertrophy, here, we propose to employ single-cell sequencing analysis to identify the cell-specific expression patterns associated with the disease, which will enhance our understanding of the pathogenesis of tonsillar hypertrophy in children with OSA and may provide directions for development of novel therapy.


Eligibility criteria: Inclusion Criteria:

Case: Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (obstructive apnoea hypopnoea index (OAHI) of ≥1/hour), with adenotonsillar hypertrophy and clinical indications for adenotonsillectomy will be recruited as cases.

Control: Non-OSA subjects (with PSG OAHI \<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.

Exclusion Criteria:

Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities.

Primary outcomes:
measure: Tonsil cell characteristics
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Kate C Chan, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002768: Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
Official title: A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

Primary outcomes:
measure: Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
timeFrame: Within 0-46 hours after last trial product administration
Secondary outcomes:
measure: Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose
timeFrame: Within 0-46 hours after last trial product administration
measure: Time from start of hypoglycaemic induction until each level of plasma glucose is reached
timeFrame: Within 0-46 hours after last trial product administration
measure: Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L
timeFrame: Within 0-46 hours after last trial product administration
measure: Hypoglycaemic symptoms score during recovery from hypoglycaemia
timeFrame: Within 0-46 hours after last trial product administration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22.
Clinical trial NCT05628168: Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Official title: Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.

Detailed description: Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with T2DM for ≥10 years determined by electrophysiological measurements were enrolled.
* The participants regularly took their diabetes medications during the assessment and treatment period.

Exclusion Criteria:

* Uncontrolled T2DM and diagnosed with T2DM for \< 10 years.
* Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.

Primary outcomes:
measure: Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
timeFrame: 5-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: El-Sheikh Zayed City
country: Egypt
facility: October 6 University
state: Giza
Study officials:
References:
Clinical trial NCT02207868: 3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH
Official title: 3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA 3D Pilot Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with pulmonary arterial hypertension associated with WHO group 1 who start with a parenteral prostanoidtherapy.

Brief summary: The aim of the study is to document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies.

The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.

Detailed description: The 3D echocardiography could provide early and detailed information about the changes in the left and right ventricle.

The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal strain soon to adapt the PAH specific therapy accordingly.

Eligibility criteria: Inclusion Criteria:

* age \>17
* pulmonary arterial hypertension (PAH) associated with WHO group 1 who start a parenteral prostanoid-therapy
* written informed consent
* prostanoid naive
* no change of the PAH specific therapy within 3 weeks of the recruitment to the study

Exclusion Criteria:

* pregnancy and lactation period
* Women of child bearing potential who do not use an effective and secure method for birth control
* severe chronic kidney insufficiency (glomerular filtration rate \<30), which will remain for more than 3 months
* liver-insufficiency Child C
* life expectancy shorter than the course of the study (for example because of malignant disease

Primary outcomes:
measure: Change of the left ventricular longitudinal strain
timeFrame: day 90 (+/- 7 days)
Secondary outcomes:
measure: wall thickness
timeFrame: 90 days (+/- 7 days)
measure: left ventricular ejection fracture
timeFrame: 90 days (+/- 7 Days)
measure: left ventricular stroke volume
timeFrame: 90 days (+/- 7 days)
measure: Tricuspid Annular Plane Systolic Excursion (TAPSE)
timeFrame: 90 days (+/- 7 days)
measure: right ventricular fractional area change
timeFrame: 90 (+/- 7 days)
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz GmbH
state: Upper Austria
Study officials:
affiliation: Krankenhaus der Elisabethinen Linz GmbH
name: Regina Steringer-Mascherbauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825368: Homeopathic Vaccine Trial
Official title: Homeopathic Vaccine Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2016-07-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 24 years
* Has received primary childhood DTaP and MMR vaccinations
* Available for a follow up visit (3 weeks after initial visit)

Exclusion Criteria:

* Received a live vaccine in the past 4 weeks
* Has had a serious allergic reaction to a previous vaccination
* Has allergies to one or more of the components of the vaccines to be used (Neomycin, egg protein)
* Has a history of encephalopathy within 7 days of receiving DTP/DTap
* Has received nosodes for Diphtheria, Tetanus, Pertussis, Measles and Mumps
* Has received an adult booster dose of conventional vaccines of diphtheria, pertussis, tetanus, mumps, and measles (Tdap or MMR)
* Has received immunosuppressive doses of steroids or anti-cancer drugs in the past 3 months
* Is pregnant or if there is a chance they could become pregnant during the next month
* Has a moderate to severe acute illness at the time of enrolment
* Has cancer, leukemia, HIV/AIDS, or any other serious immune health condition
* Has a history of Guillaume Barre Syndrome
* Has received blood transfusion, blood products, or immune globulin within the past year

Primary outcomes:
measure: Antibody levels for diphtheria
timeFrame: 3 weeks
measure: Antibody levels for pertussis
timeFrame: 3 weeks
measure: Antibody levels for tetanus
timeFrame: 3 weeks
measure: Antibody levels for mumps
timeFrame: 3 weeks
measure: Antibody levels for measles
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: