louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02326766: Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prehypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.

Detailed description: A randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic and prehypertensive subjects. Over a 12 week test period, the red ginseng group (n=31) consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31) consumed the same product without red ginseng. Fasting plasma metabolomes were profiled using UPLC-LTQ-Orbitrap mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study.

Exclusion Criteria:

* exclusion criteria included previous diagnosed clinical hypertension
* self-reported use of antihypertensive medication
* abnormal liver or renal function
* history of cardiovascular disease
* kidney disease
* cancer
* thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment
* we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.

Primary outcomes:
measure: changes from baselilne in blood pressure
timeFrame: 12 week
Secondary outcomes:
measure: changes from baseline in plasma metabolites
timeFrame: 12 week
Other outcomes:
Locations:
Study officials:
References:
citation: Cha TW, Kim M, Kim M, Chae JS, Lee JH. Blood pressure-lowering effect of Korean red ginseng associated with decreased circulating Lp-PLA2 activity and lysophosphatidylcholines and increased dihydrobiopterin level in prehypertensive subjects. Hypertens Res. 2016 Jun;39(6):449-56. doi: 10.1038/hr.2016.7. Epub 2016 Feb 4.
Clinical trial NCT06013566: SSVEP Evaluation of Brain Function (PRO)
Official title: SSVEP Evaluation of Brain Function (PRO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Traumatic Brain Injury
Keywords: Mild Traumatic brain injury
Concussion
Steady state visual evoked potential
Electroencephalography
Sports Concussion
Sports Medicine
Lead sponsor: Headsafe MFG
Sponsor class: INDUSTRY
First posted: 2023-08-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As above.

Brief summary: The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a computer, which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. Nurochek PRO is a development of the previously FDA cleared Nurochek System.

The primary objective of this clinical investigation was to evaluate the performance of the investigational device (NCPRO) against clinical diagnosis of detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion and 500 valid investigational device readings from healthy individuals who have had a plausible mechanism of sustaining a concussion, but do not have one. Additionally, readings from healthy individuals are also to be acquired.

The aim of this study was to collect data from 100 readings from individuals with concussion. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were acquired from sporting clubs, medical clinicals and schools.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 12 years and older, participating in sport-related activities.

Exclusion Criteria:

* Individuals are excluded if they have a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

Primary outcomes:
measure: Steady State Visual Evoked Potential
timeFrame: 5 days
Secondary outcomes:
measure: Recovery from m TBI
timeFrame: 30 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Headsafe
Study officials:
affiliation: Principal Investigator
name: Craig Donaldson, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029626: Glasgow-Blatschford Score Validation in Digestive Hemorrhage
Official title: Glasgow-Blatschford Score Validation for Stratification of Patients With Digestive Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to validate the Glasgow-Blatchford score for the stratification of patients with upper gastro-intestinal hemorrhage. This score is easy to calculate. It is mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as an outpatient.


Eligibility criteria: Inclusion Criteria:

* To be admitted in the university hospital for a gastrointestinal hemorrhage (vomiting of red or black blood or melena)

Exclusion Criteria:

* Age under 18
* Pregnancy
* Hemorrhage during hospitalisation
* red rectal bleeding
* No consent signed

Primary outcomes:
measure: Comparison of length of stay between patients with score equal to zero and above zero
timeFrame: june 2010
Secondary outcomes:
measure: Determination of the proportion of low risk upper gastrointestinal bleeding
timeFrame: june 2010
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Marc Girardin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage. Lancet. 2000 Oct 14;356(9238):1318-21. doi: 10.1016/S0140-6736(00)02816-6.
citation: Stanley AJ, Ashley D, Dalton HR, Mowat C, Gaya DR, Thompson E, Warshow U, Groome M, Cahill A, Benson G, Blatchford O, Murray W. Outpatient management of patients with low-risk upper-gastrointestinal haemorrhage: multicentre validation and prospective evaluation. Lancet. 2009 Jan 3;373(9657):42-7. doi: 10.1016/S0140-6736(08)61769-9. Epub 2008 Dec 16.
Clinical trial NCT00374426: Preventing Depression Recurrence in Diabetes
Official title: Preventing Depression Recurrence in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Diabetes
Keywords: depression
diabetes mellitus
depression recurrence
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-09-11
Enrollment: 262
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: To study the effectiveness of sertraline (Zoloft) in treating depression in adults with diabetes. The study will also determine whether depressed diabetic patients who have successfully responded to sertraline (Zoloft) are more likely to have depression recur if the sertraline (Zoloft) is discontinued.

Detailed description: Part A: Prevention of Depression Recurrence in Diabetes

1. To determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes.
2. To determine the relationship of sustained depression remission to social, occupational, and global func-tioning, and to quality of life and compliance with diabetes treatment.
3. To determine clinical features predictive of depression recurrence in diabetes.

Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression

1. To determine the effects of depression remission and recurrence on glycemic control.
2. To determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control.
3. To determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.

Eligibility criteria: Inclusion Criteria:

* 18-80
* Type 1 or Type 2 Diabetes
* Screen positive for depression

Exclusion Criteria:

* Are pregnant or lactating
* Are known to be hypersensitive to the drug
* Have a recent history of myocardial infarction or unstable heart disease
* Have severe hepatic disease or renal impairment (serum creatinine \> 3 mg/dl)
* The subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Patrick J Lustman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235426: Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.
Official title: Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carpal Tunnel
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.

Detailed description: Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.

Eligibility criteria: Inclusion Criteria:

* patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.

Exclusion Criteria:

1. pregnancy.
2. history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
3. history of local corticosteroid injection in the past 3 months.
4. atrophy of thenar muscles.
5. previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
6. Patients with autoimmune or hematologic disorders, NSAID consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, Hb level under 12 g/dl, and platelet count under 150,000 in ml.

Primary outcomes:
measure: VAS (Visual Analogue Scale),
timeFrame: at baseline and at 3 and 6 months post injection.
measure: Electrophysiological study of median nerve.
timeFrame: at baseline and at 3 and 6 months post injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dalia Saif
Study officials:
References:
Clinical trial NCT05697926: Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
Official title: Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: TCR-T therapy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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: Newly diagnosed patients with head and neck cancer without any treatment and willing to take part in this preclinical trial.

Brief summary: This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.


Eligibility criteria: Inclusion Criteria:

1. Gender is not limited, age 18-75 years old;
2. Estimated survival is greater than 3 months;
3. Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment;
4. Patients with head and neck cancer whose tumor tissue can be surgically harvested;
5. Volunteer to join the study and sign the informed consent.

Exclusion Criteria:

1. Infected or had been infected with COVID-19;
2. Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;
3. Patients with head and neck cancer who had received the following treatments:

   The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery;
4. Other situations that are not appropriate to be included in the clinical trial.

Primary outcomes:
measure: Clinical prognosis
timeFrame: 5 year postsurgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04149626: Dexmedetomidine Sedation in Orthopedic Surgery
Official title: Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hallux Valgus and Bunion
Sedation
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Maria Tileli
name: Chryssoula Staikou
First posted: 2019-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.


Eligibility criteria: Inclusion Criteria:

Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery

Exclusion Criteria:

Patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,

Primary outcomes:
measure: Postoperative analgesia duration
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative pain: Numerical Rating Scale (NRS)
timeFrame: 24 hours
measure: Morphine consumption
timeFrame: 24 hours
measure: Rescue analgesia
timeFrame: 24 hours
measure: Sedation
timeFrame: 24 hours
measure: Complications
timeFrame: 24 hours
measure: Delirium occurence
timeFrame: 24 hours
measure: Chronic pain: Graded Chronic Pain Scale (GCPS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
Study officials:
References:
Clinical trial NCT04615026: Prevalence of Thrombosis in COVID-Patients
Official title: Prevalence of Thrombosis in COVID-Patients in Correlation to Humoral and Cellular Immunity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all SARS CoV 2 positive patients registered at local health departments (Augsburg) are invited to join the study

Brief summary: Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection.


Eligibility criteria: Inclusion Criteria:

* SARS CoV 2 positive swap, at least 4 weeks after infection

Exclusion Criteria:

* under 18 years old no consent anemia

Primary outcomes:
measure: prevalence of thrombosis
timeFrame: 20 minutes
Secondary outcomes:
measure: correlation to immunity
timeFrame: 20 minutes
measure: Assessment of late complications
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
Study officials:
affiliation: University Hospital Augsburg
name: Alexander Hyhlik-Duerr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01593826: Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Official title: Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria: Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.

Primary outcomes:
measure: Pharmacokinetic parameter Cmax of plasma budesonide concentration
timeFrame: within 12 h
measure: Pharmacokinetic parameter Cmax of plasma formoterol concentration
timeFrame: within 24 h
measure: Pharmacokinetic parameter AUCt of plasma budesonide concentration
timeFrame: Within 12 h
measure: Pharmacokinetic parameter AUCt of plasma formoterol concentration
timeFrame: Within 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Orion Pharma Clinical Pharmacology Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Leena Mattila, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orion Corporation, Orion Pharma
name: Ulla Sairanen, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01023126: Obesity and Psychotherapy as an Alternative to Treatment
Official title: Poor Patients Adherence to Exercise and Group Therapy as an Approach to Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Therapy
Keywords: Obesity
Exercise
Psychotherapy
Lead sponsor: Feevale
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adherence to obesity treatment programs has been a limiting factor to good results in loosing weight. This study aimed to verify if obese subjects submitted to a physical exercise program and group psychotherapy would have a greater adherence, than obese people exercising only.

Detailed description: The sample was forty people, both genders, mean age: 42,2 ± 10,7 years old. Physical exercise consisted of walking and stretching three times a week, during 50 minutes, with intensity verified by the Borg Scale, during three months. One of the days were supervised by the authors while two were freely chosen by the participant, without supervision. The verified variables were: total body mass, height, body mass index, physical activity level, caloric expenditure, waist circumference and fat percentile. Half of the sample participated of group psychotherapy once weekly.

Eligibility criteria: Inclusion Criteria:

* BMI \>= 30 kg/m2

Exclusion Criteria:

* Age less than 25 or more than 62

Primary outcomes:
measure: Weight loose
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Novo Hamburgo
country: Brazil
facility: Centro Universirário Feevale
state: RS
Study officials:
affiliation: Centro Universitário Feevale
name: Cesar L Reichert, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: