louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03619291: High-intensity Functional Circuit Training and Cognitive Function
Official title: Acute Effects of High-intensity Functional Circuit Training on Cognitive Function: a Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise
Cognition
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates the acute effects of one bout of high-intensity functional circuit training on cognitive function against no-activity control and aerobic exercise.

Detailed description: Exercise has been shown to acutely improve cognitive function (CF). However, it is unknown as to how high-intensity functional circuit training (HIFCT) affects CF. This study aims to compare the acute effects of one HIFCT bout against an inactive control condition as well as against one bout of conventional aerobic exercise.

Healthy participants will be randomly allocated to either a HIFCT group, an aerobic exercise group (walking) or an inactive control group. In the HIFCT group, participants perform a 15-minute workout, which is composed of functional exercise mimicking activities of daily living (e.g. squat, step-ups) and conducted in a circuit format. Each exercise is performed at all-out intensity for 20 seconds, followed by a 10-second break. Thus, the 15-min workout consists of 30 exercise intervals.

In the control group, participants will be inactively seated for 15 minutes, reading sports brochures and literature.

In the walking group, participants will walk at moderate intensity on a treadmill for 15 minutes.

Outcomes assessed pre and post-workout include the stroop test, trail making test, stop-signal task, heart rate, subjective arousal, rate of perceived exertion and exercise enjoyment.

Eligibility criteria: Inclusion Criteria:

* 18-40 years

Exclusion Criteria:

* severe orthopaedic, psychiatric, neurological, endocrine or cardiovascular disorders
* acute illness, not completely healed injuries
* muscle soreness
* pregnancy/nursing period

Primary outcomes:
measure: interference control
timeFrame: 2 min
Secondary outcomes:
measure: cognitive flexibility/visual orientation
timeFrame: 2 min
measure: inhibitory control
timeFrame: 2 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06839391: Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS
Official title: Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Tab Block Qaulity
Keywords: hyaluronidase-bupivacaine-TAB block
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS

Detailed description: Hyaluronidase acts by catalyzing the hydrolysis of hyaluronan, decreased its viscosity, and enchasing the tissue permeability. So, this makes it a suitable additive for other drugs to speed up their distribution and delivery especially in ophthalmic surgery. Several studies showed that multiple injection techniques of TAB block were more successful with a faster onset of anesthesia and higher success rates, with a change in the incidence of complications.

This double-blinded randomized prospective study was conducted to evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS . The primary outcome of this study was the duration of sensory block, while secondary outcomes included the onset of sensory block, success rate, total doses of intraoperative rescue analgesia, number of patients needed for postoperative rescue analgesia, and complications.

Eligibility criteria: Inclusion Criteria:

* pregnant 20-45 y medical free

Exclusion Criteria:

* • Hepatic.

  * Renal.
  * Diabetic.
  * Hypertensive.
  * Cardiovascular dysfunction.

Primary outcomes:
measure: visual analogue scale
timeFrame: 2-6-10-16-24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Keeler JF, Simpson KH, Ellis FR, Kay SP. Effect of addition of hyaluronidase to bupivacaine during axillary brachial plexus block. Br J Anaesth. 1992 Jan;68(1):68-71. doi: 10.1093/bja/68.1.68.
citation: Koh WU, Min HG, Park HS, Karm MH, Lee KK, Yang HS, Ro YJ. Use of hyaluronidase as an adjuvant to ropivacaine to reduce axillary brachial plexus block onset time: a prospective, randomised controlled study. Anaesthesia. 2015 Mar;70(3):282-9. doi: 10.1111/anae.12879. Epub 2014 Oct 28.
citation: Kumar CM, Macachor J. Hyaluronidase for brachial plexus block. Anaesthesia. 2015 Sep;70(9):1097-8. doi: 10.1111/anae.13186. No abstract available.
Clinical trial NCT06760091: A Multicentric Cohort of Autoimmune Encephalitis
Official title: Multicentric Registry Study of Autoimmune Encephalitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Encephalitis
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 200
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 autoimmune encephalitis or paraneoplastic neurological syndrome will be enrolled and no additional exclusion criteria are set.

Brief summary: This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.


Eligibility criteria: Inclusion Criteria:

* 1. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:

  1. According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
  2. According to the criteria of Graus et al in 2016, diagnosed as "possible autoimmune encephalitis" and typical autoantibodies are detected in serum or cerebrospinal fluid
  3. According to the criteria of Graus et al in 2021, diagnosed as "possible or definite paraneoplastic neurological syndrome" (excluding peripheral nervous system syndrome) 3. The patient or legal representative voluntarily signed the paper informed consent form.

Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.

Exclusion Criteria:

* No additional exclusion criteria

Primary outcomes:
measure: Change in modified Rankin score (mRS) from baseline
timeFrame: 3months, 6 months, 12months, 24months
Secondary outcomes:
measure: Proportion of Subjects With Occurrence
timeFrame: 12 months, 24 months
measure: Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline
timeFrame: 3months, 6 months, 12months, 24months
measure: Changes of pathogenic antibody titers from baseline
timeFrame: 3months, 6 months, 12months, 24months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT00000291: Effects of Labetalol on Human Cocaine Use - 8
Official title: Effects of Labetalol on Human Cocaine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.

Detailed description: The goal of this study was to investigate the safety and utility of labetalol an alpha and beta adrenergic block, for cocaine dependence in humans. A total of 12 subjects were enrolled in this double blind, placebo controlled outpatient study. After baseline measures are obtained, three experimental sessions were held at least 2 days apart. Subjects were administered a single low (100 mg) or high dose of labetalol (200mg) or placebo on each of 3 experimental sessions. The labetalol doses were given in ascending order and the placebo treatment were randomly inserted into the sequence. A single dose of smoked cocaine (0.4 mg/kg) was administered 2 hrs after labetalol or placebo treatment. During the sessions, several subjective, behavioral and physiological measures were obtained.

Eligibility criteria: Inclusion Criteria:

Male/Female ages 20-55. History of smoked or intravenous cocaine use on the average of at least once a week over a six month period. Current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breat feeding and using acceptable birth control methods (e.g. birth control pills diaphragm, condoms, plus foam) during the study.

Exclusion Criteria:

Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. Current dependence on alcohol or on durgs other than cocaine. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency within the past 6 months.

Primary outcomes:
measure: Subjective
measure: Physiological measures
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pharmacol. Biochem. Behav (accepted). None
Clinical trial NCT01071291: Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Niaspan™ on Reverse Cholesterol Transport in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of cholesterol.


Eligibility criteria: Inclusion Criteria:

* Healthy Male Subjects

Exclusion Criteria :

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

Primary outcomes:
measure: Change from baseline in cholesterol efflux
timeFrame: Baseline and 12 weeks
measure: Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01306591: Bevacizumab for Neovascular Age-related Macular Degeneration
Official title: Randomized Multi-center Clinical Study：Bevacizumab for Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exudative Age-related Macular Degeneration
Keywords: neovascular age-related macular degeneration
Bevacizumab
Multicenter Randomized Study
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 210
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of neovascular Age-related macular degeneration
* Signed informed consent

Exclusion Criteria:

* No other ocular fundus diseases

Primary outcomes:
measure: EDTRS visual acuity score
timeFrame: 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week
Secondary outcomes:
measure: macular thickness in OCT
timeFrame: 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiaoxin Li
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiaoxin Li, doctor
role: STUDY_CHAIR
References:
citation: Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
citation: Fang K, Tian J, Qing X, Li S, Hou J, Li J, Yu W, Chen D, Hu Y, Li X. Predictors of visual response to intravitreal bevacizumab for treatment of neovascular age-related macular degeneration. J Ophthalmol. 2013;2013:676049. doi: 10.1155/2013/676049. Epub 2013 Aug 28.
citation: Li X, Hu Y, Sun X, Zhang J, Zhang M; Neovascular Age-Related Macular Degeneration Treatment Trial Using Bevacizumab (NATTB). Bevacizumab for neovascular age-related macular degeneration in China. Ophthalmology. 2012 Oct;119(10):2087-93. doi: 10.1016/j.ophtha.2012.05.016. Epub 2012 Jul 20.
Clinical trial NCT02384291: Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone vs. Commercially Available Bone Graft
Official title: Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone Versus Commercially Available Bone Graft. A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Floor Augmentation
Lead sponsor: Alpha - Bio Tec Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.

Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.

Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.


Eligibility criteria: Inclusion Criteria:

1. Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone will be selected for the study.
2. Men and women over the age of 18 years.
3. Patient has signed the Informed Consent.

Exclusion Criteria:

1. Chronic steroid therapy,
2. Uncontrolled diabetes,
3. Cardiovascular disease,
4. Past irradiation of head and neck
5. Maxillary sinus cysts,
6. Active chronic sinusitis,
7. Smoking more than ten cigarettes per day during the 3 months preceding this study .
8. Malignant disease in the 5 years preceding this study
9. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
10. Disease that compromise the immune system
11. Psychiatric disorder
12. Hypersensitivity to titanium, collagen or bovine bone.
13. Women who are pregnant or nursing.
14. Patients with non-treated periodontal disease.
15. Medical and/or general contraindications for intraoral surgical procedures

Primary outcomes:
measure: Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites]
timeFrame: 6 months
Secondary outcomes:
measure: Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation].
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne
name: Daniel Rothamel, Priv-Doz Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523691: Repeating Patterns of Sleep Restriction and Recovery
Official title: Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy individuals
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-02-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kg/m2
* For female participants: regular menstrual cycles
* Daily sleep duration in the normal range
* Blood chemistry in the normal range

Exclusion Criteria:

* Active infection/disease
* History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy
* Pregnant/nursing
* Respiratory disturbance index of \>5 events/hour on polysomnographic sleep study, leg movements with arousal \>10/hour; sleep efficiency \<80%
* Regular medication use other than oral contraceptives
* Donation of blood or platelets 3 month prior to or in-between study arms

Primary outcomes:
measure: stress-related markers
timeFrame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
Secondary outcomes:
measure: subjective stress-related markers
timeFrame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Monika Haack, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06571591: Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin with Metformin
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone Co-administration in Patients with Type II Diabetes with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: T2DM
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 582
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: Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.


Eligibility criteria: Inclusion Criteria:

* Adults at the time of signing the Informed Consent Form (ICF)
* Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
* Diagnosed with T2DM

Exclusion Criteria:

* Diagnosed with other types of diabetes than T2DM
* History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy
* Uncontrolled severe complications of diabetes

Primary outcomes:
measure: HbA1c
timeFrame: Week 24 of the Treatment
Secondary outcomes:
measure: HbA1c
timeFrame: Week 12 of the Treatment
measure: FPG
timeFrame: Week 12 and 24 of the Treatment
measure: Body weight
timeFrame: Week 12 and 24 of the Treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Celltrion
Study officials:
References: