louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05354466: Perioperative Respiratory Adverse events_sugammadex
Official title: Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 174
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled

Exclusion Criteria:

* a recent history of upper respiratory tract infection within 2 weeks of surgery
* allergic reaction to sugammadex
* renal failure
* liver failure
* arrhythmia

Primary outcomes:
measure: Perioperative respiratory adverse events
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes:
measure: bradycardia
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Cardiac arrest
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Anaphylaxis
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Allergic reaction
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Bronchospasm
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Nausea and vomiting
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT02901366: Mass Balance Study of FYU-981
Official title: Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Male Subjects
Keywords: Mass balance
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Mochida Pharmaceutical Company, Ltd.
First posted: 2016-09-15
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy adult subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
* Have participated in a \[14C\]-study within the last 12 months prior to dosing of the investigational drug
* Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
* Occupationally exposed worker

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 168 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 168 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 168 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 168 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 168 hours
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed
timeFrame: 168 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 168 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 168 hours
measure: Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)
timeFrame: 168 hours or 72 hours (Ae(air))
measure: Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)
timeFrame: 168 hours or 72 hours (Ae(air))
measure: Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)
timeFrame: 168 hours
measure: Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)
timeFrame: 168 hours
measure: Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air)
timeFrame: 168 hours
measure: Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air)
timeFrame: 168 hours
measure: Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces)
timeFrame: 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT03780166: A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
Official title: A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pemphigus Vulgaris
Keywords: Pemphigus vulgaris
phosphatidylinositol 3-kinase delta
immunoglobulin G autoantibodies
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.


Eligibility criteria: Inclusion Criteria:

* Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6 months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3; Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal lesions.
* Disease progression after treatment with standard therapies that are known to confer clinical benefit, or intolerant to treatment; there is no limit to the number of prior treatment regimens.
* Willingness to avoid pregnancy or fathering children.
* If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during the study period.

Exclusion Criteria:

* Pregnant or breast-feeding female.
* Participants with pemphigus vulgaris who are treatment-naive.
* Use of protocol-specified medications within defined periods before baseline.
* Evidence or history of clinically significant infection or protocol-defined medical conditions
* Laboratory values outside the protocol-defined range at screening.
* Known or suspected allergy to parsaclisib or any component of the study drug.
* Known history of clinically significant drug or alcohol abuse in the last year before baseline.
* Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Cmax of Parsaclisib
timeFrame: Up to 6 weeks
measure: tmax of Parsaclisib
timeFrame: Up to 6 weeks
measure: Cmin of Parsaclisib
timeFrame: Up to 6 weeks
measure: AUC0-t of Parsaclisib
timeFrame: Up to 6 weeks
measure: CL/F of Parsaclisib
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01883466: Health Effects of Biodiesel Exhaust Exposure
Official title: Cardiovascular Effects of Exposure to 100% Biodiesel Exhaust in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Endothelium
Keywords: Air Pollution
Biodiesel exhaust
Diesel exhaust
Vascular function
Fibrinolysis
Acute endothelial responses
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
First posted: 2013-06-21
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Urban air pollution is a major contributor to greenhouse gases and has been shown to increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing and research, with biodiesel emerging as one of the strongest contenders within international markets. The pursuit of alternative renewable fuels is incredibly complex and has powered research in agriculture, biotechnology, production, transportation, feedstocks, ecology and biomass manufacturing. In spite of this, health effects have been an almost completely overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further investigations into the chemical composition of biodiesel exhaust will also be performed.


Eligibility criteria: Inclusion Criteria:

Non-smoking, healthy male subjects. All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function.

Exclusion Criteria:

* Diabetes Mellitus
* Cardiovascular disease
* Asthma
* Respiratory infection within 2 weeks of the study
* Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
* Smokers or regular snus usage

Primary outcomes:
measure: Vascular vasomotor and fibrinolytic function
timeFrame: 4-6 hours after exposure
Secondary outcomes:
measure: Respiratory function tests
timeFrame: Baseline, 6 and 24 hours after exposure
measure: Effects of exposure on metabolomic markers in plasma
timeFrame: Baseline and 2, 4 & 24 hours after exposure
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Jenny A Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unosson J, Kabele M, Boman C, Nystrom R, Sadiktsis I, Westerholm R, Mudway IS, Purdie E, Raftis J, Miller MR, Mills NL, Newby DE, Blomberg A, Sandstrom T, Bosson JA. Acute cardiovascular effects of controlled exposure to dilute Petrodiesel and biodiesel exhaust in healthy volunteers: a crossover study. Part Fibre Toxicol. 2021 Jun 14;18(1):22. doi: 10.1186/s12989-021-00412-3.
Clinical trial NCT06169566: The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial
Official title: Analysis of Gut Microbiome in Thai Women With Polycystic Ovary Syndrome and the Synbiotics Effect on Reproductive and Cardiovascular Risk: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PCOS- Polycystic Ovary Syndrome
Lead sponsor: Maharaj Nakorn Chiang Mai Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effect of synbiotics and placebo in Thai women with polycystic ovary syndrome. The main questions it aims to answer are:

* Do synbiotics have a positive effect on the gut microbiome?
* Do synbiotics have a positive effect on reproductive outcomes?
* Do synbiotics have a positive effect on cardiovascular outcomes? Participants will be randomized, and blinded to receive either synbiotics or placebo.

While placebo is a comparison group: Researchers will compare with placebo to see if the effects on reproductive and cardiovascular risk differ.

Detailed description: Analysis of gut microbiome in Thai women with polycystic ovary syndrome and the synbiotics effect on reproductive and cardiovascular risk: A randomized controlled trial

Eligibility criteria: Inclusion Criteria:

- PCOS

Exclusion Criteria:

* ATB use

Primary outcomes:
measure: Gut microbiome in polycystic ovary syndrome
timeFrame: 12 months
Secondary outcomes:
measure: synbiotics effect on reproductive and cardiovascular risk
timeFrame: 12 months
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
Study officials:
affiliation: Department of obstetrics and gynecoloy
name: Ploywarong Rueangket, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02423226: Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Official title: Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectum Cancer
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.

Detailed description: The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.

Eligibility criteria: Inclusion Criteria:

* Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy
* Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
* Age range 18-70 years old
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

Previous serious cardiac disease

* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Chronic inflammatory bowel disease or intestinal obstruction
* Serious uncontrolled diseases and intercurrent infection

Primary outcomes:
measure: Progression free survival
timeFrame: One year
Secondary outcomes:
measure: Treatment related adverse events
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: The First People's Hospital of Changzhou
name: Changping Wu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05787626: Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects.
Official title: Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Diaphragm Issues
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. The experimental group will consist of 14 subjects who will carry out 1 weekly session of 10 minutes and who will be evaluated just before starting the intervention, after it and at 4 weeks. The control group will be made up of 14 subjects who will be evaluated in the three periods described without the need to carry out the intervention.

Detailed description: The intervention will be carried out for 4 weeks, with 1 weekly session of 10 minutes duration. The patient will go to the intervention room where the treatment procedure will be explained in detail. He will be explained verbally and with a visual demonstration of what the technique consists of and how it is going to be performed, the position that he has to adopt during and how long the intervention will last.

The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.

The patient will be asked to focus on their own breathing and the contact that the therapist will apply.

In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.

Eligibility criteria: Inclusion Criteria:

* Healthy people
* no spinal pathology
* no respiratory pathology

Exclusion Criteria:

* have suffered spinal pathologies in the last 3 months
* have suffered respiratory diseases in the last 3 months

Primary outcomes:
measure: Centimetric measurement of the thorax
timeFrame: change from baseline to one month
measure: Back range of motion
timeFrame: change from baseline to one month
measure: Inspiratory and expiratory capacity
timeFrame: change from baseline to one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00336726: Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation With Cognitive Dysfunction and Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Lead sponsor: Denver Research Institute
Sponsor class: OTHER
First posted: 2006-06-14
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male subjects having had a recent traumatic brain injury

Brief summary: Traumatic Brain Injury (TBI) is a neurologic disorder cuased by physical trauma to the brain. Neuroendocrine abnormalities in these patients have been reported, including central hypogonadism within hours of the insult and eventual recovery of the hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline. This pilot study will measure hormonal level of neuroendocine function at the time of TBI and various time points during recovery.


Eligibility criteria: Inclusion Criteria:

* Male subjects having had a recent traumatic brain injury.

Exclusion Criteria:

* Currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Veterans Affairs/University of Colorado HSC
name: Margaret E Wierman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391726: CART-19 Cells for R/R B-cell Lymphoma
Official title: CART-19 Cells For Patients With Relapsed or Refractory B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Relapsed or Refractory B-cell Lymphoma
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged between 1-65 years
* Patients with relapse/refractory B-cell lymphoma
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.

Primary outcomes:
measure: Disease-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events that are related to treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT06844526: Comparative Effects of Core Stability Versus Hoping Exercises on Trunk Stability Among Kabaddi Athletes
Official title: Comparative Effects of Core Stability Exercises Versus Hopping Exercises on Trunk Stability and Balance Among Kabaddi Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: core stability exercises
hoping exercises
trunk stability and balance
kabaddi athlets
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control design
Primary purpose: TREATMENT

Brief summary: comparative effects of core versus hoping exercises on trunk stability and balance among kabaddi athlets

Detailed description: Comparative effects of core stability exercises versus hopping exercises on trunk stability and balance among kabaddi athletes

Eligibility criteria: Inclusion Criteria:

* Males
* Aged 18-35 years
* Active players training for at least from 6 weeks
* Normal BMI (18.5-24.9 kg/m2)

Exclusion Criteria:

* Any acute inflammatory conditions of the back, spinal fractures, and systemic conditions affecting muscle performance,
* Spinal instability or any musculoskeletal, cardiac issue
* Presence of neurological deficits: history of seizure, headache, spinal cord injury

Primary outcomes:
measure: ⦁ Y balance test
timeFrame: 8 weeks
measure: ⦁ Stork stands balance test to measure static and dynamic equilibrium
timeFrame: 8 wee
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajeeha Zia, MS
role: PRINCIPAL_INVESTIGATOR
References: