louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06193148: A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants
Official title: A Study to Evaluate the Effect of Oral Administration of Jaktinib Hydrochloride Tablets on QT/Corrected QT (QTc) Interval in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration.


Eligibility criteria: Inclusion Criteria:

* Voluntarily sign informed consent, able to comply with the requirements of the study.
* Age 18-45 years old, both male and female;
* Weight: male ≥ 50 kg, female ≥ 45 kg, 19 kg/m\^2 ≤ BMI ≤26 kg/m\^2.
* 12-lead electrocardiogram (ECG) examination, 300 ms≤QTcF\<450 ms, 120 ms≤PR interval ≤200 ms, and QRS duration \<120 ms;
* The subjects (including male subjects) are willing to voluntarily take effective contraceptive measures within the next 3 months.

Exclusion Criteria:

* Have a history of risk factors for torsade de pointes, or have a family history of short QT syndrome, long QT syndrome, unexplained sudden death in young adulthood (≤40 years old), drowning or sudden infant death syndrome in first-degree relatives;
* Previous history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia;
* Subjects who had donated blood or lost ≥400 mL of blood within 3 months before screening;
* HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
* Women with positive blood pregnancy test (applicable to women) or lactating women;
* Subjects who have other factors that the investigator considers unsuitable for participation in the study.

Primary outcomes:
measure: QT Interval Corrected Using Fridericia's Formula
timeFrame: From before dosing until 48 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhu
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: LiYan Miao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02312648: Impact of Mobilization on Cardiac Surgery
Official title: Impact of an Early Mobilization Program on Functional Capacity After Coronary Artery Bypass Surgery: a Protocol of Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Keywords: Functional Capacity
Physical Exertion
Patient Care
Early mobilization
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term.

Detailed description: The hypotheses this study is that patients if conduct the program of early mobilization during hospitalization achieve better performance in the walk test (distance) at hospital discharge and 60 days after the surgical procedure compared to patients who only carry out the program of respiratory exercises. Intervention and control groups will receive breathing exercises up to 24 hours postoperatively, and the intervention group will also receive early mobilization exercises.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients admitted to elective and conventional coronary artery bypass, Body Mass Index (BMI) between 20 and 30 Kg/m2, mechanical ventilation time under than 24 hours, hemodynamic stability with or without use of positive inotropes, absence of arrhythmias and angina, mean arterial pressure (MAP) 60\<PAM\<100 mmHg, heart frequency (HR) 60\<FC\<100 bpm without signs of respiratory distress such as flaring nose, use of accessory muscles, thoracoabdominal asynchrony, respiratory frequency (f) ≤ 20 bpm without signs of infection were included in this study.

Exclusion Criteria:

* : presence of previous pulmonary disease, ejection fraction under 35% or longer than 54%, reoperation, intraoperative death or any contraindications to perform the proposed measurements and/or treatment.

Primary outcomes:
measure: Functional Capacity
timeFrame: All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory
Secondary outcomes:
measure: Intensive Care Unit (ICU) and Hospital length of stay
timeFrame: All patients will be followed for the duration of hospital stay, an expected average of 30 days
measure: Postoperative pulmonary complication (PPC)
timeFrame: All patients will be followed for the duration of hospital stay, an expected average of 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Luciana D Chiavegato, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01276548: A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
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 Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.


Eligibility criteria: Inclusion Criteria:

1. Subjects who aged 18 years or older
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

Exclusion Criteria:

1. Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
2. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
3. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit

Primary outcomes:
measure: To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate
timeFrame: up to 6 cycles
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 3 years
measure: Progression Free Survival
timeFrame: up to 3 years
measure: Time to Progression
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu, Pungnap-2 Dong
Study officials:
References:
Clinical trial NCT02247648: Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy
Official title: Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Vertigo
Nausea
Pruritus
Keywords: tramadol
shoulder surgery
pain
interscalen block
BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.

Detailed description: The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.

Eligibility criteria: Inclusion Criteria:

* aged more than 18 year old
* arthroscopic shoulder surgery on interscalen block
* able to understand the protocol
* inform consent signed

Exclusion Criteria:

* chronic pain or chronic used of narcotics
* Use of IMAO
* Use of ISRS
* Pulmonary chronic disease

Primary outcomes:
measure: quantity of hydromorphone consumed
timeFrame: 3 days
Secondary outcomes:
measure: evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
timeFrame: 3 days
Other outcomes:
measure: nausea
timeFrame: 3 days
measure: dizziness
timeFrame: 3 days
measure: pruritus
timeFrame: 3 days
Locations:
city: Montréal
country: Canada
facility: Institut de chirurgie spécialisée de Montréal
state: Quebec
Study officials:
affiliation: Head of the Anesthesia Department
name: Jean-Denis Roy, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01743248: Vestibular Schwannoma and Psychological Factors
Official title: Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vestibular Schwannoma
Keywords: vestibular schwannoma
balance
psychological factors
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2012-12-06
Enrollment: 50
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: Patients with vestibular schwanomma with an indication for surgery.

Brief summary: The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life.

But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life.

This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.

Detailed description: The research protocol is based on 5 evaluation: 3 days before surgery, 8 days, 30 days, 90 days and 360 days after surgery including posturographic tests, videonystagmography and psychological questionnaires at each evaluation.

Eligibility criteria: Inclusion Criteria:

* patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
* age between 18 and 75 years
* patients with written informed consent
* patients with Social Security affiliation

Exclusion Criteria:

* patients with psychiatrics pathologies
* ear pathology different from vestibular schwannoma (cholesteatoma of the middle ear, tympanic membrane perforation)

Primary outcomes:
measure: psycholgical factors measures
timeFrame: one year
measure: balance control performance
timeFrame: one year
measure: vestibular performance
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Cécile PARIETTI-WINKLER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161848: MRI Study - Chronic Progressive External Ophthalmoplegia
Official title: Magnetic Resonance Imaging Study of Patients With Chronic Progressive External Ophthalmoplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Progressive External Ophthalmoplegia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.

Brief summary: The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag muscles, thighs and calves in patients with the mitochondrial disease chronic progressive external ophthalmoplegia (CPEO).

Additionally an investigation of the volume of the eye muscles will be done and compared to the patient's clinical presentation of ptosis and ophthalmoplegia.

Detailed description: The lack of energy and fatigue seen in patients with mitochondrial diseases have been assumed to be caused by an energy defect because of a genetic defect in the mitochondrial DNA.

The investigators have analyzed a few MRI scans of muscles from patients with CPEO and have seen an extended amount of fat in their muscles, which seems to progress with age. The patient's symptoms might be caused by the extended amount of fat and thereby a less amount of active muscle instead of the "energy defect".

This will be investigated in a group of patients with CPEO and the results will be compared with results from a group of healthy controls.

Eligibility criteria: Inclusion Criteria:

* Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.

Exclusion Criteria:

* Patients who have metal implants in the body, for instance surgical clips, cochlear implant, pacemaker etc.
* Patients who are pregnant or breast-feeding.
* Patients who are claustrophobic

Primary outcomes:
measure: Fat fraction in the muscles of the lower bag, thighs and calves
timeFrame: 1 day
Secondary outcomes:
measure: Isokinetic muscle dynamometry of ankle flexion
timeFrame: 1 day
measure: Isokinetic muscle dynamometry of ankle extension
timeFrame: 1 day
measure: Isokinetic muscle dynamometry of knee flexion.
timeFrame: 1 day
measure: Isokinetic muscle dynamometry of knee extension
timeFrame: 1 day
Other outcomes:
measure: MRI T1 scan of eye muscles
timeFrame: 1 day
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit
Study officials:
References:
Clinical trial NCT06867848: Augmentation of Facial Wall in Defective Fresh Extraction Site for Immediate Implant Placement
Official title: Augmentation of Facial Wall in Defective Fresh Extraction Site for Immediate Implant Placement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: The Augmentation of Labial Defective Wall in Fresh Extraction Socket
Keywords: labial bone augmentation, immediate implant placement .
laminar bone membrane effect
pericardium membrane effect
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study is interventional study containing two groups, each group receiving deferent type of treatment for their result comparison.
Primary purpose: TREATMENT

Brief summary: The study is performed to clinically and radiographically assess the efficacy of using enriched bone graft combined with slowly resorbable membrane on bone quality in immediate implant placement in extraction socket in cases with localized facial bone defect.

Detailed description: The study is include twelve participants , and the patients are in rolled in two groups, group one receive implant, sticky bone and laminar bone membrane . group two receive implant, sticky bone and pericardium membrane using vestibular incision and 6 months post operative radiographically assessment is performed to measure labial bone quantity formed .

Eligibility criteria: Inclusion Criteria:

* patient with a single hopeless tooth in maxillary anterior region.
* sufficient bone apically and palatally
* presence of natural contralateral tooth for the tooth being replaced
* systemic healthy patients

Exclusion Criteria:

* extraction socket type III
* acute infection in hopeless tooth
* a heavy smoker patient
* pregnant
* had received chemotherapy or radiotherapy in previous year

Primary outcomes:
measure: primary stability of implant in Newton centimeter and soft tissue healing
timeFrame: one week postoperative
Secondary outcomes:
measure: labial bone thickness formation in millimeters
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine for girls
Study officials:
References:
Clinical trial NCT05268848: Thermography of the Foot With Plantar Orthosis Liners
Official title: Foot Thermography With the Use of Different Plantar Orthosis Lining Materials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Foot Orthosis
Temperature
Keywords: infrared thermography
orthopodia
thermometry
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objetive: To analyze the thermal effects of the types of liners used in the manufacture of the foot orthoses, as well as to establish the thermal differences among them.

Design: Quantitative, experimental, longitudinal and prospective study. Subjects: 47 individuals selected randomly, over 20 years of age Methods: 4 types of liner were studied: natural skin, synthetic leather, perforated E.V.A and E.V.A. without perforation.


Eligibility criteria: Inclusion Criteria:

People wearing sanitary footwear. 20-35 years Not having smoked or taken alcohol or exciting drinks before evaluation Without cream on the sking and not being exposed to UV rays.

Exclusion Criteria:

young or old people with respect to the age of study smokers or drinkers

Primary outcomes:
measure: Foot temperature measurement PRE
timeFrame: for a month
Secondary outcomes:
measure: Foot temperature measurement POST
timeFrame: for a month
Other outcomes:
measure: Foot temperature measurment by area
timeFrame: for 3 months
Locations:
city: Plasencia
country: Spain
facility: Elena Escamilla Martínez
state: Cáceres
Study officials:
affiliation: University of Extremadura
name: ELENA ESCAMILLA MARTÍNEZ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06966648: Pilot Study on Core Stabilization Training on Stable vs Unstable Surfaces in Young Rhythmic Gymnasts
Official title: Effect of Core Stabilization Training on Balance and Pivot Performance in Young Rhythmic Gymnasts: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postural Balance
Motor Skills
Physical Fitness
Athletic Performance
Keywords: Rhythmic gymnastics
Core stabilization
Balance training
Unstable surfaces
Pilot trial
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 16
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot randomized controlled trial will investigate the effects of a 7-week core stabilization program performed on stable versus unstable surfaces in young competitive rhythmic gymnasts. Sixteen athletes will be randomized into two groups and will be assessed for changes in static balance and pivot performance.

Detailed description: Rhythmic gymnastics requires high-level neuromuscular control, especially for skills involving balance and rotation. Core stabilization exercises are commonly included in training, but limited evidence exists regarding the impact of surface type on training effectiveness. This pilot study will compare the effects of a 7-week core stabilization program conducted on stable versus unstable surfaces on balance and pivot execution in rhythmic gymnasts aged 7-12. Participants will be randomly allocated into two equal groups and will be assessed pre- and post-intervention on selected balance and pivot tasks in accordance with Fédération Internationale de Gymnastique (FIG) standards. The study aims to inform future trials by estimating effect sizes and assessing the feasibility of the protocol.

Eligibility criteria: Inclusion Criteria:

* Female rhythmic gymnasts aged 7 to 12 years
* Minimum of 1 year of experience in rhythmic gymnastics
* Active participation in organized training at least 3 times per week
* No current musculoskeletal pain or injury
* Ability to perform all training and assessment tasks safely
* Written informed consent provided by a parent or legal guardian

Exclusion Criteria:

* History of acute lower limb or spinal injury within the past 6 months
* Presence of neurological, orthopedic, or vestibular disorders affecting balance
* Concurrent participation in other structured physical training programs outside rhythmic gymnastics
* Any medical condition that would contraindicate participation in physical exercise

Primary outcomes:
measure: Balance Duration
timeFrame: Baseline and Week 7 (post-intervention)
measure: Pivot Performance (Number of Clean Rotations)
timeFrame: Baseline and Week 7 (post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: International Hellenic University
Study officials:
References: