louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785811: Effect of Chronic Supplementation of L-arginine in the Muscular Performance
Official title: Randomized, Double Blind, Placebo Controlled Study of Parallel Groups to Evaluate the Effect of Chronic Supplementation of L-arginine in the Muscular Performance.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Muscular Fatigue
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular force the quadriceps.


Eligibility criteria: Inclusion criteria:

Healthy young adults for both sex; Age between 20 and 55 years; Slight or moderate physical activity, 30 minutes per day, at least 3 times a week;

Exclusion criteria:

Cardiac or pulmonary disease; Previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; Athletic person (intensive anaerobic activity); None practiced of physical activity regularly; Medications usage

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Fatigue Resistance Factor (FRF)
timeFrame: Throughout the study
Secondary outcomes:
measure: Maximum force in Newton (N) and fast or explosive force
timeFrame: at time 30% of the maximum isometric force
measure: Maximum force in Newton (N) and fast or explosive force
timeFrame: at time 50% of the maximum isometric force
measure: Maximum force in Newton (N) and fast or explosive force
timeFrame: at time 90% of the maximum isometric force
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05671211: Effects Of Task-Oriented Training In Individuals With Stroke
Official title: Effects Of Task-Oriented Training on Balance,Walking,Functional Mobility,Activities Of Daily Living and Quality Of Life In Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Tas-Oriented Training
Balance
Walking
Mobility
Activities of Daily Living
Quality of Life
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 28
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: The purpose of this study is to investigate the effects of task-oriented training on balance,functional mobility,walking, activities of daily living and quality of life in individuals with stroke.

Detailed description: Eligible participants will be randomized to task-oriented group or control group.Control group will receive conventional therapy generally consisted of neurophysiological approaches for 6 weeks 5 times a week for 1 hour per session.Task-oriented group will receive conventional therapy and task-oriented training for 6 weeks 5 times a week 1,5 hours per session.Each participant will be assessed before and after the 6 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Modified Rankin score between 0-3
* Having a stroke for the first time
* At least 1 month has passed since the stroke
* Able to walk 10 M with or without assistance
* Having a Mini Mental Test score of 24 and above
* Volunteering to participate in the study
* Being fluent in Turkish language

Exclusion Criteria:

* Having an additional neurological disease other than stroke
* Having an additional disease that prevents mobility
* Having a condition that prevents you from exercising
* Receiving an existing additional medical treatment for spasticity treatment
* Having a history of multiple strokes
* Having severe visual problems post stoke

Primary outcomes:
measure: Berg Balance Scale(BBS)
timeFrame: six weeks
measure: 10 Meter Walking Test(10MWT)
timeFrame: siz weeks
measure: Timed Up And Go Test (TUG)
timeFrame: siz weeks
measure: Stroke-Specific Quality of Life Scale(SS-QOL)
timeFrame: six weeks
Secondary outcomes:
measure: 5 Times Sit to Stand Test(5XSST)
timeFrame: six weeks
measure: Functional Ambulation Classification (FAC)
timeFrame: six weeks
measure: Functional Independence Scale (FIM)
timeFrame: six weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Bornova Türkan Ozilhan State Hospital Physical Therapy Unit
state: Bornova
Study officials:
affiliation: Bornova Ozilhan State Hospital Physical Therapy unit
name: ALI E. MUTLU, mD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05889611: Iterative Endotracheal Tube Cuff Pressure Monitoring
Official title: Iterative Endotracheal Tube Cuff Pressure Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Disease
Keywords: Spine Disease
Spine surgery
Intubation Cuff Pressure
Endotracheal Intubation
Upper airways
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023.

Brief summary: Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.


Eligibility criteria: Inclusion criteria:

* Elderly patient ≥ 18 years old
* Patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023
* Intubated patient with endotracheal tube under mechanical ventilation
* Sedation and curarization
* ASA 1, 2 and 3
* Duration of surgery \> 1 hour
* Subject not objecting to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* ASA 4, difficult intubation and emergency
* Lung pathologies (asthma, COPD, tracheomalacia)
* Severe heart failure
* Septic, cardiogenic or volume shock
* Morbid obesity (BMI \>40)

Primary outcomes:
measure: Balloon pressure
timeFrame: Throughout the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Study officials:
affiliation: University Hospitals of Strasbourg
name: Nicolas PARTOUCHE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02651311: Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis
Official title: Randomized Controlled Trial of the Postoperative Analgesic Efficacy of Ultrasound Guided Intermediate Cervical Plexus Block for Unipolar Sternocleidomastoid Release in Patient With Congenital Muscular Torticollis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congenital Muscular Torticollis
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at birth or shortly after birth, primarily resulting from unilateral shortening of Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some children, which is accompanied by moderate pain and discomfort. The investigators focused the effectiveness of intermediates cervical plexus block because the dermatome of sensory of cervical plexus block is correlated to that of torticollis. So the effect of analgesia could decrease the use of analgesics.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Undergoing general anesthesia for unipolar sternocleidomastoid release in patient with congenital muscular torticollis

Exclusion Criteria:

* coagulation disorder
* kidney or liver disease
* allergy to local anesthetics

Primary outcomes:
measure: Pain on the FLACC scale
timeFrame: at 5 min after postanesthesia care unit admission
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeong-gi
Study officials:
affiliation: Ajou University School of Medicine
name: yun jeong chae, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JS, Joe HB, Park MC, Ahn H, Lee SY, Chae YJ. Postoperative Analgesic Effect of Ultrasound-Guided Intermediate Cervical Plexus Block on Unipolar Sternocleidomastoid Release With Myectomy in Pediatric Patients With Congenital Muscular Torticollis: A Prospective, Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):634-640. doi: 10.1097/AAP.0000000000000797.
Clinical trial NCT01599611: Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
Official title: Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Hyperbilirubinemia
Keywords: Neonatal hyperbilirubinemia
Follow-up
Motor development
Hearing
Executive function
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children born in Denmark in the period 01.01.2000 - 31.12.2005 with a gestational age \>= 35 weeks and a total serum bilirubin \> 450 umol/L and a matched control group of children

Brief summary: The objective of this study was to investigate whether infants with total serum bilirubin \> 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.

Detailed description: Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.

Eligibility criteria: Inclusion Criteria:

* Gestational age \> 35 weeks
* Total serum bilirubin \> 450 umol/L in the neonatal period
* Born in the period 01.01.2000 - 31.12.2005

Exclusion Criteria:

* Acute intermediate or advanced bilirubin encephalopathy

Primary outcomes:
measure: Motor development
timeFrame: Age 5-10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Børneafdelingen, Aalborg Sygehus, Denmark
name: Pernille Vandborg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandborg PK, Hansen BM, Greisen G, Mathiasen R, Kasper F, Ebbesen F. Follow-up of extreme neonatal hyperbilirubinaemia in 5- to 10-year-old children: a Danish population-based study. Dev Med Child Neurol. 2015 Apr;57(4):378-84. doi: 10.1111/dmcn.12603. Epub 2014 Oct 29.
Clinical trial NCT03807011: Emergence Agitation in Pediatric Strabismus Surgery
Official title: The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Agitation
Keywords: Emergence Agitation
fentanyl
remifentanil
children
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective subumbilical surgery,
* physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria:

* history of airway problem,
* upper respiratory tract infection within 2 weeks,
* developmental delay,
* neurological or psychological disease,
* history of allergy to the drugs in our protocol were excluded in this study.

Primary outcomes:
measure: incidence of postoperative agitation
timeFrame: 5 minutes in the recovery room
measure: incidence of postoperative agitation
timeFrame: 30 minutes in the recovery room
measure: severity of postoperative agitation
timeFrame: 5 minutes in the recovery room
measure: severity of postoperative agitation
timeFrame: 30 minutes in the recovery room
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eun kyung Choi
state: Korea (the Republic Of)
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Nam-gu, Daegu
Study officials:
References:
Clinical trial NCT01545011: Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease
Official title: Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Inspiratory muscle training
COPD
Conventional respiratory rehabilitation
Dyspnea scale
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-03-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP \> 60 cmH2O).

Detailed description: Dyspnea is the main complaint of patients with COPD. Dyspnea is explained largely by the distension, objectified by measuring inspiratory capacity (IC), which places the diaphragm at a disadvantage to be effective, which raises the sensation of dyspnea.

Currently, inspiratory muscles training is recommended by the French-language Society of Pneumology, in case of an objective reduction of the strength of these muscles (corresponding to maximum inspiratory pressure \<60 cm H20).

Eligibility criteria: Inclusion Criteria:

* Patient with COPD
* Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course

Exclusion Criteria:

* Pneumonectomy, Lobectomy less than 6 months
* Cardio-pulmonary anomaly
* Max inspiratory pressure \< 60 cm H2O

Primary outcomes:
measure: Dyspnea measure
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
state: Brittany
city: Morlaix
country: France
facility: Hospital of Morlaix
state: Brittany
Study officials:
References:
Clinical trial NCT05269511: Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts
Official title: Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 2163
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, blank-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection. All subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with SARS-CoV-2. Subjects in each cohort will be randomly assigned to the Chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.


Eligibility criteria: Inclusion Criteria:

1. Household contact exposure to individuals with SARS-CoV-2 infection
2. Aged ≥18
3. General healthy or have a chronic, stable medical condition
4. Voluntarily signing a written informed consent form
5. Able to follow written and oral instructions in Chinese

Exclusion Criteria:

1. Moderate to severe symptomatic SARS-CoV-2 infection
2. An allergic history to Chinese herbal drugs or a known allergy to the ingredients of the study drug
3. Pregnancy, breastfeeding or plan to become pregnant within the study timeframe
4. Vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself)
5. Any physical examination findings, and/or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study

Primary outcomes:
measure: Proportion of subjects who have PCR confirmed SARS-CoV-2 infection
timeFrame: 3 weeks
measure: Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs
timeFrame: 3 weeks
measure: Proportion of subjects who subsequently develop COVID-19 symptoms or signs
timeFrame: 3 weeks
measure: Proportion of subjects who subsequently develop moderate to severe COVID-19 infection
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of days of symptomatic PCR confirmed SARS-CoV-2 infection
timeFrame: 3 weeks
measure: Number of days of PCR confirmed SARS-CoV-2 infection
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Chinese Medicine, Hong Kong Baptist University
state: Hong Kong
Study officials:
affiliation: School of Chinese Medicine, Hong Kong Baptist University
name: Aiping Lyu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01953211: Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity
Official title: LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, reproductive age women 18 to 35 years old, who were seeking contraception from the general gynecology clinics of the LAC and USC Medical Center were recruited. The research team identified potential candidates who were taking one of 6 possible monophasic COC formulations. Informed consent was obtained from participants by the research staff. To be eligible for participation, women reported regular menstrual cycles prior to COCs, and had taken at least 3 cycles of the same monophasic COC prior to enrollment.

Brief summary: The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (\<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.


Eligibility criteria: Inclusion Criteria:

* Healthy, reproductive age women
* 18 to 35 years old,
* seeking contraception from the general gynecology clinics of the LAC and USC Medical Center w
* taking one of 6 possible monophasic COC formulations for at least 3 cycles prior to enrollment
* regular menstrual cycles prior to COCs

Exclusion Criteria:

* Irregular bleeding
* bilateral oophorectomy
* amenorrhea
* hormone-sensitive cancer
* concurrent medications known to interfere with steroid metabolism (i.e., barbiturates, phenytoin, carbamazepine, ethosuximide, primidone, rifampin, tetracycline)

Primary outcomes:
measure: Follicle-stimulating Hormone
timeFrame: Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC and USC Medical Center
state: California
Study officials:
References: