louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01319643: Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU)
Official title: Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nervous System Diseases
Respiratory Tract Diseases
Cardiovascular Diseases
Immune System Diseases
Keywords: Oxygen
Hyperoxia
Intensive care unit
Mortality
Organ dysfunction
Postoperative care
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 660
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: Oxygen administration is a common practice in intensive care units, although concern is growing about oxygen toxicity. The aim of the study is to access whether a rigorous maintenance of a state of normal oxygenation in critically ill patients could obtain better outcomes, such as mortality, infections and organ failures, in comparison to conventional oxygen therapy practice.


Eligibility criteria: Inclusion Criteria:

* all patients admitted in a post-operative and medical intensive care unit with expected admission of at least three days. Informed consensus as soon as possible

Exclusion Criteria:

* minority
* patient discharged from ICU and successively re-admitted
* patient enrolled in other studies
* expected survival shorter than 24 hours

Primary outcomes:
measure: Mortality in ICU
timeFrame: 30 days
Secondary outcomes:
measure: Rate of organ dysfunctions (respiratory, circulation, renal, liver)
timeFrame: 30 days
measure: Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.
timeFrame: 30 days
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena
Study officials:
affiliation: Università di Modena e Reggio Emilia
name: Massimo Girardis, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, Morelli A, Antonelli M, Singer M. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1583-1589. doi: 10.1001/jama.2016.11993.
Clinical trial NCT03464643: A Prospective Study Comparing the Outcomes of Single Versus Group Culture in Preimplantation Genetic Testing Cycles
Official title: A Prospective Study Comparing the Outcomes of Single Embryo Culture Versus Group Culture in Preimplantation Genetic Testing Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Culture
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 236
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to analyze whether there is difference in the effect of single embryo culture and group culture in preimplantation genetic screening (PGS) cycle, and provide reference for the feasibility of the clinical application of medium-based noninvasive PGD. This prospective study prepares for more than 1,000 normal fertilized zygotes in each group over one year period. For the recruited patients, all normal fertilized zygotes were randomly allocated into two groups: cultured individually in 25 ul media or 2-3 embryos cultured together in 50 ul media. The blastocyst formation rates, aneuploid rates, clinical pregnancy rates, implantation rates and miscarriage rates will be compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* patients treated by preimplantation genetic diagnostic / screening cycles

Exclusion Criteria:

* number of normal fertilization zygotes is less than 6

Primary outcomes:
measure: high quality blastocyst formation rate
timeFrame: 6 days after fertilization
Secondary outcomes:
measure: embryo euploid rate
timeFrame: about one month after blastocyst biopsy
measure: embryo implantation rate
timeFrame: about three to six months after blastocyst biopsy
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive and Genetic Hospital of Citic-xiangya
state: Hunan
Study officials:
affiliation: Reproductive and Genetic Hospital of Citic-xiangya
name: Xiaojuan Wang, Doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04482543: Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C
Official title: Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C; A Multi-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Proliferative Vitreoretinopathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C proliferative vitreoretinopathy (PVR).

74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection will be done in the control group. In the intervention group, Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation rate and adverse events are the secondary outcome measures. Comprehensive ocular examination will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.


Eligibility criteria: Inclusion Criteria:

* Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C

Exclusion Criteria:

* Age of under 18 years old
* Pregnancy
* Glaucoma
* Macular disorders
* Diabetic retinopathy
* Retinal vascular occlusion
* History of penetrating ocular trauma
* Giant retinal tear
* Chronic uveitis
* History of intraocular steroid injection

Primary outcomes:
measure: Retinal reattachment rate
timeFrame: 6 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months
measure: Retinal reproliferation rate
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT02105038: Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
Official title: Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: distal radius fracture
steering
steering wheel spinner knob
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aims of the study are to better understand how upper extremity injury and immobilization influences a patient's steering ability. Patients with acute distal radius fractures treated with surgery will be recruited for study in a driving simulator. The results will hopefully assist physicians to better counsel patients with upper extremity injuries on when it is safe to return to driving.

Detailed description: The ability of an injured person to safely drive an automobile while immobilized in an upper extremity cast or splint is not well defined.

The aims of the study are to better understand how upper extremity injury and immobilization influences a patient's steering ability. The secondary aim is to further evaluate the effectiveness of a steering wheel spinner-knob to assist with one-handed driving. A steering wheel spinner knob may be a surrogate to assist with one handed driving while immobilized.

Eligibility criteria: Inclusion Criteria:

* • Acute distal radius fracture treated with surgery and initially immobilized in a cast or splint

  * Valid driver's license with 1 years of driving experience and actively driving during the last three months
  * English speaking
  * Ability to start testing within 10 days of surgery

Exclusion Criteria:

* • \<18 years of age

  * Current use of steering wheel spinner knob or hand controls while driving
  * Non-drivers
  * Multi-trauma
  * Open fractures
  * Surgical repair with external fixation
  * Concurrent distal radius/ulnar joint injury and repair
  * Any other joint besides the wrist immobilized following surgery
  * Contralateral upper extremity disability
  * Previous ipsilateral upper extremity functional deficit
  * Inability to participate for the full length of the study

Primary outcomes:
measure: Steering reaction time
timeFrame: 6 months
Secondary outcomes:
measure: Steering accuracy
timeFrame: 6 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Kyle J Jeray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01130038: Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development Coordination Disorder
Keywords: Characteristic of play
DCD
children
Typical Development
Whether there are any differences in the issue of Characteristic of play between Children with DCD and Children with Typical Development
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 4-6 years with Development Coordination Disorder ( DCD) and Children with Typical Development (controlled group)

Brief summary: There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development.


Eligibility criteria: Inclusion Criteria:

* Children with proper( age expected) intelligence and IQ level
* Study in regular education system
* The DCD diagnosis must be confirmed by a pediatrician

Exclusion Criteria:

* Score above 9 in the Movement Assessment Battery test for Children
* Score below 3.83 in Children Activity Scale for Parents
* routinely take medication
* any physical limitations
* neurologic and/or muscle disease
* any significant hearing and/ or vision limitations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gush Dan (Dan Area)
country: Israel
facility: Clalit Medical Center
Study officials:
References:
Clinical trial NCT02783638: PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers
Official title: A Open-label, Randomized, Crossover Clinical Trial to Assess the PK of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR and the Food Effect of High Fat Diet After Single Dosing in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Neuropathy Pain
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 64
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

Detailed description: Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin IR and will remain in the clinic until completion of all assessment on Day 19 including collection of PK sample. The treatment periods were separated by a washout period (10-17 days).

Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2 subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including collection of PK sample. The treatment periods were separated by a washout period (7-14 days).

Eligibility criteria: Inclusion Criteria:

* Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing

Primary outcomes:
measure: Cohort 1: Cmax
timeFrame: Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
measure: Cohort 1: AUCtau
timeFrame: Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
measure: Cohort 1: Cmax
timeFrame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
measure: Cohort 1: AUCtau
timeFrame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
measure: Cohort 2: Cmax
timeFrame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
measure: Cohort 2: AUCtau
timeFrame: YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
References:
Clinical trial NCT05986838: Effect of Laser Puncture Versus Ultraviolet Radiation on Women With Polycystic Ovarian Syndrome
Official title: Effect of Laser Puncture Versus Ultraviolet Radiation on Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided into three groups. For three months, group (A) will receive laser puncture (3 sessions per week), along with a metformin supplementation, group (B) will receive ultraviolet radiation (3 sessions per week), along with a metformin supplementation, while group (C) will receive only metformin supplementation. The follicular size will be measured using ultrasound, while, female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood analysis

Detailed description: Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided into three groups. For three months, group (A) will receive laser puncture (3 sessions per week), along with a metformin supplementation, group (B) will receive ultraviolet radiation (3 sessions per week), along with a metformin supplementation, while group (C) will receive only metformin supplementation. The follicular size will be measured using ultrasound, while, female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood analysis

Eligibility criteria: Inclusion Criteria:

* Obese nulli gravid PCOS women
* BMI 30-40 kg/m2

Exclusion Criteria:

* hyperprolactinemia
* BMI \> 40 kg/m2 Endocrinological disorders such as thyroid disease, Cushing's syndrome, Coagulopathy
* Recent use of oral contraceptive pills
* Recent use of any photosensitizing medications, such as aspirin, tetracycline, chlorothiazide, or psoralen suspicious of neoplasms

Primary outcomes:
measure: LH/FSH ratio
timeFrame: 1 month after treatment
Secondary outcomes:
measure: Serum 25-hydroxyvitamin D concentration
timeFrame: 1 month after treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed M Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02877238: Remote Preconditioning and Myocardial Protection
Official title: Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Heart Disease
Keywords: remote ischemic preconditioning
sevoflurane
total intravenous anesthetic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

Detailed description: The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.

Eligibility criteria: Inclusion Criteria:

* Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass

Exclusion Criteria:

* Previous cardiac surgery
* Urgent or emergent cases
* Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases

Primary outcomes:
measure: Troponin I levels
timeFrame: within first 24 hours after cardiac surgery
Secondary outcomes:
measure: Highest inotropic score during the first 24 hours after cardiac surgery
timeFrame: within first 24 hours after cardiac surgery
measure: Mortality at 30 days
timeFrame: 30 days
measure: Cardiac function
timeFrame: within first 24 hours of cardiac surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate professor of anesthesia
name: Sayed K Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506103: The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Hypocalcemia
Vocal Cord Palsy
Keywords: Thyroidectomy
Central neck dissection
Harmonic scalpel
Perioperative complications
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2007-07-25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.


Eligibility criteria: Inclusion Criteria:

* patients with total thyroidectomy plus central neck dissection
* if primary tumor size was more than 1 cm in papillary thyroid cancer
* there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively
* patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer

Exclusion Criteria:

* patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis
* patients had clinical or laboratory indicators of coagulation disorders
* patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve
* patients with massive extracapsular extension to the surrounding soft tissues.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Dept. of otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
Study officials:
affiliation: Dept. of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine
name: Yoon Woo Koh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41. doi: 10.1016/j.surg.2004.09.011.