louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01732185: Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
Official title: Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cystic Adenomatoid Malformation (CCAM)
Keywords: Congenital lung malformation
Congenital Cystic Adenomatoid Malformation
Cystic lung disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 45
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of CCAM.

Detailed description: Congenital lung malformations are rare diseases, characterized by the coexistence in the same individual of normal lung and localized lung malformation. Among these malformations, congenital cystic adenomatoid malformations (CCAM) represent the most important group, with an estimated incidence between 1/11 000 and 1/35 000 births. The precise mechanisms leading to these lung malformations remain poorly understood. This project aims to identify key genetic and/or molecular mechanisms associated with the occurrence of CCAM. CCAMs are collected during postnatal surgical resection. Parental agreement is required. A standardised histologic description of malformations is performed for each sample. Normal lung tissue at the periphery of the malformation is considered as control. Malformations will be analyzed in a systematic way by proteome and transcriptome, after laser microdissection. Somatic genetic abnormalities will also systematically be sought.

Eligibility criteria: Inclusion Criteria:

* Children \< 8 years
* Thoracic surgery for congenital lung malformation
* Parental written consent

Exclusion Criteria:

* Children \> 8 years
* Previous infection of the malformation
* Parental rebutal

Primary outcomes:
measure: mRNA expression
timeFrame: at Day 0
Secondary outcomes:
measure: Protein expression
timeFrame: at Day 0
measure: Somatic genetic abnormalities
timeFrame: at Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker-Enfants Malades Hospital
Study officials:
affiliation: Necker-Enfants Malades Hospital
name: Christophe Delacourt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotecha S, Barbato A, Bush A, Claus F, Davenport M, Delacourt C, Deprest J, Eber E, Frenckner B, Greenough A, Nicholson AG, Anton-Pacheco JL, Midulla F. Antenatal and postnatal management of congenital cystic adenomatoid malformation. Paediatr Respir Rev. 2012 Sep;13(3):162-70; quiz 170-1. doi: 10.1016/j.prrv.2012.01.002. Epub 2012 Apr 25.
citation: Lezmi G, Vibhushan S, Bevilaqua C, Crapart N, Cagnard N, Khen-Dunlop N, Boyle-Freyssaut C, Hadchouel A, Delacourt C. Congenital cystic adenomatoid malformations of the lung: an epithelial transcriptomic approach. Respir Res. 2020 Feb 4;21(1):43. doi: 10.1186/s12931-020-1306-5.
Clinical trial NCT03264885: Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme
Official title: Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme for Elderly With Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2017-08-29
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Elderly with visual impairment (VI) who undergo community eye screening often do not attend tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of participants following community eye screening.

Detailed description: A randomized controlled study individuals with VI with baseline visual acuity (VA) and vision-related quality of life (VRQoL) assessed in the community. Participants were randomised to either receiving ICS or usual care (UC). ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals. Participants in UC received a standard GP referral letter advising them to seek further care. Our main outcome measure was compliance to tertiary eye-care referral. Our secondary outcome measure was VA and VRQoL assessed at 3 months.

Eligibility criteria: Inclusion Criteria:

* the ability to speak English and/or Mandarin, have adequate hearing with/without hearing aids to respond to normal conversation, not currently undergoing regular assessment/care with an ophthalmologist (at least yearly), have the ability to undergo visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse in either eye after best correction

Exclusion Criteria:

* refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant

Primary outcomes:
measure: Compliance to Tertiary Care Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: SNEC
name: Marcus Ang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04563585: Position Differences and Physical Performance Among Female Team Handball Players
Official title: Position Differences and Physical Performance Among Female Team Handball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Handball Players
Position Differences
Physical Performance
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Cyprus International University
First posted: 2020-09-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this cross-sectional study, a total of 39 elite female handball players with at least of 5 years playing experience were tested. Player positions were identified for each athlete by their coaches or by self-report as: goalkeepers, centres, pivots, or wing players. All of them were playing in the premier Turkish professional handball league.

Brief summary: Our study was conducted to compare the physical performances of the upper extremity and lower extremity of handball players according to the positions they played.

In this cross-sectional study, a total of 39 elite female handball players with at least of 5 years playing experience were tested.Maximal voluntary isometric (MVIC) knee flexion and extension strength were measured using a handheld dynamometer (HDD) (Lafayette Instrument Company, Lafayette, IN). Lower extremity vertical power was identified through the use of the VertiMetric (Lafayette Instrument Company, Lafayette, IN) according to protocols suggested by Ambegaonkar et al. Trunk extension endurance was measured using the Biering-Sorensen test as previously described.The Davies test (DT) was used to assess upper body agility and stabilization.The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) was utilized to assess shoulder performance function and stability according to protocol suggested by Goldbeck and Davies.The Shark Skill Test (SST) was developed in order to assess lower extremity agility and neuromuscular control.


Eligibility criteria: All athletes were asymptomatic and had passed medical examinations prior to inclusion and participation in the study. Exclusion criteria included history of injury or surgery that may affect their lower and upper limbs and any lower and upper limb injuries within the last three months.

Primary outcomes:
measure: Muscle Strength
timeFrame: 2 weeks
measure: Lower Extremity Vertical Power
timeFrame: 2 weeks
measure: Trunk Extension Endurance
timeFrame: 2 weeks
measure: Upper Limb Performance
timeFrame: 2 weeks
measure: Lower Limb Performance
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Etlik
Study officials:
affiliation: Cyprus International University
name: Bünyamin Haksever, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089985: Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
Official title: Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Xerophthalmia
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2010-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

Detailed description: A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.

Eligibility criteria: Inclusion Criteria:

* Seen at the dry eye service at the Singapore National Eye Centre
* Age between 21 and 75 years old
* Symptomatic for dry eye or VA worse than 6/12 in Snellen chart
* Presence of corneal punctate staining involving central zone
* Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician
* No contraindication for blood extraction/plasmapheresis

Exclusion Criteria:

* HIV/HCV/HBV/syphilis

Primary outcomes:
measure: Staining
timeFrame: 4 months
Secondary outcomes:
measure: Symptoms
timeFrame: 4 months
measure: Tear-production
timeFrame: 4 months
measure: Tear-proteins
timeFrame: 4 months
measure: Tear-stability
timeFrame: 4 months
measure: Cornea
timeFrame: 4 months
measure: Conjunctiva
timeFrame: 4 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Centre
name: Louis Tong, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore National Eye Centre
name: Ronald Chung
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore Eye Research Institute
name: Roger Beuerman
role: STUDY_DIRECTOR
affiliation: Singapore General Hospital
name: Mickey Koh
role: STUDY_CHAIR
affiliation: Singapore National Eye Centre
name: Samanthila Waduthantri
role: STUDY_CHAIR
affiliation: Singapore General Hospital
name: Heng Joo Ng
role: STUDY_CHAIR
affiliation: Singapore General Hospital
name: Rohani Salleh
role: STUDY_CHAIR
References:
Clinical trial NCT03216785: SNUH MICU Cohort Study of PICS
Official title: Cohort Study of Patients Patients in the Medical Intensive Care Unit to Evaluate Postintensive Care Sydnrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Care
Registries
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the medical intensive care unit

Brief summary: Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the medical intensive care unit

Exclusion Criteria:

* Patients admitted to the intensive care unit for simple procedures
* Patients admitted for postoperative care observation

Primary outcomes:
measure: Functional status
timeFrame: 3 month
Secondary outcomes:
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00176085: Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH
Official title: Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: THCCOOH
Pharmacokinetics
Metabolism
Cannabis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits.

Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals

Detailed description: To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5 mg) and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive. For these purposes the following criteria will be studied:

THCCOOH

* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed THCCOOH-glu
* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)

Eligibility criteria: Inclusion Criteria:

* Good state of health (physically and mentally)

Exclusion Criteria:

* Any regular drug treatment within the last two months
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Smoking (regular or irregular)
* Excessive alcohol drinking (more than approximately 30 g alcohol per day)
* Positive drug screening especially THC or known or admitted drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinical Research Center, Department of Internal Medicine VI
Study officials:
affiliation: Department of Internal Medicine VI
name: Gerd Mikus, MD BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00722085: Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
Official title: Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Risk Pregnancy
Incompetent Cervix
Cerclage
Amniotic Fluid Sludge
Gestation Age at Delivery.
Keywords: Amniotic Fluid Sludge
Cerclage
Ultrasound
Preterm Delivery
Neonatal
Lead sponsor: Center For Maternal Fetal Medicine
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at CMFM

Brief summary: Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.

Detailed description: 177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have sludge. Conclusion AF sludge on ultrasound had no association with increased risk of preterm delivery in patients with cerclage.

Eligibility criteria: Inclusion Criteria:

* Cerclage
* Pregnancy Outcome data available
* Neonatal Outcome data available
* Pre and Post Cerclage Cervical length measurements
* Hx of cervical procedures, if any, available

Exclusion Criteria:

* Cervical ultrasound picture(s) unacceptable
* Any missing maternal or fetal data as stated above
* Fetal anomaly
* Cervical dilation at time of cerclage
* Placental previa or abruption
* Preterm Labor

Primary outcomes:
measure: AF Sludge as a predictor of preterm delivery in cerclage patients
timeFrame: 7 years
Secondary outcomes:
measure: Absence of AF Sludge as a predictor of preterm delivery in cerclage patients
timeFrame: 7 years
Other outcomes:
Locations:
city: Las vegas
country: United States
facility: Center For Maternal Fetal Medicine
state: Nevada
Study officials:
affiliation: Center For Maternal Fetal Medicine
name: Laura A Gorski, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875285: Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
Official title: Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperhidrosis
Iontophore
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the therapeutic effect of methotrexate iontophoresis versus coal tar ointment on the the treatment of primary palmer hyperhidrosis?

Detailed description: Some researchers stated that hyperhidrosis can render the skin susceptible to infection because of the continuous dampness of the skin. The condition may become socially, psychologically and professionally debilitating.

There are a lot of literatures concerned with studying the modalities used in the treatment of primary palmar hyperhidrosis, so this study will be conducted to compare between two of them and to show the best one for treating primary palmar hyperhidrosis.

Eligibility criteria: Inclusion Criteria:

* Patient with primary palmar hyperhidrosis to extend that their palms are wet during most of the day (score 3 and 4 in the Hyperhidrosis Disease Severity Scale) was included in this study.
* The palmer hyperhidrosis patient's age ranged from 15 to 35 years.
* All patients will be examined by dermatologist before starting the study.

Exclusion Criteria:

The study excluded the following patients:

* Patients with medical conditions that associated with hyperhidrosis are excluded, these conditions include:- hyperthyroidism, diabetes mellitus, parkinsonism, spinal cord injury, brain damage, congestive heart failure, anxiety, alcoholism and menopause.
* Patients who received any treatment with a drug that was affecting sweating e.g. (thyroxin, anxiolytics.....) that is not stopped at least 4 weeks preceding the study.
* Patients with cardiac conditions such as arrhythmia, ischemic heart disease, low exercise tolerance, low respiratory reserve were excluded.
* Patients, who have a local wound, sever eczema and severe fungal infection of the palms to minimize risk of local burn.
* Patients who have sensory disorders.
* Female patients who are pregnant and lactating.

Primary outcomes:
measure: Assessing the change in Sweat output
timeFrame: at baseline and after 4 weeks of intervention
measure: Assessing the change in degree of severity of hyperhidrosis
timeFrame: at baseline and after 4 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Nayera Radwan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04765085: Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics
Official title: Study on the Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tic Disorders
Keywords: comprehensive behavioral intervention therapy
drug therapy
Psychosocial education
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study on the clinical efficacy and change of life quality through using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)

Detailed description: This study tried to explore the clinical effect of comprehensive behavioral intervention therapy (CBIT) on tic symptoms and the effect of improving the quality of life in children with tic disorders;explore the optimal treatment plan for tic disorder by comparing the clinical efficacy of CBIT therapy, drug therapy, and psychosocial education; explore the feasibility of using quality of life as an evaluation index for functional recovery after tic disorder treatment;

Eligibility criteria: Inclusion Criteria:

* Meets the diagnostic criteria for chronic tic disorder or Tourette syndrome (TS) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), and has been diagnosed by two pediatric psychiatrists who are associate chief physicians or more;
* The age ranged from 9 to 16 years old;
* The total score of tic symptoms in the Yale global Tic Severity Scale (YGTSS) is 13-30;
* Childrens Webster's Intelligence Scale ≥ 85
* Co-morbid ADHD, but the drug treatment dose for ADHD is stable (the drug has been stabilized for more than 6 weeks), or no drug has been taken at the beginning and during the stud

Exclusion Criteria:

* There are brain organic diseases, metabolic diseases, psychiatric disorders, drug-induced involuntary movement and other extrapyramidal lesions;
* Habit reversal training and other behavioral treatments for more than 4 weeks;
* unwilling participants or disobedient subgroups in the study

Primary outcomes:
measure: Reduction rate of Tic symptom severity before and after intervention
timeFrame: Baseline, the tenth week of treatment
Secondary outcomes:
measure: overall treatment response
timeFrame: The fifth week and the tenth week of treatment and three month after treatment end
measure: life quality
timeFrame: The fifth week and the tenth week of treatment and three month after treatment end
Other outcomes:
Locations:
Study officials:
References: