louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05006898: Compound to Control Presbyopia Symptoms
Official title: Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Presbyopia
Lead sponsor: Optall Vision
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
Primary purpose: TREATMENT

Brief summary: Low dose compose to control presbyopia symptoms

Detailed description: A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.

Eligibility criteria: Inclusion Criteria:

* healthy
* Presbyopic
* 40 - 59 years

Exclusion Criteria:

* Diabetics
* Previous eye surgery
* Previous eye disease
* \> 0.50 myopia
* \> 1.5 hyperopia or astigmatism

Primary outcomes:
measure: Jaeger notation near uncorrected visual acuity change
timeFrame: 1 hour
measure: Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optall Vision
Study officials:
affiliation: Optall Vision
name: Cesar Alejandro S Galeana
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06494098: Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants
Official title: Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and/or Palate
Cleft Lip Bilateral
Keywords: Cleft palate
Cleft Lip and/or Palate
Nasoalveolar Molding
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of:

1. Decreasing cleft gap.
2. Attaining columellar length.
3. Effect on maxillary growth.
4. Treatment Duration.
5. Parents acceptance.


Eligibility criteria: Inclusion Criteria:

1. The age range from 14 -30 days after birth.
2. Has complete cleft lip and palate.
3. Parents acceptance.
4. Medically free infants.

Exclusion Criteria:

1. Syndromic patients.
2. Medically compromised patients contradicting operation.

Primary outcomes:
measure: Attaining columellar length
timeFrame: 3 month
Secondary outcomes:
measure: Treatment Duration
timeFrame: 3 month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahliya
Study officials:
References:
Clinical trial NCT02551198: Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation
Official title: Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: polyethylene glycol with ascorbic acid
oral sulfate solution
bowel preparation
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Daehang Hospital
First posted: 2015-09-16
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.

For bowel preparation, effective, well-tolerated and safe methods should be applied.

Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation

Detailed description: For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation

Eligibility criteria: Inclusion Criteria:

1. Age, between 20 and 75
2. Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy

Exclusion Criteria:

* Gastrointestinal obstruction
* Bowel perforation
* Gastric retention
* Ileus
* Toxic colitis or toxic megacolon
* Known allergies to components of the OSS and PEG-Asc
* History of colorectal resection
* History of abdominopelvic surgery within 6 months
* uncontrolled electrolyte imbalance
* hereditary Phenylketonuria
* Severe dehydration status
* seizure
* coma
* Glucose-6-phosphate dehydrogenase deficiency

Primary outcomes:
measure: Adequacy of bowel preparation
timeFrame: on the day of colonoscopy
Secondary outcomes:
measure: 5-point scale symptom questionnaire for drug tolerability
timeFrame: on the day of colonoscopy
measure: Number of Participants with Adverse Events
timeFrame: on the day of colonoscopy
measure: colonoscopy insertion time
timeFrame: on the day of colonoscopy
measure: adenoma detection rate
timeFrame: whithin 3 weeks from the day of colonoscopy
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Dae Kyung Sohn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01221961: Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
Official title: A Study to Determine the Agreement Between Masimo Monitor and Standard of Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Major Spine Surgery Procedure
Keywords: Major spine surgery
Hemoglobin
Blood transfusion
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2010-10-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing major spine surgery

Brief summary: This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb \[Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)\*.

Detailed description: \*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo multiple level spine surgery procedures
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class I - III adults of either sex
* Pregnant women

Exclusion Criteria:

* Patients with a perfusion index less than 1 or low confidence reading
* Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement
* Patient undergoing cardio-pulmonary bypass

Primary outcomes:
measure: Hemoglobin value
timeFrame: 0-8 hours
Secondary outcomes:
measure: Blood transfusion
timeFrame: 0-8 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald H Wender, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700661: A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.


Eligibility criteria: Inclusion Criteria:

* Male or Female between and including the ages of 2 and 5 years
* Patient was treated with steroids for an asthma episode in the last 3 months
* Patient was admitted to the hospital or emergency room in the last 3 months
* Patient is able to chew a tablet

Exclusion Criteria:

* Patient has been in a research study in the past 4 weeks
* Patient has visited the emergency room for an asthma episode in the past week
* Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Primary outcomes:
measure: asthma episodes in 2 - 5 year old children
timeFrame: at 12 months
Secondary outcomes:
measure: the number of treatments and duration of asthma episodes
timeFrame: at 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.
Clinical trial NCT05570461: Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan
Official title: Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: NCS University System
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This RCT will also help the clinicians to provide the best treatment to their patients for better outcomes.

The objective of the study is to determine the efficacy of Modified Constraint-induced movement therapy on the Upper Limb function of Sub-acute stroke patients in Peshawar Pakistan.

Alternative Hypothesis: There will be a difference in the means of Modified Constraint-induced movement therapyand traditional physical therapy on the upper limb function of subacute stroke patients.


Eligibility criteria: Inclusion Criteria:

* 1. Age 30 to 60 years
* 2. Both female \& male will be included.
* 3. Cognitive and lingual ability to communicate with the research staff.
* 4. A minimum of 10 degrees of active finger extension and 20 degrees of active wrist extension(16).
* 5. A history of a single stroke resulting in a hemiparesis

Exclusion Criteria:

* 1. Recurrent stroke during the training period.
* 2. Neurological or orthopedic disorders prohibiting the use of the paretic arm.
* 3. Patients who doesn't show willingness to participate in the study.

Primary outcomes:
measure: Wolf Motor function test
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00248261: Ziprasidone and Sertraline in PTSD
Official title: Effects of Ziprasidone vs. Placebo During the First Four Weeks of Eight Weeks Sertraline Treatment in Patients With Post-traumatic Stress Disorder (PTSD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post-traumatic Stress Disorder
Keywords: ziprasidone, sertraline, PTSD
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2005-11-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PTSD patients

Brief summary: Serotonin re-uptake inhibitors, such as sertraline, are the medication of choice in post-traumatic stress disorder. However, it takes several weeks before they ameliorate symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.

Detailed description: A current problem in the pharmacotherapy of PTSD is that the medication of choice, serotonin re-uptake inhibitors, take several weeks before they show considerable effects on PTSD symptoms. Addition of typical neuroleptics, such as ziprasidone, offers a potential strategy to bring about a faster symptomatic relief, because they display anxiolytic properties without the risk of dependence. Therefore, in addition to standard sertraline therapy (at least 8 weeks), we will give ziprasidone vs. placebo over the first four weeks in a double-blind randomized design.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Post-Traumatic Stress Disorder

Exclusion Criteria:

Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone

Primary outcomes:
measure: Post-Traumatic Diagnostic Scale (PDS)
timeFrame: 56 days
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 56 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: UKE, Dept. of Psychiatry and Psychotherapy
Study officials:
affiliation: UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany
name: Michael B Kellner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kellner M, Muhtz C, Wiedemann K. Primary add-on of ziprasidone in sertraline treatment of posttraumatic stress disorder: lessons from a stopped trial? J Clin Psychopharmacol. 2010 Aug;30(4):471-3. doi: 10.1097/JCP.0b013e3181e79600. No abstract available.
Clinical trial NCT00587561: Efficacy of Social Cognition Training in Schizophrenia
Official title: Efficacy of Social Cognition Training in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
social cognition
cognition
treatment
outcome
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2008-01-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy.

Objectives:

This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia.

Research Design and Methodology:

Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder
* Age between 18 and 65
* minimum of 30 days since discharge from last hospitalization
* minimum of 30 days since last change in psychiatric medications
* no housing changes in the past 30 days

Exclusion Criteria:

* current diagnosis of alcohol or substance abuse/dependence
* history of brain trauma or neurological disease
* mental retardation or developmental disability
* auditory or visual impairment that would interfere with study procedures

Primary outcomes:
measure: Social cognitive measures
timeFrame: intake, 6 months
Secondary outcomes:
measure: basic cognitive measures
timeFrame: intake, 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Heathcare System and Yale University
name: Joanna Fiszdon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02607761: Fertility Awareness in University Students
Official title: Fertility Awareness in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Video
Keywords: infertility
fertility awareness
health interventions
young adults
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2015-11-18
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recent evidence showed that undergraduate students have inappropriate knowledge about reproductive health and infertility.

The investigators' aim was to assess the effectiveness of a brief intervention (video) in increasing the knowledge regarding fertility issues, fertility risk factors and infertility definition.


Eligibility criteria: Inclusion Criteria:

* Undergraduate student

Exclusion Criteria:

* Having knowledge of a fertility problem

Primary outcomes:
measure: change in fertility knowledge
timeFrame: T1 - immediatly after intervention; T2 - one week later; T3 - one month later; T4 - 12 months later
Secondary outcomes:
measure: change in age of desired parenthood
timeFrame: T1 - immediatly after intervention; T2 - one week later; T3 - one month later; T4 - 12 months later
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: University of Porto, Faculty of Psychology and Educational and Education Sciences
Study officials:
References:
citation: Conceicao C, Pedro J, Martins MV. Effectiveness of a video intervention on fertility knowledge among university students: a randomised pre-test/post-test study. Eur J Contracept Reprod Health Care. 2017 Apr;22(2):107-113. doi: 10.1080/13625187.2017.1288903. Epub 2017 Feb 14.
Clinical trial NCT05023161: Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction
Official title: Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Growth Retardation
Keywords: Non Invasive Prenatal Testing
cell- free DNA
trisomy
placenta confined mosaic
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)

Brief summary: The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.

This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.

Detailed description: Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.

The study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.

Eligibility criteria: Inclusion Criteria:

* over 18 years old,
* treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,
* having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),
* from 16 weeks of amenorrhea or more,
* accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization

Exclusion Criteria:

Childbearing women who:

* do not accept a non-invasive prenatal diagnosis (amniocentesis)
* have a fetus with non-isolated IUGR (associated with other ultrasound signs)
* do not consent to participate in the research protocol

Primary outcomes:
measure: Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.
timeFrame: Inclusion date
Secondary outcomes:
measure: Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.
timeFrame: Inclusion date
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: