louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02638441: Psychological Profile of Women With Infertility in Egypt: A Comparative Study
Official title: Psychological Profile of Women With Infertility in Egypt: A Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: psychological health
women
anxiety
depression
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted at the department of Obstetrics and Gynecology of Ain shams university and Zagazig university and some private centres for the treatment of infertility. It will include 400 women, divided into two groups (control group and clinical group) starting from January 2016.

Brief summary: The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women

Detailed description: Comparative cross sectional study

Eligibility criteria: Inclusion Criteria:

Control group:

* Pregnant women.
* At least one live birth.
* Age group 20-40 years.

Clinical group:

* Infertile women either primary or secondary according to (WHO,2013).
* Age group 20-40ys.
* Different levels of education.
* Different methods of treatment of infertility (medical or IVF)
* Half of them from rural area the other half from urban area.

Exclusion Criteria:

* Male factor of infertility.
* The women with psychiatric disorders.
* The women with physical and medical disorders.
* The women whose current pregnancy has any problems (e.g. growth retardation, macrosomia, placenta previa, threatened abortion, or preterm labour).
* The women with history of intrauterine fetal death.

Primary outcomes:
measure: determination of the prevalence of depression among infertile women
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: professor of obstetric and gynecology
name: sherif a akl
role: STUDY_DIRECTOR
References:
Clinical trial NCT06355141: Oral Structural and Functional Problems in Children With Autism
Official title: Investigation of Oral Structural and Functional Problems in Children With Autism Secondary IDs:
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism Spectrum Disorder
Chewing Problem
Drooling
Keywords: autism
chewing
drooling
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with autism (CwA) are five times more likely to experience feeding-related problems than their typically developing peers. Oral functional problems (chewing disorder, drooling of saliva), food selectivity, inappropriate mealtime interaction, abnormal eating speed (holding food in the mouth for a long time or fast feeding) and failure to eat the usual family diet are feeding-related reported in CwA.

Brief summary: This study aims to examine oral structural and functional problems in children with autism.

Detailed description: In this descriptive study, children with autism will be screened for oral structural and functional problems. In this context, observational evaluation will be made. The presence of tongue thrust reflex, chewing performance and salivation control in children will be examined.Within the scope of the research, demographic data, parameters related to the oral motor development stage (time to transition to solid food and solid food, time to first teething) will be recorded according to parental report. Oral structural evaluation, including open mouth, high palate, oral hygiene and malocclusion, will be made observationally and recorded as present/absent. Within the scope of oral functional evaluation, tongue thrust reflex, chewing function and salivation control (dooling) will be evaluated.

The questions the investigators will test for this purpors; Q1:What oral structural and functional problems are seen in children with autism? Q2:What is the frequency of oral structural and functional problems seen in children with autism?

Eligibility criteria: Inclusion Criteria:

* Diagnosed with autism,
* Not having any additional diagnosis other than autism,
* Age between 5-15 yers

Exclusion Criteria:

* Not being able to receive the commands required to obtain working data.

Primary outcomes:
measure: Demographic Information Form
timeFrame: 1 month
measure: Time to achieve Oromotor skills
timeFrame: 1 month
measure: Oral structural assessment
timeFrame: 1 month
Secondary outcomes:
measure: Chewing evaluation
timeFrame: 1 month
measure: Drooling of saliva evaluation
timeFrame: 1 month
measure: Tongue thrust evaluation
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Aydin Adnan Menderes University
name: Ayşe Kübra Söyler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04380441: Quality of Life Model for Older Patients With AML
Official title: Development of a Quality of Life Decision-Making Model for Older Patients With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: AML, Adult
Acute Myeloid Leukemia
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-05-08
Enrollment: 206
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Malignant Hematology Department or Senior Adult Oncology Division at Moffitt Cancer Center in Tampa, Florida.

Brief summary: The purpose of this study is to describe the differences in quality of life (QOL) among newly diagnosed patients diagnosed with acute myeloid leukemia (AML) to help design a patient decision-making QOL model for aligning patients' choice of treatment with what matters the most to them.


Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* Newly diagnosed with pathology-confirmed diagnosis of Acute Myeloid Leukemia
* Within 7 days of starting a new treatment
* Must be able to read and speak English at the 8th grade level

Exclusion Criteria:

* Under 60 years of age
* Other malignancy, dementia, traumatic brain injury or individuals with central nervous system involvement of their leukemia

Primary outcomes:
measure: Difference in Quality of Life score between patients receiving intensive versus non-intensive chemotherapy
timeFrame: At baseline and at 30, 60, 90 and 180 days post treatment
measure: Difference in Quality of Life score between patients with varying disease characteristics
timeFrame: At baseline and at 30, 60, 90 and 180 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Sara Tinsley, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00528541: Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spasmodic Torticollis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 145
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: The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
* Successfully treated previously with botulinum toxin type A

Exclusion Criteria:

* Breast feeding, pregnant or could become pregnant
* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol, alcohol for cervical dystonia

Primary outcomes:
measure: Dysphagia Incidence Over 10 Weeks
timeFrame: 10 weeks
Secondary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
timeFrame: Baseline, Week 4
measure: Physician Assessment of Cervical Dystonia Severity at Week 4
timeFrame: Baseline, Week 4
measure: Global Assessment of Benefit by Physician at Week 4
timeFrame: Week 4
measure: Global Assessment of Benefit by Patient at Week 4
timeFrame: Week 4
measure: Patient Assessment of Need for Retreatment at Week 4
timeFrame: Baseline, Week 4
measure: Patient Visual Analog Assessment of Pain at Week 4
timeFrame: Baseline, Week 4
measure: Physician Comparison of Benefit to Previous Injections at Week 10
timeFrame: Week 10
measure: Patient Comparison of Benefit to Previous Injections at Week 10
timeFrame: Week 10
Other outcomes:
Locations:
city: Adelaide
country: Australia
state: South Australia
city: Zagreb
country: Croatia
city: Rome
country: Italy
city: Krakow
country: Poland
city: Istanbul
country: Turkey
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03522441: Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Akorn, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 1125
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.


Eligibility criteria: IInclusion Criteria:

* Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
* Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

* Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
* Subject has active cystic acne.
* Subject has acne conglobata.
* Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Primary outcomes:
measure: Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
timeFrame: Percent change from baseline to 12 weeks
measure: Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
timeFrame: Percent change in baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Site 11
state: California
city: Sherman Oaks
country: United States
facility: Site 10
state: California
city: Brandon
country: United States
facility: Site 1
state: Florida
city: Miramar
country: United States
facility: Site 4
state: Florida
city: Miramar
country: United States
facility: Site 5
state: Florida
city: Tampa
country: United States
facility: Site 2
state: Florida
city: Tampa
country: United States
facility: Site 3
state: Florida
city: High Point
country: United States
facility: Site 12
state: North Carolina
city: El Paso
country: United States
facility: Site 8
state: Texas
city: El Paso
country: United States
facility: Site 9
state: Texas
city: Belize City
country: Belize
facility: Site 6
city: Belize City
country: Belize
facility: Site 7
Study officials:
References:
Clinical trial NCT01378819: 3-midline-ports Cholecystectomy
Official title: Three Ports Placed in the Line Alba of the Abdomen (3-midline-ports Technique): an Alternative Approach for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: laparoscopic cholecystectomy
Postoperative pain
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.

Detailed description: The patients will be randomized into 2 groups: those patients undergoing laparoscopic cholecystectomy following the "French" technique (Group 1) and those ones undergoing the 3-midline-ports approach (Group 2).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective cholecystectomy for symptomatic gallstones.

Exclusion Criteria:

* Diagnosis of acute cholecystitis

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05337319: Prospective Registry of the Current Status of Care for Patients With Coronary Artery Disease
Official title: A Multi-center, Prospective, Registry Study to Estimate the Current Status of Care for Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with coronary artery disease

Brief summary: The study will estimate the current status of care for participants with coronary artery disease


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with discharge diagnosis as coronary artery disease (including atherosclerosis or non-athrosclerosis)

Exclusion Criteria:

* None

Primary outcomes:
measure: The overall composite of 10 performance measures for CAD care
timeFrame: Duration of hospital stay, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Shaoping Nie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00593619: Trial Comparing the Safety of Two Different Intravenous Iron Formulations
Official title: A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Perioperative Blood Conservation
Keywords: Intravenous Iron
Safety
Perioperative
Iron deficiency
Non hemodialysis population
Perioperative blood conservation
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 200
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: The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 100
* To be receiving intravenous iron

Exclusion Criteria:

* Age \< 18
* Hemodialysis
* Previous exposure to intravenous iron
* Unable to provide written consent

Primary outcomes:
measure: Incidence of severe adverse drug reactions (ADRs)
timeFrame: Immediate - during infusion
Secondary outcomes:
measure: Incidence of serious adverse drug reactions (ADRs)
timeFrame: Immediate and delayed - within 24hrs post infusion
measure: Incidence of anaphylactic/anaphylactoid ADRs
timeFrame: Immediate - during infusion
measure: Incidence of combined mild and moderate ADRs
timeFrame: Immediate - during infusion
measure: Incidence of delayed ADRs
timeFrame: delayed - within 24hrs post infusion
measure: Incidence of all-cause mortality
timeFrame: Immediate and delayed - within 24hrs post infusion
measure: Physician and nursing time required to manage ADRs
timeFrame: Immediate and delayed - within 24hrs post infusion
measure: Response in laboratory parameters
timeFrame: Within 1 month
measure: Cost effectiveness
timeFrame: Completion of study
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Ian H Chin-Yee, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre
name: Fiona E Ralley, MB ChB, FRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre
name: Cyrus C Hsia, MD,FRCPC
role: STUDY_DIRECTOR
References:
Clinical trial NCT05909319: Identification and Verification of Neutrophil Extracellular Trap Net Related Markers in Acute-on-chronic Liver Failure
Official title: Identification and Verification of Neutrophil Extracellular Trap Net Related Markers in Acute-on-chronic Liver Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute-On-Chronic Liver Failure
Keywords: Neutrophil extracellular traps
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the diagnostic criteria of Chinese Group on the Study of Severe Hepatitis B (COSSH) for acute-on-chronic liver failure

Brief summary: Acute-on-chronic liver failure (ACLF) refers to the acute deterioration of liver function in patients with chronic liver disease. Neutrophils are a major component of the innate immune system, and previous studies have revealed enhanced production of neutrophil extracellular traps (NETs) in ACLF. However, there is still a lack of systematic research on the correlation between NETs and the prognosis of ACLF. We screened NETs related biomarkers through bioinformatics analysis, which play an important role in the diagnosis of ACLF. This study will explore whether these NETs related biomarkers also play an important role in the prognosis of ACLF and further investigate their role in the pathogenesis of ACLF.


Eligibility criteria: Inclusion Criteria:

1. Patients who meet the diagnostic criteria of Chinese Group on the Study of Severe Hepatitis B (COSSH) for acute-on-chronic liver failure

Exclusion Criteria:

1. Age greater than 75 years old
2. liver cancer
3. previous liver transplantation
4. other serious extrahepatic organ diseases
5. uncontrolled bacterial infections.

Primary outcomes:
measure: mortality
timeFrame: 30 days
measure: mortality
timeFrame: 90 days
measure: mortality
timeFrame: half a year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02899819: MecoExpo Study Protocol
Official title: MecoExpo Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn
Keywords: pesticides
exposure
in utero
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 1020
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie.

These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery).

Thus, the MecoExpo project will enable the investigators to:

1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.).
2. map pesticide exposure across the Picardie region.
3. create a meconium bank in Picardie (the first ever meconium bank in France).


Eligibility criteria: Inclusion Criteria:

* All newborns in Picardie will be eligible. Good command of the French language by a least one of the two people with responsibility for the child will be required for filling out the questionnaire.
* The mother's place of residence must have been in Picardie during the last two trimesters of pregnancy.

Exclusion Criteria:

* Newborns with foetal distress

Primary outcomes:
measure: fœtal vs mother exposure - term
timeFrame: Day 2
measure: fœtal vs mother exposure - length
timeFrame: Day 2
measure: fœtal vs mother exposure - weight
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Abbeville
city: Amiens
country: France
facility: CHU Amiens
city: Amiens
country: France
facility: Groupe Santé Victor Pauchet
city: Beauvais
country: France
facility: CH Beauvais
city: Chateau-thierry
country: France
facility: CH Chateau-Thierry
city: Chauny
country: France
facility: CH Chauny
city: Compiegne
country: France
facility: Clinique Saint Come
city: Compiegne
country: France
facility: CH Compiegne
city: Creil
country: France
facility: Groupe Hospitalier Public Sud Oise
city: Laon
country: France
facility: CH Laon
city: Peronne
country: France
facility: CH Peronne
Study officials:
affiliation: CHU Amiens
name: Caroline DEGUINES, MD
role: PRINCIPAL_INVESTIGATOR
References: