louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004381: Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glucosephosphate Dehydrogenase Deficiency
Hyperbilirubinemia
Hemolytic Disease of Newborn
Keywords: glucose-6-phosphate dehydrogenase deficiency
hematologic disorders
hemolytic disease
hyperbilirubinemia
neonatal disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Rockefeller University
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in Greece.

II. Assess the safety of tin mesoporphyrin in high-risk newborns.

Detailed description: PROTOCOL OUTLINE: Patients are stratified by gestational age and sex, and randomly assigned in pairs per stratum.

One group receives a preventive dose of tin mesoporphyrin. Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration.

Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Hyperbilirubinemia associated with either of the following: Direct Coombs' test-positive ABO hemolytic disease of the newborn Glucose-6-phosphate dehydrogenase deficiency --Prior/Concurrent Therapy-- No maternal phenobarbital in last month of pregnancy --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No congenital renal abnormality Cardiovascular: No congenital heart abnormality Pulmonary: No asphyxia requiring assisted ventilation at delivery Other: Gestational age more than 210 days Birth weight at least 1500 g No other major congenital abnormality, i.e.: Central nervous system Chromosomal Gastrointestinal No evident or suspected congenital infection, e.g.: Cytomegalovirus Herpes Rubella Syphilis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Medical Center Hospital
state: Massachusetts
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: Attallah Kappas
role: STUDY_CHAIR
References:
Clinical trial NCT06526481: Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
Official title: Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Adenoma
Keywords: pituitary surgery
double nasoseptal flap
rescue nasoseptal flap
nasal morbidity
transsphenoidal pituitary surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. The nasoseptal flap technique has significantly reduced the incidence of postoperative Cerebrospinal Fluid (CSF) leaks but can cause nasal morbidity.

Detailed description: The study aims to compare nasal morbidity and function between the two techniques in patients undergoing this type of surgery. Each patient's nasal morbidity, olfaction, and postoperative complications will be assessed using various tools.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients with symptomatic pituitary macroadenoma
* Tumor size ≥ 2 cm

Exclusion Criteria:

* -Absent sphenoid pneumatization.
* Temporal or frontal extension.
* Recurrent pituitary tumor after previous surgery.
* Previous nasal surgery.
* Associated nasal disease e.g. rhinosinusitis.
* Unfit for general anesthesia.
* Refusal of surgical intervention or signing consent.

Primary outcomes:
measure: Nasal morbidity
timeFrame: at baseline preoperative and 1 month and 3 months postoperative.
Secondary outcomes:
measure: Operative data
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, Department of otorhinolaryngology
Study officials:
affiliation: Mansoura Faculty of Medicine, Masnoura University
name: Ahmad M. Al-Arman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935181: Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
diaphragm
muscle
stretching
exercises
dyspnea
respiratory muscle stretching
pulmonary rehabilitation
exercise training
improved exercise capacity, dyspnea, quality of life
Lead sponsor: Faculdade Evangelica do Parana
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week. The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.


Eligibility criteria: Inclusion Criteria:

* Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program
* With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)
* Former smokers

Exclusion Criteria:

* Patients with a known history of asthma, or severe and/or unstable heart disease
* Any other pathological condition that could impair their physical activities

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: 2 hours
Secondary outcomes:
measure: Exercise capacity
timeFrame: 2 hours
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Faculdade Evangelica do Paraná
state: Paraná
Study officials:
affiliation: Faculdade Evangelica do Paraná
name: Silvia R. Valderramas, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03825081: Pilocarpine and Brimonidine in Patients With Monofocal Lenses
Official title: Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Presbyopia
Pseudophakia
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.

Detailed description: This research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. Thirty-three subjects will take part in this research study. Baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear Infirmary (MEEI).

Eligibility criteria: Inclusion Criteria:

* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. Men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who need only +/- 2.5 D correction for reading. Given the age group selected only post menopausal women will be evaluated.

Exclusion Criteria:

* Individuals meeting any of the exclusion criteria at baseline will be excluded from study participation including: allergies to proparacaine, pilocarpine or brimonidine, eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery within the past 30 days, use of eye drops within the last seven days, participated in any other research study within the past 30 days. Patients using contact lenses.

Primary outcomes:
measure: Change in visual acuity after administration of pilocarpine and brimonidine
timeFrame: baseline; hour 1
Secondary outcomes:
measure: Change in near and distance visual acuity
timeFrame: baseline; hours 1; 3; and 6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: Matthew_Gardiner@meei.harvard.edu
name: Matthew Gardiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06162481: Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital
Official title: Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: FOCUS of Study: Time of Admission to ICU and Outcome
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 3242
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to ICU

Brief summary: An intensive care unit (ICU) is a specialized unit within the hospital where patients who need immediate medical attention are admitted both during office hours and off hours.1 Literatures report reduced working efficiency because of long working hours, unavailability of 24/7 intensivist staffing and the absence of the same level of hospital services like laboratory investigations during off hours affecting outcome of the patients. 2-6 High intensity staffing model and shorter workhours can improve the outcome.7 However, these are not always feasible in ICUs of low and middle income countries like Nepal. Any variations in outcome depending upon time of ICU admission may impact the workforce planning, medical insurance, and healthcare policy.

The aim of this study was to compare the outcomes of patients admitted to the ICU during office hours and off hours in terms of ICU mortality, duration of mechanical ventilation and length of stay.


Eligibility criteria: Inclusion Criteria:

- age \>= 16 years

Exclusion Criteria:

* Patient who were discharged on request, left against medical advice, had withdrawal of active life support

Primary outcomes:
measure: ICU length of stay
timeFrame: Each patient will be followed till death or discharge alive from ICU whichever occurs earlier
measure: days of mechanical ventilation
timeFrame: Each patient will be followed till death or liberation from Mechanical ventilation whichever occurs earlier
measure: In ICU mortality
timeFrame: each patient will be followed till death or discharge from ICU whichever is earlier
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital
state: Bagmati
Study officials:
References:
Clinical trial NCT05966181: The Effect of Repeated Simulation in Developing Social Justice Advocacy Attitudes and Skills on Nursing Student
Official title: The Effect of Repeated Simulation in Developing Social Justice Advocacy Attitudes and Skills on Nursing Student
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Education
Nursing
Keywords: Social justice
advocacy
repeated simulation
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled experimental study with pretest-posttest control group design
Primary purpose: OTHER

Brief summary: It is a randomized controlled experimental and single-blind study with a pretest-posttest control group design.

Detailed description: It is a randomized controlled experimental and single-blind study with a pretest-posttest control group design, planned to examine the effect of repeated simulation (standard patient simulation) on improving nursing students' social justice advocacy attitudes and skills.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research Being a 4th year undergraduate nursing student Having completed the theoretical education for vocational courses

Exclusion Criteria:

* Being a foreign national (due to Turkish speaking/understanding problem)

Primary outcomes:
measure: Repeated simulation
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: suheyla.ozsoy@ege.edu.tr
name: Süheyla Özsoy, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06721481: Radiofrequency Electromagnetic Fields and Pregnancy : Exposure Specificities and Evolution
Official title: Radiofrequency Electromagnetic Fields and Pregnancy : Exposure Specificities and Evolution: the RFM - Expo Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radiofrequencies Exposure
Pregnancy
Real Life Study
Keywords: radiofrequencies
exposure science
exposure meter
5G
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Swiss Tropical and Public Health Institute (Switzerland)
name: University of Basel
First posted: 2024-12-06
Enrollment: 100
Sex: FEMALE
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: 1,500 pregnant women having their first prenatal ultrasound visit at the maternity ward of the Besançon University Hospital

Brief summary: The purpose of this study is to investigate the specific features of radiofrequencies (RF) exposure (including 5G) in pregnant women, its evolution during pregnancy and the quantitative contribution of the various RF emission sources to which they are exposed.


Eligibility criteria: Inclusion Criteria:

* Pregnant women over 18 years of age;
* Subject not opposed to participating in the study;
* Patient performing the three screening ultrasounds recommended by the French National Authority for Health (HAS) at the Universitary hospital of Besançon during her pregnancy (independently or in addition to on-site clinical pregnancy monitoring); Affiliation with a French social security scheme or beneficiary of such a scheme; Living within the Universitary hospital of Besançon maternity catchment area, to cover the full range of geographical exposure, including both highly urbanized and more rural areas;

Exclusion Criteria:

* Opposition of the subject to participate in the study;
* Discontinuation of pregnancy ultrasound follow-up at Besançon University Hospital, in particular due to relocation;
* Women under court protection, guardianship, curatorship or protective supervision.

Primary outcomes:
measure: Assessing the exposure of pregnant women to radiofrequencies
timeFrame: 3 days
Secondary outcomes:
measure: Quantifying the evolution of this exposure during pregnancy
timeFrame: 3 periods of 3 days
Other outcomes:
Locations:
Study officials:
References:
citation: Birks LE, Struchen B, Eeftens M, van Wel L, Huss A, Gajsek P, Kheifets L, Gallastegi M, Dalmau-Bueno A, Estarlich M, Fernandez MF, Meder IK, Ferrero A, Jimenez-Zabala A, Torrent M, Vrijkotte TGM, Cardis E, Olsen J, Valic B, Vermeulen R, Vrijheid M, Roosli M, Guxens M. Spatial and temporal variability of personal environmental exposure to radio frequency electromagnetic fields in children in Europe. Environ Int. 2018 Aug;117:204-214. doi: 10.1016/j.envint.2018.04.026. Epub 2018 May 10.
Clinical trial NCT02149381: Psychosocial Group Interventions for Depression
Official title: Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
treatment as usual
CBASP
befriending
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Jyväskylä Central Hospital
First posted: 2014-05-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.

Detailed description: The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric outpatient clinics. The recruition is completed.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period

Exclusion Criteria:

* Psychotic disorder
* Bipolar disorder
* Current substance abuse (excluding nicotine)

Primary outcomes:
measure: Depression
timeFrame: At baseline and after intervention (at 5 months)
Secondary outcomes:
measure: Peripheral blood biomarkers
timeFrame: At baseline and after intervention (at 5 mos)
Other outcomes:
measure: Neurophysiological measurements.
timeFrame: At baseline and after intervention (5 mos)
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
state: North Savo
Study officials:
affiliation: University of Eastern Finland
name: Soili Lehto, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06677281: Impact of COVID-19 on Pregnancy Outcomes: a Systematic Review
Official title: A Systematic Review of COVID-19's Impact on Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pregnancy Outcomes
Maternal Health
Neonatal Health
Lead sponsor: Zahedan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of pregnant individuals diagnosed with COVID-19 as documented in various peer-reviewed studies. The review examines the impact of COVID-19 on pregnancy outcomes, including maternal health, delivery outcomes, and neonatal complications.

Brief summary: This systematic review aims to evaluate the impact of COVID-19 on pregnancy outcomes. It synthesizes data from various studies to provide insights into the effects of the virus on maternal and fetal health. The review focuses on key outcomes such as preterm birth, maternal complications, and neonatal health, utilizing comprehensive literature from peer-reviewed journals. By analyzing existing studies, we aim to identify trends and gaps in research regarding COVID-19 and pregnancy. This review is intended to inform healthcare providers and pregnant individuals about potential risks and considerations during the pandemic.


Eligibility criteria: Inclusion Criteria:

* Pregnant individuals diagnosed with COVID-19.
* Studies reporting pregnancy outcomes related to COVID-19 published between January 2020 and the present.
* Articles that include quantitative data on maternal and fetal outcomes.

Exclusion Criteria:

* Studies that do not report on COVID-19-related pregnancy outcomes.
* Non-peer-reviewed articles or grey literature.
* Research focusing on non-pregnant populations.

Primary outcomes:
measure: Impact of COVID-19 on Maternal and Neonatal Outcomes
timeFrame: The review encompasses studies published from January 2020 to the present, with a focus on maternal and neonatal outcomes reported within the specified time frame.
Secondary outcomes:
measure: Effects of COVID-19 on Pregnancy-Related Complications
timeFrame: The review includes data from studies published between January 2020 and the present, focusing on complications reported throughout the pregnancy and at delivery.
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Zahedan University of Medical Sciences
state: Sistan and Baluchestan
Study officials:
References: