louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04839107: Institutional Registry on Outpatient and Hospitalized COVID-19 Infected Patients
Official title: Institutional COVID-19 Patient Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with COVID-19, evaluated and followed in the hospital.

Brief summary: Creation of an Institutional Registry system for patients with confirmed COVID-19 infection with the collection of epidemiological data, risk factors, diagnosis, prognoses, treatment, follow-up and survival.

Detailed description: Ambispective observational cohort with administrative admission date corresponding to the day of positivity of the PCR test for COVID-19, and discharge date of the cohort to the date corresponding to the epidemiological discharge, last contact with the health system and / or date of death.

Due to its institutional nature, the registry will collect data from the different patients who are assisted at different levels of the institution: emergency department, hospitalization in the general ward, critical areas, outpatient monitoring (including telemedicine) and home hospitalization.

Eligibility criteria: Inclusion Criteria:

* Patient assisted by HIBA adult services
* Patient diagnosed with COVID-19

Primary outcomes:
measure: Mortality rate
timeFrame: From the date of the positivization of the PCR to the date of death or epidemiological discharge, whichever occurs first, assessed up to 30 days.
measure: Readmission rate
timeFrame: Within a month of discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital Italiano
state: Ciudad Autónoma De Buenos Aires
Study officials:
References:
Clinical trial NCT01199107: Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Anxiety
Behavior Therapy
Prolonged Exposure
Exercise
Wellness
Posttraumatic
Stress
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.


Eligibility criteria: Inclusion Criteria:

* You have PTSD
* You are between the age of 18 and 54 if female or between ages 18 and 44 if male.
* You have written physician approval/medical clearance to participate in an exercise protocol.
* Are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.

Exclusion Criteria:

* You are currently participating in a structured exercise program
* You have severe depression
* You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
* You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
* You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
* You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction

Primary outcomes:
measure: PTSD Symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Quality
timeFrame: 3 months
measure: BDNF (by blood sample)
timeFrame: 3 months
measure: General Mood and Anxiety Symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References:
citation: Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJ, Diamond A, McIntyre C, Smits JA. Exercise Augmentation of Exposure Therapy for PTSD: Rationale and Pilot Efficacy Data. Cogn Behav Ther. 2015;44(4):314-27. doi: 10.1080/16506073.2015.1012740. Epub 2015 Feb 23.
Clinical trial NCT04365907: Omarigliptin in Four Healthy Egyptian Volunteers
Official title: Enhanced Extraction Technique of Omarigliptin From Human Plasma: Applied to Biological Samples From Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 4
Sex: ALL
Minimum age (years): 23
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the four volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from four, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed \& validated) after single oral dose administration of one Marizev® tablet nominally containing 12.5 mg of Omarigliptin (first arm as 4 volunteers). The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines \& the evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Type-2 diabetes
* Hospitalized within 1 week

Primary outcomes:
measure: Plasma concentration (nMol/L) after 1.5 hours
timeFrame: 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
state: El-Sherouk
Study officials:
References:
Clinical trial NCT03927807: Oral Misoprostol Solution in Labor Induction
Official title: A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Labour,Induced
Keywords: misoprostol
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

Detailed description: Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

Eligibility criteria: Inclusion Criteria:

* Nulliparas
* Term pregnancy(equal or more than 37 wks)
* Bishop score \<6
* Cephalic presentation
* reassuring fetal heart rate pattern
* Not in labor ( no uterine contractions)
* Clinically adequate pelvis
* Singleton live pregnancy

Exclusion Criteria:

* Allergic to misoprostol or prostaglandin analogues
* Previous uterine scar( cesarean section,hysterotomy,myomectomy)
* Multiple fetal gestations
* Fetal demise
* Preterm labor
* Malpresentations
* Non reactive cardiotocography at admission
* Cephalo pelvic disproportion
* Fetal macrosomia

Primary outcomes:
measure: Mode of delivery
timeFrame: 24 hours from the first dose of induction till delivery
Secondary outcomes:
measure: Adverse maternal outcomes
timeFrame: in 24 hours
measure: Adverse neonatal outcomes
timeFrame: 24 hours post partum
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Cairo Governorate
Study officials:
affiliation: Ain Shams University
name: essam sa hagag, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 27986461
Clinical trial NCT03082807: Dietary Guide in Active Older Adult Men
Official title: Investigating the Effects of Negative Calorie Diet Compared With Low-calorie Diet Under Exercise Condition on Weight Loss and Lipid Profile in Overweight/Obese Middle-aged and Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Men
Diet Modification
Obesity
Overweight
Life Style
Weight Loss
Keywords: Caloric Restriction
Diet
Exercise
Obesity
Overweight
Sedentary lifestyle
weight loss
Men
Lead sponsor: P.L.Shupik National Medical Academy of Post-Graduate Education
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 37
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain.

Detailed description: Background and Aim: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult men with abnormal weight gain.

Materials and Methods: Participants included sedentary men (age 45-75 years) with overweight or obesity (n=37). They were randomly divided into 2 groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 37 participants, 30 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility criteria: Inclusion Criteria:

Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.

Exclusion Criteria:

History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.

Primary outcomes:
measure: Weight
timeFrame: Baseline
measure: Total cholesterol (Total-C)
timeFrame: Baseline
measure: High-density lipoprotein -cholesterol (HDL-C)
timeFrame: Baseline
measure: Low-density lipoprotein -cholesterol (LDL-C)
timeFrame: Baseline
measure: Triglycerides (TG)
timeFrame: Baseline
Secondary outcomes:
measure: Weight
timeFrame: 3-month
measure: Total cholesterol (Total-C)
timeFrame: 3-month
measure: High-density lipoprotein -cholesterol (HDL-C)
timeFrame: 3-month
measure: Low-density lipoprotein -cholesterol (LDL-C)
timeFrame: 3-month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05517707: Gravitas Feeding Tube System Placement in Neonates
Official title: Gravitas Feeding Tube System Placement in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasogastric Tube
Lead sponsor: Gravitas Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 16
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates in NICU

Brief summary: The purpose of this study is to optimize the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.


Eligibility criteria: Infants in the Newborn Intensive Care Unit requiring a 5Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5Fr Feeding Tube should only be placed if that size is appropriate.

Inclusion Criteria:

* Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
* Suitable to start enteral feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the NICU. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.

Exclusion Criteria:

* Known major upper airway malformation (e.g. tracheoesophageal fistula)
* Known major GI malformation (e.g. malrotation)
* NPO status -neonate expected to remain NPO for the following 72 hours
* Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction)
* Has had removal of part of the stomach
* Critically ill, facing imminent death
* Neonate on ECMO
* Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
* Ability to have a legally authorized representative provide informed consent

Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Primary outcomes:
measure: Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.
timeFrame: 5 months
measure: Percentage of accurate removals/dislodgements identified by the Gravitas dislodgement algorithm.
timeFrame: 5 months
measure: Adverse events (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the patient.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT01843907: Patient Participation in Prevention of Loss of Functions
Official title: Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Malnutrition
Depression
Pain
Quality of Life
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.

Detailed description: At baseline:

Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).

At follow-up three months after discharge:

BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.

The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.

Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Living in their own home with no contact to the Municipality, both before and after admission
* Discharged from Department o105 or the Acute Receiving Unit \<48 hours from admission.

Exclusion Criteria:

* Patients with life-threatening disease in the terminal stage
* Patients who does not speak and understand Danish
* Patients who are not able to communicate and collaborate, with regards to the measurements

Primary outcomes:
measure: Number of participants who have been readmitted to hospital
timeFrame: 01.03.2013 - 12.31.2014
Secondary outcomes:
measure: Mortality
timeFrame: 01.04.2014 - 31.12.2014
measure: Functional ability
timeFrame: 31.12.2014
measure: Primary Healthcare Services
timeFrame: 01.04.2013 - 31.12.2014
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Tove L. Damsgaard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04521907: Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery
Official title: Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Incidence and Risk Factors of Glaucoma After Congenital Cataract Surgery
Keywords: Glaucoma
Incidence
Congenital cataract surgery
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 177
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent congenital cataract surgery at Eye hospital of Wenzhou Medical University

Brief summary: A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. We recorded patient demographics and incidence and risk factors for glaucoma-related adverse event. This study to identify the incidence of and risk factors associated with postoperative glaucoma at various durations after congenital cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent lensectomy combined with limited anterior vitrectomy, with or without IOL implantation for congenital cataract, all by one surgeon

Exclusion Criteria:

* Patient had a preoperative IOP above 21mmHg, glaucoma, coexistent uveitis, metabolic syndromes/diseases or exposure to radiation.

Primary outcomes:
measure: Incidence of glaucoma after congenital cataract surgery
timeFrame: 2020.6.30
measure: Demographic data, including sex, age at surgery, gestational history, family history of cataract, and laterality of disease, were collected.
timeFrame: 2020.6.30
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
References: