louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00819858: Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
Official title: The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight Gain
Convalescence
Malaria
Keywords: weight loss
weight gain
malnutrition
convalescence
malaria
RUTF
RUF
supplementation
nutrition
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.

Detailed description: Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.

Children aged 6-59 months presenting with malaria caused by P. falciparum who are provided with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks and 4 weeks post-intervention).

Eligibility criteria: Inclusion Criteria:

* Age 6 to 59 months, and
* Positive rapid diagnostic test (Paracheck®) and
* Thick smear showing infection with P. falciparum and
* Informed consent from parents or guardian aged at least 18 years.

Exclusion Criteria:

* Children who are exclusively breast fed or
* Children who are severely malnourished (MUAC \<110 mm and/or bilateral oedema, or WHO weight-for-Height criteria \<3 Z-scores) or
* Presence of general danger signs or signs of severe malaria as defined by the WHO criteria, or
* Known history of allergy to malaria drugs, or
* Having a sibling enrolled in the study.

Primary outcomes:
measure: weight gain
timeFrame: 14 days
Secondary outcomes:
measure: weight gain
timeFrame: 28 days
Other outcomes:
Locations:
city: Dubie
country: Congo
facility: Central Hospital
state: Katanga
Study officials:
affiliation: nutrition expert MSF
name: Saskia van der Kam, Ir
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Kam S, Swarthout T, Niragira O, Froud A, Sompwe EM, Mills C, Roll S, Tinnemann P, Shanks L. Ready-to-use therapeutic food for catch-up growth in children after an episode of Plasmodium falciparum malaria: an open randomised controlled trial. PLoS One. 2012;7(4):e35006. doi: 10.1371/journal.pone.0035006. Epub 2012 Apr 25.
Clinical trial NCT02390258: Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
Official title: A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.


Eligibility criteria: Inclusion Criteria:

* For Parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. For Part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.
* Females must be of non-childbearing potential

Exclusion Criteria:

* Subject has a known heart disease.
* Subject has any of QTcF \> 450 msec, PR ≥ 210 msec or QRS ≥ 120 msec at screening (determined from median of three readings).
* For Part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).
* Subject has any other condition which, in the investigator's opinion will interfere with the trial.
* Subject has a systolic blood pressure (BP) \<80 or \>160 mmHg at screening or a diastolic BP \>90 or \<45 mmHg at screening.
* Subject has a clinically significant abnormal laboratory test result at screening.
* Female subject who is pregnant or breast feeding and female subjects of childbearing potential.

Primary outcomes:
measure: Number of adverse events
timeFrame: Part 1: 13 days; Part 2: 13 days; Part 3: 22 days
Secondary outcomes:
measure: Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration
timeFrame: Part 1: 13 days; Part 3: 22 days
measure: Food effect on AUC of XEN-D0103
timeFrame: 13 days
measure: Change in QTcF with XEN-D0103 and with placebo
timeFrame: 2 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: ICON Development Solutions
Study officials:
References:
Clinical trial NCT02782858: Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
Official title: An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Multiple Sclerosis Relapsing-Remitting
GNbAC1
MRI
Monoclonal antibody
Multiple Sclerosis associated retrovirus MSRV
MS
RRMS
HERV-W
Temelimab
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
Collaborators: name: Les Laboratoires Servier (LLS)
name: Institut de Recherches Internationales Servier
name: Worldwide Clinical Trials
First posted: 2016-05-25
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS).

This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.


Eligibility criteria: Main Inclusion Criteria:

* For male or female with reproductive potential, use of reliable means of contraception;
* RRMS according to the 2010 revised McDonald criteria;
* Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;
* EDSS score \< 6.0.

Main Exclusion Criteria:

* Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
* Pregnant and nursing women.

Primary outcomes:
measure: Cumulative number of Gd-enhancing T1 lesions in brain MRI
timeFrame: Week 12 to 24
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Zagreb
country: Croatia
city: Jihlava
country: Czechia
city: Tallinn
country: Estonia
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Roma
country: Italy
city: Warsaw
country: Poland
city: Moscow
country: Russian Federation
city: Belgrade
country: Serbia
city: Barcelona
country: Spain
city: Kharkiv
country: Ukraine
Study officials:
References:
citation: Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.
Clinical trial NCT03314558: Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?
Official title: Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From Chronic Obstructive Pulmonary Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
pulmonary rehabilitation
insomnia
sleep quality
physical activity
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients physically able to follow a pulmonary rehabilitation program

Brief summary: The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

Detailed description: COPD patients suffer from bad sleep quality. About 27 -50% are suffering from insomnia, and respiratory related symptoms are also inducing sleep disturbances. Recently, a correlation between altered sleep quality and low activity levels have been shown in this population. In primary insomnia, it is well established that physical activity has a positive impact on sleep quality.

The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

Eligibility criteria: Inclusion Criteria:

* COPD patients
* able to walk and cycle

Exclusion Criteria:

* Shift work
* orthopedic diseases of limbs

Primary outcomes:
measure: sleep efficiency
timeFrame: 3 +/- 2 months
Secondary outcomes:
measure: steps
timeFrame: 3 +/- 2 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHu Saint Pierre
Study officials:
References:
Clinical trial NCT02463058: Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress
Official title: Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-06-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Israel ministry of defense is examining a new protective undergarment of GORE company (chempark fabric) for the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by a BC protective undergarment under exercise-heat stress conditions.

Detailed description: In order to physiologically evaluate a new BC protective garment for the Israeli police use under exercise-heat stress conditions, 10 young and healthy civilian volunteers will participate in this study.

The subjects will undergo 5 experiment days: Recruitment day, one day of acclimatization to heat, and 3 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC protective undergarment + standard combat uniforms, new BC protective undergarment + standard combat uniforms + NBC mask).

Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.

Eligibility criteria: Inclusion Criteria:

* Aged 18-40 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Psychiatric condition.
* Any muscles or skeleton condition.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.

Primary outcomes:
measure: physiological strain (composite)
timeFrame: 4 days for each participant
Secondary outcomes:
measure: Rectal temperature
timeFrame: 4 days for each participant
measure: Skin temperature
timeFrame: 4 days for each participant
measure: Heart rate
timeFrame: 5 days for each participant
measure: Sweat rate (composite)
timeFrame: 4 days for each participant
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02628158: Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane
Official title: Correlation of Postoperative Vision and Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Keywords: Epiretinal membrane
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 91
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with epiretinal membrane who underwent vitrectomy with epiretinal membrane and internal limiting membrane removal

Brief summary: Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators evaluate whether presence of FAF may correlate to the postoperative visual outcome for epiretinal membrane.

Detailed description: 92 eyes with epiretinal membrane were performed vitreous surgery, epiretinal membrane removal and internal limiting membrane (ILM) peeling. Presence of hyperfluorescence in FAF at the macular area and best-corrected visual acuity (BCVA) was evaluated preoperatively and at postoperative 1, 3, and 6 months with ultra-wide angle imaging.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal for epiretinal membrane and had followed for more than 6 months.

Exclusion Criteria:

* The patients with follow-up less than 6 months.

Primary outcomes:
measure: Visual acuity before and after surgery
timeFrame: Changes from baseline to 1, 3, 6 months
Secondary outcomes:
measure: Presence of fluids autofluorescence at the macular area
timeFrame: Changes from baseline up to 6 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825158: Study of the Role of Hemostasis in Perioperative Anaphylaxis
Official title: Study of the Role of Hemostasis in Perioperative Anaphylaxis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemoptysis
Perioperative Complication
Anaphylaxis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will focus on any adult patient with a suspected diagnosis of perioperative anaphylactic shock

Brief summary: Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, adult
* In the perioperative period
* In whom the diagnosis of anaphylactic shock is suggested
* Patient is giving his consent to participate in the study

Exclusion Criteria:

* Subject under legal protection
* Subject under guardianship or guardianship
* Anemia less than 7 g /dl at the time of inclusion

Primary outcomes:
measure: Platelet activation
timeFrame: As soon as possible after onset of anaphylaxis
measure: Platelet activation
timeFrame: 1-2 hours after the onset of anaphylaxis
measure: Platelet activation
timeFrame: 24 hours after the onset of anaphylaxis
measure: Platelet activation
timeFrame: During the allergic workup (4-6 weeks after)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05640258: Seasickness Susceptability and Vestibular Time Constant
Official title: Seasickness Susceptability and Vestibular Time Constant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasickness
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Participants were selected from the military navy crewmembers prior to commencing of active sailing.

A vestibular time constant was calculated based on velocity step testing on a rotatory chair at baseline, 3 months and 6 month following active sailing duty.

A seasickness questionnaire (WIKER) was completed during follow-up visits. study participants were divided to three groups based on WIKER score - susceptible , non-susceptible and habituating. Vestibular time constant was compared between study groups.


Eligibility criteria: Inclusion Criteria:

* healthy male Navy sailors in basic training

Exclusion Criteria:

* History of hearing loss
* Otoscopic findings of ear pathology
* An implanted electrode
* A finding of vestibulopathy upon otoneurological examination -
* Discontinuation of active sailing for any reason during study follow-up
* Withdrawal of informed consent.

Primary outcomes:
measure: 6 month follow up vestibular time constant measurement.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Israeli Naval Medical Institute
Study officials:
References:
Clinical trial NCT06924658: Metformin in Safety and Efficacy in Gouty Patients
Official title: the Impact of Metformin Use on Clinical Outcomes in Gouty Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gout
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients


Eligibility criteria: Inclusion Criteria:

* Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.

Exclusion Criteria:

* Systemic disorders such as cardiovascular, neurological, coronary artery disease.
* Hypertension, hyperlipidemia, diabetes mellitus, active infections.
* Other inflammatory or autoimmune diseases.
* Patients on biologics,
* Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.

Primary outcomes:
measure: - Clinical assessment of disease activity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT03218358: Effect of the Intra-abdominal Pressure on the Risk of Delirium in Mechanically Ventilated Patients.
Official title: Effect of the Intra-abdominal Pressure on the Risk of Delirium in Mechanically Ventilated Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Intraabdominal Hypertension
Mechanical Ventilation Complication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 critically ill patients that remained more than 48 hours at trauma and general ICU without apparent risk factors for IAH other than the use of MV

Brief summary: intra-abdominal hypertension (IAH) and delirium are serious, high-frequency complications in intensive care unit (ICU) patients. The consequences of the complication range from high morbidity and mortality to a greater need for nursing care. We hypothesize that there could be a correlation between IAH and incidence of delirium.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders on mechanical ventilation

Exclusion Criteria:

* age under 18 years, use of muscle relaxants, abdominal operation within the previous 3 months, acute peritonitis, and abdominal mass, acute injury to the urinary bladder, acute cystitis, neurogenic bladder, pelvic hematoma, and pelvic fracture.

Primary outcomes:
measure: delirium
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References: