louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05839652: Treatment of Orthostatic Hypotension in SCI
Official title: Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypotension
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Kessler Foundation
First posted: 2023-05-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.


Eligibility criteria: Inclusion Criteria:

* traumatic spinal cord injury
* at least 12 months post injury
* injury level of C1-T6
* AIS A, B or C
* non-ambulatory
* non-ventilator

Exclusion Criteria:

* Active psychiatric disorder
* Stroke or cerebrovascular disease
* Alzheimer's Disease or dementia
* Unmanaged cardiac arrhythmias
* Concurrent systemic, hepatic, or renal disease
* Suspected or diagnosed malignancy
* Neurological disease other than SCI
* Self-reported history of three or more symptomatic episodes of AD per day

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 3 years
Secondary outcomes:
measure: Cerebral blood flow velocity
timeFrame: 3 years
measure: Symptoms of autonomic dysreflexia and orthostatic hypotension
timeFrame: 3 years
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Bronx
country: United States
facility: James J Peters VA Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05146752: The Effect of Schumann Resonance on Preterm Newborns
Official title: Application of Schumann Resonance on Premature Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extremely Low Birth Weight
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 61
Sex: ALL
Minimum age (years): 26
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.

Detailed description: Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.

Eligibility criteria: Inclusion Criteria:

* gestational age (GA) between 32 and 35 weeks
* Neonatal Therapeutic Intervention Scoring System (NTISS) score \<9

Exclusion Criteria:

* (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score\>9

Primary outcomes:
measure: Change from Baseline body weight gain at 4 weeks
timeFrame: Baseline, week1, week2, week3, week4.
Secondary outcomes:
measure: Change from Baseline sleep quality at 4 weeks
timeFrame: Baseline, week1, week2, week3, week4.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References:
Clinical trial NCT00629252: The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
PPI
P50
CANTAB
sensory gating
Schizophrenic patients according to DSM-IV
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
name: H. Lundbeck A/S
First posted: 2008-03-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia according to DSM IV
* Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)

Exclusion Criteria:

* DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder.
* DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder.
* ECG: QTc-interval \>450 msec.
* Systolic blood pressure \<100 mmHg
* Bradycardia (Hf \< 50/Min) und Arrhythmias
* Hypokalemia or Hypomagnesemia

Primary outcomes:
measure: sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
timeFrame: Before and six weeks after antipsychotic treatment
Secondary outcomes:
measure: Cognitive performances
timeFrame: Before and six weeks after antipsychotic treatment
measure: Psychopathology (PANSS rating)
timeFrame: Before and six weeks after antipsychotic treatment
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
state: ZH
Study officials:
affiliation: University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
name: Franz X. Vollenweider, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402752: System for Measuring Non-invasive Blood Flow in the Tracheobronchial Mucosa: Validation of Reproducibility
Official title: System for Measuring Non-invasive Blood Flow in the Tracheobronchial Mucosa: Validation of Reproducibility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to evaluate the reproducibility of a method of measuring blood flow rates to the tracheo-bronchial mucosa using diluted dimethyl ether as a tracer.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan

Exclusion Criteria:

* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient is pregnant
* Patient is breast feeding
* The patient is a smoker
* The patient has, or has a history of, chronic respiratory insufficiency
* The patient has a contra-indication for a treatment necessary in this study

Primary outcomes:
measure: The reproducibility of two measures of Qaw at a five minute interval
timeFrame: Five minutes
Secondary outcomes:
measure: The time necessary to complete one measure of Qaw (minutes)
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Charles Le Merre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02722252: Comparative Study of Two Embryo Culture Systems
Official title: Comparative Study of Two Embryo Culture Systems: Randomization of Attempts at In Vitro Fertilization With ICSI at the Centre for Medically Assisted Procreation at Dijon CHU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: In Vitro Fertilization with ICSI
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Couples who attempt In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)

Brief summary: The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology embryo culture systems, with incubation characteristics that are potentially superior to those provided by classical culture systems. Indeed, these two systems, available in only two MAP centres in France, make it possible to maintain a stable temperature and gaseous environment during the in-vitro development of the embryos.

It is necessary to observe the development of the embryos to determine which embryos have the highest implantation potential. These observations are done from time to time by microscope for one system and continuously using an incorporated video camera for the other (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two systems.


Eligibility criteria: Inclusion Criteria:

* Persons who have provided oral consent
* Attempt at In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
* At least 6 mature ovocytes to microinject

Exclusion Criteria:

* Persons not covered by national health insurance
* Attempt at In Vitro Fertilization (IVF)
* Fewer than 6 mature ovocytes
* Decision to transfer at the zygote stage during the multidisciplinary meeting
* Attempts made in a context of viral risk (both systems are in a virus risk-free zone)
* Attempts with surgically-harvested spermatozoa

Primary outcomes:
measure: Implantation rate
timeFrame: 16 weeks after transfer
Secondary outcomes:
measure: Rate of miscarriages
timeFrame: 16 weeks after transfer
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
citation: Barberet J, Chammas J, Bruno C, Valot E, Vuillemin C, Jonval L, Choux C, Sagot P, Soudry A, Fauque P. Randomized controlled trial comparing embryo culture in two incubator systems: G185 K-System versus EmbryoScope. Fertil Steril. 2018 Feb;109(2):302-309.e1. doi: 10.1016/j.fertnstert.2017.10.008. Epub 2017 Nov 23.
Clinical trial NCT04574752: MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
Official title: MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus
Next Generation Sequencing
Total Joint Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible

Brief summary: The aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients


Eligibility criteria: Inclusion Criteria:

* All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible.

Exclusion Criteria:

* Patients included in other prospective studies

Primary outcomes:
measure: Diagnostic techniques to identify S. aureus in total joint replacement patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03793452: Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients
Official title: Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Keywords: COPD, pulmonary rehabilitation, fear of falling, evaluation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix

Brief summary: The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of falling in COPD patients


Eligibility criteria: Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* post surgical rehabilitation
* neurologic or orthopedic disorders limiting walking
* imbalance disorders
* inability to answer to the questionnaire
* refusal to participate.
* inability to perform the pulmonary rehabilitation program.

Primary outcomes:
measure: measure of fear of falling after a pulmonary rehabilitation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Morlaix
country: France
facility: CH Pays de Morlaix
Study officials:
affiliation: CH DES PAYS DE MORLAIX
name: Marc Beaumont, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berriet AC, Beaumont M, Peran L, Le Ber C, Couturaud F. Effects of pulmonary rehabilitation on fear of falling in Chronic Obstructive Pulmonary Disease (COPD) patients: An observational study. Respir Med Res. 2022 Nov;82:100932. doi: 10.1016/j.resmer.2022.100932. Epub 2022 Jun 12.
Clinical trial NCT00146952: Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation
Official title: Evaluation of a Vibrotactile Sensory Aid Developed by the US Navy to Combat Pilot Disorientation as a Prosthesis in Patients With Postural Imbalance and Spatial Disorientation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Vestibular Diseases
Peripheral Neuropathies
Proprioceptive Disorders
Hemispatial Neglect
Keywords: Hemineglects
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2005-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. The programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.


Eligibility criteria: Inclusion Criteria:

* Sensory impairments
* Unsteadiness

Exclusion Criteria:

* High strokes

Primary outcomes:
measure: Mean time reaction to the perturbation with the feedback
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Michael A Gresty, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Adolfo M Bronstein, Pr, MD
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Christopher Kennard, Pr, MD
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Masud Husain, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05421052: Unmet Health Needs Among Students
Official title: Unmet Health Needs Among Sohag University Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unmet Health Needs
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sohag university students from both sexes above 18 years old from ( faculty medicine, pharmacy, education, specific education )

Brief summary: The concept of unmet health needs refers to the difference between health services thought necessary to treat a particular health problem and services actually received. A person who perceived the need to receive medical services but who has not obtained these services has unmet health care needs. Unmet health care may result from limited availability or unavailability of health care services, when or where they were required. Also it can be caused from individual accessibility problem, such as cost or transportation, or from acceptability problem, such as attitude toward and knowledge about health care.so, the investigators will assess the unmet health needs and identify the causes.


Eligibility criteria: Inclusion Criteria:

* all students who are more than 18 years old and approve to participate in the study

Exclusion Criteria:

* any students who refuse to participate in the study or who are under 18 years old

Primary outcomes:
measure: Assessment of the unmet health needs of Sohag university students.
timeFrame: Assess the unmet health needs of the students during the last 6 months
Secondary outcomes:
measure: Assessment of the students' awareness and attitude towards Sohag University Medical Center
timeFrame: Assess the students' use of the University Medical Center during the last year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02709252: Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
Official title: Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgery
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. The aim of this observational study is to compare changes in ΔPP and PVI related to autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.


Eligibility criteria: * American Society of Anesthesiologists (ASA) score I-II
* scheduled for elective abdominal laparoscopic surgery
* with written informed consent
* more than 18 years
* Body Mass Index \< 40 kg.m-2
* no supraventricular arrhythmias
* no heart failure with ejection fraction \<25 %
* no peripheral vascular
* no severe respiratory disease
* no end stage renal failure (creatinine clearance \<30ml/min).

Primary outcomes:
measure: Pleth variability index (in %)
timeFrame: 5 minutes
measure: Pulse Pressure variation (deltaPP) (in %)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brugmann hospital
Study officials:
References:
Clinical trial NCT04297852: The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
Official title: The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recovery
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Future Food Innovation
First posted: 2020-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this project, would be to develop a new formula, with high nutrition content on a vegan basis. The investigators expect to produce this novel vegan-based juice product, which does not exist on the marked today. The juice would consist of different selected varieties of vegetables and fruits. Beside the vegetables, the juice will also contain plant oils to increase the calorie level, as well as a protein sources containing amino acids with high anabolic effects.

The products will be tested in an intervention study on patients with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 85 years old
* Diagnosed with or show signs of UC or Crohns disease
* Mild symptoms i.e intestinal symptoms
* Has had the same medicin the previous week before starting in the study

Exclusion Criteria:

* Food or vegetable allergi
* Cognitive diseases e.g alzheimers or dementia
* Has diabetes requiring insulin or GLP-1 analog treatment (NB: No does include T2D patients, taking tablets or other diabetes therapy)

Primary outcomes:
measure: Inflammatory factors
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus university
Study officials:
affiliation: Department of clinical medicin
name: Per B Jeppesen, Prof
role: PRINCIPAL_INVESTIGATOR
References: