louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05449574: Sensory Integration Disorders in Patients With MS Including Disease Advancement and Relapses in the Last Year
Official title: Sensory Integration Disorders in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis;
Sensory integration
relapses
the advancement of the disease
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with relapsing-remitting MS were qualified for the study; aged 30 to 45

Brief summary: the aim of the study was to assess the occurrence of sensory integration disorders in people with SI depending on the stage of the disease and relapses in the last year;analysis of sensory integration disorders in patients with Ms and healthy people

Detailed description: 141 patients diagnosed with RRSM were enrolled in the study. The control group consisted of 72 healthy people. The Sensory Integration Assessment Scale in Adults (SPD) was used to test sensory integration, and an original questionnaire was carried out containing information on age, gender, frequency of relapses in the last year, and duration of the disease.

Eligibility criteria: Inclusion Criteria:

* health of a person
* aged 30-45 years
* without diagnosed disorders of sensory integration and MS

Exclusion Criteria:

* diagnosed disorders of sensory integration
* diagnosed with Ms

Primary outcomes:
measure: sensory integration disorders and relapses in the last year
timeFrame: 1 year
measure: Sensory integration disorders and the degree of disease severity
timeFrame: 1 Day
measure: Comparing the test group with the control group
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Departmen of Neurology
state: Unii Lubelskiej
Study officials:
affiliation: Department of Neurology, Pomeranian Medical University, Szczecin, Poland
name: Wioletta Pawlukowska, dr hab.
role: STUDY_CHAIR
References:
Clinical trial NCT01263574: Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome
Official title: Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Catheter Related Infections
Short Bowel Syndrome
Keywords: Catheter related infections prevention/control
Anti infective agents
Catheter related infections prevention
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.


Eligibility criteria: Inclusion Criteria:

* Age \>3 months
* Intestinal failure patients
* Silicone catheter for the administration of parenteral nutrition

Exclusion Criteria:

* Age \< 3 months
* Weight \< 5 kg
* Documented allergy to ethanol
* Evidence of tunnel site infection
* Patients receiving continuous renal replacement therapy
* Concomitant use of metronidazole

Primary outcomes:
measure: Catheter associated blood stream infection (CABSI).
timeFrame: Number of infections reported per 1000 catheter days.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Tom Jaksic, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Christopher Duggan, M.D, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604874: High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women
Official title: High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DELAYED LABOUR
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 202
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is one of the biggest public health problems of the 21st century as it increases the risk of many co-morbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium. Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.


Eligibility criteria: Inclusion Criteria:

* Spontaneous onset of labor.
* Body mass index ≥ 30 kg/m2.
* Gestational age ≥ 37 weeks.
* Singleton pregnancy.
* Cephalic presentation.
* Reassuring fetal heart rate monitoring.
* Inefficient uterine contractions during active labor
* Women who will accept to participate in the study.

Exclusion Criteria:

* Non-reassuring fetal assessment at the time of recruitment.
* Women received cervical ripening agents.
* Any patients contraindicated for vaginal delivery.
* Multiple gestations.
* Malpresentation.
* Previous cesarean delivery.
* Patients with cardiac diseases, pre-eclampsia or any other medical disorders.
* Fetal demise.
* Intrauterine growth restriction.
* Estimated fetal weight ≥ 5000 grams.
* Pre-labor rupture of membranes \> 24 hours.

Primary outcomes:
measure: The mean duration from oxytocin augmentation initiation to delivery
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT04768374: Effects of Virtual Reality on Cerebral Palsy
Official title: Effects of Virtual Reality on Cerebral Palsy; A Single-blind, Randomized Control Study: 3 Months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Uskudar University
First posted: 2021-02-24
Enrollment: 83
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Using a VR interface as a rehabilitation tool increases the fun received by the client which, in turn, increases the participation of the client to the rehabilitation sessions.

This is a study that focused on long-term effects of Virtual reality (VR) intervention on motor skills and activities of daily living (ADL) independence of children with CP.


Eligibility criteria: Inclusion Criteria:

* had to be 7 to 12 years-old,
* to be diagnosed with CP,
* to get 1 or 2 from Gross Motor Functioning Classification System,
* to get a score of 1 to 3 from Manual Ability Classification System,
* to score at least 23 from Mini Mental State Examination - children edition,
* to be able to follow verbal instructions, and
* to have the

Exclusion Criteria:

* having any surgical operation and/or botulinum toxin injection in last 6 months,
* having any visual and hearing diseases that may affect using VR, and
* participating in any other rehabilitation programs (such as physiotherapy, speech therapy, psychotherapy etc.),
* having ataxic and/or dyskinetic symptoms.

Primary outcomes:
measure: Change in Independence in Activities of Daily living (assessed with Abilhand-kids)
timeFrame: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
measure: Change in motor proficiency( assessed with Bruninsk-Oseretsky Test of Motor Proficiency 2-Brief Form (BOT2-BF))
timeFrame: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References:
Clinical trial NCT02011074: Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Patients Undergoing General Anesthesia
Official title: Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Psychologically Normal Patients Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Variability
STAI
SDS
General Anesthesia
Anxiety
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatocellular carinoma patients undegoing Hepatectomy with general anesthesia

Brief summary: Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The investigators evaluate the relation of perioperative anxiety and heart rate variability, also the impact of general anesthesia on the change of heart rate variability.


Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma patients

Exclusion Criteria:

* uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction

Primary outcomes:
measure: Heart rate variability
timeFrame: change from baseline in HRV at 10 minutes after induction of general anesthesia
Secondary outcomes:
measure: STAI score
timeFrame: change from baseline in HRV at 10 minutes after induction of general anesthesia
Other outcomes:
Locations:
city: Gangnamgu
country: Korea, Republic of
facility: Kim Myunghee
state: Seoul
Study officials:
References:
Clinical trial NCT05511974: BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients
Official title: BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: this study aims to assess the validity of BASET scoring as a new potential tool for diagnosis and grading the severity of OSAS patients and as screening of the risk factors of OSAS.

Detailed description: The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography

Eligibility criteria: Inclusion Criteria:

* All adult patients after having full night polysomnography.

Exclusion Criteria:

* Pregnant patients

Primary outcomes:
measure: assess the performance of BASET score for diagnosis of OSAS
timeFrame: up to 2 weeks.
measure: grading of the severity of OSAS patients.
timeFrame: up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT02102074: Intra-peritoneal Environmental Changes Following Surgery
Official title: Intra-peritoneal Environmental Changes Following Colorectal Surgery for Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor Cells and Tumor Markers in Peritoneal Cavity
Keywords: colon and rectal tumors
colon cancer markers
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 70
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: colon and rectal cancer patients

Brief summary: The investigators hypothesize that the presence of tumor cells and tumor markers in peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve our understanding of tumor spread and disease recurrence.


Eligibility criteria: Inclusion Criteria:

* colon and rectal cancer

Exclusion Criteria:

* none

Primary outcomes:
measure: tumor cells and tumor markers
timeFrame: 2 years
Secondary outcomes:
measure: Cytokine levels in the abdomen
timeFrame: 2 years
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Kfar-Saba
country: Israel
facility: Meir medical center
Study officials:
affiliation: Meir Medical Center
name: Shmuel Avital, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05313074: SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
Official title: SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Cancer
Keywords: COVID-19
Cancer
Immune response
Lead sponsor: National Cancer Institute, Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
First posted: 2022-04-06
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cancer patients and healthy volunteers will be compared for effectiveness of CoronaVac vaccine in parallel after 2 doses of vaccination for 15 days by neutralizing antibody test
Primary purpose: PREVENTION

Brief summary: Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Detailed description: A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Eligibility criteria: Inclusion Criteria:

* Male or Female age at least 18 years
* Patients with a diagnosis of solid tumors
* Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
* Willing and able to comply with the study procedures.
* Willing to receive a Coronavac vaccine (Sinovac).

Exclusion Criteria:

* Patients who cannot provide consent

Primary outcomes:
measure: Immune response of Coronavac vaccine in Thai cancer patients
timeFrame: 15 days after 2 doses of vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: National Cancer Institute
state: Bangkok
Study officials:
affiliation: National Cancer Institute of Thailand
name: Thanarath Imsuwansri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05372874: Treatment of Hepatitis c by Using Direct-acting Antiviral
Official title: Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C patients treated by daclatasvir/sofosbuvir or sofosbuvir /daclatasvir/ ribavirin.

Brief summary: Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).


Eligibility criteria: Inclusion Criteria:

* chronic hepatitis C patients had no other cause of liver disease

Exclusion Criteria:

* Patients with hepatitis B virus (HBV).
* Patients with acute hepatitis.
* Patients with renal insufficiency.
* Patients with Hepatocellular carcinoma (HCC) or other types of malignancy.
* Patients on current use of melatonin.
* Patients using of any of medications that have interaction with melatonin.
* Patients work in night shifts.
* Patients are consuming a lot of caffeine or heavy smokers.

Primary outcomes:
measure: Change in malondialdehyde (MDA) level.
timeFrame: 12 weeks following end of treatment.
measure: Change in melatonin level.
timeFrame: 12 weeks following end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tanta University
name: Sabry A AbouSaif, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University
name: Sally E Abu-Risha, Associate professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Al-Azhar University
name: Medhat I Abd-El Hamed, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02822274: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03004274: Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients
Official title: Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
Collaborators: name: Fondation Hôpital Saint-Joseph
First posted: 2016-12-28
Enrollment: 100
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 goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. This is a split-wound study, thereby providing an internal control within each wound. Each side of the wound will be randomized to receive one of the two suturing techniques. Patients and raters will be blinded to the suture technique used in both wound-halfs.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Brachioplasty, Tighplasty, abdominoplasty, circumferential dermolipectomy in a massive weight loss patient
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness

Primary outcomes:
measure: Scar cosmesis
timeFrame: 15 days
measure: Scar cosmesis
timeFrame: 1.5 months
measure: Scar cosmesis
timeFrame: 3 months
measure: Scar cosmesis
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of Scar Width
timeFrame: 3 months
measure: Measurement of Scar Width
timeFrame: 6 months
measure: Adverse Events
timeFrame: 15 days
measure: Adverse Events
timeFrame: 1.5 months
measure: Adverse Events
timeFrame: 3 months
measure: Adverse Events
timeFrame: 6 months
measure: Time spent suturing the wound
timeFrame: up to 24h
measure: Number of suture thread needed
timeFrame: up to 24h
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Josph Hospital
Study officials:
References: