louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05975216: Relinking Diagnosed but Untreated HCV Patients Back Into Care.
Official title: Relinking Diagnosed but Untreated HCV Patients Back Into Care.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C Virus Infection
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Positive hepatitis C serology with positive or unknown HCV RNA.

Brief summary: Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.

Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.


Eligibility criteria: Inclusion Criteria:

* Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels database
* ≥18 years

Exclusion Criteria:

* Positive HCV serology with negative HCV RNA
* Previously eradicated patients in UZ Brussel

Primary outcomes:
measure: Retrospective data collection
timeFrame: before contacting the patient
measure: Prospective interventional study
timeFrame: from first contact of the patient till 12 weeks after end of treatment.
Secondary outcomes:
measure: Reason lost in follow-up
timeFrame: from first contact of the patient till 12 weeks after end of treatment.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT05296616: Sleep Quality, Stress Level and Heart Rate Variability of University Students
Official title: The Effect of Mindfulness-Based Stress Reduction Intervention on Sleep Quality, Stress Level and Heart Rate Variability of University Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Quality
Stress Level
Heart Rate Variability
Lead sponsor: İstanbul Yeni Yüzyıl Üniversitesi
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on sleep quality, stress level and heart rate variability of university students Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.

Hypotheses:

H1: The sleep quality level scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the students in the control group. H2: Students in the intervention group participating in the mindfulness-based stress reduction initiative will decrease their stress level level scores compared to the students in the control group. H3: The heart rate variability of the students in the intervention group participating in the mindfulness-based stress reduction initiative will be higher than the students in the control group.

H4: The sleep quality level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores. H5: The stress level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores. H6: The heart rate variability level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.


Eligibility criteria: Inclusion Criteria:

* Being a student of the relevant faculty,
* No barriers to accessing technology for participation in the online program,
* No visual or hearing impairment

Exclusion Criteria:

* Not being a student of the relevant faculty,
* Having barriers to accessing technology for participation in the online program,
* Having visual or hearing impairment

Primary outcomes:
measure: Sleep Quality Level
timeFrame: for 8 months
Secondary outcomes:
measure: Stress Level
timeFrame: for 8 months
measure: Heart Rate Variability
timeFrame: for 8 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Merve Bat Tonkus
Study officials:
References:
Clinical trial NCT03565016: Consequences of At-risk Alcohol Consumption in ICU Patients
Official title: Consequences of At-risk Alcohol Consumption in ICU Patients : the Impact OH Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Abuse
Alcoholism
Keywords: Alcohol use disorders
agitation
intensive care unit
restlessness
alcohol withdrawal syndrome
alcohol-dependence
heavy drinking
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 150
Sex: ALL
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: patients aged 18 years old or more admitted in ICU non-at-risk drinkers or at-risk drinkers according to the National Institute of Alcohol Abuse and Alcoholism criteria

Brief summary: At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.

Detailed description: Alcohol-use disorder has a significant impact on morbidity in surgical intensive care units and is known to cause alcohol withdrawal syndrome which mortality can reach 50% if left untreated. The aim of the study was to assess the impact of alcohol use disorder on one-year mortality and adverse ICU outcomes such as agitation in a Medical Intensive Care Unit.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients aged 18 years old or more admitted in ICU

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: One-Year Mortality
timeFrame: The primary outcome measure was assessed at one year after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Mickael Vour'ch, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847516: Predictors of Clinical and Neurological Outcome in Traumatic Posterior Fossa Epidural Hematoma
Official title: Predictors of Clinical and Neurological Outcome in Traumatic Posterior Fossa Epidural Hematoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Posterior Fossa Epidural Hematoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Traumatic Posterior fossa epidural hematoma

Brief summary: The posterior fossa is a small space in the skull containing the brainstem and cerebellum. If a mass such as a hemorrhage grows in this region, particularly the brainstem and 4th ventricle, it can block the normal flow of cerebral spinal fluid leading to hydrocephalus, increased intracranial pressure.Posterior fossa extradural hematoma (PFEDH) is a rare neurosurgical entity, resulting in rapid clinical deterioration. The accumulation of blood in a potentially small space between the dura and occipital bone cause compression of the brain stem.These hematomas constitute almost 4% to 12.9% of all extradural hematoma cases.

The extradural hematomas of the posterior fossa may be categorized as acute or delayed defined with respect to the brainstem compression appearing within or after 24 hours of injury, respectively. Acute PFEDH is characterized by medullar failure, occipital trauma associated with severe pain in the nuchal area, altered consciousness followed by rapid brainstem compression, respiratory depression, and subsequent death if not treated timely and appropriately.Whereas, headache, neck pain, dysfunction of lower cranial nerve in response to PF lesions and cerebellar signs. The clinical features of PFEDH are nonspecific; it may include occipital headache, vomiting due to raised intracranial pressure, and decreased consciousness level leading to death. The skull fractures must be considered as a predisposing factor for the development of delayed extradural hematomas.

The aim of this study is :

* To evaluate the outcome of patients with traumatic post fossa Epidural hematoma
* list the predictors of outcome for patients with post fossa Epidural hematoma


Eligibility criteria: Inclusion Criteria:

* Any age
* Traumatic Posterior fossa epidural hematoma

Exclusion Criteria:

* Spontaneous type of epidural heamatoma

Primary outcomes:
measure: The postoperative GOS score
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06573216: Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020
Official title: Clinical Trial on the Effectiveness and Safety of Blood Pressure Function System of Wrist Ambulatory Blood Pressure Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Huawei Device Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 128
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 accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.


Eligibility criteria: Inclusion Criteria:

1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form;
2. Subjects must be willing and able to follow the study procedures;
3. Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.

Exclusion Criteria:

1. Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period;
2. Subjects with sickle cell disease;
3. Subjects with prior mastectomy or arm lymph node dissection;
4. Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);
5. Subjects with wounds on the limb at the measurement site or inflammation of the wrist
6. Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb;
7. Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial;
8. Subjects who have participated in other clinical trials within 30 days that may affect this trial;
9. Subjects who, in the opinion of the investigator, should not participate in this clinical trial.

Primary outcomes:
measure: Blood pressure mean deviation and standard deviation- evaluation criterion 1
timeFrame: 30 minutes
measure: Blood pressure mean deviation and standard deviation- evaluation criterion 2
timeFrame: 30 minutes
measure: The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chenzhou
country: China
facility: Bin Peng
state: Hunan
Study officials:
References:
Clinical trial NCT00586716: Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients
Official title: IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Detailed description: The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Eligibility criteria: Inclusion Criteria:

* 12 years of age or older
* diagnosed with end stage renal disease
* currently receiving either hemodialysis or peritoneal dialysis
* active on the kidney or kidney/pancreas transplant list
* medical clearance of the kidney donor if live related transplant
* elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list

Exclusion Criteria:

* received IVIG within 6 months prior to enrollment
* HIV positive
* Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
* Selective IgA deficiency or known antibodies to IgA
* Allergy to human immune globulin
* Pregnant or breast feeding

Primary outcomes:
measure: Elimination of Donor Specific Antibodies
timeFrame: 1 year
Secondary outcomes:
measure: Negative B and T Cell Crossmatch
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda Universtiy Adventist Health Sciences Center
name: Okechukwu Ojogho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05291416: Sarcopenia in Children
Official title: Sarcopenia; a New Issue in Juvenile Idiopathic Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Juvenile Idiopathic Arthritis
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: For all patients, we collected the anthropometric data including weight, height, and expressed it as Z scores for age and sex. Body mass index (BMI) was calculated as weight (kg)/height (m2). The disease duration, AJI subtype, disease activity, and treatment were recorded.

Brief summary: Juvenile idiopathic arthritis (AJI), is a frequent inflammatory disease in children, characterized by pain, arthritis, and deformities. Chronic inflammation leads to physical inactivity and can be associated with muscle weakness around affected joints, low bone strength, and mass(3). To our knowledge, no study has focused on the prevalence of sarcopenia in JIA and the data on the muscle disorder are lacking. The purpose of the present study is to detect sarcopenia and identify associated factors in children with JIA


Eligibility criteria: Inclusion Criteria:

* children with juvenile idiopathic arthritis fulfilling the ILAR criteria

Exclusion Criteria:

* We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.

Primary outcomes:
measure: skeletal muscle mass
timeFrame: 4 months
Secondary outcomes:
measure: muscle strenght
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05320016: Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery
Official title: Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Day Surgery
Patient Outcome Assessment
Quality of Recovery
Remimazolam
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 38
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman scheduled for ambulatory gynecological surgery under general anesthesia

Brief summary: Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.

Detailed description: To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.

Eligibility criteria: Inclusion Criteria:

* Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
* American Society of Anesthesiology grade 1 or 2

Exclusion Criteria:

* Underlying diseases: liver, kidney, brain nervous system, glaucoma
* Patients with BMI greater than 30 and less than 18.5
* Patients diagnosed with sleep apnea
* Alcohol or drug dependent patients
* Patients with severe or acute respiratory failure
* Lactose intolerance
* Dextran 40 hypersensitivity
* Patients in shock or coma

Primary outcomes:
measure: Quality of recovery
timeFrame: 24 hours after ambulatory hysteroscopic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang-Hwan Do
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04007016: A New Pelvic Osteotomy Method for Open Reduction
Official title: A New Pelvic Osteotomy Method for Open Reduction in the Treatment of Developmental Dysplasia of the Hip in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 2
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were evaluated and treated in the same hospital and the same surgeon did all the operation. The study was carried out between Mar 2016 and May 2018.

Brief summary: Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric orthopedic surgeons. In our clinical work, the investigators found some defect the operation procedure. When the surgeons were not familiar to the PO, it may injured the triradiate cartilage or easily be absorbable of the distal iliac. Here, the investigators found a new pelvic osteotomy just from the inner "L shaped" iliac osteotomy (ILSO) to treat DDH. This approach was in a visible part of the sciatic notch and not presumed to be in the ischium, completely out of sight. Comparing to the PO method, the investigators' operation method was easy to master and had less complications.


Eligibility criteria: Inclusion Criteria:

* over two years old
* open reduction and acetabular osteotomy
* diagnosed as developmental dysplasia of the hip

Exclusion Criteria:

* a previous history of DDH surgery
* teratologic dislocations
* cerebral palsy
* other spastic or neuromuscular disease

Primary outcomes:
measure: preoperative acetabular index
timeFrame: 6th month after surgery
measure: Wiberg's mean center-edge angle
timeFrame: 6th month after surgery
Secondary outcomes:
measure: blood loss
timeFrame: 1st day after surgery
measure: avascular necrosis (AVN)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00187616: Questioning Patients About Adverse Medical Events
Official title: Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Keywords: adverse events
clinical trial methodology
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 214
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.

Detailed description: 214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplasia were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind).

Eligibility criteria: Inclusion Criteria:

* Male, age \> 49, American Urological Association Symptom Index \> 8
* Max urine flow rate \> 4 and \< 15

Exclusion Criteria:

* prior prostate cancer or surgery
* use of medications that affect urination
* severe concomitant illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephen Bent, MD
role: PRINCIPAL_INVESTIGATOR
References: