louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02206139: Level of Burn Out of Surgical Residents Working in All Hospitals of Lahore
Official title: Burn Out Among Surgical Residents Working at All Institutes in Lahore: An Area of Grave Concerns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Out Syndrome
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2014-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General surgical residents of All the Hospitals Of Lahore

Brief summary: The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article entitled "Staff Burnout" in which he discussed job dissatisfaction precipitated by work-related stress. A broadly applicable description defines burnout as a state of mental and physical exhaustion related to work or care giving activities. A long-standing conceptual and operational definition characterized burnout as a triad of emotional exhaustion (emotional over extension and exhaustion), depersonalization (negative, callous, and detached responses to others), and reduced personal accomplishment (feelings of competence and achievement in one's work) In the World Health Organization International Classification of Diseases, 10th revision, burnout is defined as a "state of vital exhaustion." Although no specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental Disorders, burnout is a clear syndrome with significant consequences.

Burnout in health care professionals has gained significant attention over the last several years. Given the intense emotional demands of the work environment, clinicians are particularly susceptible to developing burnout above and beyond usual workplace stress. Residency training, in particular, can cause a significant degree of burnout, leading to interference with individuals' ability to establish rapport, sort through diagnostic dilemmas, and work though complex treatment decision making. Overall, burnout is associated with a variety of negative consequences including depression, risk of medical errors, and negative effects on patient safety. The goal of this review is to provide medical educators and leaders with an overview of the existing factors that contribute to burnout, the impact of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.


Eligibility criteria: Inclusion Criteria:

* General Surgical resident

Exclusion Criteria:

* Residents of all other specialties
* All the General surgical consultants

Primary outcomes:
measure: average working hours of residents
timeFrame: upto 3 months
Secondary outcomes:
measure: emotional exhaustion
timeFrame: 3 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hospitals
state: Punjab
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
Study officials:
affiliation: SIMS/SHL
name: Sami Ullah, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01563939: Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour
Official title: Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour: is Demand Bolus Required for Optimal Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Labour analgesia
Pregnancy
IVPCA
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidural analgesia for pain relief in labor may not be suitable for all patients, and intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative. The purpose of this study is to assess the effectiveness of two methods remifentanil administration in the form of either an infusion or PCA demand bolus (intravenous injection of a single dose over a short period of time). Currently, our hospital gives remifentanil by demand bolus, however it may be equally effective, with less side effects, to give the drug as an infusion.

Detailed description: The study will be conducted as a randomized trial with two arms: Group I- continuous infusion of remifentanil with stepwise increase in infusion rates and Group II- demand bolus only with stepwise increase in bolus dose, as per the patient's analgesic requirement. Visual analog scores will be the primary outcome. Maternal and fetal side effects will be recorded. The results of this study will determine the regimen that suits the patients needs for painless labor with high efficacy, less adverse effects and a higher patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Term pregnancy in labour with singleton fetus in cephalic presentation
* Patients requesting systemic analgesia
* Patients with contraindication for regional anesthesia without fetal compromise (coagulopathy, thrombocytopenia, refusal, etc.)

Exclusion Criteria:

* Refusal to sign written informed consent
* Inability to communicate in English
* Opioid dependence or addiction
* Patients on Methadone
* Allergy or hypersensitivity to remifentanil
* Fetal heart rate abnormalities
* Fetal congenital anomalies

Primary outcomes:
measure: Pain score
timeFrame: 24 hours
Secondary outcomes:
measure: Maternal satisfaction
timeFrame: 24 hours
measure: Consumption of remifentanil
timeFrame: 24 hours
measure: Crossover to epidural
timeFrame: 24 hours
measure: Side effects
timeFrame: 24 hours
measure: Fetal & Neonatal outcomes
timeFrame: 48 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Mrinalini Balki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638039: Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysentery
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
First posted: 2012-07-11
Enrollment: 330
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.


Eligibility criteria: Inclusion Criteria:

* Lab-confirmed Shigella or ETEC
* Individuals or patients without diarrheal disease

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Identification of cases of shigellosis and ETEC-associated diarrhea
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikvah
country: Israel
facility: Leumit Health Care System
state: Elad
city: Afula
country: Israel
facility: Emek Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Netanya
country: Israel
facility: Sansz Medical Center - Laniado Hospital
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: School of Public Health, Sackler Faculty of Medicine, Tel Aviv University
name: Daniel Cohen, MPH, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05262439: Post Market Clinical Follow Up of ResMed Mask Systems
Official title: Post Market Clinical Follow Up of ResMed Mask Systems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 500
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: TREATMENT

Brief summary: Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

Detailed description: This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.

Eligibility criteria: Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants who ≥ 18 years of age
* Participants being treated for OSA for ≥ 6 months
* Participants currently using a suitable mask system
* Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards

Exclusion Criteria:

* Participants using Bilevel flow generators
* Participants who are or may be pregnant
* Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Participants believed to be unsuitable for inclusion by the researcher
* Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)

Primary outcomes:
measure: Apnea Hypopnea Index (event/hour)
timeFrame: up to 90 days
measure: Usage Hours (hours/night)
timeFrame: up to 90 days
measure: Leak (L/minute)
timeFrame: up to 90 days
measure: CPAP Pressure (cmH2O)
timeFrame: up to 90 days
measure: Adverse Events
timeFrame: up to 90 days
Secondary outcomes:
measure: General Usability
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Medical Affairs ResMed
state: New South Wales
Study officials:
affiliation: ResMed
name: Jeff Armistead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03659786: Single-center Prospective Cumulus Cell Test Study
Official title: Cumulus Cell Messenger Ribonucleic Acid (mRNA) Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 100
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle


Eligibility criteria: Inclusion Criteria:

* scheduled for intracytoplasmatic sperm injection (ICSI) and single or double embryo transfer on day 3
* patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with Highly Purified human Menopausal Gonadotropin (HP-hMG)
* undergoing first or second IVF or ICSI cycle with transfer
* Body Mass Index (BMI) between 17 and 33.
* regular menstrual cycle (between 24 and 35 days)

Exclusion Criteria:

* smokers (\> 10 cigarettes per day)
* patients requesting Pre-implantation Genetic Diagnosis (PGD)
* patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
* couples where the partner has an extremely low sperm count e.g.: extreme oligo-astheno-teratozoospermia (OAT) (\< 100.000/ml) or scheduled for testicular sperm extraction (TESE)
* results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect

Primary outcomes:
measure: Clinical pregnancy as observed by ultrasound
timeFrame: 2 months after embryo transfer
Secondary outcomes:
measure: Positive beta-hCG Pregnancy as observed by serum analysis
timeFrame: 12-17 days after embryo transfer
measure: Live birth by questionnaire
timeFrame: at least 9 months after embryo transfer
measure: Cumulative pregnancy
timeFrame: 2 years after embryo transfer
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Johan Smitz, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Van Vaerenbergh I, Adriaenssens T, Coucke W, Van Landuyt L, Verheyen G, De Brucker M, Camus M, Platteau P, De Vos M, Van Hecke E, Rosenthal A, Smitz J. Improved clinical outcomes after non-invasive oocyte selection and Day 3 eSET in ICSI patients. Reprod Biol Endocrinol. 2021 Feb 19;19(1):26. doi: 10.1186/s12958-021-00704-5.
Clinical trial NCT04938739: Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
Official title: Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effectiveness of cognitive-behavioral therapy on functional outcomes, pain, and pain-related anxiety in patients with chronic nonspecific low back pain

Detailed description: Back pain has considerable negative effects on the quality of life of affected individuals. Individuals with new-onset back pain have an increased risk of lower quality of life scores, and the negative effect on quality of life increases with persistent pain. Patients with chronic back pain report a quality of life that is lower than individuals without pain and that is comparable to those of individuals with life-threatening diagnoses. In addition, back pain is associated with worry and fears, particularly about the (sense of) self and socialrelationships and especially when pain persists longer than expected.

Eligibility criteria: Inclusion Criteria:

1. Thirty patients with non-specific chronic low back pain from both sexes will be included.
2. Subjects with normal body mass index (18 to 25).
3. The age of patients range from 20 to 35 years.
4. Duration of pain more than 3 months up to 2 years.
5. Normal cognition score 26 or above according to MoCA Scale.7. Highly educated at least high school.

Exclusion Criteria:

The patients will be excluded if they have any of the followings:

1. Lumbar canal stenosis.
2. Lumbar discogenic lesions.
3. Any inflammatory arthritis, tumors, infection involving the lumbar spine.
4. Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
5. Previous lumbar surgery or trauma.
6. Subjects with a history of any neurologic disease.
7. Cauda equina Syndrome.
8. Patients suffering from psychological, cognitive or emotional disturbance.
9. Patients who had previously participated in cognitive behavioral therapy.
10. Deafness and blindness.

Primary outcomes:
measure: Assessing the change in pain intensity
timeFrame: Baseline and 6 weeks post-intervention
measure: Assessing the change in back function
timeFrame: Baseline and 6 weeks post-intervention
Secondary outcomes:
measure: Assessing the change in anxiety related to pain
timeFrame: Baseline and 6 weeks post-intervention
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic - Faculty of Physical Therapy - Cairo University
Study officials:
affiliation: Horus University in Egypt
name: Manar Abdelgalil, Abdelgalil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04704739: Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205
Official title: A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG1205 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1205 Microtracer and Single Oral [14C]-GLPG1205 Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.


Eligibility criteria: Inclusion Criteria:

* Male between 18-64 years of age (extremes included) (Part 1) and between 45-64 years of age (extremes included) (Part 2), on the date of signing the informed consent form.
* A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
* Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).

Exclusion Criteria:

* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, cannot participate in the study.

Primary outcomes:
measure: Absolute oral bioavailability (F) (%)
timeFrame: Between Day 1 and Day 22
measure: Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%)
timeFrame: Between Day 1 and Day 22
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
affiliation: Galapagos NV
name: Ekaterina Tankisheva, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05197439: Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease
Official title: Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dexmedetomidine
Postoperative Delirium
Deep Brain Stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's Disease
* Exist non-motor symptoms
* Undergoing selective DBS.
* Age ≥60 years.
* Obtain written informed consent.

Exclusion Criteria:

* preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18)
* history of psychoactive
* allergic or intolerant to dexmedetomidine
* severe bradycardia (heart rate lower than 40 beats/min) or sick sinus syndrome, second-degree or third-degree atrioventricular block
* severe hepatic dysfunction (Child-Pugh class C)
* severe renal dysfunction requiring renal replacement therapy before the surgery
* medical records documented inability to communicate in the preoperative period due to language barrier or other situations.

Primary outcomes:
measure: The incidence of postoperative delirium.
timeFrame: Postoperative 5 days
Secondary outcomes:
measure: The severity of postoperative delirium.
timeFrame: Postoperative 5 days
measure: Postoperative pain
timeFrame: within 3 days after surgery.
measure: Quality of recovery.
timeFrame: First day after surgery
measure: Quality of sleep
timeFrame: the second and the third day after surgery
measure: Cognitive function
timeFrame: before surgery and 5 days after surgery
measure: Anxiety and depression
timeFrame: before surgery and 5 days after surgery
measure: Parkinson's disease related status
timeFrame: before surgery and 5 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital
name: Yuming Peng, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: