louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01678703: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
Official title: Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Abortion, Nonmedical
Keywords: late abortion
laminaria
Misoprostol
Cervical preparation
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-09-05
Enrollment: 84
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.

The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.

The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.

Detailed description: This is a prospective randomized study.

The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.

Primary outcome measures will include:

Initial cervical opening and the need for further dilatation at the procedure Procedure duration

Difficulty score performing the abortion

Complications during and after the procedure

Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure

Eligibility criteria: Inclusion Criteria:

* Pregnant patients with a viable singleton
* Pregnancy 14-20 weeks of gestation
* Admitted for termination of pregnancy

Exclusion Criteria:

* Contraindication for administration of Misoprostol
* Patients with more than one previous cesarean section scar
* Patients with impaired coagulation
* Significant pulmonary or cardiac disease
* Non viable pregnancy
* Placenta accreta or previa by ultrasound

Primary outcomes:
measure: Initial cervical opening and the need for further dilatation at the start of the procedure
timeFrame: 8-12 hours after insersion of laminaria or Misoprostol
Secondary outcomes:
measure: pain score during cervical preparation and after the procedure
timeFrame: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia
Other outcomes:
measure: The degree of difficulty to accomplish the abortion
timeFrame: at the time of performing the surgical abortion
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Tel Aviv University, Sackler Medical School, Israel
name: Ron Sagiv, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05104203: TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery
Official title: Perioperative Analgesia Efectivity of Thoracolumbar Interfascial Plane Block Compared Modified Thoracolumbar Interfascial Plane Block in Posterior Lumbal Decompression and Stabilization: Research in Intraoperative Hemodynamic and qNox and Total Morfin Comsumption and Postoperative IL-6 Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Surgical Procedure, Unspecified
Keywords: Erector Spinae Plane Block
opioid consumption
numerical rating scale
Interleukin 10
Interleukin 6
Thoracolumbal Interfascial Plane Block
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.

Detailed description: This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient was given the PCA, and total morphine consumption was assessed.

Eligibility criteria: Inclusion Criteria:

1. Patients undergo thoracolumbar Decompression and Stabilization Surgery
2. Age between 18-65 years old
3. BMI \>18,5 kg.m2, and BMI\< 30 kg/m2
4. ASA 1-3
5. No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done

Exclusion Criteria:

1. Obese patient, with BMI\>30 kg.m2
2. Alergic to local anesthetics
3. Underweight patient with BMI \<18,5 kg/m2"

Primary outcomes:
measure: Hemodynamic
timeFrame: approximately 15 minutes within surgery
Secondary outcomes:
measure: qNox Score
timeFrame: before induction of anesthesia, 15, 30, 45 minutes after the block was done.
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT05147103: Investigation of the Duration of Low-intensity Focused Ultrasound
Official title: Investigation of the Duration of Low-intensity Focused Ultrasound
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Development of LIFU for Clinical Purposes
Keywords: low-intensity focused ultrasound
transcranial magnetic stimulation
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-visit study, testing various LIFU durations
Primary purpose: BASIC_SCIENCE

Brief summary: This project examines the effects of various durations of noninvasive neuromodulation on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions of the hand.


Eligibility criteria: Inclusion Criteria:

* Above criteria and must understand and speak English.

Exclusion Criteria:

* Contraindications to MRI, CT, or TMS

  1. Claustrophobia
  2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for \>10 minutes
  7. History of alcohol or drug dependence

Primary outcomes:
measure: Waveforms
timeFrame: Outcomes assessed throughout participation - an average of 3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
References:
citation: Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1.
citation: Legon W, Ai L, Bansal P, Mueller JK. Neuromodulation with single-element transcranial focused ultrasound in human thalamus. Hum Brain Mapp. 2018 May;39(5):1995-2006. doi: 10.1002/hbm.23981. Epub 2018 Jan 29.
citation: Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12.
Clinical trial NCT04824703: Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients
Official title: Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Therapy
Keywords: Oxygen therapy and Mortality
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 106
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: To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients


Eligibility criteria: Inclusion Criteria:

* adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day

Exclusion Criteria:

* inclusion in other trial
* severe acute respiratory distress syndrome at time of admission
* acute Chronic obstructive airway disease exacerbation
* pregnancy
* Carbon monoxide poisoning
* Guillain Barre syndrome

Primary outcomes:
measure: Change in Stroke volume in milliliters
timeFrame: Change from Baseline stroke volume At ICU admission and through study completion An average 6 months
measure: Change in ejection fraction of heart in percentage
timeFrame: Change from baseline ejection fraction at icu admission and through study completion An Average 6 months
Secondary outcomes:
measure: Acute respiratory distress syndrome
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Sepsis
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Stroke
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Mechanical Ventilator free days
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Shock
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Surgery revision
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Vasopressor
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: ICU stay
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Hospital stay
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
measure: Mortality
timeFrame: From icu admission date to icu discharge date an average of 2 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan university hospital
Study officials:
References:
Clinical trial NCT04450303: Social Anxiety Telehealth Therapy Study
Official title: Social Anxiety Telehealth Therapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. These problems may be especially acute for individuals with social anxiety disorder (as many as 12% of Americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. This project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.


Eligibility criteria: Inclusion Criteria:

* Age 18+,
* Liebowitz Social Anxiety Scale (LSAS) total score \> 50
* Fluent spoken and written English
* Access to the internet via a smartphone or computer with a camera
* Ability to provide informed consent.

Exclusion Criteria:

* History of mania or psychosis
* Moderate or severe substance use disorder within the past year
* Current psychiatric diagnosis of greater impairment than that arising from social anxiety
* High risk for suicide (\>8 on the Mini International Neuropsychiatric Interview suicidality section)
* Prior exposure therapy (more than 2 sessions)
* Current psychotropic medication use
* Current psychotherapy other than couples counseling.

Primary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 12 weeks
measure: Satisfaction with Therapy and Therapists Scale (STTS)
timeFrame: 12 weeks
measure: UCLA Loneliness Scale version 3
timeFrame: 12 weeks
Secondary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 24 weeks
measure: UCLA Loneliness Scale version 3
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tali Ball, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00043303: Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
Official title: A Multicenter Study of the Safety and Anti-Fibrotic Efficacy of Interferon-Gamma 1b (Actimmune) in Patients With Severe Lever Fibrosis or Compensated Cirrhosis Due to Hepatitis C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Fibrosis
Cirrhosis
Keywords: hepatitis C
liver fibrosis
liver cirrhosis
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2002-08-09
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.

IFN-g 1b is not currently approved for the treatment of liver fibrosis.

Detailed description: This study will evaluate the safety and tolerability of IFN-g 1b in patients with advanced liver fibrosis and cirrhosis due to hepatitis C. This study will also evaluate whether IFN-g 1b is effective in reducing the amount of fibrosis in the liver.

Eligibility criteria: * Men or women 18 to 75 years
* Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA
* History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated
* Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system.
* Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted)
* Must meet minimum blood chemistry requirements
* Cannot have unstable or uncontrolled thyroid disease
* Cannot have a variety of other diseases (listed in protocol
* Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.

Primary outcomes:
measure: Ishak fibrosis score
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: InterMune
name: Steven Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04112290: A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
Official title: A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Keywords: Atrial fibrillation
Ventricular tachycardia
Arrhythmia
Hypertrophic cardiomyopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-10-02
Enrollment: 260
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: Adult patients with hypertrophic cardiomyopathy who are participating in (or previously participated in) Mayo Clinic study 17-003514 and/or 16-009474

Brief summary: The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.

Detailed description: Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.

Eligibility criteria: Inclusion Criteria:

* Currently or previously enrolled in 17-003514 and 16-009474
* Adults age \>18 years-old with a diagnosis of hypertrophic cardiomyopathy
* Both sexes
* Able to consent

Exclusion Criteria:

* Vulnerable study population
* Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
* Pacemaker/ICD implantation
* Pregnancy

Primary outcomes:
measure: Atrial fibrillation incidence in hypertrophic cardiomyopathy
timeFrame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
measure: Atrial fibrillation recurrence in hypertrophic cardiomyopathy
timeFrame: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
measure: Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
timeFrame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeffrey Geske, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04604990: National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
Official title: National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SLE (Systemic Lupus)
Keywords: SLE
Lupus erythematosus
Outcomes
Phenotypes
Observational
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from KSU-SLE specialized clinic. The clinic receive general referral from general rheumatology clinics in KSU and general referral from other clinics inside or outside KSU. The estimated number is 1000 patients.

Brief summary: SLE disease in Saudi Arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . Up until now, there has been no prospective cohort study for SLE patients in Saudi Arabia. As a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.


Eligibility criteria: Inclusion Criteria:

1. Adult patients defined as age greater than 18 years old.
2. Patients should fulfil one of the following classification criteria for SLE (ACR, SLICC or ACR/EULAR criteria).
3. No restriction on time of diagnosis.

Exclusion Criteria:

* Patients who don't fulfil classification criteria mentioned above.

Primary outcomes:
measure: Disease Accrual damage among SLE patients in Saudi Arabia
timeFrame: over 10 years
measure: Disease Accrual damage among SLE patients in Saudi Arabia
timeFrame: over 10 years
measure: Disease Accrual damage among SLE patients in Saudi Arabia
timeFrame: over 10 years
Secondary outcomes:
measure: Patient reported outcome
timeFrame: over 5 years
measure: Patient reported outcome
timeFrame: over 5 years
measure: Fetal and maternal outcomes in patients with SLE
timeFrame: over 5 years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: king Saud University medical city
state: Central Province
Study officials:
References:
citation: Almaghlouth IA, Hassen LM, Alahmari HS, Bedaiwi A, Albarrak R, Daghestani M, Alqurtas E, Alkhalaf A, Bedaiwi M, Omair M, Almogairen S, Alarfaj H, Alarfaj A. National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol. Medicine (Baltimore). 2021 Jul 30;100(30):e26704. doi: 10.1097/MD.0000000000026704.