louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03155555: Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery
Official title: Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Anesthesia, Endotracheal
Mechanical Ventilation
Fluid Responsiveness
Keywords: Fluid Responsiveness
Pediatric surgery
General endotracheal anaesthesia
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-05-16
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients consenting for inclusion

Brief summary: The purpose of this study is to evaluate whether carotid Doppler peak systolic velocity can be an easy to measure possible surrogate for echocardiographic measurement of aortic peak systolic velocity variation which is an index of fluid responsiveness in mechanically ventilated children intra-operatively.


Eligibility criteria: Inclusion Criteria:

• Patients scheduled for mon-cardiac surgeries under general endotracheal anaesthesia in supine position with expected duration more than 1 hour

Exclusion Criteria:

* Known congenital heart disease
* Any non-sinus rhythm, arrhythmias
* Patients on vasoactive medications
* Chest wall deformities, situs non solitus (eg. dextrocardia)
* Patients scheduled for open chest surgeries
* History of neck surgery/ carotid interventions

Primary outcomes:
measure: Comparison of carotid peak systolic velocity variation with aortic peak systolic velocity variation
timeFrame: Measurements made within 3 minutes
Secondary outcomes:
measure: Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows
timeFrame: Measurements made within 3 minutes
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
Study officials:
affiliation: Junior Resident
name: Subhrashis Guha Niyogi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niyogi SG, Sen IM, Jayant A, Mandal B, Bhardwaj N, Yaddanapudi S, Mathew P. Surrogate indices of aortic peak systolic velocity variation to monitor fluid responsiveness in pediatric non-cardiac surgery: a prospective observational study. J Clin Monit Comput. 2020 Dec;34(6):1159-1166. doi: 10.1007/s10877-019-00431-8. Epub 2019 Dec 7.
Clinical trial NCT01342055: Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
Official title: Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2011-04-26
Enrollment: 38
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.


Eligibility criteria: Inclusion Criteria:

* Is a healty male between 20 and 55 years old
* Has BMI result between 19 and 26 kg/m2 at screening
* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Agrees to use an adequate means of contraception during clinical trials

Exclusion Criteria:

* Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
* Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
* Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history

Primary outcomes:
measure: Cmax, AUClast
timeFrame: Day 34
Secondary outcomes:
measure: AUCinf, Tmax, t1/2(beta)
timeFrame: Day 34
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Kim YH, Choi HY, Jin S, Noh YH, Kim MJ, Park HJ, Lim HS, Bang K, Lee SH, Bae KS. Tolerability and pharmacokinetics of two formulations of megestrol acetate under fed conditions in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):439-47. doi: 10.1016/j.clinthera.2014.09.022. Epub 2014 Oct 23.
Clinical trial NCT05409755: Radiofrequency in Female Pattern Hair Loss
Official title: Efficacy of Fractional Needling Radiofrequency in Female Pattern Hair Loss, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Pattern Baldness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pattern hair loss, also called androgenetic alopecia (AGA) is considered the most common cause of hair loss in both males and females affecting approximately 85% of males and 50% of females over 50 years of age.

Detailed description: RF (Radiofrequency) based devices have also been shown to be successful in promoting hair growth, thought to occur through the induction of growth factors in the papillary dermis. Studying the effect of fractional needling radiofrequency in the treatment of female pattern hair loss will pave the way for more treatment options for this common disease.

Eligibility criteria: Inclusion Criteria:

* Patients with female pattern hair loss

Exclusion Criteria:

* - Pregnancy and lactation.
* Bleeding tendency.
* Cases who received treatment (systemic or topical) in the last 3 months before treatment.
* Scarring alopecia.
* Other associated causes of alopecia

Primary outcomes:
measure: Clinical examination by Sinclair scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01928355: Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with greater body mass index

Brief summary: There is some evidence to suggest that obesity is a risk factor for the development of cognitive dysfunction, although this is not a universal finding. This discordance might be ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of metabolic risk factors. We examined whether the association of obesity with cognitive dysfunction is dependent on the individual's metabolic health.

60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol, triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as 'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results: Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized as metabolically healthy. Relative to non-obese healthy participants, after adjustment for baseline covariates, the metabolically unhealthy obese participants had elevated risk of cognitive dysfunction although the metabolically healthy obese did not. The association between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic health, although further work is required to confirm these findings.

In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese patients suffer from higher incidences of cardiovascular complications such as atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are three different types of Hp which differ in their antioxidant ability. Several clinical studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular diseases.


Eligibility criteria: Inclusion Criteria:

Freely given written informed consent BMI\>=30

Exclusion Criteria:

Evidence of Chronic Liver Diseases Pregnant Women

Primary outcomes:
measure: Transient elastography
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03319355: Multicomponent Therapy for Fibromyalgia
Official title: The Effect of a 12-week Multicomponent Therapy in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: multicomponent therapy
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: AZ Alma
First posted: 2017-10-24
Enrollment: 136
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia.

From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.


Eligibility criteria: Inclusion Criteria:

* woman with fibromyalgia
* between the age of 20 and 50
* agreement with therapy protocol

Exclusion Criteria:

* high indication of depression measured with the Beck Depression Index

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 6weeks
measure: Tampa scale for kinesiophobia
timeFrame: 6weeks
measure: Beck Depression Index
timeFrame: 6 weeks
measure: Pain Coping Inventory
timeFrame: 6 weeks
measure: Pain at tenderpoints
timeFrame: 6 weeks
measure: Grip strength
timeFrame: 6 weeks
measure: Walking
timeFrame: 6 weeks
measure: cycling
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05291455: Lacosamide in Neonatal Status Epilepticus
Official title: Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epilepsy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lacosamide in neonatal status epilepticus

Detailed description: The study will assess the efficacy of Lacosamide in neonatal status epilepticus

Eligibility criteria: Inclusion Criteria:

* neonates with status epilepticus

Exclusion Criteria:

* congenital anomalies or organ dysfunction

Primary outcomes:
measure: number of children with cessation or improved duration of status epilepticus
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
affiliation: Kafrelsheikh University
name: abeer salamah, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152255: MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)
Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: HIV-1 Infection
Keywords: Treatment of HIV-1 Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.


Eligibility criteria: Inclusion Criteria:

* Other than HIV infection, patient's baseline health is judged to be stable
* Patient is documented HIV-1 positive
* Patient has not received an investigational agent or licensed ART with in the past 30 days

Exclusion Criteria:

* Patient has a history of stroke, chronic seizures, or major neurological disease
* Patient has a history of cancer
* Patient has used any immune therapy agents or immunosuppressive therapy within the past month
* Patient requires or anticipates the use of any prescription or non-prescription drugs during the study
* Patient has a current diagnosis of acute hepatitis, has a history of Hepatitis C or has positive Hepatitis B surface antigen
* Patient consumes excessive amounts of alcohol (greater than 3 servings per day) or caffeine (greater than 6 servings per day)
* Patient is an excessive smoker (more than 10 cigarettes per day)
* Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Primary outcomes:
measure: Change from baseline in plasma HIV-1 RNA
timeFrame: Baseline and Day 7
measure: Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences
timeFrame: through Day 21
Secondary outcomes:
measure: C(24 hour) of MK6186
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153955: Earlier Mobilization Post Acute Thrombectomy
Official title: Earlier Mobilization Post Acute Thrombectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Keywords: Mobilization
Thrombectomy
Ischemia
Cerebrovascular Disorders
Brain Diseases
Recovery
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 0
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: This is a phase III trial trying to determine whether 12-hour bed rest following thrombectomy for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Received thrombectomy (may have also received intravenous tPA) for a diagnosis of acute ischemic stroke
* TICI 2b/2c/3 score following thromectomy
* Patient and/or Legally Authorized Representative provide consent

Exclusion Criteria:

* TICI 0/1/2a score following thrombectomy
* Venous thromboembolism present at symptom onset
* Pneumonia present at symptom onset
* STEMI at symptom onset
* Positive troponins at symptom onset according to local values
* Bone fracture at symptom onset
* Intubation anticipated or occurred
* Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
* Pre-screening systolic blood pressure \< 110 mmHg
* Resting pulse oximetry \< 92% (with or without supplemental oxygen)
* Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
* Baseline modified Rankin Scale score \> 2
* Known Pregnancy
* Patient not anticipated to survive 3 months
* Patient not anticipated to follow-up at 3 months

Primary outcomes:
measure: 90 Day Modified Rankin Scale (mRS) score
timeFrame: 90 days post bed rest
Secondary outcomes:
measure: Pneumonia
timeFrame: Duration of hospitalization stay, average 5 days
measure: Venous Thromboembolism
timeFrame: Duration of hospitalization stay, average 5 days
measure: Neurological Worsening
timeFrame: Duration of hospitalization stay, average 5 days
measure: Readmission
timeFrame: 90 days post bed rest
measure: Length of Stay
timeFrame: Duration of hospitalization stay, average 5 days
Other outcomes:
Locations:
Study officials:
affiliation: UMass Medical School
name: Brian Silver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06170255: Depression Treatment and Risk for Cardiovascular Disease
Official title: Depression Treatment and Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute of Mental Health (NIMH)
First posted: 2023-12-14
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.


Eligibility criteria: Inclusion Criteria:

Males and females age 21-75

Meet diagnostic criteria for major depressive disorder

Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.

Levels of depressive symptoms of at least moderate level (beck depression inventory II score \> 19 of 63 possible points; or a Hamilton depression rating scale \> 12 of 50 possible points)

Exclusion Criteria:

A verbal expression of current, significant, suicidal ideation; a score of \> 15 on the beck scale for suicidal ideation

Score of \>1 on any single item of the Beck Scale for Suicidal Ideation

Score of \> 1 on the item assessing suicidal ideation on the beck depression inventory II.

Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)

Current use of an antidepressant medication

Currently in psychotherapy.

Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent

Diagnosis of CVD.

Primary outcomes:
measure: Feasibility
timeFrame: 2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05851755: Italian Lung Cancer Observational Study
Official title: Italian Lung Cancer Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Cancer
Lead sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Sponsor class: OTHER
Collaborators: name: S. Andrea Hospital
name: Azienda Policlinico Umberto I
name: Azienda Ospedaliero, Universitaria Pisana
name: Università degli Studi dell'Aquila
name: University of Milan
name: Azienda Ospedaliera di Perugia
name: Monaldi Hospital
name: Azienda Ospedaliera di Bolzano
name: AUSL Romagna Rimini
name: European Institute of Oncology
name: Università degli Studi di Ferrara
name: Azienda Socio Sanitaria Territoriale di Mantova
First posted: 2023-05-10
Enrollment: 1000
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: PaTientsin with lung cancer and an indication for respective surgery

Brief summary: LUCENT is an observational study focused on malignant pulmonary and tracheo-bronchial disease. It involves a large proportion of reference Italian thoracic surgery centers. The relevance of the study is related to the epidemiology of lung cancer in the world - also known as "Big Killer" - and the high mortality rates both in males and females.

The aim of his prospective study is to collect a large bulk of postoperative patients' outcome data and to produce up-to-date descriptive statistics of patients undergoing surgery for lung cancer. These results will be pivotal to compare the clinical results of all the relevant specialities involved in the care of lung cancer such as medical oncologists and radiation oncologists.


Eligibility criteria: Inclusion Criteria:

* Patients with lung cancer
* informed consent

Exclusion Criteria:

* alcohol or drug abuse
* age \< 18
* inability to express consent

Primary outcomes:
measure: Lung cancer surgery outcomes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
Study officials:
affiliation: University of Aquila
name: Roberto Crisci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Luca Bertolaccini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS ISMETT -UPMC ITALY
name: Alessandro Bertani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043155: Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia
Official title: Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vaccination Refusal
Survivorship
Keywords: Covid19
Vaccination
Gynaeoncology cancer
Cancer survivor
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female cancer survivors or care-taker undergoing national covid 19 vaccine

Brief summary: A short survey involving 100 participants was conducted online to explore the understanding of Covid 19 pandemic impact and importance of vaccination among cancer survivors.


Eligibility criteria: Inclusion Criteria: Female cancer survivors or care-taker undergoing national covid 19 vaccine -

Exclusion Criteria: Male, not cancer survivors

-

Primary outcomes:
measure: Vaccination refusal
timeFrame: 8 months
measure: Reason for Refusal of Vaccine
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Dept O&G, UKM Medical Centre
Study officials:
References: