louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02424201: Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.
Official title: Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Primary Postpartum Haemorrhage
Keywords: uterine atony
Lead sponsor: Lagos State University
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 660
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.

Detailed description: This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.

Eligibility criteria: Inclusion Criteria:

* singleton in longitudinal lie and cephalic presentation

Exclusion Criteria:

* refusal of consents, multiple gestation

Primary outcomes:
measure: mean blood loss
timeFrame: 1 hour of delivery
Secondary outcomes:
measure: number of participants with untowards effects
timeFrame: 1 hour of delivery
Other outcomes:
Locations:
Study officials:
References:
citation: Ottun TA, Adewunmi AA, Rabiu AK, Olumodeji AM, Oladipo OM, Olalere HF. Misoprostol and oxytocin versus oxytocin alone in the active management of the third stage of labour: a randomised, double-blind, placebo-controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1048-1053. doi: 10.1080/01443615.2021.1995342. Epub 2021 Dec 27.
Clinical trial NCT04288401: Prevalence of Osteosarcopenic Obesity in Older Adults
Official title: Prevalence of Osteosarcopenic Obesity in Older Community-dwelling Adults in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Sarcopenia
Osteopenia
Osteoporosis
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Goztepe Training and Research Hospital
First posted: 2020-02-28
Enrollment: 460
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older adults at the age of 65 or over

Brief summary: Osteosarcopenic Obesity (OSO) is a syndrome characterized by the loss of bone and muscle in addition to increase in the fat tissue as a result of aging process. It is the latest point of impairment in the bone,muscle and adipose tissue in older adults. OSO, as the name suggests, is the combination of three syndrome frequently encountered in the elderly: osteopenia/osteoporosis, sarcopenia and obesity. The aims of study are to determine the prevalence of OSO syndrome in community-dwelling adults of Turkey and determine the possible factors regarding risk of falling in this population


Eligibility criteria: Inclusion Criteria:

* Age of 65 or over
* Being had been examined for all the primary outcome measures (i.e. the results of primary outcomes must be in the patient's file)

Exclusion Criteria:

* Severe cognitive dysfunction
* not being able to walk independently for 4 m

Primary outcomes:
measure: T score
timeFrame: 1 hour
measure: Muscle Strength
timeFrame: 5 minutes
measure: Muscle Mass
timeFrame: 2 minutes
measure: Muscle Performance
timeFrame: 3 minutes
measure: Obesity
timeFrame: 2 minutes
Secondary outcomes:
measure: Comorbidity
timeFrame: 3 minutes
measure: History of falls
timeFrame: 1 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Goztepe Training and Research Hospital
Study officials:
References:
citation: Kolbasi EN, Demirdag F. Prevalence of osteosarcopenic obesity in community-dwelling older adults: a cross-sectional retrospective study. Arch Osteoporos. 2020 Oct 20;15(1):166. doi: 10.1007/s11657-020-00829-x.
Clinical trial NCT03137901: Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring
Official title: Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 40
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 scheduled for major surgery

Brief summary: This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO monitoring ( EV-1000, Edwards Lefesciences, USA)

Detailed description: Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for major surgery which requires a CO and PPV monitoring as standard of care

Exclusion Criteria:

* patients with arrhythmias like atrial fibrillation
* patients with valvular insufficiency

Primary outcomes:
measure: Agreement and precision of PPV and CO during 5 surgical phases (postinduction, pre incision, postincision, end of surgery and at least one episode of hypotension)
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
Study officials:
affiliation: Erasme
name: Alexandre Joosten, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joosten A, Jacobs A, Desebbe O, Vincent JL, Sarah S, Rinehart J, Van Obbergh L, Hapfelmeier A, Saugel B. Monitoring of pulse pressure variation using a new smartphone application (Capstesia) versus stroke volume variation using an uncalibrated pulse wave analysis monitor: a clinical decision making study during major abdominal surgery. J Clin Monit Comput. 2019 Oct;33(5):787-793. doi: 10.1007/s10877-018-00241-4. Epub 2019 Jan 3.
Clinical trial NCT00155467: Establish a CT Images Database of Patients With Congenital Heart Disease
Official title: Establish a CT Images Database of Patients With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Keywords: CT
children
congenital
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Setup CT images database of congenital heart disease.

Detailed description: Setup CT images database of congenital heart disease.

Eligibility criteria: Inclusion Criteria:

- congenital heart disease

Exclusion Criteria:

-

Primary outcomes:
measure: diagnostic accuracy
Secondary outcomes:
measure: senstivity
measure: specificity
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dept. Medical Imaging, NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: Shyh-Jye Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05729867: Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC
Official title: Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Biliary Obstruction
Hepatocellular Carcinoma
Keywords: Self expandable metal stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.

Detailed description: In this study, endoscopic biliary drainage was performed using fully covered self-expancdable metal stent for malignant biliary obstruction caused by HCC. Main outcome is efficacy and safety of this procedure including clinical success rate, technical success rate, stent patency, stent dysfunction, and any adverse events during the follow-up period.

Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years or older, those who consented to the clinical research participation and signed a written consent form
* Obstructive jaundice caused by unresectable hepatocellular carcinoma

Exclusion Criteria:

* Patients who have previously undergone surgical biliary drainage
* Patients who need to remain percutaneous transhepatic biliary drainage
* Patients whose life expectancy is less than 3 months (BCLC stage D without a treatment plan for hepatocellular carcinoma)
* Patients who cannot undergo endoscopic procedure according to the judgment of the researcher

Primary outcomes:
measure: Clinical success rate
timeFrame: 1 month
measure: Technical success rate
timeFrame: 1 day
Secondary outcomes:
measure: Stent patency duration
timeFrame: 1 year
measure: Stent migration rate
timeFrame: 1 year
measure: Stent dysfunction rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Hyub Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05803967: Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems
Official title: Baduanjin Exercising Effects on Women With Hypothyroidism and Cognitive Problems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subclinical hypothyroïdism
Cognitive Impairment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly

Detailed description: Females (forty in number) with sub-clinical hypothyroidism exhibit cognitive problems, they are elderly, will be divided to exercised group (baduanjin training will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20) and other non exercised group (number of patients will be 20) . all women of groups will received their prescribed daily one-dose medication tablet (levothyroxine).

Eligibility criteria: Inclusion Criteria:

* female with sub-clinical hypothyroidism
* females with mild cognitive impairment
* females with obesity (obesity class one)

Exclusion Criteria:

* neurological problems
* orthopedic problems

Primary outcomes:
measure: thyroid stimulating hormone
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: systolic blood pressure
timeFrame: it will be measured after 12 weeks
measure: triglycerides
timeFrame: it will be measured after 12 weeks
measure: Addenbrooke Cognitive Examination
timeFrame: it will be measured after 12 weeks
measure: diastolic blood pressure
timeFrame: it will be measured after 12 weeks
measure: low density lipoprotein
timeFrame: it will be measured after 12 weeks
measure: cholesterol
timeFrame: it will be measured after 12 weeks
measure: high density lipoprotein
timeFrame: it will be measured after 12 weeks
measure: body mass index
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali MA Ismail
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05079867: Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
Official title: Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Cochlear Implant
Cochlear Microphonics
Electrocochleography
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 12 months of age who will receive a cochlear implant

Brief summary: Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

Detailed description: Branches:

* Perimodiolar (PM)
* Lateral wall (PL)

Follow up schedule:

Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)

Eligibility criteria: Inclusion Criteria:

Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz

Exclusion Criteria:

Medical or pharmacological comorbid condition that contraindicates cochlear implantation.

Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.

Surgical impossibility to follow the guidelines of the minimally traumatic technique.

Primary outcomes:
measure: Amplitude of cochlear microphonics
timeFrame: 0-12 months
Secondary outcomes:
measure: Cochlear implant impedance
timeFrame: 0-12 months
measure: Residual hearing
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Capital federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Federico A Di Lella, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724967: CeraVe Diabetes Mellitus
Official title: Clinical Evaluation of CeraVe Hydrating Cleanser and Moisturizing Cream for the Improvement of Skin Condition in Patients With Diabetes Mellitus (DM) Related Skin Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Complications
Keywords: cutaneous complication of DM
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: CeraVe
First posted: 2021-01-26
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin Line for the improvement of skin condition in patients with diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Men or women between the ages of 18 and 75 years of age.
2. Willing to provide written informed consent.
3. A diagnosis of diabetes mellitus (DM).
4. DM-related skin changes classified into one or more of the following four categories: i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of DM complications; iv) skin reaction to DM treatment.

Exclusion Criteria:

1. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in CeraVe Hydrating Cleanser or Moisturizing Cream
2. History of allergic contact dermatitis secondary to cleansers or moisturizers.
3. Has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy).
4. Has any clinical manifestation in the treatment are(s) or other disorders that, in the investigator's opinion, may affect assessments or the study products.
5. Inability to attend all study visits and follow treatment regimen.

Primary outcomes:
measure: Percentage of Participants Reporting Adverse Events (AE)
timeFrame: Up to 33 days
measure: Number of Participants at Each GAIS Grading Scale
timeFrame: At 33 days
measure: Number of Participants at Each Dry Skin Scale
timeFrame: At 33 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Robert Kirsner, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02057367: Scalp Nerve Block and Opioid Consumption in Brain Surgery
Official title: The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Tumour
Keywords: supratentorial brain tumour
craniotomy
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

Detailed description: Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

A Prospective Randomized Double Blind Control

Eligibility criteria: Inclusion Criteria:

1. Patients who have supratentorial brain tumor
2. Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
3. Patients have been general anesthetized with endotracheal intubation and control ventilation
4. Patients who have provided consent for the participation in the research and for the use of their medical record in research

Exclusion Criteria:

1. Pregnant patients
2. Patients who have a history of local anesthetic allergy and/ or anaphylaxis

Primary outcomes:
measure: Intraoperative opioid consumption
timeFrame: During the supratentorial craniotomy surgery
Secondary outcomes:
measure: systolic blood pressure change
timeFrame: within 5 minutes after skull pin insertion
measure: Heart rate change
timeFrame: within 5 minutes after skull pin insertion
Other outcomes:
measure: extubation
timeFrame: end of surgery, before transferring to the intensive care unit
Locations:
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Pathomporn Pin-on, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00325767: Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
Official title: Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mucociliary Clearance
Keywords: mucociliary clearance
beta-adrenergic drugs
inhalation
aerosol
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2006-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized order.

Detailed description: In healthy lungs, inhaled insoluble material such as bacteria, viruses, antigens, and toxins deposit in the tracheobronchial airway mucus and are removed from the lung in a matter of hours by mucociliary clearance (MCC). When MCC is overwhelmed or impaired, some mucus can be removed by mechanical or cough clearance (CC). Impairment of MCC typically leads to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization, and chronic inflammation.

Racemic albuterol has been shown to stimulate MCC in various patient populations. Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects. We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* non-smoking males and non-pregnant females greater than or equal to 18 years of age
* forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted values
* normal systolic and diastolic blood pressures

Exclusion Criteria:

* history of heart disease, irregular heartbeat, hypertension
* history of diabetes, hyperthyroid
* history of pneumonia, tuberculosis
* history of seizure disorder, depression, hospitalization in the last month for non-elective purposes, cold or flu in the previous three months

Primary outcomes:
measure: Lung mucociliary clearance
measure: Lung cough clearance
Secondary outcomes:
measure: Forced expiratory volume in 1 second
measure: Forced vital capacity
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Eudowood Division of Pediatric Respiratory Sciences
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Beth L Laube, Ph.D.
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: Jeffrey C Cleary, M.D.
role: PRINCIPAL_INVESTIGATOR
References: