louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02645435: Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
Official title: Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthropathy of Hip
Surgery
Lead sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.

Methods:

The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.

Detailed description: Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.

Methods:

The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.

Eligibility criteria: Inclusion Criteria:

* Hip arthritis

Exclusion Criteria:

* BMI\>35

Primary outcomes:
measure: Clinical outcome of direct hip approach
timeFrame: 32 months
Secondary outcomes:
measure: radiological positioning of cup in the replaced hip
timeFrame: 32 months
measure: radiological positioning of the stem in replaced hip
timeFrame: 32 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03243435: Sienna+MR Long-term Uptake
Official title: Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 34
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all 34 patients from the previous study are included

Brief summary: In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable.


Eligibility criteria: inclusion:

* participation in previous study
* informed consent
* no contraindications for MRI scan

exclusion:

* contraindications for MRI scan

Primary outcomes:
measure: I) Analysis if the supraparamegnetic Tracer is still detectable
timeFrame: 04/2017
Secondary outcomes:
measure: Analysis to which degree of impairment of Imaging is detected
timeFrame: 04/2017
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
Study officials:
References:
Clinical trial NCT00067535: Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1
Official title: Potential Interactions Between IV Cocaine and RPR 102681
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-08-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681

Detailed description: Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681

Eligibility criteria: Inclusion Criteria:

Includes but is not limited to:

* Non-treatment seekers
* DSM-IV criteria for cocaine abuse or dependence
* Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements

Exclusion Criteria:

Please contact site for more information.

Primary outcomes:
measure: Hemodynamic response to cocaine and subjective response to cocaine
timeFrame: 3x / 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769635: CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension
Official title: Impact of Continuous Positive Airway Pressure Therapy on Pulmonary Hypertension and Exercise Capacity in Newly Diagnosed Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of \>70% nights \[380\] obtained from device download with AHI\<5 /hr

Echocardiography:

It was performed initially to diagnose pulmonary hypertension and repeated after three months of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP.

Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40 mmHg), moderate (41-55 mmHg), and severe (\>55 mmHg) degrees.

Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular systolic pressure (RVSP).


Eligibility criteria: Inclusion Criteria:

All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH).

Exclusion Criteria:

* Patients aged \< 18 years
* Patients with secondary PH, due to pulmonary diseases, or left ventricular heart diseases , or chronic thromboembolic disorders.
* Patients on long term oxygen therapy (LTOT).
* Patients with respiratory neuromuscular weaknesses or chest wall deformities.
* End-organ failure and malignancies
* Obesity hypoventilation syndrome.

Primary outcomes:
measure: change of mean pulmonary artery pressure measured by echo
timeFrame: 3 months
Secondary outcomes:
measure: Exercise capacity improvement measured by six minute walking test
timeFrame: 3 months
measure: Exercise capacity improvement measured by maximun o2 consumption
timeFrame: 3 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Ahmad Abbas
state: Sharkia
Study officials:
References:
Clinical trial NCT00124735: A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Official title: An Open-label, Randomized, Phase IIIB, Multicenter Trial to Evaluate the Pharmacodynamic Parameters of Intubation Bolus, and Bolus and Infusion Maintenance Doses of Zemuron® in Pediatric and Adolescent Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 149
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).


Eligibility criteria: Inclusion Criteria:

* Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

Exclusion Criteria:

* Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trials will not be allowed to enter.

Primary outcomes:
measure: Total Dose of Zemuron (Rocuronium) Administered
timeFrame: during surgery
Secondary outcomes:
measure: Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%
timeFrame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
measure: Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%
timeFrame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
measure: Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%
timeFrame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Other outcomes:
Locations:
Study officials:
References:
citation: Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.
Clinical trial NCT06832735: Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital
Official title: Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Polycystic Ovary Syndrome (PCOS) Women
Keywords: PCOS
Quality of life
PCOSQ
BMI
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital during the period of 6 months.

Brief summary: It is well-established that PCOS women suffer from anxiety, depression, and markedly reduced QoL ,but There has not yet been a nationally representative study to evaluate the PCOS health related Qol and factors affecting it among women in Egypt. So here we try to cover this gap in this study that will be designed to record the QOL of women with PCOS and factors affecting it.

This study aims to assess the health related quality of life of polycystic ovary syndrome and determine factors affecting the HRQOL


Eligibility criteria: Inclusion Criteria:

* • Female cases between 18 and 45.

  * Females diagnosed with PCOS per Rotterdam criteria , the most commonly accepted and used for PCOS, a diagnosis is confirmed if any two of the three features (hyperandrogenism, oligomenorrhea or anovulation, and polycystic ovaries) are present in a woman of reproductive age

Exclusion Criteria:

* • Females below 18 years old.

  * Females above 45 years old.
  * Patients having major life event or problem also affecting quality of life.

Primary outcomes:
measure: health related quality of life of women with PCOS
timeFrame: 2 months after answering the polycystic ovary syndrome questionnaire
Secondary outcomes:
measure: Factors affecting health related quality of life of women with PCOS
timeFrame: 2 months after collecting data from the medical chart
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: faculty of medicine Sohag university
Study officials:
References:
Clinical trial NCT01390935: SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World
Official title: SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real WorldMulticenter, Retrospective Observation Study in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Keywords: guideline adherence
systolic heart failure
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: admission for systolic heart failure in general hospital

Brief summary: The purpose of this study is to survey the guideline compliance of the cardiologists in the treatment of systolic heart failure in Korea

Detailed description: Major improvement in the medical management of CHF has been achieved in the past decades.

But there is no doubt that prognosis of heart failure patients remains poor. The compliance to the standard treatment can be one of reasons. But very little data concerning this in Korea is available.

Eligibility criteria: Inclusion Criteria:

* Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009
* Subjects, age 20 or/and above
* Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria;
* Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly
* Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration

Exclusion Criteria:

* Subject who expired during hospitalization

Primary outcomes:
measure: Mean of modified Guideline Adherence Indicator(mGAI-3)
timeFrame: 1year
Secondary outcomes:
measure: Percentage of participants with each class drug prescribed
timeFrame: 1year
measure: Percentage of participants with daily target dose reached
timeFrame: 1year
measure: Percentage of all cause mortality
timeFrame: 1year
measure: Percentage of All cause hospitalization
timeFrame: 1year
measure: Mean of mortality or rehospitalization rate according to mGAI-3
timeFrame: 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06210035: Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease
Official title: Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2024-01-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD). We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory. Healthy adults aged 18-35 who meet all eligibility criteria will be invited to this study. Participants will be asked to engage in one week of daily meditation practice or no-intervention control task at home. They will also be asked to visit the lab twice, once before and once after the intervention, to provide blood samples to assess plasma biomarkers of AD and to complete emotion questionnaires and a memory test.


Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Aged between 18-35 years old
* Agree to provide blood samples
* Healthy adults who weigh at least 110 pounds
* Agree to devote 40 minutes daily to this study for a week

Exclusion Criteria:

* Have a disorder that would affect heart rhythm or function (e.g., abnormal cardiac rhythm, dyspnea, heart disease including coronary artery disease, angina and arrhythmia)
* Regularly practicing any relaxation, meditation or yoga that involve breathing focused practices lasting for more than an hour each week

Primary outcomes:
measure: Change in plasma amyloid beta levels
timeFrame: Measured from blood draws before and after a one-week intervention
measure: Change in plasma Ab42/40 ratio
timeFrame: Measured from blood draws before and after a one-week intervention
Secondary outcomes:
measure: Change in plasma pTau-181/tau ratio
timeFrame: Measured from blood draws before and after a one-week intervention
measure: Change in emotional well-being
timeFrame: Measured before and after a one-week intervention
Other outcomes:
measure: Episodic memory
timeFrame: Measured after a one-week intervention
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT04278235: Expanded Access to Elezanumab
Official title: Expanded Access to Elezanumab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Acute Spinal Cord Injury (SCI)
Acute Ischemic Stroke
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-02-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

- The participant must not be eligible for an elezanumab clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05669235: Differences Between Women With COVID-19 and Long Covid
Official title: Differences Between Women Who Have Suffered COVID-19 With Respect to Those Who Have Suffered Long Covid: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Long covid
Women
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have suffered from COVID-19 who have or have not had symptoms since then.

Brief summary: The coronavirus disease of 2019 (COVID-19) has infected more than 630 million people and resulted in more than 6.5 million deaths worldwide. Among the possible sequelae of the virus, a disorder called long COVID has shown to affect about 10% of those infected, mostly adult women, without comorbidities.

Long COVID corresponds to a multisystemic syndrome following the acute period of the disease, in which the person maintains persistent symptoms such as fatigue, dyspnea, cough, memory loss, muscle and joint pain, among others.

Now that time has passed, it is necessary to verify why there are women who present symptoms of long covid and others do not.


Eligibility criteria: Inclusion Criteria:

* Women between 18 and 65 years
* That they have passed COVID-19 at least once.
* Whether or not they have symptoms secondary to COVID-19.

Exclusion Criteria:

* They do not want to sign the informed consent.

Primary outcomes:
measure: Fatigue Assessment Scale
timeFrame: Baseline
Secondary outcomes:
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: Baseline
measure: Quality of life (EQ-5D)
timeFrame: Baseline
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Inventario de Depresión de Beck (BDI-2)
timeFrame: Baseline
measure: 30 second sit-to-stand
timeFrame: Baseline
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References: