louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03275844: Physical Capacity and Activity in Children With Congenital Heart Disease
Official title: Physical Capacity and Activity in Children With Congenital Heart Disease in Chile
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Defects, Congenital
Tetralogy of Fallot
Keywords: Physical activity
Physical capacity
Children
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with congenital heart diseases

Brief summary: Congenital malformations correspond to defects in organ morphogenesis identifiable at birth or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital Heart Disease corresponds, in particular, to structural defects of the heart or major blood vessels thereof may or may not be associated with other types of syndromes.The resolution is usually surgical.

Also, these patients present a decrease in physical fitness, psychological imbalance, lower quality of life and risk significant morbidity and mortality from respiratory infections among other problems.

This can have severe consequences for health in the medium and long term. The habits acquired during childhood and adolescence are determinant for the adult life, being relevant levels of activity and physical condition, especially in children with pathologies.

In this way, it is vital to know from childhood parameters that indicate the baseline state of these patients according to the levels of physical activity, exercise capacity, nutritional status and quality of life. These will be key indicators to take into account in the future, to adapt rehabilitation plans that will reduce the effects of their condition.

The objective of this protocol is To characterize the levels of Activity, and Physical Capacity of children with congenital heart disease regularly treated at the Cardiovascular Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and sex.


Eligibility criteria: Inclusion Criteria:

* Children with Tetralogy of Fallot corrected
* Age from 6 to 15 years
* Assistants to periodic control at HLCM Cardiovascular Center

Exclusion Criteria:

* Morbid obesity
* Musculoskeletal disorders that impede physical activity
* Neurological comorbidity
* Respiratory comorbidity in the last 30 days.
* Pacemaker users

Primary outcomes:
measure: Moderate-to-vigorous physical activity
timeFrame: 1 week
Secondary outcomes:
measure: Six minute walking test
timeFrame: 1 hour
measure: Steps
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Univeridad de Chile
name: Homero Puppo, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT01737944: Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration
Official title: Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: methotrexate injection, subcutaneous, autoinjector
Lead sponsor: Antares Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics (PK) study

Detailed description: To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Eligibility criteria: Inclusion Criteria:

* Male or female \>18 years of age with diagnosed Rheumatoid Arthritis(RA).

Exclusion Criteria:

* Chronic or acute renal disease
* Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk

Primary outcomes:
measure: Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX
timeFrame: 24 Hour period
measure: Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX
timeFrame: 24 Hour period
measure: Bioequivalence Based Upon Dose-Normalized Cmax for MTX
timeFrame: 24 Hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: Altoona Center for Clinical Research
name: Alan J Kivitz, MD;CPI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850144: Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®
Official title: Comparison of Tiotropium Pharmacokinetics After Inhalation From Tiotropium Easyhaler® Product Variants and After Spiriva® Capsules Administered Via HandiHaler®; Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
Primary purpose: BASIC_SCIENCE

Brief summary: Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.


Eligibility criteria: Main inclusion criteria:

1. Healthy males and females
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. Written informed consent obtained

Main exclusion criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease
2. Any condition requiring regular concomitant treatment
3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Primary outcomes:
measure: Peak tiotropium concentration in plasma (Cmax)
timeFrame: between 0-72 hours after dosing
measure: Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)
timeFrame: 0-30 minutes after dosing
measure: Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
timeFrame: 0-72 hours after dosing
Secondary outcomes:
measure: Time to reach peak concentration in plasma (tmax)
timeFrame: between 0-72 hours after dosing
Other outcomes:
measure: Adverse events
timeFrame: througout the study, an average 9 weeks
Locations:
city: Espoo
country: Finland
facility: Clinical Pharmacology Unit, Orion Corporation
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Corporation Clinical Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01055444: Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
Official title: An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Impingement Syndrome
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 20
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 purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome

Detailed description: The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Eligibility criteria: Inclusion Criteria:

* Pain associated with shoulder impingement syndrome in a single shoulder
* Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
* Have positive Hawkins and Neers signs

Exclusion Criteria:

* Have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline visit
* Have used any injected pain medication within 14 days preceding the Screening/Baseline visit
* Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
* Have a history of and/or past diagnosis of severe hepatic disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pain intensity
timeFrame: Two weeks
Secondary outcomes:
measure: Pain interference with activities (general, normal work, and sleep)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Boise
country: United States
facility: Injury Care Medical Center
state: Idaho
Study officials:
name: Richard Radnovich, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05496244: ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy
Official title: ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: GYN Disorders
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients present with gynecological disease that may be treated by surgical intervention

Brief summary: Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy

Detailed description: A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

Eligibility criteria: Key Inclusion Criteria:

* Patient is willing to participate and to comply with the study procedures
* Patient present with gynecological disease that may be treated with surgical intervention

Key Exclusion Criteria:

* Life expectancy for less than 1 year

Primary outcomes:
measure: Describe treatment decision
timeFrame: Enrollment Completion
measure: Describe patient outcome
timeFrame: 12 Months
measure: Describe impact of patient factors on outcome
timeFrame: 12 Months
measure: Complications of medical interest
timeFrame: 90 days
Secondary outcomes:
measure: Quality of Life Impact per patient reported questionnaires
timeFrame: 12 Months
measure: Describe the impact of surgeon experience on outcome
timeFrame: 12 Months
measure: Describe the performance and use of Intuitive instruments
timeFrame: 12 Months
measure: Describe the performance and use of Intuitive systems
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Freiburg, Germany
name: Ingolf Juhasz-Böss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Rennes, France
name: Vincent Lavoué, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04491344: Leipzig Childhood Obesity Study
Official title: Extended Geno- and Phenotyping of Overweight and Obese Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Obesity
Keywords: Single nucleotide polymorphisms
Obesity
Insulin resistance
Metabolic syndrome
Oral glucose tolerance test
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese children and adolescents

Brief summary: The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.

Detailed description: In order to identify single nucleotide polymorphisms blood and serum samples during oral glucose tolerance testing are routinely obtained from pediatric patients visiting the adiposity outpatient clinic.

Eligibility criteria: Inclusion Criteria:

* all pediatric patients seen in the adiposity outpatient clinic
* informed patient consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Gene-dependent association with phenotypical traits in overweight and obese children
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Antje Körner, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741844: A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence
Official title: Regulatory Post Marketing Surveillance of Intelence Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immune Deficiency Syndrome
Keywords: Acquired Immune Deficiency Syndrome
TMC125
Etravirine
Intelence
AIDS
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with etravirine for treatment of AIDS.

Brief summary: The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

Detailed description: This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of etravirine in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients who are prescribed with etravirine for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion Criteria:

* Known hypersensitivity to Intelence
* Intelence coadministered with medicinal products that are highly dependent on CYP3A and CYP2C9 for clearance
* Patients with galactose intoralance, Lapp lactase deficiency, and glucose-galactose malabsorption

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: Up to 30 days from end of treatment
Secondary outcomes:
measure: Number of patients with viral load
timeFrame: Screening, Week 12, Week 24
measure: Number of patients with CD4 T-cell count
timeFrame: Screening, Week 12, Week 24
Other outcomes:
Locations:
city: Dae-Gu
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06235944: Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics
Official title: The Efficacy of Post-operative Analgesia of Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacral Erector Spinae Plane Block
Caudal Block
Penile Surgeries
Pediatrics
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 70
Sex: MALE
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will be conducted to compare the efficacy of ultrasound guided Sacral Erector Spinae Plane Block to caudal block on pain management in penile surgeries in pediatrics.

Detailed description: The erector spinae plane block (ESPB) is a relatively new interfacial plane block that is used for postoperative analgesia in penile surgeries in pediatrics.

The sacral ESPB is a technique known to block the posterior branches of the sacral nerves. Also it blocks the lumbosacral plexus especially the sacral spinal nerves (S2_S4) when applied to high levels.

Caudal epidural block in children is one of the most widely administrated technique of regional anesthesia; it is an efficient way to offer perioperative analgesia for painful sub umbilical interventions. It enables early ambulation, hemodynamic stability and spontaneous breathing in patient groups at maximum risk of difficult airway.

Caudal block is a known worldwide technique but with some risks such as subdural, intra vascular injection, infection, injury to the nerve root or local anesthesia. Therefore, we try a new technique as sacral ESPB.

Eligibility criteria: Inclusion Criteria:

* Children aged between 3 to 6 years.
* Male children.
* American Society of Anesthesiologists (ASA) I - II.
* Male who admitted for penile surgeries.

Exclusion Criteria:

* Parents who refused regional anesthesia.
* Patients presented with symptoms or signs of increased intracranial tension.
* Patients presented with advanced kidney, cardiac or liver diseases.
* Coagulation and bleeding disorders.
* Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
* Pre-existing neurologic disease (e.g. lower extremity peripheral neuropathy).
* Patients with known allergy to study drugs.
* Patints with developmental or mental delay.

Primary outcomes:
measure: Time to first rescue analgesic.
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total rescue analgesia consumption
timeFrame: 24 hours postoperatively
measure: The degree of pain
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05575544: Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation
Official title: A Randomized Control Trial to Determine Whether Electroacupuncture(EA) Intervention With Morphine Can Reduce the Intraoperative Pain and Early Post-operative Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Catheter Ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized control trial to determine whether electroacupuncture(EA) intervention with Morphine can reduce the intraoperative pain and early post-operative complications in patients undergoing catheter ablation of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Atrial fibrillation
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. A history of allergy to acupuncture;
2. With uncontrolled congestive heart failure;
3. Having significant valvular disease;
4. Having moderate-to-severe pulmonary hypertension;
5. With myocardial infarction or stroke within 6 months of screening;
6. With Significant congenital heart disease;
7. Ejection fraction was \<40% measured by echocardiography;
8. Allergic to contrast media;
9. Contraindication to anticoagulation medications;
10. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
11. Left atrial thrombus;
12. Having any contraindication to right or left sided heart catheterization

Primary outcomes:
measure: The severity of intraprocedural pain during the catheter ablation procedure
timeFrame: up to 1 month after enrollment
measure: The severity of intraprocedural nausea during the catheter ablation procedure
timeFrame: up to 1 month after enrollment
Secondary outcomes:
measure: The dose of morphine used during the catheter ablation procedure
timeFrame: up to 1 month after enrollment
measure: the change of blood pressure during the catheter ablation procedure
timeFrame: up to 1 months after enrollment
measure: Change of the the radio of IL6/IL10 before and after the ablation procedure
timeFrame: up to 1 months after enrollment
measure: Incidence of complications
timeFrame: up to 6 months after enrollment
Other outcomes:
Locations:
Study officials:
References: