louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01765205: Newborn Screening for Critical Congenital Heart Disease
Official title: The Efficacy of Newborn Screening for Critical Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cardiovascular Malformation
Keywords: congenital cardiovascular malformation
newborn
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy newborns and newborns diagnosed with congenital cardiovascular malformations

Brief summary: Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.

Detailed description: This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 12 hours -2 weeks.
* Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
* Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)

Exclusion Criteria:

* Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.

Primary outcomes:
measure: To measure the oxygen saturation using pulse oximetry.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Barry J Byrne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652105: Randomized Trial of Preoperative Diets Before Bariatric Surgery
Official title: Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Bariatric Surgery
Gastric Bypass
Keywords: Gastric bypass
Preoperative diet
Prodimed
Lead sponsor: Lievensberg Ziekenhuis
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 100
Sex: ALL
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: Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

Detailed description: Morbid obesity, defined as a body mass index (BMI) of \> 40 kg/m² or \> 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of \> 40 kg/m² and another 10 million people have a BMI of \> 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities.

In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

Eligibility criteria: Inclusion Criteria:

* morbid obesity according to IFSO criteria

Exclusion Criteria:

* previous bariatric or gastric surgery
* severe psychiatric disorders

Primary outcomes:
measure: Preoperative weight loss before bariatric surgery
timeFrame: 2 weeks
Secondary outcomes:
measure: - operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bergen op Zoom
country: Netherlands
facility: Bariatric Centre Lievensberg hospital
Study officials:
References:
Clinical trial NCT04878705: Safety and Tolerability of TWP-201 in Healthy Female Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Single Dose, Escalation, Phase I Clinical Trial to Evaluate the Safety and Tolerability of TWP-201 in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Infertility
Lead sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight ≥ 45 kg, 19 ≤ body mass index (BMI) ≤ 28 kg /m2;
* Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value);
* The levels of sex hormones were normal or abnormal without clinical significance at the time of screening;
* The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance;

Exclusion Criteria:

* Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment;
* Known the history of ovarian hyperstimulation syndrome (OHSS);
* Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting \< 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia;
* Any FSH or HMG preparations were used within 3 months before the first study;
* Pregnancy or lactating women.

Primary outcomes:
measure: Incidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
timeFrame: An average of 1 year
Secondary outcomes:
measure: Maximum measured plasma concentration (Cmax) of TWP-201;
timeFrame: 28 days
measure: Time to maximum plasma concentration (Tmax) of TWP-201;
timeFrame: 28 days
measure: Half-life (T1/2) of TWP-201.
timeFrame: 28 days
measure: Pharmacodynamics(PD).
timeFrame: 28 days
measure: Pharmacodynamics(PD).
timeFrame: 28 days
measure: Immunogenicity profile of TWP-201.
timeFrame: 28 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Medical Center
name: Shengbin Ren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00872105: Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Official title: A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clavicle Fracture
Fractures
Keywords: clavicle
fractures
distal
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Fraser Health
name: University of British Columbia
name: London Health Sciences Centre
name: University of Calgary
name: Nova Scotia Health Authority
name: Winnipeg Regional Health Authority
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: The Ottawa Hospital
First posted: 2009-03-31
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 16 to 60 years of age
* Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
* Fractures within 28 days post injury
* Provision of informed consent

Exclusion Criteria:

* Pathological fractures
* Non-displaced (cortical contact) distal clavicle fractures
* Open clavicle fractures
* Presence of vascular injury
* Fractures more than 28 days post-injury
* Limited life expectancy due to significant medical co-morbidity
* Medical contraindication to surgery
* Inability to comply with rehabilitation or form completion
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Primary outcomes:
measure: The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Jeremy A Hall, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04674605: A Prospective Cohort Study Of Myasthenia Gravis
Official title: A Prospective Cohort Study Of Myasthenia Gravis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myasthenia Gravis
Myasthenia Gravis Crisis
Keywords: Myasthenia Gravis
Prognostic prediction
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 200
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed.

This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.


Eligibility criteria: Inclusion Criteria:

* Meeting the diagnosis of myasthenia gravis

Exclusion Criteria:

* Malignant tumor or other serious chronic disease

Primary outcomes:
measure: Myasthenia gravis foundation of America post intervention status
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: YuZhong District
Study officials:
References:
Clinical trial NCT04245605: Invasive Coronary Angiography Early in Ischemic Heart Failure
Official title: Invasive Coronary Angiography Early in Ischemic Heart Failure (ICE-HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Keywords: Coronary angiography
Invasive strategy
Myocardial infarction
Troponin
Heart failure
Lead sponsor: Institute for Clinical Evaluative Sciences
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 2994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients in Ontario, Canada with acute heart failure

Brief summary: To compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care


Eligibility criteria: Inclusion Criteria: Adult patients with acute heart failure, hospitalized in Ontario, Canada, with evidence of possible ischemic heart disease, defined as at least one of: a) prior myocardial infarction, b) troponin elevation, or c) angina.

Exclusion Criteria:

* Recent myocardial infarction
* Coronary angiogram or revascularization within previous 3 months before admission
* Nonresidents of Ontario, invalid health card number
* HF diagnosed after admission
* Admission BNP or NT-proBNP not diagnostic of HF
* Died within 14 days of admission
* Palliative within 6 months prior to hospital admission
* Elevated creatinine concentration
* Documented anaphylactic contrast allergy
* Ischemic or hemorrhagic stroke within 3 months prior to admission
* Highest category of Hospital Frailty Risk Score
* Active severe bleeding at time of hospital admission
* Absolute platelet count \< 20
* Metastatic cancer

Primary outcomes:
measure: All-cause mortality
timeFrame: 2 years
measure: Cardiovascular mortality
timeFrame: 2 years
Secondary outcomes:
measure: All-cause hospital readmission
timeFrame: 2 years
measure: Heart failure readmission
timeFrame: 2 years
measure: Readmission for myocardial infarction
timeFrame: 2 years
measure: Rates of revascularization
timeFrame: 90 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: ICES
name: Douglas Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06824805: Hypertension, Ethnicity and Exercise Trial
Official title: Hypertension, Ethnicity and Exercise Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (IHG) and a single bout of aerobic endurance exercise (AEX) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1 hypertension of South-Asian or African descent living in Suriname.


Eligibility criteria: Inclusion Criteria:

* • Age 18 - 65 years

  * Patients with high- normal BP (SBP: 130 - 139 mmHg or and DBP: 85 - 89 mmHg) or stage I hypertension (SBP: 140 - 159 mmHg or DBP: 90 - 99 mmHg) according to the ESC/ESH guidelines \[15\]
  * Asian or African descent
  * Do not meet the level of physical activity recommended by the WHO based on self-report \[15\]
  * Non-medicated patients or patients using a maximum of 2 antihypertensive drugs

Exclusion Criteria:

* • Functional or mental limitation limiting the correct execution of an exercise bout

  * History of ischemic stroke, autonomic neuropathy, cardiovascular, renal, or pulmonary disease by self-report
  * Diabetes type I or II
  * Pregnancy
  * The presence of exercise induced signs of myocardial ischemia or complex ventricular arrhythmia during CPET
  * Patients using three or more antihypertensive drugs or patients with resistant hypertension

Primary outcomes:
measure: office blood pressure at 30 minutes post exercise
timeFrame: 30 minutes postexercsie
Secondary outcomes:
measure: daytime blood pressure
timeFrame: mean of 8 hours after the intervention
Other outcomes:
Locations:
city: Paramaribo
country: Suriname
facility: Anton De Kom University
Study officials:
References:
Clinical trial NCT06215105: Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
Official title: Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aneurysm Cerebral
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ruptured or unruptured intracranial aneurysms who will be treated endovascularly with commercially available MicroVention devices at the direction of the treating physician.

Brief summary: To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.


Eligibility criteria: Inclusion Criteria:

1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
2. Patient's IA will be treated using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the CAR study and prior to enrollment.

   Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
3. Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment or no later than 48 hours post procedure for emergent treatment of a ruptured aneurysm.
4. Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.

Exclusion Criteria:

1. Target aneurysm has been previously treated via surgical or endovascular means.
2. Patient is enrolled in another device or drug study in which participation could confound study results.
3. Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).
4. Patient has been previously enrolled into this study.

Primary outcomes:
measure: RROC
timeFrame: 1 year
measure: RROC
timeFrame: 1 year
measure: RROC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
name: TBD TBD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710405: The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery
Official title: The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery:Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain Management After Surgery
Keywords: pediatric
thoracoscopic surgery
pain control
lidocaine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection

Exclusion Criteria:

* cardiac dysfunction requiring vasopressors or inotropic agents
* atrioventricular block or bradycardia
* Liver or kidney dysfunction
* Hypersensitivity to local anesthetics

Primary outcomes:
measure: FLACC (ace, Legs, Activity, Cry, Consolability scale) Score
timeFrame: up to 1 hour after surgery
Secondary outcomes:
measure: Remifentanil dose
timeFrame: throughout surgery (up to 3 hours)
measure: ANI (Analgesia Nociception Index)
timeFrame: throughout surgery (up to 3 hours)
measure: FLACC scores
timeFrame: 6 hours, 12 hours, and 24 hours postoperatively
measure: Total analgesic dosage administered postoperatively
timeFrame: up to 3 days after surgery
measure: Postoperative complications
timeFrame: until discharge (up to 3-4 days after surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: