louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01173536: A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
Official title: A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Parallel-Group Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 61
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.


Eligibility criteria: Inclusion Criteria:

* Female, over 45 years of age
* In good health, as determined by the absence of clinically significant findings from the screening visit
* Body mass index between 18 and 32 kg/m\^2 inclusive, with a body weight \> 45 kg
* Of non-childbearing potential

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis
* Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Personal or family history of congenital long QT syndrome or family history of sudden death
* Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study

Primary outcomes:
measure: The QTcF (QT interval corrected by Fridericia's correction method)
timeFrame: Throughout study or until early discontinuation
Secondary outcomes:
measure: Change in ECG from baseline
timeFrame: Throughout study or until early discontinuation
measure: Pharmacokinetic parameters of GDC-0449
timeFrame: Throughout study or until early discontinuation
measure: Incidence, nature and severity of adverse events
timeFrame: Throughout study or until early discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Jean Ayache, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06112236: Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia
Official title: Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypophosphatemia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 250
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: lung transplant recipient

Brief summary: The aim of this study is to generate evidence regarding hypophosphatemia after iron infusion in lung transplant recipients in context of anemia and/or iron deficiency.


Eligibility criteria: Inclusion Criteria:

* lung transplant recipient
* treated at the University Hospital Zurich between 2015 until 2022

Exclusion Criteria:

* Denied general consent

Primary outcomes:
measure: Change of serum phosphate level
timeFrame: Baseline and up to 90 days after iron infusion
Secondary outcomes:
measure: Change of urin phosphate level
timeFrame: Baseline and up to 90 days after iron infusion
measure: Change of hemoglobin
timeFrame: Baseline and up to 90 days after iron infusion
measure: Change of mean corpuscular volume (MCV)
timeFrame: Baseline and up to 90 days after iron infusion
measure: Change of mean corpuscular hemoglobin (MCH)
timeFrame: Baseline and up to 90 days after iron infusion
measure: Change of serum magnesium
timeFrame: Baseline and up to 90 days after iron infusion
measure: Change of serum and urin calcium
timeFrame: Baseline and up to 90 days after iron infusion
measure: Change of serum albumin
timeFrame: Baseline and up to 90 days after iron infusion
measure: Complications after iron infusion
timeFrame: 2015-2022
measure: Predictors
timeFrame: baseline and up to 90 days after iron infusion
measure: Therapeutic management
timeFrame: 2015 to 2022
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT01022736: Plasma Gabapentin Concentration During and Following Cardiac Bypass
Official title: Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiopulmonary Bypass
Keywords: gabapentin
pharmacokinetics
visual analogue pain scale
cardiopulmonary bypass
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 16
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: This open label investigation is to determine whether cardiopulmonary bypass affects plasma gabapentin concentration after preoperative administration in the setting of cardiac bypass surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before separation from bypass, 30 minutes following bypass and then before and 2 hours following each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and morphine equivalents will be documented for one day following surgery.


Eligibility criteria: Inclusion Criteria:

* scheduled for cardiac bypass surgery involving median sternotomy and CPB
* signed informed consent

Exclusion Criteria:

* history of chronic pain
* regular opioid consumption
* regular anticonvulsant consumption
* regular gabapentin or pregabalin use
* recent congestive heart failure
* ejection fraction \<35%
* chronic pulmonary disease
* liver disease
* renal insufficiency (preoperative creatinine \> 140umol/L
* history of adverse reaction to acetaminophen

Primary outcomes:
measure: plasma concentrations of gabapentin
timeFrame: 1 hour before surgery, 10 min following initiation of bypass, 10 min before separation from bypass, 30 min following bypass, and then before and 2 hours following each of the next 3 doses of gabapentin
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University and Kingston General Hospital
name: Joel Parlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parlow J, Gilron I, Milne B, Dumerton-Shore D, Orr E, Phelan R. Cardiopulmonary bypass does not affect plasma concentration of preoperatively administered gabapentin. Can J Anaesth. 2010 Apr;57(4):337-42. doi: 10.1007/s12630-010-9269-5. Epub 2010 Jan 29.
Clinical trial NCT07007936: Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Oral SSS17 Capsules in the Treatment of Anemia Following Total Hip or Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Postoperative Anemia
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of orally administered SSS17 capsules in patients with postoperative anemia following elective total hip or knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent obtained

   -
2. Age 18-70 years (inclusive)

   -
3. Candidates for hip/knee arthroplasty

   -
4. No DVT on pre-op venous ultrasound

   -
5. Screening Hb 80-110 g/L (no transfusion indication) - 6. Commitment to effective contraception

Exclusion Criteria:

1. Hypersensitivity to the investigational product or any of its components
2. Any other condition causing chronic anemia
3. Coagulopathy or unstable anticoagulant dosing during screening
4. Any of the following laboratory abnormalities at screening:

   1. Serum albumin \<35 g/L
   2. ALT or AST \>3×ULN
5. Active infections or carrier status including:

   * Known HIV infection
   * Active syphilis
   * Active HBV infection (HBsAg-positive with HBV DNA \>10³ copies/mL)
   * Active HCV infection (anti-HCV positive with detectable HCV RNA)
6. Acute joint injury with active trauma or infection at screening
7. Cognitive impairment or psychiatric disorders,current or history of epilepsy
8. Treatment with ESAs (erythropoiesis-stimulating agents) or HIF inhibitors within 30 days prior to dosing
9. History of severe thromboembolic events or hematopoietic disorders
10. Malignancy history
11. Severe cardiovascular diseases including:

    * Unstable coronary artery disease
    * Heart failure (NYHA Class III/IV)
    * Myocardial infarction/stroke 12 .Poorly controlled hypertension

13. Alcohol abuse 14.Pregnancy or lactation 15.Participation in other drug trials within 3 months prior to enrollment 16.Any other condition deemed by the Investigator to compromise subject safety or trial validity

Primary outcomes:
measure: Change from baseline in hemoglobin
timeFrame: Day 8，Day 15，Day 29
Secondary outcomes:
measure: Proportion of subjects requiring transfusion and transfusion volume
timeFrame: Day 29
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
Clinical trial NCT03812536: Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
Official title: Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications, Postoperative
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 104
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: The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.

Detailed description: This study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). The spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. The no void group will be 50 patients who will be discharged home from the PACU once they meet ambulatory surgery center discharge criteria per hospital guidelines. Patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. A post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old
* Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision

Exclusion Criteria:

* Age \< 18 yo or \> 80 yo
* Prisoners
* Pregnant Women
* Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study

Primary outcomes:
measure: PACU Time
timeFrame: This measure will be recorded through the study period.
Secondary outcomes:
measure: 30-day Readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Syed Husain, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06289036: Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging
Official title: Predicting Prognosis in Subacute Ischemic Stroke Through Brain Perfusion and Collateral Circulation With Multimodal Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with moderate-to-severe stenosis/occlusion of the MCA or carotid artery admitted to the First Hospital of Hebei Medical University between July 2022 and October 2023.

Brief summary: We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL. Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale \[mRS\] ≤ 2) and poor prognosis (mRS \> 2).


Eligibility criteria: Inclusion Criteria:

1. Confirmed unilateral internal carotid artery/MCA atherosclerotic stenosis/occlusion with a stenosis degree \> 50% verified through computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
2. Presence of IS or transient ischemic attack (TIA) symptoms in the circulating blood supply area within the preceding 48 h.
3. Asymptomatic patients with no history of IS or TIA in the past 6 months.
4. Performance of 4D ASL tests during hospitalization.

Exclusion Criteria:

1. Moderate-to-severe stenosis/occlusion of the contralateral internal carotid artery/middle cerebral arteries.
2. Age ≤ 18 years old.
3. Cardioembolic cerebral infarction.
4. Moyamoya disease.
5. Combined or previous cerebral hemorrhage or subarachnoid hemorrhage
6. History of previous cerebral infarction.
7. Claustrophobia or the presence of intracranial metal implants, cochlear implants, or pacemakers.

Primary outcomes:
measure: Modified Rankin Scale（mRS） score after 3 months of onset
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Shujuan Tian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01965236: Influence of Sodium Intake on Left Ventricular-arterial Coupling
Official title: Influence of Sodium Intake on Left Ventricular-arterial Coupling in Hypertension: Biomechanical Assessment and Modelisation of Left Ventricular Function With Arterial Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: hypertension, sodium intake, left ventricular function
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to asses the effectiveness of the aorta-ventricular coupling according to low and high sodium intake in 28 controled hypertensive patients.

Detailed description: Comparison of left ventricular function in two groups of 13 patients according to their different salt's consumption in double blind and crossover study. Performance estimation of the left ventricle by echocardiographic and central arterial pressure by tonometry.

Eligibility criteria: Inclusion Criteria:

* Hypertension stage 1, with medium or high risk, when the treatment (mono or therapy without diuretics) is efficient, when the great pressure is reached (\<140/90 mmHg)
* High sodium intake (sodium urinary excretion for 24h (UNaV) \> or = 170 mmol/24h before visit 0
* Limited sodium intake objective (UNaV\<85 mmol/24h)attempted at the end of the limited sodium intake period of 2 weeks
* Patients aged between 18 and 80 years
* Subject has given written informed consent
* Subject has subscribed a health care insurance

Exclusion Criteria:

* Secondary hypertension
* Complications associated with the arterial hypertension : history of cardiovascular diseases or myocardial infarction, cerebrovascular accident, coronary disease, ...
* Arterial hypertension associated with cardiopathy
* Arterial hypertension associated with nephropathy
* Arterial hypertension associated with diabetes
* Measure of central arterial pressure by tonometry is impossible
* Cardiac echogenicity is not satisfactory for the analysis of left ventricular loop analysis
* Patient refuses informed consent
* Follow-up impossible for 15 weeks
* Pregnant or women without efficacy contraception
* Patient without freedom by administration decision
* Patient in exclusion period
* Patient without french insurance
* Adult protected by the law

Primary outcomes:
measure: ultrasound volume, imaging "strain" and tonometry
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie University Hospital of Montpellier
Study officials:
affiliation: Department of intern Medicine and arterial Hypertension Lapeyronie University Hospital of Montpellier, Montpellier, France, 34295
name: Guilhem DU CAYLAR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03599336: RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
Official title: Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Humerus Fracture
Humerus
Shoulder Fractures
Shoulder Arthropathy Associated With Other Conditions
Arthropathy Shoulder
Shoulder Injury
Arthropathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.


Eligibility criteria: Inclusion criteria

* Displaced 3- and 4-part proximal humerus fractures.
* Age greater than or equal to 65 years old.

Exclusion Criteria

* Less than 65 years old.
* Medical comorbidities precluding surgical treatment or anesthesia
* Dementia or inability to provide adequate follow up.
* Pathologic fractures
* Open fractures
* Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

Primary outcomes:
measure: Function as described by ASES score at 1 year follow-up.
timeFrame: 2 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jonathan D Barlow
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT06859736: Survey on the Characteristics of Traditional Medicine Syndromes in Urticaria Patients At Le Van Thinh Hospital
Official title: Survey on the Characteristics of Traditional Medicine Syndromes in Urticaria Patients At Le Van Thinh Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urticaria
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit patients diagnosed with acute or chronic urticaria at Le Van Thinh Hospital, Vietnam. The study population will include adult patients (≥15 years old) who meet the eligibility criteria. The focus of the study is to classify Traditional Medicine (TM) syndromes in urticaria patients and explore their association with disease severity. Participants will undergo TM-based diagnostic assessment to determine the prevalence of TM syndromes such as Blood Heat generating Wind, Blood Stagnation generating Wind, and Blood Deficiency generating Dry Wind

Brief summary: This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in urticaria patients at Le Van Thinh Hospital. Urticaria is a common dermatological condition that significantly impacts patients' quality of life. However, there is limited research on TM syndrome classification in this patient group. The study will collect data on symptoms, TM syndromes, and disease severity to determine common syndromes and their associations with clinical manifestations.

The study will be conducted as a cross-sectional, observational study with an estimated 200 participants. Eligible patients are those aged 18 years or older, diagnosed with acute or chronic urticaria, and willing to participate. The primary outcomes include the prevalence of TM syndromes, itching severity measured by the Visual Analogue Scale (VAS), and the correlation between TM syndromes and itching severity.

The study is approved by the Institutional Review Board (IRB) of the University of Medicine and Pharmacy at Ho Chi Minh City and will be conducted from December 2024 to April 2025 at Le Van Thinh Hospital, Vietnam.


Eligibility criteria: Inclusion Criteria:

* Patients aged 15 years or older.
* Diagnosed with acute or chronic urticaria based on modern medical criteria.
* Willing to participate and provide informed consent.

Exclusion Criteria:

* Patients with other dermatological conditions that may interfere with the diagnosis of urticaria.
* Patients currently using medications that may alter symptom presentation (e.g., antihistamines, corticosteroids, immunosuppressants).
* Patients who refuse to participate in the study

Primary outcomes:
measure: Prevalence of Traditional Medicine Syndromes in Urticaria Patients
timeFrame: At the time of patient enrollment (Baseline assessment, within the first visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: