louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05055687: Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD/MAD)
Official title: A Randomized, Double-Blind, Single- Multiple Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.

Detailed description: This study is divided into two parts: A and B.Part A discusses the safety and tolerability of IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged between 18 and 45 years (inclusive).
2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
3. History of clinically significant food or drug allergy.
4. A QT interval corrected using Fridericia's formula \>450 msec.
5. eGFR\<90mL/min/1.73m2.

Primary outcomes:
measure: Part A:Number of patients with adverse events [Safety and Tolerability]
timeFrame: Day 1 to Day 7
measure: Part B:Number of patients with adverse events [Safety and Tolerability]
timeFrame: Day 1 to Day 12
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
Study officials:
References:
Clinical trial NCT05771987: Permanent Pacing for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.
Official title: Permanent Pacing as a Treatment for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 10
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 present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of Obstructive Hypertrophic Cardiomyopathy (OHCM) to pacing, in terms of reduction of Left Ventricular Outflow Tract (LVOT) pressure gradient and functional capacity improvement.

The Primary Objective is to demonstrate a long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise \> 30% in patients responding to acute stimulation test


Eligibility criteria: Inclusion Criteria:

* unequivocal diagnosis of HCM, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness \>15 mm or \> 13 mm in familial HOCM) and non dilated LV in the absence of another cardiac or systemic disease capable of producing the same magnitude of hypertrophy;
* patients in whom coronary disease has been excluded;
* presence of severe refractory symptoms (NYHA class II-IV), as evidenced by moderate-to-severe functional disability resulting from exertional dyspnea or chest pain sufficient to support a desire for alternative treatment modalities, following administration (in standard dosages) of beta-blocker and either disopyramide or verapamil, independently or in association;
* peak instantaneous LV outflow tract gradient \> 50 mm Hg (resting or provoked), estimated by continuous wave Doppler;

Exclusion Criteria:

* end-stage phase of HCM (unless CRT therapy is considered);
* ejection fraction \<50% (unless CRT therapy is considered);
* severe mitral valve disease (+++) not related to systolic anterior movement and/or papillary muscle abnormalities;
* age below 18 years.

Primary outcomes:
measure: Reduction of LVOT pressure gradient
timeFrame: 3 months
Secondary outcomes:
measure: Clinical improvement: change in NYHA class
timeFrame: 6-12 months
measure: Clinical improvement: change in exercise capacity
timeFrame: 6-12 months
measure: Clinical improvement: change in peak VO2
timeFrame: 6-12 months
measure: Clinical improvement: change in NT-proBNP concentration
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT05258487: The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
Official title: The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Blood Loss
Thoracolumbar Spine Surgery
Keywords: Blood Loss
Thoracolumbar Spine Surgery
VIBe
Blood Transfusion
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2022-02-28
Enrollment: 121
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 undergoing elective open, posterior thoracolumbar surgery

Brief summary: This is a single-center, prospective, observational study that will compare the blood transfusion rate between intraoperative bleeding severity characterized using the Validated Intraoperative Bleeding Scale (VIBe).

Detailed description: Primary Aim: Assess the association between the VIBe scale and intraoperative and postoperative blood transfusion rates for posterior thoracolumbar spine surgery.

Primary Hypothesis: Patients with higher recorded VIBe grades during the five stages of spine surgery (exposure, decompression, instrumentation, fusion, and closing) will have a higher rate of receiving blood transfusions.

Secondary Aims: Determine the association between the VIBe scale and other postoperative outcomes and complications.

Eligibility criteria: Inclusion Criteria:

* Ages 18 to 88 years
* Patients receiving elective open, posterior thoracolumbar surgery

Exclusion Criteria:

* Patients receiving non-elective or trauma surgery
* Patients with pathologic spine fracture or metastatic disease to the spine
* Patients receiving thoracolumbar surgery through anterior or lateral approach
* Patients receiving spine surgery for debridement of suspected or confirmed infection

Primary outcomes:
measure: Receiving Perioperative Blood Transfusion
timeFrame: From day of surgery until discharge from hospital, assessed up to 2 weeks following surgery.
Secondary outcomes:
measure: Total Estimated Blood Loss During Surgery (mL)
timeFrame: From the start to the end of surgery, assessed up to 1 day following surgery when estimated blood loss is reported and documented.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Steven C Ludwig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.surg.2016.09.022. Epub 2016 Nov 10.
Clinical trial NCT02423187: Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin
Official title: Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Ulcer
Duodenal Ulcer
Keywords: Stomach ulcer
Duodenal ulcer
Rabeprazole
Recurrence
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 1568
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with long-term combination therapy with low-dose aspirin

Brief summary: To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.


Eligibility criteria: Inclusion criteria:

1. Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole).
2. Patients with a history of gastric/duodenal ulcers.
3. Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.

Exclusion criteria:

1. Patients with gastric/duodenal ulcers at the start of administration of rabeprazole.
2. Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole.
3. Patients with contraindication for rabeprazole.

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: 52 weeks
Secondary outcomes:
measure: Recurrence rate of peptic ulcer
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
name: Katsuya Sugizaki
role: STUDY_DIRECTOR
References:
Clinical trial NCT01862887: A Study to Investigate the Effect of PH-797804 on QTc Interval
Official title: A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 On QTc Interval In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for males.

Primary outcomes:
measure: QTcF Interval
timeFrame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
Secondary outcomes:
measure: QTcI Interval
timeFrame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06249087: Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident
Official title: A Randomized Controlled Trial to Explore Effect of Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the psychological condition and experience of the two groups.

Detailed description: The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by video fluoroscopic Swallowing Study.
* Clear consciousness.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.

Primary outcomes:
measure: Generalized Anxiety Disorder 7
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: day 1 and day 15
measure: Self-made questionnaire
timeFrame: day 1 and day 15
measure: The Reintegration to Normal Living Index
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT03465787: A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
Official title: A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Acutely Psychotic Patients with Schizophrenia
Latuda
Lurasidone
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-03-14
Enrollment: 210
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent and aged between 19 and 75 years of age.
2. Meets DSM-5 criteria for a primary diagnosis of schizophrenia.
3. CGI-S ≥ 4 at screening and baseline.
4. Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
5. Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
6. Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

1. The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia)
2. Subject has participated in a prior trial of lurasidone.
3. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
4. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
5. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Primary outcomes:
measure: Mean change in Total PANSS Score From Baseline at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Mean change in CGI-S score From Baseline at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
state: Seoul, Dongjak-gu
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jung Hee Yeon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05866887: Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Official title: Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Acute Lymphoblastic Leukemia
Leukemia
Acute Lymphoblastic Leukemia
Keywords: Pediatric Acute Lymphoblastic Leukemia
Leukemia
Acute Lymphoblastic Leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research study is to understand the acceptability and feasibility of the Sleep ALL Night intervention among children with Acute Lymphoblastic Leukemia (ALL) in hopes of improving the discussion of sleep disorders with clinical providers.

The name of the intervention used in this research study is: Sleep ALL Night, which is a sleep intervention program comprised of an action plan tool and psychoeducational website.

Detailed description: This research study is to conduct a single-arm pilot study to determine the acceptability and feasibility of Sleep ALL Night for children with Acute Lymphoblastic Leukemia (ALL).

Participation in this research study is expected to last 1 month.

It is expected about 30 children will take part in this research study.

The National Cancer Institute (NCI) is providing funding for this research study through a grant.

Eligibility criteria: Inclusion Criteria:

* Patient in the Maintenance Phase of therapy on or as per DFCI 16-001 and has completed at least two cycles of maintenance therapy to allow adequate recovery from the more intensive Consolidation phase.
* English or Spanish speaking child and primary caregiver (parent/guardian).
* Child aged 4-12 years.

Exclusion Criteria:

* Primary team declines permission to approach.
* Children with critical illness (defined as ICU admission)

Primary outcomes:
measure: Enrollment Rate of Participants
timeFrame: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.
measure: Acceptability of Intervention Measure Scale Score
timeFrame: At Week 4
measure: Intervention Assessment Completion Rate
timeFrame: Up to 1 month after the conclusion of the study period, up to 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Kira Bona, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04575987: Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders
Official title: How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery Candidate
Weight Loss
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 709
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women had a bariatric surgery in Poitiers university hospital center (France)

Brief summary: Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.


Eligibility criteria: Inclusion Criteria:

* Women,
* aged from 18 to 50 years old the day of their surgery,
* had a bariatric surgery in Poitiers university hospital center (France),
* are under french social security system.

Exclusion Criteria:

* to be under guardianship or tutelage measures
* to express opposition to participate to this study.

Primary outcomes:
measure: Prevalence of the main PFD
timeFrame: minimum 18 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: