louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01026961: Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
Official title: A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Heart Rate
Blood Pressure
Arrhythmias
Keywords: Safety
heart rate
systolic and diastolic blood pressure
arrhythmias
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 50 years;
* Clinical examination without abnormal findings
* Ability to understand the nature and purpose of the study, including the risks and adverse effects

Exclusion Criteria:

* Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia
* History of serious adverse reactions or hypersensitivity any drug
* Hypersensitivity to the drug study drugs or chemically related compounds

Primary outcomes:
measure: To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs
timeFrame: 15 days
Secondary outcomes:
measure: Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing
timeFrame: 15 days
measure: To report and evaluate adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Scentryphar Pesquisa Clinica Ltda.
state: São Paulo
Study officials:
affiliation: Novartis
name: Novartis Biociências S.A
role: STUDY_DIRECTOR
References:
Clinical trial NCT00972361: Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children
Official title: Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Abnormalities
Keywords: Adenoidectomy
Tonsillectomy
Ventilation Tubes
Preoperational screening
Coagulation Profile
Lupus anticoagulant
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.

The data will include cause of referral, laboratory analysis performed and results.

If the data allows the outcome of the operation and bleeding complications, will also recorded.

Brief summary: Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children.

A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for further evaluation and recommendations before surgery.

The purpose of this study is to summarize the causes of referrals in a cohort of 200 children and to assess the further laboratory analysis preformed and the results obtained.

Detailed description: Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.

The data will include cause of referral, laboratory analysis performed and results.

If the data allows the outcome of the operation and bleeding complications, will also recorded.

Eligibility criteria: Inclusion Criteria:

* All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery

Exclusion Criteria:

* No exclusion are applicable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Study officials:
affiliation: Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178461: The Effect of Warmed Parenteral Fluids During Delivery
Official title: The Effect of Warmed Parenteral Fluids During Vaginal Delivery and Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery, Obstetric
Keywords: Caesarean Section
Delivery
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 7000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization two 2 groups according to temperature of IV fluids. One group will receive room temperature fluids and the other group will receive body temperature fluids.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.

Detailed description: Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* term pregnancies
* receiving parenteral fluids

Exclusion Criteria:

* high order pregnancies
* preterm pregnancies (before 37 weeks of gestation)
* known fetal major anomaly
* known fetal significant chromosomal/genetic abnormality

Primary outcomes:
measure: Length of the second stage of labor
timeFrame: up to 5 hours from complete cervical dilation
Secondary outcomes:
measure: Prevalence of perineal tears and episiotomies
timeFrame: immediately after vaginal birth
measure: Neonatal APGAR score
timeFrame: up to 5 minutes from delivery
measure: The rate of prolonged second stage
timeFrame: immediately after completion of the delivery.
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Clalit Health Services
name: Hanoch Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02616861: Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
Official title: A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Cyclerion Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-11-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.

Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.


Eligibility criteria: Inclusion Criteria:

* Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
* Subject's body mass index score is \> 18.5 and \< 30.0 kg/m2 at the Screening Visit
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
* Subject is in good health and has no clinically significant findings on a physical examination
* Other inclusion criteria per protocol

Exclusion Criteria:

* History of any clinically significant medical condition
* Other exclusion criteria per protocol

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: 42 Days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 42 Days
measure: Blood Pressure
timeFrame: 42 days
measure: Area under the plasma concentration time curve during a dosing interval (AUC)
timeFrame: 42 Days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: 42 Days
measure: Heart rate
timeFrame: 42 Days
measure: Serum cGMP
timeFrame: 42 Days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Ironwood Investigator
state: Texas
Study officials:
affiliation: Ironwood Pharmaceuticals
name: John Hanrahan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05472961: Eye Movements in Visual Search
Official title: Eye Movement Studies of Visual Search
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: eye tracker
visual perception
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are asked to view an array of objects on a computer screen equipped with a noninvasive eye tracker. They are asked to search for a target object among one or more distractor objects and may be asked to respond to a feature of the target object with a key press that was selected via a gaze shift.
Primary purpose: BASIC_SCIENCE

Brief summary: Using a noninvasive eye tracker, the investigators will measure how participants move their eyes to objects arrayed on a computer screen. Participants will be asked to find one element among many.

Detailed description: The investigators measure how quickly and how accurately participants can move their eyes from a central fixation point to a target object arrayed with one or more distractor objects. A noninvasive eye tracker will be used to measure their eye movements. Participants may also be asked to make a decision about a feature of the target they have selected with a key press. Difficulty of the search for the target object and difficulty of the decision about a feature of the target object will be manipulated.

Eligibility criteria: Inclusion Criteria:

* Sona System users (open to the public)

Exclusion Criteria:

* participants that fail the Ishihara color vision screening test
* participants with acuity worse than 20/20 with or without correction
* children under 18
* adults over 50

Primary outcomes:
measure: Eye Tracking Data
timeFrame: During 1-2 hour experimental session
measure: Response Data
timeFrame: During 1-2 hour experimental session
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
Clinical trial NCT01576861: Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth Hormone Deficiency
Chronic Heart Failure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 28
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: After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.


Eligibility criteria: Inclusion Criteria:

* Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
* Age range 18-80 years
* Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
* Left Ventricular ejection fraction 40% or less
* Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine \< 9 ng/ml)
* Written Informed consent

Exclusion Criteria:

* Acute proliferative or severe non-proliferative diabetic retinopathy
* Active malignancy
* Evidence of progression or recurrence of an underlying intracranial tumor
* Unstable Angina or recent myocardial infarction
* Serum Creatinine levels \> 2.5 mg/dl
* Severe liver disease (Child-Pugh B-C)

Primary outcomes:
measure: Peak Oxygen Consumption
timeFrame: after 48 months
measure: Side effects
timeFrame: Any side effects recorded after 6,24 and 48 months
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: after 48 months
measure: Left Ventricular End-Systolic Volume
timeFrame: after 48 months
measure: Left Ventricular End-Diastolic Volume
timeFrame: after 48 months
measure: Quality of Life
timeFrame: after 48 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Department of Internal Medicine, Cardiovascular and Immunological Sciences
state: Campania
Study officials:
References:
Clinical trial NCT00264628: GW679769 In Fibromyalgia
Official title: An Outpatient, Randomised, Double-blind, Placebo Controlled, Parallel Group Exploratory Study to Evaluate Safety, Tolerability and Efficacy of GW679769 in Patients With Fibromyalgia Syndrome Comorbid With Depression.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Depression
Fibromyalgia
Keywords: NK1-antagonist
Depression
Fibromyalgia
GW679769
Outpatient
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769 up to 120 mg dose compared to placebo in patients with ACR(American College of Rheumatology)-defined fibromyalgia, co-morbid with depression.


Eligibility criteria: Inclusion criteria:

* Diagnosis of fibromyalgia (ACR criteria).
* Non-severe depression (HAM-D score \>14 \<24).
* Women must commit to consistent use of an acceptable method of birth control.

Exclusion criteria:

* Severe depression (HAM-D score \> 24).
* Unable to discontinue medications for pain or depression.
* Laboratory and ECG value at screening outside sponsor defined ranges.
* Positive to stool occult blood test.

Primary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) total score
timeFrame: throughout study
Secondary outcomes:
measure: Effect of GW679769 vs placebo in health-related quality of life outcomes
timeFrame: throughout study
measure: Relationship between PK of GW679769 and clinical outcome in patients
timeFrame: throughout study
measure: Safety and Tolerability
timeFrame: throughout study
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03699761: The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
Official title: Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectum Cancer
Keywords: Anastomotic leakage
Complication
Reoperation
Pelvic Peritonization
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 1000
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: A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.


Eligibility criteria: Inclusion Criteria:

* Matching the diagnostic criteria of rectal adenocarcinoma
* Laparoscopic or robotic radical surgery for rectal cancer
* Preoperative TNM staging T1-3N0-2M0
* No history of malignant tumors by preoperative examination
* Middle and low rectal cancer
* Tumor size of 4 cm or less
* ASA 1-3 scores
* Written informed consent by the patient
* The patient is willing to randomize to any group

Exclusion Criteria:

* Previous abdominal surgery
* Past malignant tumor history
* Preoperative examination suggests distant metastasis
* Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
* Emergency operation

Elimination criteria

* The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
* The anastomosis is located above the peritoneum reflex
* Intraoperative conversion to laparotomy
* Change the surgical method to perform Miles or Hartmann surgery
* Postoperative pathologically confirmed non-adenocarcinoma
* The patient asked to withdraw

Primary outcomes:
measure: Grade III-IV complications
timeFrame: 30 days
Secondary outcomes:
measure: Rate of reoperation
timeFrame: 30 days
measure: Detection of inflammation markers
timeFrame: 7 days
measure: The rate of anastomotic leakage
timeFrame: 30 days
measure: Hospital time
timeFrame: 30 days
measure: Overall complication rate
timeFrame: 30days
measure: Estimated blood loss
timeFrame: 1 day
measure: Operation time
timeFrame: 1 day
measure: Postoperative bleeding
timeFrame: 7 days
measure: Intestinal obstruction
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: LARS
timeFrame: 12 months
measure: Acute inflammatory Response
timeFrame: 7 days
measure: Acute inflammatory Response
timeFrame: 7 days
measure: Detection of other inflammation markers
timeFrame: 7 days
measure: Treatment cost
timeFrame: 30 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: General Surgery Center of PLA
Study officials:
References:
Clinical trial NCT02020161: Clinical Guidelines for APL Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: APL
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed


Eligibility criteria: Inclusion Criteria:

* Genetic diagnosis of acute promyelocytic leukemia

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Recurrence within 1 year of treatment
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References:
Clinical trial NCT00774761: A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic
Obstructive
Pulmonary
Disease
COPD
Pharmacodynamic
Pharmacokinetic
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 97
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.


Eligibility criteria: Inclusion Criteria:

* Able to understand the requirements of the study and provide consent
* Medical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* Female of child-bearing potential to use adequate birth control

Exclusion Criteria:

* Diagnosis of asthma
* Other significant disease than COPD
* Has donated a unit of blood within 30 days of study, or intends to donate
* QTc greater than 0.460 seconds
* Subjects who had radiation or chemotherapy in the previous 12 months
* Subjects who had lung resection
* History of illegal drug abuse or alcohol abuse within the past 5 years

Primary outcomes:
measure: Plasma AUC(0-t) after 1 week of dosing
timeFrame: PK sampling over 24 hrs
Secondary outcomes:
measure: FEV1
timeFrame: pre-dose and 2 hrs post-dose
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Panama City
country: United States
facility: Investigative Site
state: Florida
city: Madisonville
country: United States
facility: Investigative Site
state: Kentucky
city: Sunset
country: United States
facility: Investigative Site
state: Louisiana
city: Charlotte
country: United States
facility: Investigative Site
state: North Carolina
city: Medford
country: United States
facility: Investigative Site
state: Oregon
city: Greenville
country: United States
facility: Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Investigative Site
state: South Carolina
city: Union
country: United States
facility: Investigative Site
state: South Carolina
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Spokane
country: United States
facility: Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Investigative Site
state: Washington
Study officials:
References: