louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03401580: Efficacy of Fixed-doses of Antihypertensive and Statin Drugs
Official title: Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hypertension
Dyslipidemia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia.

Detailed description: * Fase II, national, multicenter, randomized, double-blind.
* Maximal duration: 8 weeks;
* 04 visits;
* Safety and efficacy evaluation.

Eligibility criteria: Inclusion Criteria:

* Participants of both sexes aged between 18 and 65 years;
* Participants diagnosed with uncontrolled hypertension (stage 1), according VII Brazilian Guideline of Hypertension;
* Participants diagnosed with dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Signed consent.

Exclusion Criteria:

* Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
* Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);
* Participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 500 mg / dL;
* Participants with hypertension (stage 2 or 3) according VII Brazilian Guideline of Hypertension;
* History of congestive heart failure (CHF) functional class III or IV (NYHA);;
* Any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants;
* Creatine phosphokinase (CPK) levels above the established laboratory normal range;
* Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range;
* Body mass index (BMI) ≥35 kg / m²;
* Immunocompromised participants (eg.: malignancies, patients with Acquired Immunodeficiency Syndrome etc);
* Chronic use of drugs that may interact with the drugs of the study;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Reduction of systemic blood pressure measured between the first visit and last visit
timeFrame: 8 weeks
measure: Percentage of reduction of LDL-c between the first visit and the last visit.
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02423980: G-Pen™ for Hypoglycemia Rescue in T1D Patients
Official title: G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoglycemia
Lead sponsor: Xeris Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

Detailed description: Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose \< 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 24 months

Exclusion Criteria:

* Pregnant or Lactating
* HbA1c \>10.5% at screening
* Use of \> 2.0 U/kg total insulin dose per day
* Inadequate bilateral venous access in both arms
* Renal insufficiency
* Congestive heart failure, NYHA class II, III or IV
* Active malignancy within 5 years from screening
* Major surgical operation within 30 days prior to screening
* Seizure or bleeding disorder
* Glycogen storage disease
* Active substance or alchohol abuse

Primary outcomes:
measure: Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment
timeFrame: 0-90 minutes
Secondary outcomes:
measure: Time to Plasma Glucose > 70 mg/dL
timeFrame: 0-90 minutes
measure: Time to Resolution of Induced Hypoglycemia Symptoms
timeFrame: 0-30 minutes
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
Study officials:
References:
Clinical trial NCT00736580: Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery
Official title: Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery
Glove Perforation
Keywords: Cesarean delivery
Surgical Needles
blunt-tip needles
surgical glove perforation
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2008-08-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is assessing whether there is a decrease in surgical glove punctures using blunt tipped needles compared with sharp needles for suturing during Cesarean Delivery.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age undergoing Cesarean Delivery

Exclusion Criteria:

* Patient less than 18 years of age.
* Patient not undergoing Cesarean Delivery.

Primary outcomes:
measure: Surgical Glove Perforation.
timeFrame: 1 week
Secondary outcomes:
measure: Surgeon Satisfaction by Likert Scale.
timeFrame: 1 week
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Michael L Stitely, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stitely ML, Close J, Ferda A, Mehra S, Malson B, Hembree W. Glove perforations with blunt versus sharp surgical needles in caesarean delivery: a randomized trial. W V Med J. 2013 Sep-Oct;109(5):32-6.
Clinical trial NCT05798780: The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors
Official title: The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Cavity Cancer
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
* Able to speak and read English
* Able to consume food orally
* Willing to consume an alternative Mediterranean diet
* Scheduled to receive treatment with radiation or chemoradiation
* Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
* Able to provide informed consent

Exclusion Criteria:

* Women who are pregnant
* Head and Neck Cancer not the primary diagnosis
* Patients scheduled to receive surgery
* Patients on enteral or parental nutrition

Primary outcomes:
measure: Number of Participants Recruited - Feasibility
timeFrame: 12 Months
measure: Number of Participants who Complete Questionnaire - Retention - Feasibility
timeFrame: 12 weeks
measure: Participant Satisfaction of Timeline - Feasibility
timeFrame: 12 weeks
measure: Participant Average Attendance - Assessment Completion - Adherence
timeFrame: 12 weeks
measure: Number of Participants who Complete Task/Goals - Adherence
timeFrame: 12 weeks
measure: Participant Satisfaction Assessed with 5 Point Scale - Acceptability
timeFrame: 12 weeks
measure: Participant Intent to Continue Assessed with 5 Point Scale - Acceptability
timeFrame: 12 weeks
measure: Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Sylvia Crowder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030080: Way to Be Active IV (Framing vs Incentives)
Official title: A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Framing vs Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Pedometers
Walking
Financial incentives
Sedentary lifestyle
Behavioral economics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-01-08
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18.
* Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

* Pregnant or lactating
* Currently participating in another physical activity study

Primary outcomes:
measure: Proportion of Days a Participant Walks 7000 Steps or More
timeFrame: Throughout 6-month study
Secondary outcomes:
measure: Average Number of Steps Per Day
timeFrame: Throughout the 6-month study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Kevin Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel MS, Volpp KG, Rosin R, Bellamy SL, Small DS, Fletcher MA, Osman-Koss R, Brady JL, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Asch DA. A Randomized Trial of Social Comparison Feedback and Financial Incentives to Increase Physical Activity. Am J Health Promot. 2016 Jul;30(6):416-24. doi: 10.1177/0890117116658195. Epub 2016 Jul 15.
Clinical trial NCT02292680: Childhood Measures of NICU-based Chemical Exposure
Official title: Novel Biomarkers for Exposures in the Neonatal Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Development
Keywords: dentin
environmental exposures
neurodevelopmental outcomes
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who were cared for as neonates in the Mount Sinai NICU

Brief summary: This study aims to identify early life exposures to metals and chemicals by measuring the concentration of metals and organic compounds in shed primary teeth. The researchers will also investigate associations between the presence of these chemicals in teeth and children's social, emotional, and neuro-development.

Detailed description: Since children begin shedding their primary teeth around age 6, the investigators will enroll children who will be turning 6 in the next two years. First, the investigators will follow up with the children's development by conducting a battery of non-invasive neurodevelopmental tests. Also, the parents will be asked to complete a questionnaire called the Child Behavior Checklist, which assesses behavioral problems. Then, each child's parent will be asked to send the research team 2-3 teeth that their child has shed, or to send teeth as they are shed over the next three years. Dr. Stroustrup's collaborator, Dr. Manish Arora, will perform a temporal analysis of chemical distribution for each tooth to determine each child's environmental exposures during the perinatal and neonatal periods.

Eligibility criteria: Inclusion Criteria:

* 4-6 years of age in 2014 (six years of age by the end of 2016)
* Cared for as a neonate in Mount Sinai's NICU

Exclusion Criteria:

* Parent documented in Mount Sinai's database is no longer the legal guardian
* Non-English-speaking parents

Primary outcomes:
measure: Chemical Concentration in deciduous teeth
timeFrame: up to 5 years
Secondary outcomes:
measure: Child Behavior Checklist
timeFrame: up to 3 years
measure: Wechsler Preschool and Primary Scale of Intelligence
timeFrame: up to 3 years
measure: Development Neuropsychological Assessment (NEPSY)
timeFrame: up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Ichan School of Medicine at Mount Sinai
name: Annemarie Stroustrup, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870180: EyeBag Effectiveness in Meibomian Gland Dysfunction
Official title: Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian Glad Dysfunction
EyeBag
Hot Compress
Dry Eyes
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 18
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: Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.

Detailed description: Study Design

Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score

Eligibility criteria: Inclusion Criteria:

* 18 or over
* Have otherwise healthy eyes
* Are prepared not to wear contact lens for the 2 weeks of the trial
* Have a NITBUT \<10s
* OSDI score: greater than or equal to 12
* Symptom frequency at least "some of the time"
* Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid

Exclusion Criteria:

• Blepharitis

Primary outcomes:
measure: Change in Ocular Symptoms
timeFrame: Between baseline and 2 weeks
measure: Change in Tear Film Quality
timeFrame: Between baseline and 2 weeks
Secondary outcomes:
measure: Change in Ocular redness
timeFrame: Between baseline and 2 weeks
measure: Change in Lipid layer thickness
timeFrame: Between baseline and 2 weeks
measure: Change in Meibomian Glands
timeFrame: Between baseline and 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University
state: West Midlands
Study officials:
References:
citation: Bilkhu PS, Naroo SA, Wolffsohn JS. Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye. Br J Ophthalmol. 2014 Dec;98(12):1707-11. doi: 10.1136/bjophthalmol-2014-305220. Epub 2014 Jul 4.
Clinical trial NCT01934062: Induction Hypotension in Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Surgical Patients
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients from Nationwide Children's Hosp.

Brief summary: This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure.


Eligibility criteria: Inclusion Criteria:

* Patients between ages of 1 year to 8 years will be included in the study.
* Patients with ASA physical classification 1 and 2 will be studied.

Exclusion Criteria:

* Patients with any cardiovascular or kidney diseases will be excluded from the study.

Primary outcomes:
measure: Hypotension
timeFrame: Baseline, 5, 10, & 15 mins. post induction
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02672462: Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study
Official title: The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Shanghai Golden Leaf MedTec Co. Ltd
Sponsor class: INDUSTRY
First posted: 2016-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.


Eligibility criteria: Inclusion Criteria:

* Ages of 18 to 75, male or female;
* Main renal artery, with or without accessary renal arteries, with length

  * 20mm;
* Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and

  * 180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring;
* Agrees to take part in the trial and signs the written, informed consent.

Exclusion Criteria:

* Renal artery abnormalities that are inappropriate for the procedure;
* Pregnant or plan to become pregnant;
* History of orthostatic hypotension;
* Type I diabetes;
* Estimated GFR\<40mL/min/1.73m2;
* Only one kidney or prior kidney transplantation;
* Bleeding tendency or other coagulation related diseases;
* Acute or severe systemic infection;
* Prior renal artery interventional procedures or prior RDN treatment;
* History of stroke or TIA;
* Malignant tumor or end-stage illnesses;
* Secondary hypertension;
* Acute coronary events within 2 weeks;
* Other conditions that deem unsuitable for the procedure, in the opinions of investigators.

Primary outcomes:
measure: blood pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital
name: Gengshan Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801762: Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology
Official title: Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Mauna Kea Technologies
First posted: 2008-12-03
Enrollment: 195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The goal of the study is to develop a novel approach to obtain real time optical biopsy of urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel fibered confocal microscope.


Eligibility criteria: Inclusion Criteria:Research subjects with suspected urinary tract pathology (e.g., bladder tumors) who are scheduled to undergo cystoscopy with possible excisional biopsy (e.g. transurethral resection of bladder tumor) in the operating room.\&#xA; Exclusion Criteria:History of hypersensitivity to fluorescein; active urinary tract infection; pregnant; currently breast feeding;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: Joseph C. Liao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sonn GA, Jones SN, Tarin TV, Du CB, Mach KE, Jensen KC, Liao JC. Optical biopsy of human bladder neoplasia with in vivo confocal laser endomicroscopy. J Urol. 2009 Oct;182(4):1299-305. doi: 10.1016/j.juro.2009.06.039. Epub 2009 Aug 14.