louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06017921: Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA
Official title: Effect of Eszopiclone on Adherence to Continuous Positive Airway Pressure (CPAP) and Severity of Insomnia in Patients With Comorbidity Between Insomnia and Obstructive Sleep Apnea (COMISA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Insomnia
Keywords: COMISA
Obstructive Sleep Apnea
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The comorbidity between obstructive sleep apnea (OSA) and insomnia (COMISA) is common, and associated with poorer sleep quality. CPAP adherence among COMISA patients is worst than among those with OSA only. The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months.

Detailed description: The comorbidity between OSA and insomnia (COMISA) is common. COMISA leads to additive impairment of quality of sleep and quality of life compared to patients with insomnia or OSA alone. Patients with COMISA demonstrate worse adherence to CPAP compared to patients with isolated OSA. The best therapeutic approach for patients with COMISA is still unclear. Hypnotics have not been tested among patients with COMISA and indication for CPAP.

The investigators will compare the effect of Eszopiclone 3mg or placebo for 14 days on adherence to CPAP after 30 days and after 6 months. In addition, the investigators will assess the effect eszopiclone on insomnia severity, quality of life, anxiety.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Insomnia;
* Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography.

Exclusion Criteria:

* Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that potentially impair CPAP use;
* Use of hypnotics for more than 7 days in the last 2 months;
* Renal dysfunction (serum creatinine \>2mg/dL);
* Severe liver or cardiac dysfunction;
* Alcoholism;
* Previous CPAP or mandibular advancement device for OSA treatment in the last 12 months.

Primary outcomes:
measure: Short-term CPAP adherence (use > 4 hours per night through Resmed program)
timeFrame: 4 weeks
Secondary outcomes:
measure: Long-term CPAP adherence (use > 4 hours per night through Resmed program) Compare sleep quality, insomnia and anxiety
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
Study officials:
References:
Clinical trial NCT05245721: Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
Official title: Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Agitation, Emergence
Post Operative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment


Eligibility criteria: Inclusion Criteria:

* Age 2_12 years
* Both genders
* ASA I_II
* Children undergoing infra-umbilical surgeries

Exclusion Criteria:

* Guardians refusal
* congenital anomalies at the lower spine or meringues
* Increased intracranial pressure
* Skin infection at site of injection
* Bleeding diathesis
* Known allergy to any drugs used

Primary outcomes:
measure: Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
timeFrame: Up to 2 hours postoperative
Secondary outcomes:
measure: Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
timeFrame: For 24 hours postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00200421: A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension
Official title: A Double-Blind, Randomized, Multi-Center, Active Comparator, Five Treatment Study of the Effects of Nebivolol Compared to Atenolol on Cardiovascular Hemodynamics and Exercise Capacity in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Nebivolol
Atenolol
Exercise
Hypertension
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 110
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 purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.

Detailed description: This was a pilot, phase II, double-blind, randomized, muticenter, active-comparator, five treatment parallel group dosing and mechanistic study. The study consisted of two phases: 1) screen/washout/single-blind placebo run-in and 2) randomization/treatment. There was a minimum of five scheduled study visits.

Eligibility criteria: Inclusion Criteria:

* An average sitting diastolic blood pressure (DBP) of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Secondary Hypertension
* Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy

Primary outcomes:
measure: The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.
Secondary outcomes:
measure: The change in sub-maximal exercise duration at end of treatment compared to baseline.
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03905421: Quality of Life Assessed With the PAH SYMPACT Questionnaire
Official title: Quality of Life Assessed With the PAH SYMPACT Questionnaire in the Pulmonary Hypertension Clinic
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic.

Brief summary: Researchers are evaluating quality of life in pulmonary hypertension subjects using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire and assessing the questionnaires' performance with regard to relationship to other markers of disease severity, response to treatment, and outcome in a clinical practice setting.

Detailed description: Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic. The PAH-SYMPACT questionnaire will be administered either in written form or by telephone interview.

On the second 100 patients implement a standardized palliative care referral program for patients with Group 1 and 3 PH and high SYMPACT scores\> 1.0.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or above
* Consents to participate
* Documented group I PAH based upon these hemodynamic criteria: (mPAP \> 20, PCW 18 or less, PVR \> 3 Wood units
* Mean PAP \> 20, PCW ≤ 18, PVR \> 3 Wood units
* Parenchymal lung disease that in the opinion of the investigator qualifies patient as group III PH
* Documented chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease with intent to treat with surgery, balloon pulmonary angioplasty, and/or PH medication

Exclusion Criteria:

* Left sided heart disease (LVEF\<50%, PAWP\>18)
* Any other known concomitant life-threatening disease with a life expectancy \<12 months
* Any other clinically relevant and/or serious chronic medical condition that would affect study participation in the opinion of the investigator
* Non English speaking

Primary outcomes:
measure: Quality of life in pulmonary hypertension subjects
timeFrame: Baseline
measure: Quality of life in pulmonary hypertension subjects
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hilary M DuBrock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02418221: A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
Official title: A Doubleblind, Placebo-controlled, Cross-over Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase (DAOSiN®) Supplementation in Case of DAO Enzyme Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histamine Intolerance
Keywords: histamine, biogenic amines, diamine oxidase
Lead sponsor: IPSC AG
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Graz
name: Sciotec Diagnostic Technologies GmbH
First posted: 2015-04-16
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.

Detailed description: The clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. However, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. Various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open.

A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. By administration of DAO before provocation an attenuation of the symptoms is to be expected.

Eligibility criteria: Inclusion Criteria:

* Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far

Exclusion Criteria:

* pregnancy
* coronary heart disease
* labile hypertension
* bronchial asthma
* periodical therapy using H1-blockers
* chirurgical intervention with the GI tract within the previous 3 months
* participation in a clinical trial within the previous 4 weeks

Primary outcomes:
measure: Reduction of biogenic amine symptoms (determined via symptom score)
timeFrame: 24 hrs after start of provocation
Secondary outcomes:
measure: Serological parameters
timeFrame: Up to 90 min after provocation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Environmental Dermatology and Venereology, Medical University of Graz
Study officials:
affiliation: Sciotec Diagnostic Technologies GmbH
name: Albert Missbichler, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01350921: Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers
Official title: A Sequential, Open Label Study to Compare the Pharmacokinetics, Safety and Tolerability of Ticagrelor and Venlafaxine Given Concomitantly in Healthy Subjects Aged 18 to 45 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Keywords: phase 1
ticagrelor
venlafaxine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2

Exclusion Criteria:

* History of clinically significant disease or disorder as judged by the investigator
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug.
* History of haemophilia, von Willebrand´s disease, lupus anticoagulant or other diseases/syndromes that may alter or increase bleeding.
* History of previous or ongoing psychiatric disease

Primary outcomes:
measure: area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)
timeFrame: Multiple assessments during day 8 and 9.
Secondary outcomes:
measure: Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)
timeFrame: Multiple assessments during day 1 and 9-11
measure: Safety and tolerability of ticagrelor and venlafaxine when given concomitantly by assessments of amount of adverse events
timeFrame: Multiple assessments from day -1 do day 12 and a single assessment at follow up visit.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Wilmington
name: Jay Horrow, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Mölndal
name: Mirjana Kujacic, PhD
role: STUDY_CHAIR
affiliation: Quintiles Kansas Overland Park US
name: Kelli Craven, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04563221: Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Official title: Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Benign prostatic hyperplasia (BPH)
Prostatic artery embolization (PAE)
Lower urinary tract symptoms (LUTS)
Prostate artery embolization
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 0
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 45 years and ≤ 85 years old
* Prostate volume ≥ 40 mL and ≤ 300 mL
* Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
* Refractory or intolerant to medical management
* Ineligibility for or refusal of surgical management
* No evidence of prostate cancer

Exclusion Criteria:

* History of pelvic cancer
* Neurogenic bladder disorder
* Bladder diverticula greater than 5 cm or bladder stones
* Acute urinary retention with Foley catheter dependence
* Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
* Prior surgical prostate intervention
* Active participation in another clinical trial

Primary outcomes:
measure: Number of patients with treatment related adverse events assessed by CTCAE v4.0.
timeFrame: 12 months post PAE
measure: Mean change from baseline in symptom score using the IPSS scale at 6 months
timeFrame: Baseline and 6 months post PAE
Secondary outcomes:
measure: Mean change from baseline in Qmax (maximum urinary flow)
timeFrame: Baseline, 6 months and 12 months post PAE
measure: Mean change from baseline in PVR (post void residual)
timeFrame: Baseline, 6 months and 12 months post PAE
measure: Mean change from baseline in prostate volume
timeFrame: Baseline, 6 months and 12 months post PAE
measure: Mean change from baseline in IPSS to measure long-terms subjective outcome
timeFrame: Baseline, 12 and 24 months post PAE
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrew Picel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05977621: Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
Official title: Acquisition of Trans-Rectal Ultrasound [TRUS] Images of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking for Image-Guided Brachytherapy: A Pre-feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eigen
First posted: 2023-08-04
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing brachytherapy as part of the standard plan for their gynecologic cancer diagnosis (defined above) will be our target population. Only women will be eligible for this study. Women of all races/ethnicities will be eligible, and accrual is expected to reflect the population of patients seen in the Duke Radiation Oncology Clinic.

Brief summary: The purpose of this study is to utilize transrectal ultrasound (TRUS) images of the intact and post-hysterectomy female pelvis in order to provide feasibility information for a Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in image guided brachytherapy. The fusion and needle guidance will be performed using Eigen Health's navigation system that currently provides targeted MR/Ultrasound fusion based prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.


Eligibility criteria: Inclusion Criteria:

* Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma.
* Treatment plan must include curative-intent definitive radiation that includes brachytherapy treatments with or without concurrent chemotherapy
* Adults ≥ 18 years of age
* ECOG Performance Status 0-2

Exclusion Criteria:

* Patients with active rectal bleeding or rectal ulcer

Primary outcomes:
measure: Number of patients whose MRI and ultrasound images are fused
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University Health System (DUHS)
name: Dianda Ayala-Peacock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01521221: Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension
Official title: Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Orthostatic Hypotension
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood pressure, heart rate and symptoms will be continuously measured. First study will evaluate the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the position changes.

Detailed description: Study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

Study 2. in continue with study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Performing hand-grip at 50-70% grip force for 1 minute Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

Eligibility criteria: Inclusion Criteria:

* Man or women
* 18 years of age or older
* Diagnosed with orthostatic hypotension due to Parkinson's disease, multiple system atrophy or pure autonomic failure
* Orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration

Exclusion Criteria:

* Pregnant or breast feeding

Primary outcomes:
measure: Change in orthostatic blood fall after tilting with and without hand grip.
timeFrame: 10 minutes after tilting the subjects.
Secondary outcomes:
measure: Change in the intracranial blood flow after tilting with and without hand grip.
timeFrame: 10 minutes after tilting.
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Movement disorders unit, the Department of Neurology, Sourasky Medical Center
Study officials:
affiliation: Deputy Chief, the Department of Neurology, Sourasky Medical Center
name: Amnon Mosek, MD
role: PRINCIPAL_INVESTIGATOR
References: