louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002071: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Official title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of erythropoietin administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.

Substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: Ortho Pharmaceutical Corp
state: New Jersey
Study officials:
References:
citation: Rarick M, Wilson E, Bernstein-Singer M, Gill PS, Muggia F, Levine AM. Double-blind placebo controlled study of recombinant human erythropoietin in AIDS patients with anemia caused by HIV infection and zidovudine. Int Conf AIDS. 1989 Jun 4-9;5:195 (abstract no MBO48)
Clinical trial NCT05811871: Assessing Factors in Tinnitus Patients' Clinical Study Experiences
Official title: Examining Variables Affecting Patient Participation in Clinical Trials for Tinnitus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tinnitus
Keywords: tinnitus
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tinnitus patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in tinnitus clinical studies, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with tinnitus who may be invited to participate in clinical research in the years to come.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with tinnitus
* Willing to comply with all study related procedures and assessments
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* No documented diagnosis of tinnitus
* Any other health problems that would prohibit safe participation in the study
* Pregnant or planning to become pregnant while enrolled in the study

Primary outcomes:
measure: Number of tinnitus patients who decide to enroll in a clinical study
timeFrame: 3 months
measure: Rate of tinnitus patients who remain in a clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Natalini E, Fioretti A, Riedl D, Moschen R, Eibenstein A. Tinnitus and Metacognitive Beliefs-Results of a Cross-Sectional Observational Study. Brain Sci. 2020 Dec 23;11(1):3. doi: 10.3390/brainsci11010003.
citation: Farr MR, Moraleda Deleito J, Xu Y, Ray J. Developing a one-stop tinnitus service: outcomes of a joined up management strategy: a retrospective observational cohort study. J Eval Clin Pract. 2016 Feb;22(1):93-97. doi: 10.1111/jep.12442. Epub 2015 Aug 28.
citation: Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821.
Clinical trial NCT06168071: Transauricular Vagus Nerve Stimulation in Children
Official title: Safety, Tolerability and Neurophysiological Response of Transauricular Vagus Nerve Stimulation in Children Without Brain Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypoxia-Ischemia, Brain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children.

The main questions it aims to answer are:

* What is the safety, tolerability, and physiological response of taVNS in children?
* Does the electroencephalogram (EEG) change during taVNS?

Participants will

* undergo a brief titration session where taVNS will be titrated to below perceptual threshold
* receive one session of 30 minutes of taVNS
* undergo clinical EEG monitoring during taVNS
* Continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes
* Answer tolerability questions before, during and after 30 minute taVNS session


Eligibility criteria: Inclusion Criteria:

* Admitted for clinical EEG for spell characterization at investigator's institution

Exclusion Criteria:

* known history of brain injury
* known history of bradycardia
* congenital heart disease
* pregnant
* pacemaker or wearable defibrillator
* undergoing active cancer treatment

Primary outcomes:
measure: Safety: Heart rate
timeFrame: Baseline and continuously for 30 minutes during study visit. It will be recorded and assessed every 5 minutes during 30 minute study visit.
measure: Safety: Oxygen saturation
timeFrame: Baseline and continuously for 30 minutes during study visit. It will be recorded and assessed every 5 minutes during 30 minute study visit.
measure: Tolerability: Face, Legs, Activity, Cry, Consolability (FLACC)
timeFrame: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.
measure: Tolerability: Tolerance Questionnaire
timeFrame: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alyssa Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04929171: Myofascial Pain and Central Sensitization
Official title: The Impact of Nociplastic Pain Features on the Response to Physical Therapy in Patients With Primary Myofascial Pain: A Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofascial Pain
Physical Therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were drawn from new patients evaluated at a tertiary care spine and musculoskeletal clinic.

Brief summary: This prospective, observational cohort pilot study compared pain phenotyping and functional measures in 30 participants with non-acute neck and/or shoulder girdle pain consistent with primary myofascial pain at 3-months following a physical therapy referral to study the impact of their baseline degree of pain amplification.


Eligibility criteria: Inclusion Criteria:

* English-speaking participants
* Diagnosed by their physician with non-acute (more than two weeks) neck and/or shoulder girdle primary myofascial pain
* Referred to a physical therapy treatment.

Exclusion Criteria:

* In an effort to reduce the potential that another medical condition could lead to a secondary myofascial pain response, extensive comorbid exclusion criterion.
* Use of chronic high-dose opioid medication greater than 100 mg oral morphine equivalents per day.
* Individuals receiving or applying for compensation or disability.
* The inability to provide informed consent.
* Severe physical impairment (e.g., blindness, deafness)
* Co-morbid medical condition limiting function (e.g., malignant cancer)
* Reported illicit drug use
* Severe psychiatric condition that would limit judgment.
* Lack of internet access.

Primary outcomes:
measure: Change in Neck Disability Index
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in PEG Score
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: David J Kohnsd, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693871: Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion
Official title: Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Atrial Appendage Velocity
Left Atrial Structure
Left Atrial Function
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation between the ages of 18 and 80 received atrial fibrillation radiofrequency ablation combined with left atrial appendage occlusion, and recovered to sinus rhythm after the operation. According to the different left atrial appendage emptying speed, it is divided into a higher left atrial appendage emptying speed group and a lower left atrial appendage emptying speed group.

Brief summary: Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure can not only improve symptoms in patients with non-valvular atrial fibrillation, but also prevent left atrial appendage thrombosis. The safety and effectiveness of left atrial appendage occlusion have been confirmed by randomized controlled trials and actual experience. Among patients with different left atrial appendage emptying speeds, there are limited studies on the structure and function of the left atrial appendage after LAA closure. In this study, patients with persistent nonvalvular atrial fibrillation were selected for radiofrequency ablation combined with LAA closure. The sinus rhythm was restored after the operation. According to the different emptying speed of the left atrial appendage, they were divided into a high-flow rate group and a low-flow rate group. The differences in the structure and function of the left atrium between the two groups were analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients who received atrial fibrillation radiofrequency ablation combined with left atrial appendage closure.

Exclude Criteria

* Patients with incomplete data.
* Device embolism.
* Residual shunt around the device found by transesophageal echocardiography greater than 5 mm.
* Mitral valve stenosis.
* Artificial valve.
* Atrial septal defect.
* Dilated cardiomyopathy
* Moderate Severe mitral regurgitation

Primary outcomes:
measure: Changes in the structure of the left atrium
timeFrame: 1year
measure: Changes in the function of the left atrium
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT06294171: Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone
Official title: Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Keywords: peizosurgery , osseodensification , modified ridge splitting , dental implant
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone.

Detailed description: Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture. Atrophic edentulous jaws can represent a significant challenge to the successful use of endosseous implants for prosthetic reconstruction of the edentulous mandible.

A collapsed alveolar ridge demonstrating a narrow width (less than 5 mm in many cases) and grossly adequate alveolar height is the most common candidate for the RSP.

Beginners in RSP should initially choose a 4-5 mm thickness of an even maxillary alveolar ridge and strive to almost double it in width.

A 3-mm alveolar ridge generally consists of 3 thin bone layers (in a horizontal sandwich fashion): 2 cortical plates (about 1 mm each) separated by 1 cancellous layer (about 1 mm). The wider the cancellous bone layer (the layer where the split is done), the easier it will be to accomplish the RSP

Eligibility criteria: Inclusion criteria:

1. Patient's age ≥18 years.
2. Absence of any medical disease that compromise wound healing.
3. Patient with good oral hygiene.
4. Narrow alveolar bone (3-4 mm) with minimum alveolar bone height of (12 mm).

Exclusion criteria:

1. Uncontrolled medically compromised patients.
2. Heavy smokers (\> 10 cigarettes per day).
3. Patient with parafunctional habits.
4. Local infection at implant site.

Primary outcomes:
measure: expansion rate
timeFrame: immediately
measure: expansion rate
timeFrame: after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad College of Dentistry
Study officials:
References:
Clinical trial NCT01869478: Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke
Official title: Endovascular Arterial Reperfusion vs. Intravenous ThromboLYsis for Acute Ischemic Stroke (EARLY): A Randomized Pilot Study of Ultra-early (<2 Hours) and Early (2-4.5 Hours) Reperfusion Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Ischemic Stroke
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 1
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: This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Definite or probable ischemic stroke
* CT angiographic (CTA) evidence of intracranial vascular occlusion (internal carotid, middle cerebral - M1 or M2 divisions, anterior cerebral, posterior cerebral, or basilar artery) within 3.5 hours of symptom onset
* Able to receive assigned treatment within 4.5 hours of symptom onset
* Written informed consent from patient or surrogate, if unable to provide consent

Exclusion Criteria:

* CT evidence of early infarction in \>1/3 of middle cerebral artery distribution
* Blood pressure \> 185/110 mmHg refractory to anti-hypertensive therapy
* History of intracranial hemorrhage
* History of ischemic stroke within past 3 months
* History of major surgical procedure within past 14 days
* Gastrointestinal or genitourinary bleeding within past 14 days
* Glucose \<50 or \>400mg/dL
* Platelet count \<100,000
* International normalized ratio (INR) ≥ 1.7
* Known history of bleeding diathesis

Primary outcomes:
measure: Recanalization Rate of Primary Intracranial Occlusion
timeFrame: 24 hours
Secondary outcomes:
measure: Mean Score on Modified Rankin Scale at 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Kevin M Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367678: Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients
Official title: Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Induced Injury
Necrosis, Pressure
Complication of Device Insertion
Airway Morbidity
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2011-06-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females.

Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa.

Insertion success rate and oropharyngeal leak pressure were also measured.


Eligibility criteria: Inclusion Criteria:

* ASA I/II
* female
* age 19-65 years

Exclusion Criteria:

* \< 19 years
* had a known or predicted difficult airway
* a body mass index \> 35 kg m-2, or
* were at risk of aspiration

Primary outcomes:
measure: pharyngeal mucosal pressure
timeFrame: every 5 minutes during steady state anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
city: Zürich
country: Switzerland
facility: Christian Keller MD, M.Sc.
Study officials:
affiliation: Schulthess Klinik
name: Christian Keller, MD, M.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00494078: Efficiency of Continuous Glucose Monitoring in Critically Ill Patients
Official title: Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: critical illness
hyperglycemia
intensive insulin therapy
glucose monitoring
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-06-29
Enrollment: 120
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 whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.

Detailed description: Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* Admitted critically ill patients expected to stay \>48h on the ICU after initiation of intensive insulin therapy.
* Age \> 18 years.

Exclusion Criteria:

* Admitted patients expected to stay \<48h
* Age ≤ 18 years

Primary outcomes:
measure: Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
timeFrame: 72h
Secondary outcomes:
measure: Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias
timeFrame: 72h
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Medicine III
name: Ulrike Holzinger, MD
role: PRINCIPAL_INVESTIGATOR
References: