louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05401214: Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
Official title: Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-06-02
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
* A confirmed homologous recombination repair (HRR) gene alteration as identified by a genomic assay through use of a validated test
* Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
* Willing to receive concomitant prednisone/ prednisolone 10 milligrams (mg) (not provided by Janssen) daily while receiving niraparib/abiraterone acetate (Nira/AA) combination treatment
* Willing to continue treatment with gonadotropin-releasing hormone (GnRH) analogue if not surgically castrated

Exclusion Criteria:

* Prior treatment with a Poly ADP-ribose Polymerase (PARP) inhibitor
* Prior systemic therapy for mCRPC (that is, taxane-based chemotherapy, androgen signaling inhibitors). Ongoing androgen deprivation therapy (ADT), prior systemic treatment (example, apalutamide, enzalutamide, darolutamide, docetaxel) for earlier disease settings (example, hormone sensitive disease, non-metastatic castration-resistant disease); and treatment recently initiated with abiraterone acetate for mCRPC less than or equal to (\<=) 60 days is permitted
* Other treatment options available or participant eligible or able to participate in a clinical trial for first line mCRPC with HRR gene alterations
* Moderate-severe pain
* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03524014: Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.
Official title: Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis E Infection in Humans and in Environment
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusions during 2 years (2018-2019):

* HEV infection, liver-related syndroms (either acute or chronic), n=20
* HEV-infection, neurological (n=5; controls n=5) or renal syndroms (5-10; controls n= 5-10)

Brief summary: The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.


Eligibility criteria: Inclusion Criteria:

* HEV-infected patients, with hepatitis and/or neurological and/or renal symptoms

Exclusion Criteria:

* Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (hepatitis B, hepatitis C, hepatitis A ...)

Primary outcomes:
measure: Anti-HEV IgM (qualitative assay);
timeFrame: 2 years
measure: HEV RNA (quantitative PCR assay)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Schvoerer
Study officials:
References:
Clinical trial NCT01692314: Effect of Resistance Training on Microvascular, Hemodynamic and Physical Parameters in Obese Adolescents
Official title: Effect of Resistance Training on Microvascular Reactivity, Endothelial Function, Inflammatory Markers, Body Composition, Blood Pressure, Heart Rate and Physical Fitness in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Endothelial function
Microvascular reactivity
Obesity
Adolescents
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2012-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the effect os resistance training on microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart rate, body composition and physical fitness in obese adolescents.


Eligibility criteria: Inclusion Criteria:

* Tanner pubertal stage of development between three and five
* age between 13 up to 17 years old

Exclusion Criteria:

* presence of chronic diseases (diabetes mellitus, nephropathy and/or hypertension),
* musculoskeletal injury,
* smoking and
* to be in use of any medication.

Primary outcomes:
measure: Microvascular Reactivity
timeFrame: Three months
Secondary outcomes:
measure: Endothelial function
timeFrame: Three months
Other outcomes:
measure: Hemodynamic parameters
timeFrame: three months
measure: Imflammatory markers
timeFrame: three months
measure: Body composition
timeFrame: three months
measure: Physical fitness
timeFrame: three months
Locations:
city: Rio de Janeiro
country: Brazil
facility: Laboratory for Clinical and Experimental Research in Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro
state: RJ
Study officials:
affiliation: State University of Rio de Janeiro
name: Eliete Bouskela, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01031914: Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
Official title: Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure Users Using Paced Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Paced Breathing
OSA
sleep/wake detection
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be evaluating the algorithm's ability to correctly distinguish between sleep and wake.


Eligibility criteria: Inclusion Criteria:

* Age 21-70
* Diagnosis of obstructive sleep apnea (OSA)
* Current adherent CPAP user (has been using CPAP nightly for at least 2 weeks).
* On CPAP pressures of 5-10cm.
* Subjects wishing to complete a day or evening appointment need to have significant daytime sleepiness (Epworth Sleepiness Scale score of 8 or above)
* Able and willing to provide written informed consent
* English speaking

Exclusion Criteria:

* Participation in another interventional research study within the last 30 days
* Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
* Inability to tolerate nasal CPAP mask due to problems breathing solely through their nose.
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCo2≥55mmHg)
* Severe oxygen desaturation on the polysomnography (PSG), i.e. Sa02 \< 70% for 10% of the study.
* Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
* Currently using supplemental oxygen
* Regular use of sleeping pills or stimulants (\> 3 nights a week)
* Currently working night shift or rotating day/night shift
* Drowsy Driving or near miss accident in the past 6 months
* Inability to tolerate or track to Paced Breathing device during initial habituation session in lab
* Chronic insomnia, Restless legs syndrome, or severe periodic limb movement disorder (PLMD - PLMAI\>20/hr).

Primary outcomes:
measure: Sleep/Wake Algorithm
timeFrame: The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Philips Respironics
state: Massachusetts
Study officials:
affiliation: Philips Respironics
name: David P White, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165514: Cobb Angle Measurement of Kyphosis and Scoliosis
Official title: Traditional Cobb Angle Measurement of Kyphosis and Scoliosis Using Lunar IDXA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis
Scoliosis
Keywords: spinal curvatures
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2014-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.

Detailed description: To determine if bone density scanning (DEXA) and the use of a computer software program can make accurate measurements of the curvature(s) of the spine (Cobb angle)in patients with kyphosis and scoliosis compared to x-rays of the spine.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Have Kyphosis or Scoliosis
* Have had an x-ray of the spine performed within 3 months time

Exclusion Criteria:

* Are unwilling to read and sign this document
* Are pregnant or if you have not had a negative pregnancy test just prior to the iDXA scan.
* Have severe deformities of your back
* Unable to lay on the scanning table for the scan

Primary outcomes:
measure: Cobb angle measurements in degrees of spine curvature
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Hospital
name: Yebin Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00953914: Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
Official title: Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Keywords: pyridostigmine
autonomic modulation
diabetes mellitus
heart rate variability
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.

Detailed description: The reduced heart rate variability is associated with increased risk of death in patients with diabetes mellitus. Cholinesterase inhibition with pyridostigmine bromide increases heart rate variability in normal individuals and congestive heart failure subjects but its effects on patients with diabetes mellitus is unknown. Based on those evidences, we will test if the short-term administration of pyridostigmine bromide increases heart rate variability in patients with diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus

Exclusion Criteria:

* myocardial infarction
* acute ischemic syndromes
* second or third degree atrioventricular block
* active alcoholism
* thyroid dysfunction
* chronic obstructive pulmonary disease
* history of intolerance to pyridostigmine.

Primary outcomes:
measure: autonomic modulation assessed by heart rate variability
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ruy S. Moraes, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behling A, Moraes RS, Rohde LE, Ferlin EL, Nobrega AC, Ribeiro JP. Cholinergic stimulation with pyridostigmine reduces ventricular arrhythmia and enhances heart rate variability in heart failure. Am Heart J. 2003 Sep;146(3):494-500. doi: 10.1016/S0002-8703(03)00319-3.
Clinical trial NCT04144114: The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males
Official title: The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amino Acids
Keywords: Amino Acids
Intramuscular Anabolic Signaling
Endocrine Response
Resistance Training
Lead sponsor: Deerland Enzymes
Sponsor class: INDUSTRY
Collaborators: name: Lipscomb University
First posted: 2019-10-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL). To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway. To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.


Eligibility criteria: Inclusion Criteria:

* • At least one-year of resistance training experience

  * Free of any physical limitations (determined by health and activity questionnaire).
  * Between the ages of 18 and 35.
  * Ability to leg press a weight equivalent to 1.5 times their body mass

Exclusion Criteria:

* • Inability to perform physical exercise (determined by health and activity questionnaire)

  * Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
  * Physical injury preventing the athlete from participating in offseason training
  * Any chronic illness that causes continuous medical care

Primary outcomes:
measure: Amino acid absorption
timeFrame: 4 weeks
measure: mTORC1 pathway
timeFrame: 4 weeks
measure: Endocrine markers
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Lipscomb University
state: Tennessee
Study officials:
References:
Clinical trial NCT02565095: Interaction of Otolith Stimulation and Carotid Baroreflex in Humans
Official title: Interaction of Otolith Stimulation and Carotid Baroreflex in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is well documented that a few days stay in space induces a change in the vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the disappearance of gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory input, the investigators should also expect to see an alteration of the vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.

The first objective of this project is to study the carotid baroreflex under different supine (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, male and / or female aged 18-30 years
* subject affiliated to a social security scheme, agreeing to participate in the study and who provided informed consent.

Exclusion Criteria:

* who participated in a clinical trial within less than the period of exclusion from this project
* with a past or present history of heart disease, vascular, neurological, respiratory, rheumatological, metabolic or otologic.
* pregnant women (dosage beta HCG)
* having taken any medication heart, vascular, neurological, respiratory, rheumatological, metabolic or might interfere on vestibular test results during the two years preceding the experiment.
* smoking or smoking more than 5 cigarettes / day, 1 cigarette / day or 1 pipe / day

Primary outcomes:
measure: Arterial flow in Common Carotid Artery (EchoDoppler)
timeFrame: baseline
measure: Arterial flow in Internal Carotid Artery (EchoDoppler)
timeFrame: Baseline
measure: Arterial flow in External Carotid Artery (EchoDoppler)
timeFrame: Baseline
measure: Arterial flow in Vertebral Artery (EchoDoppler)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Laboratoire de Physiologie, CHU de Caen
Study officials:
References:
Clinical trial NCT01538914: Analgesic Effect of Intravenous Patient-Controlled Analgesia (IV PCA) Versus Paravertebral Block After Video Assisted Thoracic Surgery (VATS)
Official title: A Comparison Between the Analgesic Effect of Intravenous Patient-controlled Analgesia and of Paravertebral Block After Video Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain After Video Assisted Thoracic Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
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 compare the analgesic effect of paravertebral block with that of intravenous patient-controlled analgesia after video assisted thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* patients receiving video assisted thoracic surgery

Exclusion Criteria:

* patients with cardiovascular disease
* patients with neurologic disease
* patients with contraindications to paravertebral block or epidural block
* patients with history of previous VATS
* patients with pain at the expected incision site

Primary outcomes:
measure: severity of acute postoperative pain when moving
timeFrame: 24 hours after VATS
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02933814: Liposomal Bupivacaine in Ambulatory Hand Surgery
Official title: Liposomal Bupivacaine in Ambulatory Hand Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 0
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 study is being done to evaluate pain management regimens following ambulatory hand surgery. Improved pain control may be associated with decreased complications, decreased pain scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be two groups. One group will receive liposomal bupivacaine. One group will not. The results will be compared.

Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will participate in this study at LLU.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age and over undergoing ambulatory hand surgery involving soft tissue and subfascial structures, including: CMC arthritis, flexor and extensor tendon injury, symptomatic ganglia, hand and finger fractures

Exclusion Criteria:

* Patients who are unable to give informed consent to participate in this study
* Patients with a documented history of hypersensitivity reactions to local anesthetic agents
* Patients with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
* Patients who are currently pregnant
* Patients with impaired hepatic function
* Patients with underlying nerve damage or impairment
* Patients with renal impairment/failure
* Patients whose career/livelihood require a great deal of hand dexterity, in whom a complication could cause a significant impact on life and career (ex: musician, dentist)

Primary outcomes:
measure: Post-operative Opioid Use
timeFrame: At scheduled intervals up to 168 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Chair of the Department of Plastic Surgery
name: Subhas Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: