louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00863590: A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
* Female subject is postmenopausal
* Subject is within 20% of ideal body weight
* Subject is a nonsmoker

Exclusion Criteria:

* Subject has multiple or severe allergies to food or medications
* Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
* Subject has any infections, including HIV
* Subject consumes excessive amounts of caffeine or alcohol
* Subject has donated blood or taken another investigational drug in the last month
* Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Primary outcomes:
measure: safety and tolerability based on assessment of clinical and laboratory adverse experiences
timeFrame: Part I: 12 Weeks, Part II: 13 Weeks
Secondary outcomes:
measure: Plasma concentration of MK0822
timeFrame: Up to 336 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.
Clinical trial NCT00754390: Effects of Calcium and Phytate on Zinc Absorption
Official title: Effects of Calcium and Phytate on Zinc Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Zinc Absorption
Keywords: dietary zinc absorption
dietary phytic acid
dietary calcium
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2008-09-18
Enrollment: 17
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study is determine the effects of dietary calcium and phytate on zinc absorption.

Detailed description: Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope, followed by retention monitoring in a whole body scintillation counter for 4 weeks. All four 4 experimental diets are tested with each subject, in randomized order, for a total of 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Average weight for height

Exclusion Criteria:

* Medications other than birth control pills or hormone replacement therapy,
* Pregnancy within last 6 months

Primary outcomes:
measure: Zinc Absorption
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: United States Department of Agriculture Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Janet R Hunt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977703: Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
Official title: Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Advanced Heart Failure
LVAD
Left Ventricular Assist Device
Heart-Assist Devices
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Thoratec Corporation
First posted: 2013-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.


Eligibility criteria: Inclusion:

* Age ≥ 18
* Advanced Heart Failure
* Scheduled for Heartmate II LVAD implant
* With existing ICD

Exclusion:

-Age \< 18

Primary outcomes:
measure: Time to first ICD shock following LVAD implant
timeFrame: Within 12 months following LVAD implant
Secondary outcomes:
measure: Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection
timeFrame: Within 12 months following LVAD implant
measure: Frequency of ICD generator change prior to definitive therapy
timeFrame: Within 12 months following LVAD implant
measure: Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes
timeFrame: Within 12 months following LVAD implant
measure: Frequency of arrhythmic syncope
timeFrame: Within 12 months following LVAD implant
measure: Hospitalization frequency for decompensated congestive heart failure
timeFrame: Within 12 months following LVAD implant
measure: Determine survival to heart transplantation following LVAD implant
timeFrame: Within 12 months following LVAD implant
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Christopher Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.
Clinical trial NCT03510403: Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
Official title: Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Obstructive Sleep Apnea
Lead sponsor: Seven Dreamers Europe SAS
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
name: nastent.inc
First posted: 2018-04-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.


Eligibility criteria: Inclusion Criteria:

* Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5\<AHI)
* BMI≤30kg/m²
* Patient with good motivation to use the nasal device,
* Informed consent signed,
* Patient with social protection.

Exclusion Criteria:

* Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
* Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
* Patient with one or more documented contraindication to use Nastent™,
* no regular partner,
* contraindication for sleep endoscopy,
* Psychiatric or neurological disorders (epilepsy),
* Progressive cancer or chronic inflammatory disease,
* AHI including more than 5 central apnea per hour,
* Allergy to one component of Nastent™.

Primary outcomes:
measure: Efficacy : change from baseline Snoring Intensity at 1 month
timeFrame: 1 month
measure: Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
timeFrame: 1 month
Secondary outcomes:
measure: Change from baseline Sleepiness at 1 month
timeFrame: 1 month
measure: Change from baseline Nasal Obstruction at 1 month
timeFrame: 1 month
measure: Observance
timeFrame: 1 month
measure: Adverse Events [Safety and Tolerability]
timeFrame: 1 month
measure: Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
timeFrame: 1 month
measure: Physician satisfaction
timeFrame: 1 month
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Cabinet ORL de Bordeaux
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Créteil
country: France
facility: Henri-Mondor Hospital
city: Montpellier
country: France
facility: Beau-Soleil Private Hospital
city: Paris
country: France
facility: Centre Médical Veille Sommeil
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Foch Hospital, Suresnes, FRANCE
name: Marc Blumen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05008003: Vit D3 for Early Symptoms of COVID-19
Official title: Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Ayub Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Liaquat University of Medical & Health Sciences
First posted: 2021-08-17
Enrollment: 50
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 aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.

Detailed description: There is currently no specific early-stage therapeutic treatment available for COVID-19.

Vitamin D3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent.

The present study is aimed to investigate the treatment benefits of vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older, of either gender
* Patients must be tested positive for SARS-CoV-2 by RT-PCR
* Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
* Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
* Patients must be under the care of a Physician for diagnosis of COVID-19
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
* Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis
* Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
* Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
* Patients with gallstone obstruction
* Hypothyroid suppering patients
* Patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/L);
* Pregnant patients

Primary outcomes:
measure: SARS-CoV-2 Negativity by RT-PCR
timeFrame: From day 1 to day 14
measure: COVID-19 symptoms improvement
timeFrame: From day 1 to day 14
Secondary outcomes:
measure: Changes in CRP level
timeFrame: From day 1 to day 14
measure: Changes in D-dimer level
timeFrame: From day 1 to day 14
measure: Changes in LDH level
timeFrame: From day 1 to day 14
measure: Changes in ferritin level
timeFrame: From day 1 to day 14
measure: Changes in full blood count
timeFrame: From day 1 to day 14
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Ayub Teaching Hospital
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT06167603: Exploring Brain Molecular Imaging and Blood Biomarkers in Subjects With Glucocerebrosidase Mutations: Toward a Precision Medicine Approach to Characterize Parkinson's Disease Clinical Trajectories
Official title: Exploring Brain Molecular Imaging and Blood Biomarkers in Subjects With Glucocerebrosidase Mutations: Toward a Precision Medicine Approach to Characterize Parkinson's Disease Clinical Trajectories
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: IRCCS National Neurological Institute "C. Mondino" Foundation
First posted: 2023-12-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PD patients with and without GBA mutations and asymptomatic GBA mutation carriers, relatives of GBA-PD patients.

Brief summary: Glucocerebrosidase (GBA) mutations are the most common risk factor for Parkinson's Disease (PD). GBA-related PD(GBA-PD) exhibits a more malignant phenotype as compared to no-carriers. Still, the mechanisms behind the increased malignancy in GBA-PD are not well understood. The definition of biomarkers able to stratify PD clinical trajectories in PD is therefore crucial to identify effective treatments and support diagnosis.The investigators will examine the role of GBA-mutations in accelerating a-synuclein (a-syn) and synaptic pathologies in PD by combining neuroimaging (positron emission tomography-PET), biochemical and clinical features. This will illuminate the pathophysiology underlying GBA-mutations in PD and identify biomarkers for the malignant PD phenotype. Also, the investigators will combine longitudinal clinical and imaging/biochemical features to define a prognostic algorithm for predicting disease faster progression in GBA-PD and monitoring disease trajectories in unaffected GBA carriers.


Eligibility criteria: Inclusion Criteria:

* PD diagnosis according to MDS-PD criteria and for GBA-PD group, presence of heterozygous GBA mutations;
* disease duration 3-7years.

Exclusion Criteria:

* other neurological or systemic diseases;
* presence of mutations in another PD gene;
* impossibility or unwillingness to perform FDG-PET.

Primary outcomes:
measure: FDG-PET to measure cerebral metabolism between Parkinson's subjects with a mutation in GBA gene (MP-GBA) compared to patients with idiopathic Parkinson's.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Neurological Institute Foundation Casimiro Mondino
Study officials:
References:
Clinical trial NCT03065803: Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.
Official title: Clinical Assessment of Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in The Esthetic Zone: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption After Tooth Extraction
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2017-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.


Eligibility criteria: Inclusion Criteria:

* Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar.
* Cause of tooth extraction is due to caries, trauma or failed endodontic treatment.
* Only teeth with intact buccal bone plate will be considered for this study.
* Patients who are cooperative, motivated and hygiene conscious.
* Patients whose age is \>18 years

Exclusion Criteria:

* Systemic conditions/disease that contraindicated surgery.
* Patients on drugs that may compromise bone healing.
* Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
* Smokers.
* Patients with Psychologic disorder.
* Pregnancy or lactation.
* Presence of acute periodontal or periapical pathology.

Primary outcomes:
measure: measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02253303: Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-
Official title: Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
Collaborators: name: Katsunari Takifuji
First posted: 2014-10-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
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 midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.

Detailed description: Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.

Eligibility criteria: Inclusion Criteria:

* Tumor size is less than 5cm
* No history of laparotomy
* No bowel obstruction by tumor

Exclusion Criteria:

* Patients who can't respond to medical question
* Patients who receive steroids or insulin therapy
* Uncontrolled DM
* Severe respiratory failure(HOT)

Primary outcomes:
measure: cosmetic effect
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 7 days, 14 days and 30 days
Other outcomes:
measure: Incisional hernia
timeFrame: 1 year
Locations:
Study officials:
affiliation: Second Department of Surgery, Wakayama Medical University
name: HIroki Yamaue, Chief prof.
role: STUDY_DIRECTOR
References:
citation: Samia H, Lawrence J, Nobel T, Stein S, Champagne BJ, Delaney CP. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should we be avoiding the midline? Am J Surg. 2013 Mar;205(3):264-7; discussion 268. doi: 10.1016/j.amjsurg.2013.01.006. Epub 2013 Jan 31.
citation: Singh R, Omiccioli A, Hegge S, McKinley C. Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc. 2008 Dec;22(12):2596-600. doi: 10.1007/s00464-008-9845-8. Epub 2008 Mar 18.
citation: Lee L, Mappin-Kasirer B, Sender Liberman A, Stein B, Charlebois P, Vassiliou M, Fried GM, Feldman LS. High incidence of symptomatic incisional hernia after midline extraction in laparoscopic colon resection. Surg Endosc. 2012 Nov;26(11):3180-5. doi: 10.1007/s00464-012-2311-7. Epub 2012 May 12.
Clinical trial NCT04341103: AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience
Official title: AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Organ Transplant Rejection
COVID-19
Lead sponsor: CareDx
Sponsor class: INDUSTRY
First posted: 2020-04-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid organ (liver, heart, lung or kidney) transplant recipients diagnosed with suspected or confirmed case of COVID-19

Brief summary: The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19

Detailed description: An observational case series of patients with solid organ transplants who have been admitted with suspected COVID-19 utilizing AlloSure dd-cf DNA to help guide immunosuppression management balancing the treatment of sepsis and avoiding allograft rejection.

Eligibility criteria: Inclusion Criteria:

* Liver, Heart, Lung or Kidney organ transplant recipient with a suspected or confirmed diagnosis of COVID-19

Exclusion Criteria:

Primary outcomes:
measure: Assessing the utility of AlloSure dd-cfDNA to guide clinical immune-optimization for transplant patients with COVID-19
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: