louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02085122: Exercise and Noninvasive Ventilation in Heart Failure Patients
Official title: Impact of Noninvasive Ventilation With Two Levels of Pressure on Exercise Tolerance in Subjects With Heart Failure: Randomized and Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF) subjects, hampering performance in activities of daily living. In this context, noninvasive ventilation (NIV) has been used to minimize such impairment, increasing functional capacity Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A randomized crossover clinical trial with allocation concealment consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.


Eligibility criteria: Inclusion Criteria:

* Both sexes, 18-60 years
* body mass index (BMI) \<30 kg/m2
* functional class II-III according to the New York Heart Association
* of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45% - echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)\> 55mm
* Diameter Systolic left Ventricular (LVSD)\> 45mm )
* optimized from the point of view of drug and (6) clinical stability

Exclusion Criteria:

* (1) unstable angina, myocardial infarction or heart surgery three months before the beginning of the research

  (2) chronic orthopedic, infectious or metabolic diseases

  (3) FEV1/FVC \<70% predicted characterizing obstructive respiratory disorder; (4) active smokers

  (5) Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) \<60 bpm, recent trauma, nausea and vomiting face

Primary outcomes:
measure: Cardiopulmonary Exercise Test
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Departamento de Fisioterapia da UFPE
state: Pernambuco
Study officials:
References:
citation: Olson TP, Johnson BD. Influence of cardiomegaly on disordered breathing during exercise in chronic heart failure. Eur J Heart Fail. 2011 Mar;13(3):311-8. doi: 10.1093/eurjhf/hfq177. Epub 2010 Oct 16.
citation: Carvalho LA, Brandao DC, Campos SL, Vidal TMS, Remigio MI, Martins SM, Dornelas de Andrade A. Noninvasive Ventilation Before Maximum Exercise Test Increases Exercise Tolerance in Subjects With Heart Failure: A Crossover Study. Arch Phys Med Rehabil. 2017 May;98(5):849-855. doi: 10.1016/j.apmr.2016.09.129. Epub 2016 Oct 26.
Clinical trial NCT00639522: Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
Official title: A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Carcinoma
Keywords: Liposomal paclitaxel
Maximum tolerated dose
Pharmacokinetics
Gastric carcinoma
Lead sponsor: Nanjing Sike Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.

Detailed description: The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.

Eligibility criteria: Inclusion Criteria:

* Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
* No prior systemic chemotherapy with taxane at least 6 months before the recruitment;
* At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Patients who are expected to live at least 3 months;
* Obtaining informed consent;

Exclusion Criteria:

* Receiving other chemotherapy or radiotherapy during the administration;
* Symptomatic metastatic brain tumor;
* Allergy to any study medication;
* Pregnancy or breast feeding;
* Severe heart diseases;
* Uncontrolled mental diseases;
* Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr;
* Neutrophils（ANC）\<2000/μL;platelets\<100，000/μL;hemoglobin（HB）\<9.0 g/dL;

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: 6 weeks
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 48 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital,Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Science
name: Jinwan Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02685722: UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers
Official title: Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Difficult to Healing of Skin Ulcers
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 78
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study for a six-month trials, Randomized, open, and parallel comparison before and after its own, Stage test includes screening stage, treatment period and follow-up period. In accordance with chronic wound criteria for the patient, By producing the principle of random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according to the situation of wound healing time and decided to use the secondary treatment, To observe the clinical efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Older than 17 year old male or female (pregnancy);
* Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years of age must be signed by the guardian informed consent;
* The process of psychological stability, can finish the tes

Exclusion Criteria:

* Allergic constitution, or known allergic to pork or beef source products, gao min physique person;
* The wound is more than 10 cm by 10 cm;
* People with mental illness, drug abusers and or other items;
* 1 month used or are using the sugar metabolism of drugs, such as corticosteroids, thiazide diuretics, tricyclic antidepressants, etc;
* 3 month participated in other similar test;
* Serious infectious disease not controller;
* With surgery, such as severe trauma stress situation;
* Always had a history of tumor;
* Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Relative Wound Area Regression of 40% or More at 6 Week
timeFrame: 6 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: xiaobing Fu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914822: The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects
Official title: The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pharmacological Action (PA)
Keywords: Ritalin
methylphenidate hydrochloride
experimental pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 41
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. To examine whether Ritalin has analgesic properties in healthy subjects.
2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a broader, non-specific effect on high mental functions.


Eligibility criteria: Inclusion Criteria:

* Male subjects between the ages of 20 to 40
* Healthy subjects without known disease and without any chronic pain
* Subjects without known cognitive problems, which can understand the research and its goals
* Subjects who are not taking any medications
* Subjects without hearing problems
* Subjects without attention deficit disorder (ADHD) problems

Exclusion Criteria:

* Subjects who are known to suffer from any disease or any chronic pain
* Subjects taking psychotropic drugs (except Ritalin) or any analgesics
* Subjects who have any contradictions for ritalin administration
* subjects with suspected cognitive disability

Primary outcomes:
measure: Experimental pain intensity measured on a visual analogue scale (0-100)
timeFrame: 4 hours
Secondary outcomes:
measure: effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations
timeFrame: 4 hours
measure: pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
Study officials:
affiliation: Rambam Helthcare Campus, Haifa, Israel 31096
name: Elon Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03928522: Antibiotic Elution in Total Knee Arthroplasty
Official title: Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Replacement
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 60
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 the study is to characterize and quantify the level of antibiotics eluted from antibiotic laden cement after primary cemented total knee arthroplasty.

Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria.

Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.

Detailed description: Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria.

Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.
* Primary diagnosis of knee osteoarthritis

  * Exclusion Criteria:
* Diminished mental capacity
* Vancomycin allergy
* Tobramycin allergy
* Patient history requiring IV administration of vancomycin or tobramycin perioperatively
* Chronic kidney disease stage III and stage IV

Primary outcomes:
measure: Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Orthopedics
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Charles Lawrie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537522: Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contact Lens Base Curve (BC) Fit and Comfort
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.


Eligibility criteria: Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
* The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
* The subject must be willing and able to adhere to the instructions set out in the protocol.
* The subject must be an adapted soft contact lens wearer in both eyes.
* The subject must be willing to wear the study contact lenses up to 14 hours/day.
* The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
* The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
* The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
* The subject must require a visual correction in both eyes (no monofit or monovision allowed).
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

* Current 1-DAY ACUVUE® TruEye® wearers
* Anisometropia of 1.00 D or greater
* Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
* Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
* Pregnancy or lactation
* Diabetes
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Primary outcomes:
measure: Correlation Between Subjective CLUE Comfort and Keratometry
timeFrame: 3-day follow-up
measure: Correlation Between Subjective CLUE Comfort and Corneal Diameter
timeFrame: 3-day follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
Study officials:
References:
Clinical trial NCT04223622: Effects of ASC Secretome on Human Osteochondral Explants
Official title: Secretome from Mesenchymal Stem/stromal Cells on Human Osteochondral Explants: Cocktail of Factors Secreted by Adipose-derived Stromal Cells (ASC) for the Treatment of Osteoarthritis And/or for Articular Regeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: mesenchymal stem/stromal cells
conditioned medium
extracellular vesicles
ASC
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Upon signing the Informed Consent, 24 male/female patients undergoing orthopedic surgery at IRCCS Istituto Ortopedico Galeazzi and matching the inclusion and esclusion criteria will be recruited.

Brief summary: Since the need of finding effective disease-modifying anti-osteoarthritis (OA) treatments is still unmet, with this study the investigators aim to gather further evidences of the therapeutic potential of Mesenchymal Stem/stromal Cell (MSC) secretome in order to pave the way to its future use as a cell-free biological product. In detail, the investigators predict to validate the promising results obtained in vitro, ex vivo on osteochondral explants, an OA model more representative of the physiological situation.


Eligibility criteria: Inclusion Criteria:

* males and females
* age≥18 years old
* patients hospitalized in IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Ortopedico Galeazzi, undergoing arthroplasty

Exclusion Criteria:

* age\<18 years old
* patients unable to sign the Informed Consent
* positivity to serological test (HIV-Human Immunodeficiency Virus, HCV -Hepatitis C Virus, HBV -Hepatitis B Virus and TPHA -Treponema Pallidum Hemagglutination Assay)

Primary outcomes:
measure: Validation of the cell-free approach based on the use of ASC secretome on an ex vivo OA model by evaluation of cell viability, histological features and gene/protein expression of cartilage and bone biomarkers
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
state: MI
Study officials:
References:
citation: Niada S, Giannasi C, Gomarasca M, Stanco D, Casati S, Brini AT. Adipose-derived stromal cell secretome reduces TNFalpha-induced hypertrophy and catabolic markers in primary human articular chondrocytes. Stem Cell Res. 2019 Jul;38:101463. doi: 10.1016/j.scr.2019.101463. Epub 2019 May 15.
Clinical trial NCT06033222: A Study of Perturbation of Human Small Intestinal Colonic Permeability
Official title: Developing an Approach to Perturbation of Human Small Intestinal and Colonic Permeability in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals.

Detailed description: Randomized, parallel-group, placebo-controlled, blinded, dose-response study using Castor oil and see the effects it has on small bowel and colonic permeability measured in healthy female and male adults.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-obese, non-pregnant volunteers.
* 1:1 Male/Female Ratio.
* BMI \< 30 kg/m\^2.

Exclusion Criteria:

* Diabetes.
* Uncontrolled hypertension (with BP measured \> 140/90mmHg in the CRTU)
* BMI ≥ 30 kg/m\^2.
* Chronic NSAID use (\> 1 day/week).
* Use of oral antibiotics for 2 weeks prior to and during the entire 5 day study period.
* Known intolerance of castor oil.
* Diagnosis of gastrointestinal diseases that are associated with abnormal intestinal or colonic permeability such as inflammatory bowel diseases, irritable bowel syndrome and celiac disease.
* Prior intestinal or colonic resection.
* Participation in highly vigorous exercise such as running \> 5 miles per day in week prior to the permeability test.

Primary outcomes:
measure: Change in urinary excretion of 13^C-mannitol
timeFrame: 0-2 hours, 2-8 hours and 8-24 hours
Secondary outcomes:
measure: Change in urinary excretion of lactulose
timeFrame: 0-2 hours, 2-8 hours and 8-24 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00714922: Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)
Official title: Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare clinical outcomes from PRK and SBK using FDA-approved laser technology in the same patient

Detailed description: Patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with PRK and the fellow eye treated with SBK.

Eligibility criteria: Inclusion Criteria:

* Patients deemed to be suitable candidates for bilateral LASIK surgery

Exclusion Criteria:

* Patients who desire monovision correction rather than bilateral distance correction

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Manifest refraction
timeFrame: 6 months
measure: Wavefront aberration value
timeFrame: 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, John Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Majid Moshirfar, MD
role: PRINCIPAL_INVESTIGATOR
References: