louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04861857: Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults
Official title: Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to 12 Weeks of Eccentric Resistance Training in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy, Muscular
Aging
Inflammation
Cholesterol Deposition
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.

Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt.

Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect.

Therefore, the central hypothesize is that PR consumed while being engaged in a RET can provide more energy substrates and improve muscle recovery, redcue inflammatory markers and improve lipid metabolism. To date, no studies have studied its function on recovery from exercise nor in the elderly.


Eligibility criteria: Inclusion Criteria:

* age \>60 years
* BMI \>18 and \<30 kg/m2
* stable body weight in the past 3 months
* valid medical certifacate for practice of physical activity

Exclusion Criteria:

* diabetes or pre-diabetes as for ADA guidelines
* chronic diseases (cardiovascular, liver, respiratory, cancer, etc)
* acute inflammatory status
* regular practice of intense physical activity (\>2 sessions/week)
* treatment with steroids in the past 3 months
* regular use of \>50g/die of Parmigiano Reggiano

Primary outcomes:
measure: Leg lean Mass
timeFrame: Change from baseline to up to 12 weeks
Secondary outcomes:
measure: inflammatory marker: IL-6
timeFrame: Change from baseline to up to 12 weeks
measure: cholesterol
timeFrame: Change from baseline to up to 12 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
References:
Clinical trial NCT04200157: Testing the Decoy Effect to Increase Tobacco Treatment Uptake
Official title: Testing the Decoy Effect to Increase Tobacco Treatment Uptake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Smoking
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from ResearchMatch.org. People who are in ResearchMatch.org's database will be eligible if they are 18 years or older and self-report current tobacco use.

Brief summary: Prior research has shown that the context in which program options are presented to consumer impacts consumer choice (known as the 'decoy effect'). The aims of this study are to: (1) test whether the decoy effect can impact smokers' selection of hypothetical tobacco treatment options; (2) examine sociodemographic moderators of the decoy effect; and and (3) examine whether presenting the time and clinical effectiveness of of the different treatment options modifies the decoy effect.

Detailed description: The investigators will recruit and conduct a cross-sectional online survey through ResearchMatch (www.researchmatch.org) with 600 tobacco users across the country. The survey will ask participants for their preferences regarding hypothetical tobacco treatment programs. Participants will be randomized to 12 conditions (n=50 per condition). Each condition has a different combination of treatment options. The survey will also assess sociodemographics and tobacco use behaviors. All participants will be asked if they would like to receive information about the state's smoking cessation quitline. Participants who would like to receive information will be given the 1800-QUIT-NOW number and smokefree.gov website address.

Eligibility criteria: Inclusion Criteria:

* Self-reported current tobacco use

Exclusion Criteria:

-

Primary outcomes:
measure: Number of counseling calls chosen
timeFrame: 6 months
measure: Number of weeks until quit date chosen
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health - Translational Research Building
state: New York
Study officials:
References:
citation: Rogers ES, Vargas EA, Voigt E. Exploring the decoy effect to guide tobacco treatment choice: a randomized experiment. BMC Res Notes. 2020 Jan 2;13(1):3. doi: 10.1186/s13104-019-4873-0.
Clinical trial NCT01125657: A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
Official title: Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Pharmacokinetics of YM150
Keywords: YM150
bioequivalence study
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 44
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.


Eligibility criteria: Inclusion Criteria:

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria:

* Received any investigational drugs within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 7 days before the study
* A deviation from the assessment criteria of physical examinations or laboratory tests
* A deviation from the normal reference range of coagulation test \[PT (INR) or aPTT\]
* History of drug allergies
* Upper gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Concurrent or previous malignant tumor
* Previous treatment with YM150

Primary outcomes:
measure: Plasma concentration of YM150 and its metabolites measured by blood sample
timeFrame: for 3 days after drug administration
Secondary outcomes:
measure: Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
timeFrame: or 3 days after drug administration
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03811457: Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Official title: Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma Leukemia
Keywords: CAR-T cell, CD19, Lymphoma, Leukemia
Lead sponsor: UWELL Biopharma
Sponsor class: INDUSTRY
Collaborators: name: Liaocheng People's Hospital
First posted: 2019-01-22
Enrollment: 9
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.


Eligibility criteria: Inclusion Criteria:

* CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
* Absolute lymphocyte count, ALC )≧600/μl
* HIV, HTLV, Syphilis negative
* GPT ≦200 U/L
* Cr ≦221 umol/L
* Adequate venous access for apheresis, and no other contraindications for leukapheresis.
* Voluntary informed consent is given.

Exclusion Criteria:

* Body weight \< 20Kg
* Pregnant women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene or cell therapy products.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Expected survival\< 12 weeks
* Received investigational drug or device within 30 days pre-trial;
* Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.

Primary outcomes:
measure: The adverse events associated with CAR T cell product infusions are assessed.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng People Hospital
state: Shandong
Study officials:
affiliation: UWELL Biopharma
name: Cheng-Yi Kuo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03574857: Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
Official title: Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Heart Failure Acute
Cardiovascular Diseases
Keywords: Loop diuretics
Heart failure
Diuretic resistance
Thiazide diuretics
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 5
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 primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) \<40%
* Refractory fluid overload:
* Unresponsive (\<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)
* English or Spanish-speaking subjects
* Willing and able to comply with study procedures

Exclusion Criteria:

* Baseline thiazide use prior to admission or prior to study enrollment
* Renal replacement therapies (RRT) or glomerular filtration rate (GFR) \<30 mL/min at the time of enrollment
* Pregnant women
* Cognitive impairment
* Prisoners
* Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices
* History of cardiac transplant
* Reported allergy to thiazides
* No enteral access or unable to take medications enterally
* Palliative diuretics
* Systolic blood pressure (SBP) \<90 mm Hg prior to randomization
* Patients receiving concomitant lithium therapy

Primary outcomes:
measure: Net urine output at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Net urine output at 48 hours
timeFrame: 48 hours
measure: Net fluid balance over 12 hours
timeFrame: 24 hours
measure: Net fluid balance over 24 hours
timeFrame: 48 hours
measure: Weight change
timeFrame: 48 hours
Other outcomes:
measure: Electrolyte disturbances
timeFrame: 48 hours
measure: Worsening renal function
timeFrame: 48 hours
measure: Hospital length of stay
timeFrame: Assessed until hospital discharge, an average of 7 days
measure: ICU length of stay
timeFrame: Assessed until hospital discharge, an average of 7 days
measure: In-hospital mortality
timeFrame: Assessed until hospital discharge, an average of 7 days
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
References:
Clinical trial NCT00002057: Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Official title: Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: Nystatin
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Systemic or oral antibiotics.
* Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.

Patients with the following conditions are included:

* AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
* Able to follow instructions regarding the use of a pastille.
* Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
* Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Systemic candidiasis.
* Hypersensitivity to nystatin.
* Suspected or proven candidal esophagitis.

Patients with the following are excluded:

* Systemic candidiasis.
* Projected survival of less than 6 months.
* Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
* Hypersensitivity to nystatin.
* Suspected or proven candidal esophagitis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Veterans Administration Med Ctr / Univ of Alabama
state: Alabama
city: Princeton
country: United States
facility: Bristol - Myers Squibb Co
state: New Jersey
Study officials:
References:
Clinical trial NCT01763957: Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
Official title: The Effectiveness of Circular Muscle Exercise (the Paula Method) as Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence (SUI) in Menopausal Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress Urinary Incontinence
Sexual Satisfaction
Quality of Life
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.


Eligibility criteria: Inclusion Criteria:

* women after menopause (12 months with no period)
* aged 40 or more
* have a positive pad test leakage of 1-50 grams
* no systemic or local hormonal therapy
* literate in Hebrew and/or English

Exclusion Criteria:

* women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
* pelvic surgery within the last 6 months
* post hysterectomy or oophorectomy genital prolapse grade 3 or higher

Primary outcomes:
measure: change in the quantity of urinary leakage, measured by the one hour pad test
timeFrame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Secondary outcomes:
measure: change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID
timeFrame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
measure: improvement of sexual function
timeFrame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
measure: improvement of quality of life
timeFrame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorith Hochner-Celnikier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04679857: Substitution of the PCL in TKA With UC or PS Design
Official title: Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patient Reported Outcome
Knee Osteoarthritis
Knee Arthroplasty
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 127
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: RCT comparing UC and PS TKA

Detailed description: RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament

Eligibility criteria: Inclusion Criteria:

* scheduled for TKA

Exclusion Criteria:

* higher constraint needed

Primary outcomes:
measure: ROM
timeFrame: 10 years
measure: Patient reported outcome
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
state: Saxonia
Study officials:
affiliation: University Hospital Carl Gustav Carus, TU Dresden
name: Jörg Lützner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02354157: The Nutritional Effect of Parental Use of Food as a Reward
Official title: Field Observation of Adverse Nutritional Effect of Parental Use of Food as a Reinforcer for Non-food Related Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children's Nutrition Intake
Keywords: children dietary pattern
control rules
instrumental learning
food reinforcement
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2015-02-03
Enrollment: 207
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The parents or guardians of 207 children (97 boys and 110 girls) aged from 6 to 12 (M=8.98, SD=1.67) completed the study. Participants were recruited from metropolitan Montreal, Canada.

Brief summary: Control rules are common parental practices that use food as reward to encourage children to conduct parents' preferred behaviors. This field observational study aims to examine whether control rules are associated with children's increased fat, carbohydrate and total energy intake in everyday eating, and whether this effect is moderated by individual differences in sensitivity to reward, and by gender differences.

Detailed description: Control rules are parental practices that use food as an instrumental reinforcer to encourage children to behave in a normative manner in non-food domains. Since food high in fat or sugar is usually chosen as a reinforcer for control rules, these rules may lead to children's increased preference and every day intake of food high in sugar/fat. Research propositions were examined in 207 six to twelve-year-old children (97 boys and 110 girls). Their parents reported the children's everyday dietary intake through a food frequency questionnaire, and provided information regarding the children's sensitivity to rewards as well as an indication of how frequently they enforce family control rules.

Eligibility criteria: Inclusion Criteria:

* participants have 6-12 years old children

Exclusion Criteria:

* N.A.

Primary outcomes:
measure: Food Frequency Questionnaire
timeFrame: last month recall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: