louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01457976: A Survey on Attitudes on Financial Incentives
Official title: A Survey on Attitudes on Personal Responsibility and the Use of Financial Incentives for Health Promotion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Colon Cancer
Keywords: cancer
obesity
personal responsibility
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult American and Germans

Brief summary: The study concerns a survey of attitudes of the public on issues around personal responsibility for health and the use of financial incentives to promote health in the U.S. and Germany. All data are gathered anonymously through online platforms. Two separate professional panel providers are used for access to members of the public. All participants are people who have voluntarily joined a survey panel in the past through an informed consent process and currently serve as panel members.


Eligibility criteria: Inclusion Criteria:

* none other than age

Exclusion Criteria:

* none other than age

Primary outcomes:
measure: Survey respondents are presented with scenarios that seek to elicit views and attitudes on the concepts of personal responsibility, and the acceptability of financial incentives. The analysis will present these views and attitudes in aggregate form.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Online survey
state: Pennsylvania
Study officials:
affiliation: School of Medicine, University of Pennsylvania
name: Kevin Volpp, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00728676: Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive Behaviors
Official title: Pilot Study to Evaluate the Effects of Kuvan on Adult Individuals With Phenylketonuria With Measurable Maladaptive Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phenylketonuria
Keywords: PKU,
Phe,
PAH,
Kuvan,
Trp,
Tyr
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2008-08-06
Enrollment: 10
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: Individuals with PKU followed at our clinic

Brief summary: To validate the outcome measures and the tolerability of Kuvan treatment in the improvement of behavioral symptoms in 10 selected adults with Phenylketonuria (PKU) with or without mental retardation.


Eligibility criteria: Inclusion Criteria:

* Biochemical confirmation of PKU,
* Measurable maladaptive behavior at baseline,
* Signed informed consent,
* Not pregnant or lactating,
* Females on birth control if applicable,
* Willing to comply.

Exclusion Criteria:

* Subjects or care provider unreliable, use of investigational products within 30 days prior to enrollment,
* Pregnant or lactating,
* Concurrent disease or condition that would interfere with study participation or safety, ie multiple psychotropic meds, any condition the PI renders the subject at high risk, on drugs that inhibit folate synthesis,
* Concurrent use of levodopa.

Primary outcomes:
measure: Pattern of change from baseline to 6 and 12 months in Vineland scale standard scores, evaluated with a repeated measure ANOVA approach.
timeFrame: One year
Secondary outcomes:
measure: Correlation and regression methods (non-linear if appropriate) to examine the relationship between changes in behavior and in amino acid profiles.
timeFrame: one year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Shoji Yano, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05346276: PET Imaging of LAG-3 Expression
Official title: 68Ga-DOTA-hLAG-3 PET Imaging of LAG-3 Expression in Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor, Solid
Keywords: Tumor
Solid
LAG-3
68Ga-DOTA-hLAG-3
PET/CT
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with various types of cancer undergo 68Ga-DOTA-hLAG-3 PET/CT for comprehensively evaluation of LAG-3 expression.
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-DOTA-hLAG-3 positron emission tomography/computed tomography (PET/CT) for the evaluation of LAG-3 expression in primary and/or metastatic tumors, compared with histopathological results.

Detailed description: Participants with cancer underwent 68Ga-DOTA-hLAG-3 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the LAG-3 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-DOTA-hLAG-3 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.

Eligibility criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order);
* (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
* (iii) patients who had scheduled 68Ga-DOTA-hLAG-3 PET/CT scans;
* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions;
* (ii) patients with pregnancy;
* (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression
timeFrame: 30 days
Secondary outcomes:
measure: Evaluate the inter-tumor heterogeneity
timeFrame: 30 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First affiliated hospital of xiamen university
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Long Sun, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05458076: A Study of QLS1128 and in Combination With Ritonavir in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Single-and Multiple-dose Escalation, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QLS1128 and in Combination With Ritonavir in Healthy Participants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate safety, tolerability and pharmacokinetics of QLS1128 sustained-release tablets and in combination with ritonavir tablets in healthy participants


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between ages of 18-45 years.
* Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 27 kg/m2.
* Female participants of child-bearing potential/ Male subjects had fertile female partners must agree to use effective contraception from screening until 30 days after last dose.

Exclusion Criteria:

* Participant who have a past history of COVID-19 infection or are currently showing symptoms of COVID-19 infection.
* Participant who have been treated with any SARS-COV-2 neutralizing antibody or participated in clinical trials related to SARS-COV-2 (e.g., SARS-COV-2 neutralizing antibody, oral drug clinical trials, etc.).
* Participant who tested positive for SARS-COV-2 nucleic acid during the screening period, or who were positive for COVID-19 antibody if not vaccinated against COVID-19.
* Participant who have a clear history of allergy to drugs, food or pollen, or are allergic to ritonavir tablets and QLS1128 sustained-release tablets.
* Any clinical serious disease of cardiovascular, endocrine, neurological, digestive, respiratory, hematological, metabolic, psychiatric or other systems determined by the investigator may interfere with the results of this clinical trial.

Primary outcomes:
measure: The Adverse events of QLS1128
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: The PK parameters of QLS1128
timeFrame: Day 1 to Day 3
Other outcomes:
measure: The PK parameters of QLS1128
timeFrame: Day 1 to Day 3
measure: The PK parameters of QLS1128
timeFrame: Day 1 up to Day 7
measure: The PK parameters of QLS1128
timeFrame: Day 1 up to Day 7
Locations:
city: Jinan
country: China
facility: Qilu Pharmaceutical Co., Ltd.
state: Shandong
Study officials:
affiliation: Qilu Pharmaceutical Co., Ltd.
name: yunfei ju, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06084676: Organoid Model Predictive of Response to Immunotherapies
Official title: Organoid Model Predictive of Response to Immunotherapies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are planning on receiving a fresh biopsy sample will be identified in the IU Oncology outpatient clinics or by referral from outside physicians.

Brief summary: The purpose of this study is to create models out of tissue samples and treat those models with the same immunotherapy treatment the patient will be receiving, in order to validate this process and to predict responses to therapies and use it to choose the best treatments for people in the future. The researchers will then examine the direct effects of the treatment on those models.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Biopsy proven diagnosis of cancer
4. Able to obtain at least 2 16 gage cores of fresh tissue safely (3 or more cores preferred)
5. Planning to undergo standard of care Immunotherapy
6. Baseline standard of care CT within 8 weeks of starting Immunotherapy

Exclusion Criteria:

1. Inability to provide fresh biopsy sample
2. Any active infections
3. Any conditions that in the opinion of treating physician and the study team will compromise the ability of the patient to receive prescribed treatment to assess the response.

Primary outcomes:
measure: Calculate overall patient response rate
timeFrame: Baseline to 12 months
measure: Reliability of organoid development
timeFrame: Baseline to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Mateusz Opyrchal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03684876: Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery
Official title: Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiorenal Syndrome
Keywords: cardiac surgery
venous congestion
diuretic depletion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 40
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: patient age \>=18 years

Brief summary: Following cardiac surgery, right ventricular function may be altered leading to increase central venous pressure and decrease in renal blood flow. The investigator's standard care includes use of diuretic to avoid interstitial fluid accumulation. The aim of the study is to assess cardiac and renal function before and after depletion by using diuretics

Detailed description: The study will compare cardiac and renal data before and 6 hours after use of diuretic

* Echocardiographic measure of right function (S wave, TAPSE, ventricle surfaces, inferior vena cava diameter) and left function (LVEF, cardiac output
* Renal function: cumulative diuresis, creatinine level variation and incidence of acute kidney injury using KDIGO classification (creatinine level\>26.5 or diuresis\<0.05 ml kg-1 h-1)

Eligibility criteria: Inclusion Criteria:

patient undergoing elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* heart transplantation
* use of vasopressor
* chronic renal disease (DGF under 30 ml min-1)
* endocarditis
* patient under ECLS or CPIA
* patient under 18-year-old

Primary outcomes:
measure: change in renal glomerular filtration before and 6 hours after use of diurectic
timeFrame: at baseline (o hours) and 6 hours after use of diuretic
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT02124876: Accommodating for Residual Limb Fluid Volume Change
Official title: Accommodating for Residual Limb Fluid Volume Change
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diurnal Residual Limb Fluid Volume Fluctuation
Keywords: amputee
prosthetics
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-04-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transtibial amputee currently using prosthetic limbs

Brief summary: The purpose of this study is to quantify residual limb fluid volume changes between morning and afternoon hours, and to determine if fluid volume change is correlated with activity.


Eligibility criteria: Inclusion Criteria:

* transtibial amputation
* at least 18 months after amputation surgery
* ability to walk on a treadmill and stand for 90 seconds

Exclusion Criteria:

* skin breakdown on the residual limb

Primary outcomes:
measure: Residual limb fluid volume
timeFrame: 1 day
Secondary outcomes:
measure: Duration of walking and moving
timeFrame: 1 day
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT00492076: Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
Official title: A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Asthma
Keywords: Specific immunotherapy
Mite
Asthma
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 45
Sex: ALL
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.

Detailed description: The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Mild/moderate persistent asthma
* Positive skin prick test or specific IgE to mites
* Age: 14-55 years old

Exclusion Criteria:

* Immunotherapy contraindications
* Allergy to other inhalant allergens
* Previous immunotherapy (5 years)with mites

Primary outcomes:
measure: Reduction in inhaled corticosteroids
timeFrame: 4 months
Secondary outcomes:
measure: Reduction in symptoms and rescue medication Tolerability
timeFrame: 4 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino, Allergology Service
state: Navarra
Study officials:
affiliation: Hospital Virgen del Camino
name: Ana I Tabar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356376: The Effects of Pain and Pain Relief on Peripheral Nerve Excitability
Official title: The Effects of Pain and Pain Relief on Peripheral Nerve Excitability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Analgesia
Keywords: Pain
Excitability
Microneurography
Autonomic nervous system
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2024-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Subjects

Brief summary: This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief.

The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic.


Eligibility criteria: Inclusion Criteria:

* Healthy Participants able to give informed consent.

Exclusion Criteria:

* Chronic pain conditions
* Neurological or Psychiatric disease
* Other major diseases
* Pain medication within the last 24 hours

Primary outcomes:
measure: C-fiber excitability
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Action potential duration (ms)
timeFrame: Through study completion, an average of 6 months
measure: Action potential amplitude (V)
timeFrame: Through study completion, an average of 6 months
measure: Heart-rate variability (ms)
timeFrame: Through study completion, an average of 6 months
measure: Blood pressure variability (mmHg)
timeFrame: Through study completion, an average of 6 months
measure: Sympathetic Skin Response (V)
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Danish Pain Research Center
Study officials:
References:
Clinical trial NCT00718276: Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D
Official title: Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy postmenopausal women
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 35
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopausal women.

* Trial with medicinal product

Detailed description: We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at baseline between 20 to 60 nmol/l, body mass index: \< 30 kg/m2

to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus

Eligibility criteria: Inclusion criteria:

* Postmenopausal women
* Age 50 to 75 years
* Body mass index 18-29 kg/m2
* 25-hydroxyvitamin D levels 20 to 60 nmol/l
* Caucasian
* Generally healthy

Exclusion criteria:

* Serum calcium \> 2.6 nmol/L
* Use if dietary supplements (\> 400 IU vitamin D per day, \> 600 mg of calcium per day)
* Hypertension
* Diseases that carry the risk of hypercalcemia
* Use of any drug that interferes with bone metabolism in the last 12 months (bisphosphonates estrogen receptor modulators, PTH, calcitonin)
* Oral HRT in the last 6 months
* Extreme diets
* Fracture or fall in the last 3 months
* Current smoking or alcohol abuse
* Planning on a sunny vacation in the course of the trial
* Kidney stone history
* Creatinine clearance \< 30 ml/min
* Co-medications: anticoagulants, PTH, corticosteroids, thiazide diuretics, digoxin, anticonvulsants, malabsorption,z C

Primary outcomes:
measure: serum 25(OH)D levels
timeFrame: repeated assessments over 4 months
Secondary outcomes:
measure: muscle strength, blood pressure, blood glucose, bone markers
timeFrame: repeated assessments over 4 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Centre on Aging and Mobility
state: ZH
Study officials:
affiliation: University Hospital Zurich, Centre on Aging and Mobility
name: Heike Bischoff Ferrari, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: