louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02030119: Way to Be Active III (Framing Incentives)
Official title: A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Framing Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Sedentary lifestyle
Pedometers
Obesity
Physical Activity
Financial Incentives
Behavioral Economics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-01-08
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 18.
2. Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

1. A score of "high" on the International Physical Activity Questionnaire (IPAQ) activity level scale
2. BMI less than 27
3. Pregnant or lactating
4. Participation in another physical activity study

Primary outcomes:
measure: Proportion of Days Each Individual Walks 7000 Steps Per Day or More
timeFrame: Throughout the 6 month study
Secondary outcomes:
measure: Average Number of Steps Per Day
timeFrame: Throughout the 6 month study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin M Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA
role: STUDY_DIRECTOR
References:
citation: Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.
Clinical trial NCT05077319: Characteristics and Outcome of Patients With COVID-19 in ICUs in South Tyrol
Official title: Characteristics and Outcome of Patients With COVID-19 Associated Respiratory Failure Treated in South Tyrol, Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
COVID-19 Acute Respiratory Distress Syndrome
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria dell'Alto Adige
First posted: 2021-10-14
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure

Brief summary: The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy.

Detailed description: In this observational, retrospective study the epidemiology, characteristics, therapeutic interventions and outcome of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy, are assessed. Data extracted from the medical patients' records include type and duration of respiratory support (high-flow nasal oxygen, non-invasive ventilation, invasive ventilation), need for tracheostomy, vasopressor needs, antibiotic therapy, corticosteroid treatment, laboratory values (interleukin-6, C-reactive protein, procalcitonin, D-dimer, lymphocyte count), lengths of stay in the ICU and mortality.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure

Exclusion Criteria:

* SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other pathologies (i.e., not respiratory failure)

Primary outcomes:
measure: Mortality
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Eurac research
Study officials:
affiliation: Institute of Mountain Emergency Medicine
name: Simon Rauch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02970019: Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
Official title: A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease


Eligibility criteria: Inclusion Criteria:

1. Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
3. Male or female aged 18 to 65 years (both inclusive)
4. Diagnosed with Parkinson's disease

Exclusion Criteria:

1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
2. Diagnosis of Parkinson's disease Dementia (probable, possible)
3. Presence of severe dyskinesias
4. History of brain surgery for Parkinson's disease

Primary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Secondary outcomes:
measure: Peak plasma concentration
timeFrame: 4 weeks
measure: Area under the plasma concentration versus time curve
timeFrame: 4 weeks
measure: Time of observed peak plasma concentration
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: SPARC Site 03
state: California
city: Panorama City
country: United States
facility: SPARC Site 05
state: California
city: DeLand
country: United States
facility: SPARC Site 01
state: Florida
city: Orlando
country: United States
facility: SPARC Site 02
state: Florida
city: Raleigh
country: United States
facility: SPARC Site 04
state: North Carolina
Study officials:
References:
Clinical trial NCT02483819: Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostate Hyperplasia
Keywords: Elderly patient
NICOM
TURP
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 20
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patients undergoing transurethral resection of the prostate under spinal anesthesia

Brief summary: The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients.


Eligibility criteria: Inclusion Criteria:

1) Twenty (ASA status I \~ III) patients, ages 65 to 80 yr old, who were scheduled for transurethral resection of the prostate under spinal anesthesia

Exclusion Criteria:

1. if there were contraindications for spinal anesthesia including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
2. history of coronary artery bypass surgery
3. history of dementia
4. have a difficulty in understanding informed consent or refuse to sign the informed consent
5. patients height under 150 cm

Primary outcomes:
measure: change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients
timeFrame: change from baseline 1 min before the anesthesia, 10 min after anesthesia, 10 min after surgery, 20 min after surgery, 30 min after surgery, at the end of the surgery
Secondary outcomes:
measure: change of the electrolyte
timeFrame: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
measure: change of the hemoglobin
timeFrame: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
measure: estimated absorbed irrigation fluid during the surgery
timeFrame: during the surgery
measure: incidence of TURP syndrome
timeFrame: followed for the duration of hospital stay, an expected average of 7 days.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03023319: Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Official title: Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Mesothelioma
Bladder Cancer
Ovarian Cancer
Peritoneal Cancer
Thymoma
Thymus Cancer
Uterine Cervical Cancer
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.


Eligibility criteria: Inclusion Criteria:

* Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer.
* Measurable disease
* Life expectancy of greater than 3 months.
* Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria:

- Untreated or symptomatic brain metastases.

Primary outcomes:
measure: Dose-limiting toxicity of the combination of bosutinib and pemetrexed
timeFrame: 21 days
measure: Maximum tolerated dose of the combination of bosutinib and pemetrexed
timeFrame: completion of dose escalation
Secondary outcomes:
measure: Adverse events of the combination of bosutinib and pemetrexed
timeFrame: 16 weeks
measure: Anti-tumor response rate
timeFrame: 6 and 12 weeks
measure: Progression-free survival
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Georgia Cancer Center
state: Georgia
Study officials:
affiliation: Augusta University Georgia Cancer Center
name: Nagla Karim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05887219: Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Official title: Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melasma
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. The sample size was calculated by WHO Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20% azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response. Efficacy was assessed in both groups at the end of therapy after six months.


Eligibility criteria: Inclusion Criteria:

* Female patients
* Aged 20 to 45 years
* Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face)
* Diagnosed by consultant dermatologist on clinical presentation under wood's light.

Exclusion Criteria:

* Pregnant patients
* Women taking contraceptive pills at the time of study or past 12 months
* Any chronic illness
* Allergy to any of the agents used in the treatment
* Those taking any topical and systemic treatment for melasma in the last one month

Primary outcomes:
measure: Melasma Area and Severity Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Zahra Nigar
state: KPK
Study officials:
References:
Clinical trial NCT02073019: A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers
Official title: A Phase I, Two Part Study Exploring the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effect of Ascending Doses of BL-8040 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* BMI between 18 and 30 kg/m2 and Weight ≥ 60 Kg
* Subjects must be either surgically sterilized (vasectomy), or if their partner is of childbearing potential, must use two methods of contraception, one of which must be a barrier method, from the first dose until 3 months after the last dose
* Subject is able and willing to comply with the requirements of the protocol

Exclusion Criteria:

* History of clinically significant disease
* Any illness within the 4 weeks prior to the screening examination
* Any history of alcohol and/or drug of abuse addiction and/or active / past (up to 2 years before screening) nicotine consumption
* Clinically relevant deviation from normal in the physical examination and vital signs at screening or baseline
* Clinically relevant laboratory abnormalities identified at screening or baseline
* Positive tests at screening for HIV I \& II, hepatitis B and/or hepatitis C in both parts or positive tests for Syphilis, HTLV I \& II and Nucleic Acid Test (NAT) for HIV and HBV
* Positive test for urine drugs of abuse or by anamnesis (Barbiturates, Benzodiazepines, Amphetamines, Opiates, Cocaine, Cannabinoids, Methadone, Phencyclidine, and Tricyclic Antidepressants) and/or positive alcohol blood test
* Subjects who have lost or donated in excess of 400 mL of blood within 3 months prior to Day 1 of the study

Primary outcomes:
measure: Number of subjects with Adverse Events
timeFrame: Up to 7 days after treatment comletion
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Clinical Research Center
Study officials:
affiliation: BioLineRx, Ltd.
name: Arnon Aharon, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01480219: Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g
Official title: Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Melanoma Skin Carcinoma
Keywords: voriconazole
non-melanoma skin cancer
confounding
statistical adjustment
risk adjustment
lung transplant
heart/lung transplant
immunosuppression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2011-11-28
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study. Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.

Brief summary: The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large U.S. commercial health plan.

Detailed description: N/A. All patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database were sampled.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study.

Exclusion Criteria:

* Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.

Primary outcomes:
measure: Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)
timeFrame: Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01622218: The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
Official title: The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Hernia
Inguinal Hernia
Keywords: Medical clown
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.


Eligibility criteria: Inclusion Criteria:

* ages 4-10 years old
* undergoing elective umbilical or inguinal hernia repair surgery
* ASA Physical Status = 1

Exclusion Criteria:

* None

Primary outcomes:
measure: Children: WBS (Wong Baker Faces Pain Rating Scale)
timeFrame: 24 hours
Secondary outcomes:
measure: Use of analgesics
timeFrame: During the 24 hours following the surgery
measure: Cytokines levels
timeFrame: End of precedure, before waking up
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Beer Sheva
country: Israel
facility: Assuta Medical Center
Study officials:
References:
Clinical trial NCT00800618: A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
Official title: A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women


Eligibility criteria: Inclusion Criteria:

* Healthy women of childbearing potential with a regular menstrual cycle

Exclusion Criteria:

* Evidence or history of any major disease
* Pregnant or nursing women
* Requirement for chronic medication

Primary outcomes:
measure: Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.
timeFrame: 1 month
measure: PF-02413873 pharmacokinetics
timeFrame: 1 month
measure: Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: