louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06087172: Validity of 6 Minutes Stepper Test in Hypertension
Official title: Validity and Reliability of 6 Minutes Stepper Test in Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Hypertension
Keywords: Stepper Test
Exercise Capacity
Cardiac Rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed with systemic (arterial) hypertension and convenient with inclusion and exclusion criterias.

Brief summary: The six minutes stepper test (6MST) was used assess exercise capacity of individuals having different chronic conditions. In the literature, there are some validation studies analyzing validity of 6MST. In this study, the main aim was to analyse validation of 6MST in hypertensive individuals.

Detailed description: 6MST is a space-safe, feasible and sensitive test to assess exercise capacity. In the literature, there are lots of field tests assessing exercise capacity of individuals with chronic status. But common field tests eg 6MWT requires long spaces and it could become an important barrier in clinical settings. Hypertension is a common chronic disease and hypertensive individuals are important candidates of cardiac rehabilitation. As an important outcome assesing exercise capacity are very important before and after cardiac rehabilitation. In this study, the main aim was to investigate reliability and validity of 6MST in systemic hypertension.

Eligibility criteria: Inclusion Criterias:

* Being 18 to 65 years,
* Diagnosed with hypertension and willing to participate the study.

Exclusion Criterias:

* having a neurological, cognitive and/or orthopedic disease that affect the measurements,
* severe respiratory disease (FEV1 \< 35%; FVC \< 50%),
* presence of acute infection,
* any malignancy,
* dementia,
* any cardiovascular event in the last 6 months,
* uncontrolled hypertension and diabetes
* body mass index (BMI) higher than 40 kg/m2

Primary outcomes:
measure: exercise capacity
timeFrame: through study completion two day
measure: functional capacity
timeFrame: through study completion two day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ebru Calik Kutukcu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00881972: Physical Activity and Glycemic Control
Official title: Physical Activity and Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will test the effects of daily physical activity on variations in blood glucose control.


Eligibility criteria: Inclusion Criteria:

* Young, healthy

Exclusion Criteria:

* Chronic disease

Primary outcomes:
measure: Blood glucose fluctuations
timeFrame: days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: Univerisity of Missouri-Columbia
name: John P Thyfault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04991272: 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature
Official title: Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Keywords: hypothermia
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.

Detailed description: During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.

Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.

Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion Criteria:

* moderate to severe cardiopulmonary, renal impairment
* thyroid disease
* any infection sign
* abnormal temperature prior to induction of general anesthesia (\<36'C or \>37.5'C)
* refusal to participate in the study
* unable to understand the study

Primary outcomes:
measure: incidence of hypothermia at the end of the operation
timeFrame: approximately 1-2hours after induction (at the end of operation)
Secondary outcomes:
measure: change in temperature before and end of operation
timeFrame: on arrival at the OR upto 1-2hours after induction (at the end of the operation)
measure: incidence of shivering
timeFrame: upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
measure: thermal comfort
timeFrame: upto 1hour after end of the operation (at discharge of postanesthesia care unit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital
Study officials:
affiliation: Associate professor
name: In-Jung Jun, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091272: A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers
Official title: A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04995274 After Administration Of Single Oral Doses To Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteer
safety
pharmacokinetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Detailed description: The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.

Eligibility criteria: Inclusion Criteria:

* For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing women; women of childbearing potential. Female subjects must be of non childbearing potential defined by a history of surgical sterilization (eg, hysterectomy or bilateral oophorectomy) or post menopausal status (complete absence of menses for at least two consecutive years) and elevated FSH concentration in women between 45 and 55.

Primary outcomes:
measure: Safety Endpoints (AE's, Vital signs (supine & standing BP, PR), Triplicate ECG, 8 hours of cardiac telemetry postdose, Clinical safety laboratory endpoints, Digit Symbol Substitution Test (DSST), Drug Effect Questionnaire (DEQ), Clinical
timeFrame: up to 21 days post dose
measure: examinations)
timeFrame: up to 21 days post dose
measure: Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.
timeFrame: up to 7 days post dose
measure: Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.
timeFrame: up to 7 days post dosing
Secondary outcomes:
measure: Plasma aldosterone concentrations
timeFrame: through 1 day post dosing
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03662672: Rib Raising for Post-operative Ileus
Official title: Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Pseudo-Obstruction
Manipulation, Osteopathic
Postoperative Care
Postoperative Nausea and Vomiting
Postoperative Complications
Osteopathic Medicine
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are conducting a randomized controlled trial the use of rib raising for post-operative ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all patients undergoing major abdominal surgery and once they have been enrolled, we will randomize them to receive daily rib raising or a control technique where we place hands on the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to reduce post-operative ileus and hospital length of stay by up to 50%.


Eligibility criteria: Inclusion Criteria:

* Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)

Exclusion Criteria:

* Open abdomen for \>72 hours
* Prior history of major post-operative complications
* Intolerance to anesthesia
* Co-morbidities including osteoporosis and osteopenia
* Spine or rib fractures
* Pregnancy
* Prisoners
* History of osteopathic manipulation
* Recruitment delayed beyond 48 hours
* Surgeon requested exclusion

Primary outcomes:
measure: Length of Stay
timeFrame: 0-14 days
Secondary outcomes:
measure: Time to first meal
timeFrame: 0-14 days
measure: Time to first flatus
timeFrame: 0-14 days
measure: Time to first bowel movement
timeFrame: 0-14 days
measure: Need for nasogastric tube postop
timeFrame: 0-14 days
measure: Nausea/vomiting postop
timeFrame: 0-14 days
Other outcomes:
Locations:
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
References:
citation: Baltazar GA, Betler MP, Akella K, Khatri R, Asaro R, Chendrasekhar A. Effect of osteopathic manipulative treatment on incidence of postoperative ileus and hospital length of stay in general surgical patients. J Am Osteopath Assoc. 2013 Mar;113(3):204-9.
citation: Crow WT, Gorodinsky L. Does osteopathic manipulative treatment (OMT) improves outcomes in patients who develop postoperative ileus: A retrospective chart review. International Journal of Osteopathic Medicine. 2009;12(1):32-7.
citation: Herrmann EP. Postoperative adynamic ileus: its prevention and treatment by osteopathic manipulation. The DO. 1965;6(2):163-4.
Clinical trial NCT01630772: Physical Therapy in Pregnant Women With Preeclampsia
Official title: Influence of a Physical Therapy Protocol in Maternal and Fetal Hemodynamics in Pregnant Women With Preeclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Preeclampsia
Keywords: women with preeclampsia
physical therapy
maternal-fetal hemodynamics
perinatal outcomes
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the influence that has a physical therapy protocol in maternal and fetal hemodynamics in relation to blood pressure, maternal and fetal responses and perinatal outcomes.

Detailed description: The hypertensive disorders in pregnancy affecting 5-8% of pregnant women worldwide, contributing significantly to maternal and fetal complications. Various forms of hypertensive disorders occurring during pregnancy, including preeclampsia and chronic hypertension with superimposed preeclampsia. These two disorders present with high blood pressure and proteinuria, and often lead to the hospitalization of pregnant women.

The objective is to evaluate the effectiveness of a physical therapy protocol used in pregnant women with preeclampsia on blood pressure, maternal-fetal outcomes and perinatal outcomes.

Participants in the study pregnant women with preeclampsia and hypertension with superimposed pre-eclampsia, hospitalized, with no significant complications that may impair the normal course of pregnancy. All pregnant women are monitored through laboratory and clinical data and the fetus monitored by tests that assessed their vitality, in addition, pregnant women in the intervention group performed the proposed physiotherapeutic the study protocol.

Eligibility criteria: Inclusion Criteria:

Participed of The study, high-risk pregnant women with gestational age between 24 and 38 weeks, hospitalized with a diagnosis of preeclampsia or chronic hypertension with superimposed preeclampsia, with no other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal well.

Exclusion Criteria:

* Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;
* 24-hour proteinuria above 2 g
* Laboratory abnormalities (thrombocytopenia, alteration of renal function, elevated liver enzymes, elevated bilirubin);
* Request the patient to leave the project.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: The Hospital Clinics, University of Sao Paulo
state: Sao Paulo
Study officials:
References:
Clinical trial NCT00091572: Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Official title: Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Keywords: Metastatic Melanoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2004-09-14
Enrollment: 859
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 this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, stage IV, surgically incurable melanoma
* Age 18 years or older
* World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Meets protocol requirements for specified laboratory values
* Must be able to take oral medication
* Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin).
* Women of childbearing potential and men must be practicing a medically approved contraception.
* Must provide written informed-consent to participate in the study.
* Must have full recovery from major surgery or adjuvant treatment
* No clinically uncontrolled infectious disease including HIV or AIDS-related illness

Exclusion Criteria:

* Ocular melanomas
* Brain Metastases
* Prior cytokine or chemotherapy for stage IV disease
* Pregnant or nursing women

Primary outcomes:
measure: Overall Survival
timeFrame: The final analysis was to be performed when at least 616 deaths had occurred.
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
measure: Objective Response Rate in Subjects With Measurable Lesions
timeFrame: Treatment continued until disease progression or unacceptable toxicity.
measure: Duration of Objective Response
timeFrame: Treatment continued until disease progression or unacceptable toxicity.
Other outcomes:
Locations:
Study officials:
References:
citation: Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.
Clinical trial NCT03023072: Evaluation of an Incontinence Product
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Incontinence
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Care Unit

Brief summary: The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.


Eligibility criteria: Inclusion Criteria:

* English speaking/reading adults, age ≥ 18 years
* Incontinent (fecal, urine, or dual incontinence)
* Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
* Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
* Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent

Exclusion Criteria:

* Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
* Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
* Is considered to be near death or requires hospice care

Primary outcomes:
measure: Patient exposure time following an incontinence event
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Patient satisfaction surveys
timeFrame: Through study completion, an average of 6 months
measure: Staff satisfaction surveys
timeFrame: Through study completion, an average of 6 months
measure: Family/patient support member surveys
timeFrame: Through study completion, an average of 6 months
measure: Incidence of incontinence associated skin irritation and breakdown issues
timeFrame: Through study completion, an average of 6 months
measure: Incidence of pressure injuries
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Regional Medical Center
state: Indiana
Study officials:
References:
Clinical trial NCT04822272: MagneThermoPro : Magnetic Resonance Thermography of Human Prostate
Official title: MagneThermoPro : Magnetic Resonance Thermography of Human Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Diagnosis
Keywords: MRI
prostate
thermometry
laser
ablation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance

Detailed description: Prostate MRI has become the benchmark examination to search for tumor targets, thanks to a multi-parameter protocol, including T2 sequences, diffusions, and T1 with gadolinium injection. A PIRADS prognostic score is performed on the different sequences and if the lesions are at high risk of malignancy (PIRADS 4 and 5), a targeted biopsy is performed. Minimally invasive ablations called focal treatments are developing more and more: HIFU, cryotherapy, laser, etc. Ultrasound remains the most widespread examination due to its availability, but with less sensitivity than MRI. Ablations are performed under ultrasound with fusion of MRI images In order to assess the ablation area under MRI, the measurement of temperature variations appears necessary to verify the effectiveness of ablation and the lesion volume. Temperature maps are feasible in cardiac MRI during radiofrequency. The thermal mapping MRI sequence is performed in cardiac MRI at the IHU in Bordeaux.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patient with indication of injected multi-parameter MRI for the diagnosis of prostate cancer.
* Signed informed consent.
* Person affiliated or beneficiary of health insurance

Exclusion Criteria:

* MRI contraindications (Pace Maker, metallic foreign body, metallic heart valve).
* Contraindication to gadolinium salt,
* Patient under legal protection

Primary outcomes:
measure: signal noise ratio
timeFrame: End of MRI exam (hour 1)
Secondary outcomes:
measure: temperature variance
timeFrame: End of MRI exam (hour 1)
measure: spatial distortion measurement
timeFrame: End of MRI exam (hour 1)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: