louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00922129: Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
Official title: A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Sirolimus
Calcineurin inhibitor
prostate cancer
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the role and effectiveness of conversion to sirolimus versus CNI reduction in renal transplant patients with prostate cancer.

Detailed description: This study is designed to support the optimal use of mTOR-inhibitor by providing data for the safe and effectiveness use with sirolimus. This study will take into account effectiveness aspects such as malignancy-free survival cancer by reducing the overall exposure to calcineurin inhibitor.

Eligibility criteria: Inclusion Criteria:

* Male patients ≤ 50 years in their post renal transplant follow-up;
* Biopsy confirmed prostate cancer;
* Stable renal function with GFR ≥ 40 mL/min.

Exclusion Criteria:

* Patients with metastatic disease;
* Uncontrolled hyperlipidemia;
* Proteinuria \> 500 mg/day;
* Biopsy evidence of acute rejection within the past 3 months;
* Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication;
* Patients with mental illness;
* Inability to cooperate or communicate with the investigator or unable to complete self administered questionnaires.

Primary outcomes:
measure: Malignancy-free survival
timeFrame: Months 3, 9, 15, 21
Secondary outcomes:
measure: Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)
timeFrame: Weeks 1, 3, 6, Months 3, 6, 9, 12, 15, 18, 21 and 24
measure: Testosterone levels
timeFrame: Months 6, 12, 18 and 24
measure: Quality of life
timeFrame: Months 6, 12, 18 and 24
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster Institute of Urology, McMaster University
name: Anil Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457529: The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.
Official title: The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cervical radiculopathy is characterized by neurological dysfunction caused by compression and inflammation of the spinal nerves or nerve roots of the cervical spine. Rolotherapy is a regenerative therapeutic method that consists of injecting irritant solutions into the injured areas.

Detailed description: Hyperosmolar dextrose is the most common agent. Administering proliferant substances can accelerate the tissue healing process by inducing cellular rupture and inflammatory response, leading to collagen deposition, cellular growth factor production, and regeneration. Dry needling used to relieve trigger point release in deep and superficial muscles. Both treatment interventions will apply to cervical radiculopathy patients to measure the effectiveness of treatment.

Eligibility criteria: Inclusion Criteria:

* Age group between 20-50 years
* Both male and female
* Unilateral pain starting in the cervical spine and radiating to the upper limb.
* Pain aggravated by upper limb movement
* Restricted range of motion of arm

Exclusion Criteria:

* History of Spinal infection
* Spinal Cord Injury
* History of Vertebral tumor and factures
* History of cervical or intracranial surgery
* History of Radiating pain to bilateral upper limb.

Primary outcomes:
measure: Neck Disability Index
timeFrame: 12 Months
measure: WHO Quality of Life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Iqbal Mahmooda Hospital, Iffat Anwar Medical Complex and Life line Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03858829: Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease
Official title: Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease - (Fact-CAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
physical activity
cardiac rehabilitation
validation studies
psychometrics
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease.

Detailed description: Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease. A scale for Fear of ACTivity in patients with CAD (Fact-CAD) was created through semi-structured focus group interviews with patients. Face and content validity of Fact-CAD was verified. The scale was applied to 250 patients who had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months. Psychometric analysis included model fit, unidimensionality, reliability, local dependency, differential item functioning and external construct validity. Analyses were performed using the Rasch Analysis Model.

Eligibility criteria: Inclusion Criteria:

* Subject has had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months.

Exclusion Criteria:

* Acute cardiac event within the last month
* Attendance to cardiac rehabilitation
* İnability to read and understand,
* İnability to ambulate or unwillingness to participate

Primary outcomes:
measure: A scale for fear of activity
timeFrame: baseline
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: baseline
measure: Beck Depression Inventory
timeFrame: baseline
measure: Beck Anxiety Inventory
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Ozyemisci-Taskiran O, Demirsoy N, Atan T, Yuksel S, Coskun O, Aytur YK, Tur BS, Karakas M, Turak O, Topal S. Development and Validation of a Scale to Measure Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD). Arch Phys Med Rehabil. 2020 Mar;101(3):479-486. doi: 10.1016/j.apmr.2019.09.001. Epub 2019 Sep 25.
Clinical trial NCT00563329: Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial
Official title: Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smokers who are not willing to quit in the near future but intend to reduce smoking
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2007-11-26
Enrollment: 3826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The aims of this study are (1) to examine the effect of smoking reduction intervention (reduction counseling and nicotine replacement therapy, NRT) (a) on smoking cessation and (b) on reducing daily cigarette consumption among smokers not willing to quit smoking but want to reduce smoking, and (2) to examine the effect of adherence intervention in producing a higher (a) adherence rate, (b) reduction rate, and (c) quit rate.


Eligibility criteria: Inclusion Criteria:

* Age 18 or above
* Ethnic Chinese male or female
* Smokes at least 2 cigarettes per day
* Have no intention to quit in the near future
* Intends to reduce smoking in the next 7 days
* Has no contraindication to NRT

Exclusion Criteria:

* Subjects who are psychologically or physically unable to communicate
* Children and teenagers (age below 18)
* Pregnant or intention to become pregnant within the next 6 months
* Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions

Primary outcomes:
measure: quit rate
timeFrame: 6 months
measure: Reduction Rate (reduction of cigarette consumption by at least 50% compared with baseline)
timeFrame: 6 months
measure: Adherence Rate to NRT
timeFrame: 4 weeks
Secondary outcomes:
measure: Validated quit rate (by measuring exhaled CO and urinary cotinine level)
timeFrame: 6 months
measure: Quit rate without validation
timeFrame: 1 month
measure: self-reported use of NRT for at least 4 weeks or 8 weeks, without cotinine validation
timeFrame: 1 month / 3 month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: HAHO
city: Hong Kong
country: China
facility: Hong Kong Council on Smoking and Health
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: Department of Community Medicine, Faculty of Medicine, The University of Hong Kong
name: TH Lam, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00486629: Impact of Diet and Exercise Activity on Pregnancy Outcomes
Official title: Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Gestational Diabetes
Type 2 Diabetes
Keywords: Exercise
Diet
Pregnancy
Obesity
Macrosomia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
name: Public Health Agency of Canada (PHAC)
First posted: 2007-06-14
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Lifestyle questionnaire on mothers and offspring. Tests on glucose tolerance and epigenetic analysis in offspring.
Primary purpose: PREVENTION

Brief summary: The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring.

We hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 DM in mothers and their children.

Detailed description: Impact of lifestyle intervention on excessive gestational weight gain

Eligibility criteria: Inclusion Criteria:

* Pregnancy \< 20 weeks.
* Expressed interest in study and willingness to consent to participate in the study.

Exclusion Criteria:

* Obstetric or medical contraindications for exercise according to 2002 SOCG guideline (ruptured membranes, preterm labor, incompetent cervix, hypertensive disorders of pregnancy, growth restricted fetus, placenta previa, persistent bleeding in 2nd or 3rd trimester, significant metabolic, cardiovascular, respiratory or systemic disorder) (5, 6).
* Pre-existing diabetes (except a history of GDM, but not in current pregnancy).
* Multiple gestations.

Primary outcomes:
measure: Excessive weight gain during pregnancy
timeFrame: 2007-2023
Secondary outcomes:
measure: macrosomia, requirement of delivery procedures
timeFrame: 2007-2025
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Garry Shen, MD PhD
role: STUDY_CHAIR
References:
citation: Hui AL, Back L, Ludwig S, Gardiner P, Sevenhuysen G, Dean HJ, Sellers E, McGavock J, Morris M, Jiang D, Shen GX. Effects of lifestyle intervention on dietary intake, physical activity level, and gestational weight gain in pregnant women with different pre-pregnancy Body Mass Index in a randomized control trial. BMC Pregnancy Childbirth. 2014 Sep 24;14:331. doi: 10.1186/1471-2393-14-331.
Clinical trial NCT06873529: The Experiences of Women with Spinal Cord Injury Regarding Fertility, Contraception and Pregnancy
Official title: The Evaluation of Experiences of Women with Spinal Cord Injury Regarding Fertility, Contraception and Pregnancy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Cord Injury
Keywords: fertility
contraception
pregnancy
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with spinal cord injury who have been injured for at least 1 year

Brief summary: The aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.

Detailed description: Although some studies exist in the literature on contraception and pregnancy in women with spinal cord injury, the data still remain insufficient.

The aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.

Eligibility criteria: Inclusion Criteria:

* Ages 18-55
* Post-spinal cord injury period \> 1 year

Exclusion Criteria:

* Having cognitive impairment

Primary outcomes:
measure: Evaluation of experiences with fertility, contraception and pregnancy
timeFrame: through study completion, an average of one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Merve Örücü Atar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943929: Correlation Between Headaches and Septum and Nasal Mucosa Contact
Official title: Correlation Between Headaches and Septum and Nasal Mucosa Contact
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasal Septum Deviation
Headache
Keywords: Nasal septum
Headache
Mucosa contact point headache
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients older than 18 years whom underwent sinuses or facial tomography.

Brief summary: Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with limited number of patients, have proposed the association between nasal septum contact and headache. The International Classification of Headaches Disorders proposed specific diagnostic criteria for this entity.

With the major use of CT scans, the contact between nasal mucosa and septum is daily observed in many patients without complaint of headache.

The purpose of this study is to determine if there is any correlation between nasal and septum mucosa contact and the prevalence of headache. The investigators hypothesized that no correlation will be found using CT scans in a large series of patients.

Detailed description: Every patient older than 18 years old whom underwent sinuses or facial computed tomography will be asked to answer a questionnaire, where he will be able to describe his headache features (if present) . This information will be correlated with patient images findings, which are going to be evaluated by head and neck radiologists blinded for clinical information. Logistic regression model will be used to verify this association; the presence of sinusitis and fever will used be as covariates.

Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years whom underwent sinuses or facial tomography.

Exclusion Criteria:

* Patients with clinical history of trauma

Primary outcomes:
measure: Complain of Headache during last 3 months (binary response - question answered by the patient at the moment of CT scan)
timeFrame: within less than a day from the date that CT scan is performed
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Yves B Costa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Ellison F Cardoso, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03695029: Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
Official title: Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Virus Infection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

Detailed description: This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Eligibility criteria: Inclusion criteria:

* Women aged 20-45 years in 28 to 32 weeks of pregnancy
* Positive HBsAg and HBeAg
* Serum viral load above 6 log10 IU/mL

Exclusion criteria:

* Major systemic disease of the mother or fetus
* Positive anti-HIV or anti-HCV
* Under treatment of antiviral therapy
* Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
* Pregnant woman whose amniocentesis reveals any genetic abnormality

Primary outcomes:
measure: Child HBsAg 6 mo
timeFrame: 6 months after delivery
Secondary outcomes:
measure: Child HBsAg 12 mo
timeFrame: 12 months after delivery
measure: Maternal ALT elevation
timeFrame: 6 months after delivery
measure: Maternal HBeAg-seroconverion
timeFrame: 12 months after delivery
measure: Maternal renal
timeFrame: 6 and 12 months post delivery
measure: Materna bone marker
timeFrame: 6 and 12 months post delivery
measure: Children's growth
timeFrame: 6 and 12 months after birth
measure: Children's growth
timeFrame: 6 and 12 months after birth
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00146029: Companion Pharmacogenetic Study to UMCC 9900/9901
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Keywords: Patients who participated in UMCC 9900/9901 (Phase II Studies of Tailored-Dose Docetaxel in Metastatic Breast Cancer)
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-05
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: The purpose is to examine the original breast tumor material to see how much of a metabolizing enzyme (CYP3A4) is present in tumor material. The researchers want to see if this is in any way associated with how the patient responded to docetaxel. They also want to examine the genes in the tumor that are responsible for the production of CYP metabolizing enzymes, to see if they are normal or if they have polymorphisms, or change compared to 'normal' CYP metabolizing enzymes.


Eligibility criteria: Inclusion Criteria:

* Patients who participated on UMCC 9900/9901
* Living patients must give written informed consent

Exclusion Criteria:

* No tumor block tissue available

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Anne F. Schott, M.D.
role: PRINCIPAL_INVESTIGATOR
References: