louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03613493: Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
Official title: Acceptability of HPV Self-sampling Tools for Cervical Cancer Prevention in Jamaican Women: A Theory-based Approach to Culturally-tailored Message Design
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Keywords: HPV
self-sampling
culture
message design
health communication
Jamaica
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 175
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The proposed study aims to increase HPV screening behaviors in Jamaican women by examining the acceptability of HPV Deoxyribonucleic Acid (DNA) self-sampling tools, and to determine the most culturally appropriate and effective message design for promoting such a tool in this context.


Eligibility criteria: Inclusion Criteria:

* Jamaican women, aged 30 to 65.

Exclusion Criteria:

* Women who report having had a hysterectomy,
* have had a history of cervical cancer,
* Women who are currently up-to-date on cervical cancer screening (have had a Pap in the last 3 years or have had a Pap smear/HPV co-test within the past 5 years),
* Adults unable to consent, children, pregnant women and prisoners.

Primary outcomes:
measure: Number of Participants That Used and Returned Their Self-sampler Kit.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Susan E Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00984711: Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice
Official title: A Phase IV, Post-marketing, Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: PerCuro Clinical Research Ltd
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with active rheumatoid arthritis

Brief summary: This study was designed to gather data regarding the efficacy and safety of Rituxan in clinical practice whereby patients may present with concomitant medical conditions, medications as well as varying presentations of rheumatoid arthritis not always captured within the "purer" population seen in an industry sponsored clinical trial.


Eligibility criteria: Inclusion Criteria:

* Subjects with active rheumatoid arthritis as defined by ACR criteria
* \> 18 years of age at time of consent
* Able to start RITUXAN therapy per the approved product monograph within approximately 30 days of confirmed enrollment

Exclusion Criteria:

* Known Type 1 hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary cell proteins or to any component of RITXAN as per approved Product monograph
* Presence of any significant and or uncontrolled medical condition, which in the Investigator's opinion, precludes the use of RITUXAN as outlined in the Product Monograph

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
Study officials:
affiliation: PerCuro Clinical Research Ltd
name: Christopher Atkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541111: Magnesium Associated With Morphine for Cancer Pain Relief
Official title: Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Keywords: Cancer pain
Magnesiun
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

Detailed description: The study is prospective, randomized, double-blind. The patients will be allocated into two groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged \> 18 years of both genders with cancer pain, will be studied.

The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo capsules are identical. Everyone will receive morphine as needed.

Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after 1, 2, 3. and 4wk.

The patient will note the intensity of pain and side effects at home. Functional performance assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be assessed by the QLQ-c30.

Eligibility criteria: Inclusion Criteria:

* After approval by the Ethics Committee and signed informed consent,
* 40 patients, \> 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied

Exclusion Criteria:

* Were excluded from the study patients with hypersensitivity to drugs and pregnant

Primary outcomes:
measure: Pain relief
timeFrame: 12 wk
Secondary outcomes:
measure: Morphine dose
timeFrame: 12 wk
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01366911: Stem Cells Predicting Orthopedic Outcomes
Official title: Can Stem Cells Predict Orthopaedic Outcomes? The Correlation of Bone Density Findings Post Total Hip Arthoplasty With Stem Cell Assays Obtaned at Time of Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthroplasty
Keywords: stem cells
QCT testing
Bone density findings
mesenchymal stem cells
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic surgical patients at specific clinic

Brief summary: This is a pilot study to provide preliminary data of the association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays, obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic surgical outcomes.

Detailed description: Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs.

This ability to identify older individuals with compromised stem cell function could offer opportunities to develop and test new preventative and therapeutic strategies to improve outcomes.

Eligibility criteria: Inclusion Criteria:

* subjects who previously had a total hip arthroplasty and had stem cell assays completed on excess bone marrow

Exclusion Criteria:

* Subjects who do not wish to participate.

Primary outcomes:
measure: Can Stem Cells Predict Orthopaedic Outcomes?
timeFrame: Enrollment expected to begin June 2011and this pilot study is expected to be completed by May 2012.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Orthopaedic Surgery
state: Nebraska
Study officials:
affiliation: UNMC
name: Kevin Garvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897311: Effect of Modulation of TENS in Pain After Cesarean Section
Official title: Hypoalgesic Effect of TENS Modulation in Post-Cesarean Pain: A Clinical Trial Controlled and Randomized.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: cesarean section
pain
transcutaneous electrical nerve stimulation
postpartum period
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.

Detailed description: Mothers were randomly divided into three groups (G100, G4 and placebo (GP) - appliance off) and evaluated by NRS (numeric rating scale) before, immediately after application of TENS, and every 20 minutes until he was one hour after the application of electroanalgesia, to verify its effectiveness over time.

Eligibility criteria: Inclusion Criteria:

* aged 18 years
* present pain at the site of surgical incision less than three according to Category Numerical Scale (NRS)
* literate oriented as to time and space
* with spinal anesthesia before surgery
* incision pfannenstiel type with absence of genitourinary pathology
* primiparous or multiparous

Exclusion Criteria:

* patients with abnormal sensitivity to clinical examination
* demyelinating diseases
* spinal cord injury
* hemorrhage
* infection
* fever
* anesthetic complications
* hypertension, mammary, intolerance, irritation or strong discomfort at the injection site caused by TENS

Primary outcomes:
measure: Intensity of pain after cesarean
timeFrame: after TENS application
Secondary outcomes:
Other outcomes:
Locations:
city: Parnaíba
country: Brazil
facility: Santa Casa de Misericordia Hospital and State Hospital Dirceu Arco Verde
state: Piauí
Study officials:
affiliation: University Federal Piauí
name: Janaina Mayer de Oliveira Nunes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Clinical trial NCT03323411: End-of-life Intervention for African American Dementia Caregivers
Official title: Community-based End-of-Life Intervention for African American Dementia Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalopathy, Ischemic
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-10-27
Enrollment: 355
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: African American family caregivers over the age of 18 who attend four specific urban mega churches who meet the eligibility criteria for the study.

Brief summary: In a community-based approach, the investigators long-term goal is to empower African American family caregivers who are designated healthcare proxies to make informed end-of-life treatment decisions for participants with moderate to severe dementia before a life-threatening medical crisis occurs.

Detailed description: The investigators conducted a randomized controlled trial for efficacy of the Advance Care Treatment Program in an African American church-based community model. The investigators compared the effect of the experimental and control groups on knowledge, self-efficacy, intentions and behaviors from 4 urban African American churches randomly assigned to experimental (n=2) or control (n=2) conditions,304 (experimental n=152; control (n=152) health care proxies of participants that have advanced stage dementia: (a) were concurrently recruited in small classes each with 8-9 healthcare proxies.

Eligibility criteria: "Inclusion Criteria"

* Caregiver spouse or adult child of care recipient
* Caregiver knowledgeable about care recipient's medical history
* Care recipient must be African American
* Care recipient must have moderate to severe stage dementia
* Care recipient must lack decisional capacity

"Exclusion Criteria"

* Not a caregiver
* Care recipient not African American,
* Care recipient without moderate to severe dementia

Primary outcomes:
measure: Knowledge of dementia
timeFrame: Three years
measure: Knowledge of cardiopulmonary resuscitation (CPR), mechanical ventilation (MV), tube feeding (TF)
timeFrame: Three years
measure: Self efficacy
timeFrame: Three years
measure: Intention to make a Care Plan
timeFrame: Three years
Secondary outcomes:
measure: Written Care Plan
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Gloria J Bonner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06293911: Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome
Official title: Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Gingival Bleeding
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.

Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.

Then, they will be randomly divided into two groups according to the home treatment:

* in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study
* in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.

Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.


Eligibility criteria: Inclusion Criteria:

* not bedridden patients with Down syndrome
* gingival inflammation and bleeding

Exclusion Criteria:

* lack of compliance signalled by caregivers
* other systemic diseases

Primary outcomes:
measure: Change in Bleeding on Probing (BOP%)
timeFrame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
measure: Change in Plaque Control Record (PCR%)
timeFrame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
measure: Change in Dental mobility
timeFrame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
measure: Change in Modified Gingival Index
timeFrame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
measure: Change in compliance
timeFrame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
measure: Change in product satisfaction
timeFrame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino"
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02374411: Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
Official title: A Survey of the Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudomyxoma Peritonei
Appendiceal Neoplasms
Pancreatic Neoplasms
Neoplasm Metastasis
Adenocarcinoma
Sarcoma
Uterine Neoplasms
Lead sponsor: Edward-Elmhurst Health System
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIPEC surgeons based internationally

Brief summary: The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.


Eligibility criteria: Inclusion Criteria:

* Surgeon trained in and performing the HIPEC procedure

Exclusion Criteria:

* Not performing the HIPEC procedure

Primary outcomes:
measure: Collect questionnaire data from 150 HIPEC surgeons
timeFrame: Three months
Secondary outcomes:
measure: HIPEC surgeon practices of patient nutritional support assessed by questionnaire
timeFrame: Three months
measure: HIPEC surgeon attitudes toward patient nutritional support self-assessed by questionnaire
timeFrame: Three months
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
Study officials:
affiliation: Edward Hospital
name: George I Salti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02432911: Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
Official title: A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.

Detailed description: Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.

Eligibility criteria: Inclusion Criteria:

* Acute myeloid leukemia except APL
* ECOG PS：0-3
* Unfit or unwilling to receive intensive therapy

Exclusion Criteria:

* The one who has already received induction therapy no matter what the outcome is.
* Active cancer patients who are needed to receive treatment;
* Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）；
* Active heart disease

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
measure: complete remission rate
timeFrame: 4 months
measure: relapse free survival
timeFrame: 3 years
measure: treatment-related mortality
timeFrame: 2 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Treatment and Diagnosis Center of Leukemia
state: Tianjin
Study officials:
References:
Clinical trial NCT00248911: The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers
Official title: The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancers
Gynecologic Cancer
Keywords: Breast cancer
Gynecologic cancers
Meditation
Stress-reduction
Cognitive-affective behavioral learning
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Avon Foundation
First posted: 2005-11-04
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 101
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.

Detailed description: The objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.

Eligibility criteria: Inclusion Criteria:

* All women with stage I-III breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study.

Exclusion Criteria:

* Patients who refuse to participate will be excluded
* Patients with Metastatic cancer are excluded.

Primary outcomes:
measure: Quality of life will be assessed by within patient differences in the FACT-G (General Functional Assessment of Cancer Treatment Scale), as well as with the disease specific subscales at baseline and at 12 months.
timeFrame: Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College-New York Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Complementary and Intergrative Medicine, New York Presbyterian Hospital-Weill Cornell Medical College
name: Joseph Loizzo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: