louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03286647: Oral Hygiene Self-efficacy in Patients With Grief
Official title: Evaluation of Oral Hygiene Self-efficacy in Patients With Grief: a Short-term Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Grief
Keywords: grief, periodontal disease
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG)

Detailed description: Aim: to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and complicated grief (CG). Study design: randomized controlled trial. Setting: Institute of Psychiatry-FMUSP (Ipq-FMUSP). Subjects: cases: patients seeking for treatment or under treatment for CG (Group 1), and patients with normal grief (Group 2). Controls: Hospital staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP (Group 3). Method. Psychiatric evaluation: Structured Clinical Interview (SCID), Texas Revised Inventory of Grief (TRIG) and clinical interview. Intervention: instruction of oral hygiene. Dental evaluation: probing depth, clinical attachment level, bleeding on probing, and frequency of plaque at six sites per tooth. Procedures: all participants will complete the psychiatry and dental evaluation at baseline. The bleeding on probing and frequency of plaque will be recorded at baseline, once a week (1 month follow-up) and at 3 months. The probing depth and clinical attachment level will be recorded at baseline and at 3 months. After 3 months, the patients will be referred for dental treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of grief or complicated grief
* Informed consent signature

Exclusion Criteria:

* Patients with severe major depressive disorder at risk for suicide;
* Substance abuse or dependence,
* Psychotic disorders
* Systemic alteration that precludes periodontal clinical examination

Primary outcomes:
measure: Frequency of dental plaque
timeFrame: Change from baseline, 1 and 3 months after oral hygiene instruction
Secondary outcomes:
measure: probing depth
timeFrame: Change from baseline and 3 months after oral hygiene instruction
measure: clinical attachment level
timeFrame: Change from baseline and 3 months after oral hygiene instruction
measure: Bleeding on probing
timeFrame: Change from baseline, 1 and 3 months after oral hygiene instruction
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry - FMUSP
state: Sao Paulo
Study officials:
affiliation: Professor
name: Francisco Lotufo-Neto, PhD
role: STUDY_CHAIR
affiliation: Fellowship
name: Ana Cristina Solis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374647: Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts
Official title: Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Renal Allograft
Keywords: Renal
Kidney
Transplant
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.


Eligibility criteria: Inclusion Criteria:

* Male and female patients between 18 and 75 years of age.
* Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
* Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
* Capable of providing written informed consent.
* No known contraindications to treatment with sirolimus.

Exclusion Criteria:

* Pregnant or lactating.
* Acute rejection within 90 days prior to study randomization.
* More than one biopsy proven acute rejection episode prior to study randomization.
* Previously received or are receiving an organ transplant other than kidney.
* Receiving sirolimus prior to entry.
* Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
* Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
* History of malignancy in the past 5 years.
* Require dialysis at the time of study entry.

Primary outcomes:
measure: Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.
Secondary outcomes:
measure: Renal allograft function at 6 and 12 months.
measure: Incidence of biopsy proven acute rejection at 6 and 12 months.
measure: Time to first rejection.
measure: Total number of rejection episodes per patient.
measure: Graft loss and patient death.
measure: Incidence of treatment failure.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Steve Woodle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00619047: The Role of Impact Activity in Peripubertal Bone Accrual
Official title: The Role of Impact Activity in Peripubertal Bone Accrual
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Mineral Density
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 131
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were recruited into the following three groups based on their exposure to gymnastic activity. A) control, no gymnastic activity. B)retired gymnasts, who participated at study onset, but stopped gymnastics activity during the course of the study. C) active gymnast, who continues participation in gymnastics throughout the duration of the study.

Brief summary: Osteoporosis has been established as a major public health problem, primarily effecting women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis, yet little is known about the specifics of bone accrual. Physical activity has been identified as an important modifiable factor controlling bone accrual. It is has been shown that increased activity during peri-pubertal years increase bone mineral content during adulthood. Thus, strategies designed to increase peak bone mass should target the peri-pubertal years of critical bone acquisition.

Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater in girls who engage in impact activity than in those who do not.

Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after cessation of the activity, resulting in greater bone mineral density in girls who participate in impact activity during a portion of the peri-pubertal years than in those who never participated in impact activity.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 10-12 will be asked to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Institute for Human Performance
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Tamara A Scerpella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01621347: Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women
Official title: Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Pregnancy
Keywords: HIV
Pregnancy
Postpartum
Women
Medication Adherence
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: Swiss HIV Cohort Study
First posted: 2012-06-18
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant and Postpartum Women enrolledin the HIV adherence program at the pharmacy of Department of Ambulatory Care and Community Medicine in Lausanne

Brief summary: The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.

Detailed description: Data of all consecutive pregnant women included in the adherence enhancing program of the Pharmacy, Department of ambulatory care \& community medicine, are collected. In this program, adherence is measured and enhanced by electronic monitoring, pill count, motivational interviewing and interdisciplinary collaboration. Electronic monitoring data are collected during pregnancy and postpartum, and compared. Barriers and facilitators are collected using interview's marks.

Eligibility criteria: Inclusion Criteria:

* Pregnant Women
* HIV-positive
* Antiretroviral medication delivered in electronical monitors

Exclusion Criteria:

* Monitored period during pregnancy \< 1 month

Primary outcomes:
measure: Change in patient adherence during pregnancy and postpartum
timeFrame: before delivery (1 to 9 month) and postpartum (6 month)
Secondary outcomes:
measure: Adherence barriers and facilitators
timeFrame: pregnancy and postpartum (6 months)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Policlinique Médicale Universitaire
state: Vaud
Study officials:
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Marie-Paule Schneider, PhD
role: STUDY_CHAIR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Aurélie Gertsch, PhD-Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Olivier Bugnon, Professor
role: STUDY_CHAIR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Odile Michel, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hosppitalier Universitaire Vaudois
name: Matthias Cavassini, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT03021447: Prediction of Postoperative Pain by Injection Pain of Propofol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholecystitis, Acute
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for laparoscopic cholecystectomy will be included.

Brief summary: Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity.

Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity.

Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.


Eligibility criteria: Inclusion Criteria:

* America Society of Anesthesiologists class I-II
* Laparoscopic cholecystectomy

Exclusion Criteria:

* Pregnancy
* Illiteracy

Primary outcomes:
measure: postoperative pain intensity_1
timeFrame: 10 min after postanesthesia care unit admission
Secondary outcomes:
measure: postoperative pain intensity_2
timeFrame: 20 min after postanesthesia care unit admission
measure: postoperative pain intensity_3
timeFrame: 30 min after postanesthesia care unit admission
measure: postoperative pain intensity_4
timeFrame: 4 hours after operation
measure: postoperative pain intensity_8
timeFrame: 8 hours after operation
measure: postoperative pain intensity_12
timeFrame: 12 hours after operation
measure: postoperative pain intensity_24
timeFrame: 24 hours after operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05276947: The Use of Peanut Ball in Labor in Obese Women
Official title: The Effect of Peanut Ball Use on Labor Process and Maternal - Neonatal Outcomes in Obese Pregnants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Long
Keywords: Peanut ball
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be an intervention group and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.

Detailed description: After being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. The peanut ball will be used with a sheath that is changed for each participant. Pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). No intervention will be made by the researcher. They will receive standard care by the service nurse.

Eligibility criteria: Inclusion Criteria:

* Admitted for delivery
* Maternal BMI \> 30kg/m2 at admission
* Gestational age \> 37 weeks 0 days
* Singleton pregnancy
* Cephalic presentation
* Cervical dilatation less than 5 cm
* Turkish speaking

Exclusion Criteria:

* Pre-pregnancy BMI \< 30kg/m2
* Gestational age \< 37 weeks 0 days
* Multifetal gestation
* Intrauterine fetal demise
* Musculoskeletal problems
* Receiving magnesium sulfate
* High risk pregnancies (Preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios)

Primary outcomes:
measure: Labor time
timeFrame: From 5 cm of cervical dilatation to the second stage of labor
Secondary outcomes:
measure: Pain level
timeFrame: Latent phase, active phase and at cervical dilatation 10 cm (on contractions)
measure: Operative vaginal delivery rate
timeFrame: From 5 cm of cervical dilatation to the expulsion phase of labor
measure: Type of delivery
timeFrame: From 5 cm of cervical dilatation to the expulsion phase of labor
measure: Maternal complications
timeFrame: From 5 cm of cervical dilatation to the expulsion phase of labor
measure: Neonatal complications
timeFrame: From 5 cm of cervical dilatation to the expulsion phase of labor
measure: Birth satisfaction
timeFrame: Postpartum first hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
Study officials:
affiliation: Gulhane Faculty of Nursing, University of Health Sciences
name: Gulten GUVENC, PhD, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT06073847: A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Official title: Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 137
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: Adult participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who were previously treated with ruxolitinib

Brief summary: The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review \& Assessment Service.


Eligibility criteria: Inclusion Criteria:

* Participants 19 years of age or older
* Participants who will receive fedratinib according to the approved label
* For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered
* Participants who signed the informed consent form

Exclusion Criteria:

* Participants who have been prescribed fedratinib for an indication not approved in Korea
* Participants who have been prescribed fedratinib at a dose not approved in Korea
* Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bristol-Myers Squibb YH
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0001
city: Seoul
country: Korea, Republic of
facility: Novotech Laboratory Korea Co., Ltd.
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04584047: Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing
Official title: Evaluation of Cell-based Non-invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling as a Tool to Confirm the Pregnancy With an Unaffected Fetus Following Preimplantation Genetic Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Diagnoses
Preimplantation Genetic Diagnosis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Arcedi Biotech
name: Aarhus University Hospital
name: Viborg Regional Hospital
name: Horsens Hospital
name: Randers Regional Hospital
name: Kolding Sygehus
name: Rigshospitalet, Denmark
First posted: 2020-10-12
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to investigate whether cell-based non-invasive prenatal testing (cbNIPT) can be used as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for monogenic disorders (PGT-M).


Eligibility criteria: Inclusion Criteria:

* Achieved pregnancy following preimplantation genetic testing

Exclusion Criteria:

* None

Primary outcomes:
measure: Agreement between cbNIPT and CVS (The gold standard)
timeFrame: Immidiately after the results from cbNIPT and CVS has been obtained
Secondary outcomes:
measure: Effectiveness of fetal cell isolation
timeFrame: Immidiately after genetic testing of the isolated fetal cells
measure: Effectiveness of testing the genetic variant of interest
timeFrame: Immidiately after genetic testing of the isolated fetal cells
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Fertility Unit, Aalborg University Hospital
Study officials:
References:
Clinical trial NCT03700047: GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Official title: A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheek Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 270
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.


Eligibility criteria: Inclusion Criteria:

- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.

Exclusion Criteria:

- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit

Primary outcomes:
measure: Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Galderma Study site
state: California
city: Sacramento
country: United States
facility: Galderma Study Site
state: California
city: Solana Beach
country: United States
facility: Galderma Study Site
state: California
city: Miami
country: United States
facility: Galderma Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Galderma Study Site
state: Florida
city: New Orleans
country: United States
facility: Galderma Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Galderma Study Site
state: Maryland
city: Chestnut Hill
country: United States
facility: Galderma Study Site
state: Massachusetts
city: Mount Kisco
country: United States
facility: Galderma Study Site
state: New York
city: New York
country: United States
facility: Galderma Study Site
state: New York
city: New York
country: United States
facility: Galderma Study Site
state: New York
city: Charleston
country: United States
facility: Galderma study site
state: South Carolina
city: Bellaire
country: United States
facility: Galderma study site
state: Texas
city: Dallas
country: United States
facility: Galderma Study site
state: Texas
city: Salt Lake City
country: United States
facility: Galderma Study Site
state: Utah
Study officials:
References: