louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04723615: Orebro Musculoskeletal Screening Questionnaire-12
Official title: Evaluation of Turkish Validity, Reliability and Practicality of Örebro Musculoskeletal System Screening Questionnaire-12
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Injury
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be contacted via Google forms after the entire translation process of the questionnaire is completed. Participants will be 18-65 years and have any musculoskeletal problems (spine, upper or lower extremities).

Brief summary: The research is a study with methodological design. The validity, reliability and practicality of the Örebro Musculoskeletal System Screening Questionnaire-12 will be investigated. In this context, a questionnaire will be applied to the participants to take part in the study after the translation process is completed.

Detailed description: Musculoskeletal disorders are quite common in developed and developing countries. Musculoskeletal disorders cause economic burdens in the individual and social field. In addition, getting reports is one of the main causes of reduced productivity and work disability. Therefore, inexpensive and easily applicable screening questionnaires are needed to determine the patient population with high risk musculoskeletal disorders. The Örebro Musculoskeletal Screening Questionnaire is a practical questionnaire that can evaluate musculoskeletal disorders and is tailored to the WHO-ICF themes. For this reason, the aim of the study is to translate the Örebro Musculoskeletal System Survey-12 into Turkish intercultural translation and to investigate the construct validity, reliability and practicality.

Eligibility criteria: Inclusion Criteria:

* Having any musculoskeletal problems (spine, upper or lower extremities)
* Being in the age range of 18-65

Exclusion Criteria:

* Pregnancy
* Having of red flag signs.

Primary outcomes:
measure: Orebro Musculoskeletal Screening Questionnaire-12
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Emel Taşvuran Horata
Study officials:
affiliation: Afyonkarahisar Health Science University
name: EMEL TAŞVURAN HORATA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tasvuran Horata E, Demir P, Yagci G, Erel S, Eken F, Gabel CP. The validity and reliability of the Turkish version of the 12-item Orebro musculoskeletal screening questionnaire (OMSQ-12-TR). Disabil Rehabil. 2023 Dec;45(25):4288-4295. doi: 10.1080/09638288.2022.2089918. Epub 2022 Jun 25.
Clinical trial NCT05313815: Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
Official title: Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
high risk prostate cancer
high-risk prostate cancer
node positive prostate cancer
nod-positive prostate cancer
hypofractionation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Able to provide informed consent.
* Histologic diagnosis of prostate adenocarcinoma.
* ECOG performance status 0-1.
* High-risk localized disease by NCCN criteria (\>cT3, Grade group \>4, or PSA \>20 ng/mL) or clinical N1 disease.
* Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))

Exclusion Criteria:

* Prior pelvic radiotherapy.
* Contraindications to radiotherapy

Primary outcomes:
measure: Acute Grade >2 Gastrointestinal Toxicity
timeFrame: Baseline to 5-year follow-up
Secondary outcomes:
measure: Patient-reported quality-of-life assessed by EPIC-26
timeFrame: Baseline to 5-year Follow-up
measure: Measure the severity of lower urinary tract symptoms during the study
timeFrame: Baseline to 5-year Follow-up
measure: Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity
timeFrame: Baseline to 5-year Follow-up
measure: Measure of oncologic outcomes
timeFrame: Baseline to 5-year Follow-up
measure: Measure of oncologic outcomes
timeFrame: Baseline to 5-year Follow-up
measure: Measure of onocologic outcomes
timeFrame: Baseline to 5-year Follow-up
measure: Prostate cancer specific survival based on death from prostate cancer
timeFrame: Baseline to 5-year Follow-up
measure: Overall survival
timeFrame: Baseline to 5-year Follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
Study officials:
References:
Clinical trial NCT01658215: Nicotine Patch - Multidose Bioequivalence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Smokers
Keywords: Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation.

Up to day 7


Eligibility criteria: Inclusion Criteria:

* Healthy subject aged 18 to 45 years (inclusive)
* Current Smoker of \>or = 5 and \< or = 15 cigarettes/day
* Fagerström score \< or =5 at selection
* Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion Criteria:

* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch

Primary outcomes:
measure: Pharmacokinetic profile
timeFrame: Blood samples will be collected Day 3 and Day 6
Secondary outcomes:
measure: Clinical safety (reported adverse events)
timeFrame: up to day 7
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
References:
Clinical trial NCT00726115: Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531
Official title: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 56
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: The main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy subjects


Eligibility criteria: Inclusion criteria:

* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
* history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.

Primary outcomes:
measure: Pharmacokinetics, routine Lab tests, Vital signs, ECG
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rueil Malmaison
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02266615: Biobank Clinical Genetics Maastricht (KG01)
Official title: Biobank Clinical Genetics Maastricht
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 3600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital and who get blood or tissue sampled for DNA diagnostics.

Brief summary: Collection of coded biomaterial and clinical data with patients consent for future research.

Detailed description: Collection of coded biomaterial and clinical data with patients consent for future research, with the purpose to indentify new gene mutation and prossibilities for treatment in the future.

Eligibility criteria: Inclusion Criteria:

* New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital
* Withdrawal of body material for genetic diagnostics.

Exclusion Criteria:

* Patient does not understand the Dutch language.

Primary outcomes:
measure: Comparing genes to discover unknown functions
timeFrame: Genes will be sequenced and compared, within an expected average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Head of department
name: W. van Zelst-Stams, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06556615: Health Related Quality of Life (HrQoL) in Classical Homocystinuria (CBS Deficiency)
Official title: Development and Validation of a Standardized Assessment Instrument for Health-related Quality of Life (HrQoL) in Patients With Classical Homocystinuria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Homocystinuria
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CBS deficiency from age 8 years

* Parents of patient(s) \< 18 years with cognitive impairment
* Parents of patients between age 4 and 7
* Experts on CBS deficiency

Brief summary: Patients, parents of young / handicapped patients, and experts will be interviewed to collect contents relevant for HrQoL in CBS deficiency. Based on these data, a questionnaire will be developed and tested for comprehensibility in patients and parents of young / handicapped patients. A final questionnaire version will be tested for psychometric criteria including validity and reliability.


Eligibility criteria: Inclusion criteria

* Patients with CBS deficiency from age 8 years
* Parents of patient(s) \< 18 years with cognitive impairment
* Parents of patients between age 4 and 7
* Experts on CBS deficiency
* Able to give informed consent as documented by signature

Exclusion criteria

- Sufficient command of the German or the English language

Primary outcomes:
measure: HrQol
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Kinderspital Zürich
Study officials:
References:
Clinical trial NCT05386615: Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
Official title: Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Fibroid
Keywords: Uterine Fibroids
Exablate
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pre- and peri- menopausal women with Uterine Fibroids

Brief summary: The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.

Detailed description: This is an observational study only for all consented subjects who undergo an Exablate treatment. The Exablate procedure is a commercial treatment. The objective of this registry is to collect data about the effect of Exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.

Eligibility criteria: Inclusion Criteria: - - Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system. Exclusion Criteria: -

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai No. 1 Hospital
city: Shanghai
country: China
facility: Shanghai No.1 Hospital
Study officials:
References:
Clinical trial NCT05902715: The Socket Shield Technique, a Prospective Cohort Study of 20 Patients
Official title: The Socket Shield Technique: Stability of the Buccal Peri-implant Bone After Partial Root Removal - a Prospective Cohort Study of 20 Patients, With 18 Months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Health
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 23 implants with socket shield were followed for 18 months. buccal bone thickness and survival rates registered.

Detailed description: Aims: This study aims to collect data on implant survival, bone volume maintenance, and complications associated with the socket shield technique.

Materials \& methods: The study involved the placement of 23 implants using the socket shield technique in 20 patients. AstraTech EV implants were used, and no bone substitutes or connective tissue grafts were applied. Patients were monitored for 18 months, recording implant survival, volumetric bone analysis on CBCT scans, interproximal bone levels, bone sounding, pink esthetic scores, and complications. Prosthetic procedures were also described, including temporary and final restorations.

Eligibility criteria: Inclusion Criteria:

* • Hopeless teeth suitable for immediate implant placement

  * Only single-rooted teeth in the maxilla
  * Intact buccal and palatal bone plate
  * Intact buccal root portion
  * Any periodontal phenotype (thin, thick)

Exclusion Criteria:

* • Horizontal root fracture below bone level

  * Smoking
  * Systemic pathology influencing bone healing
  * Active periodontal disease

Primary outcomes:
measure: buccal bone thickness
timeFrame: 18 months
Secondary outcomes:
measure: Cumulative survival rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Rutger Dhondt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06010615: Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.
Official title: Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 75 and over with RH+ HER2- breast cancer who received adjuvant chemotherapy between 01/01/2012 and 01/01/2020, within the Regional Cancer Network of Bourgogne-Franche-Comté - oncoBFC

Brief summary: Localized breast cancers are defined as high-risk when they include lymph node involvement, Ki67 \>30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic signature result.

Under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is recommended.

Patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of side-effects, which may necessitate dose reductions and a reduction in the intensity of chemotherapy. For curative adjuvant treatment, it is recommended to maintain a relative dose intensity (RDI) \> 85%. A few publications have demonstrated the prognostic impact of a relative dose intensity \< 85% for patients aged over 65. For several years now, the need for a specific assessment of elderly patients has been emphasized, prior to initiating oncological treatment (G8 score, onco-geriatric consultation).

This study is a retrospective descriptive study of patients aged over 75 treated with adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for RH+ HER2 - breast cancer in Franche Comté.

Thus the investigators wish to identify patients at risk of receiving sub-optimal relative dose intensity, in order to guide early and targeted supportive care or geriatric co-management interventions.


Eligibility criteria: Inclusion Criteria:

* Women aged 75 or over
* Patient with localized RH+HER2- breast cancer
* Patient treated with adjuvant chemotherapy in Franche Comté between January 2012 and December 2019

Exclusion Criteria:

* Age \< 75
* Patient with metastatic breast cancer
* Patient who received neoadjuvant chemotherapy
* HER2+ breast cancer patient
* Breast cancer patient with missing or negative hormonal status
* Patient with localized recurrence of breast cancer with indication for new adjuvant therapy

Primary outcomes:
measure: Proportion of patients receiving relative dose intensity (RDI) <85%
timeFrame: 01/01/2012 to 31/12/2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02600715: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Official title: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Urinary Urge Incontinence
Urinary Bladder, Neurogenic
Painful Bladder Syndrome
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.


Eligibility criteria: Inclusion Criteria:

* Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
* No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
* Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)

Exclusion Criteria:

* Currently pregnant
* Currently nursing a baby
* Anticipated geographic relocation within the first 3 months following treatment
* Allergy to morphine, belladonna, or opiates
* Patients will be excluded if participating in another research study
* Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded

Primary outcomes:
measure: Change in Bladder Injection Pain
timeFrame: Baseline and intraoperative
Secondary outcomes:
measure: Pre-analgesia Pain Score
timeFrame: Baseline
measure: Post-operative Pain Score
timeFrame: Postoperative (within 10 minutes of the end of the BoNT procedure)
measure: Number of Participants Declining to Complete Procedure Due to Pain Intolerance
timeFrame: Intraoperative
measure: Postoperative Voiding Trial Results
timeFrame: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)
measure: Post Void Residual (PVR)
timeFrame: 2 Weeks
measure: Number of Participants With Evidence of Infection or Positive Urine Culture
timeFrame: 2 Weeks
measure: Participant Satisfaction With Pain Control
timeFrame: Postoperative (within 10 minutes of the end of the BoNT procedure)
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Wichita Women's Pelvic Surgery Center at Associates in Women's Health
state: Kansas
city: Wichita
country: United States
facility: University of Kansas School of Medicine - Wichita
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Edgar LeClaire, MD, FACOG
role: PRINCIPAL_INVESTIGATOR
References: