louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01664169: Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303
Official title: Validation of Circulating Biomarkers Using the Immunological Multiparameter Chip Technology (IMPACT) on Plasma Specimens Collected on CALGB 80303
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
stage IIB pancreatic cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-14
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pancreatic cancer and previously enrolled on CALGB-80303.

Brief summary: RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic cancer treated on study CALGB-80303.

Detailed description: OBJECTIVES:

* To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the same Immunological Multiparameter Chip Technology (IMPACT) assay.
* To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for progression-free survival (PFS), and other circulating biomarkers in study BO17706, can be replicated in study CALGB-80303 using the same IMPACT assay.
* To explore the relationship between efficacy and other biomarkers measured in the plasma samples.

OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.

The following markers are analyzed in EDTA plasma samples using the Immunological MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.

Eligibility criteria: Patients must have been registered to CALGB-80303

* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or metastatic disease

Primary outcomes:
measure: Overall survival
timeFrame: 1 month
measure: Progression free survival
timeFrame: 1 month
measure: Number and percentage of responder
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CALGB Statistical Office at Duke University Medical Center
name: Herbert Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422069: Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan
Official title: Registry on Post Menopausal Osteoporosis in Gynecology Setting in Pakistan (REPOSE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-21
Enrollment: 624
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll gynecology outpatients in Pakistan who meet eligibility criteria for observation.

Brief summary: This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Age 50 years or greater

Exclusion Criteria:

* Previously diagnosed osteoporosis, or receiving treatment for osteoporosis

Primary outcomes:
measure: Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results
timeFrame: Up to 12 months
Secondary outcomes:
measure: Use of various PMO treatment modalities
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
city: Karachi
country: Pakistan
city: Karachi
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
city: Lahore
country: Pakistan
city: Lahore
country: Pakistan
city: Rawalpindi
country: Pakistan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01571869: Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols
Official title: Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mildly Hypercholesterolemic Subjects
Keywords: Plant sterol - hypercholesterolemia - dairy - meal
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.


Eligibility criteria: Inclusion Criteria:

* male and post-menopausal female aged 40-80 years;
* BMI between 22 and 32 kg/m2,
* Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
* Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
* Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
* Have to give written consent to take part in the study

Exclusion Criteria:

* Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95\<SBP\>140 mmHg and/or 45\<DBP\>90 mmHg),
* Previous history of symptomatic vascular disease, TG level \> 2,8 g/l,
* History of metabolic or gastrointestinal disease with the exception of appendicectomy,
* Consumption of large amounts of alcohol,
* Having undergone general anesthesia in the month prior to pre-selection,
* Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* Having serious or acute disease likely to influence study results or involved in life time,
* Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
* Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
* In a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* For female subjects: likely to change her hormonal substitutive treatment,
* Currently in an exclusion period following participation in another clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ste-anne-de-bellevue
country: Canada
facility: McGill University
state: Quebec
Study officials:
References:
Clinical trial NCT05041569: Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study
Official title: Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Description of Local Modifications of Lymph Nodes or Bundles With the FABIR Sequence in MRI
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient presenting for imaging as part of their treatment

Brief summary: Inclusion (J0):

* Information
* Verification of inclusion and non-inclusion criteria
* Collection of consent
* MRI examination with injection of contrast product as part of the treatment comprising the sequences:

T1 TFE 1.0 iso 3D FLAIR injected Injected elliptical venous angiography 0.4mm iso or less 3D SWIp multiecho 3D T1 injected FABIR iso without injection (added as part of care in case of suspected ASH or meningitis) FLAIR 1.0 without injection (added as part of care for suspected ASH or meningitis) T2 BFFE XD (added by search) FABIR iso injected (added by research) 3D PD T1 0.55 MSDE iso injected (added by research)

Clinical information (SRM on inclusion, on discharge and at 3 months and recurrence within the year) will be collected from the patient's medical file


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Performing an MRI injected as part of care for one of the following reasons:
* suspicion of pathology likely to be associated with narrowing or obstruction of one or more venous sinuses (cerebral thrombophlebitis, tissue damage with venous extension, idiopathic HIC
* venous narrowing or obstruction proven by one of the above pathologies, requiring as part of routine care an injected MRI (search for impact, monitoring, pre-therapeutic assessment or prognosis)
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Absolute contraindication to MRI
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Using a new MRI sequence for the detection of lymph nods
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hhopital fondation adolphe de rothschild
Study officials:
References:
Clinical trial NCT01224769: Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders
Official title: A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, as Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed or Refractory Chronic Lymphoproliferative Disorders
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab

Brief summary: This retrospective study collects and evaluates the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.


Eligibility criteria: Inclusion Criteria:

* patients with relapsed or refractory chronic lymphoproliferative disorders
* salvage treatment with bendamustine +/- rituximab
* age ≥ 18 years

Exclusion Criteria:

* previous treatment with bendamustine

Primary outcomes:
measure: overall response rate
timeFrame: within 1 month after end of treatment
Secondary outcomes:
measure: grade III and IV (NCI Common Toxicity Criteria) adverse events
timeFrame: within 1 month after end of treatment
measure: prognostic factors
timeFrame: within 1 month after end of treatment
measure: progression free survival
timeFrame: within 1 month after end of treatment
measure: overall survival
timeFrame: within 1 month after end of treatment
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Gruppo Italiano Studio Linfomi
Study officials:
affiliation: Gruppo Italiano Studio Linfomi
name: Emilio Iannitto, MD
role: STUDY_CHAIR
affiliation: Gruppo Italiano Studio Linfomi
name: Fortunato Morabito, MD
role: STUDY_DIRECTOR
affiliation: Gruppo Italiano Studio Linfomi
name: Stefano Luminari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05620069: Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury
Official title: The Effect of Listening to Music on Sleep Disturbances in Patients With Acquired Brain Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Sleep Disturbance
Keywords: Brain injury
Acquired brain injury
Sleep disturbance
Music
Music therapy
Lead sponsor: Vejlefjord Rehabilitation
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Aalborg University
First posted: 2022-11-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An Injury to the brain may lead to sleep-wake disturbances which may negatively influence functional recovery, quality of life and general rehabilitation.

The purpose of this study is to investigate the effect of music listening on sleep disturbances after acquired brain injury (ABI).

During a 2 week intervention period patients with ABI will listen to music for appr. 30 minutes before going to sleep. Records of their sleep quality are compared to records of sleep quality from 2 weeks without music intervention.

H1 Hypothesis: Music listening (ML) improves sleep quality after ABI in patients.

H0 Hypothesis: Music listening (ML) has no effect on sleep quality after ABI in patients.

Detailed description: Participants are recruited from Vejlefjord Rehabilitation - a neurorehabilitation center in Denmark.

Patients who meet the inclusion criteria are enrolled in the study after informed consent. Participants are randomly allocated to two conditions (ML+Treatment as usual (TAU) or TAU only in a crossover design. Randomization is done by sealed envelope, and after two weeks of either ML+TAU or TAU the participants switch condition.

Participants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period. Participants will rate sleep quality and liking of the intervention.

Information about injury, demographic and socioeconomic status are derived from patient journals.

Eligibility criteria: Inclusion Criteria:

* in-patients with ABI being treated at Vejlefjord Rehabilitation during the entire project period
* age \> 18 years
* sleep-wake disturbances corresponding a score of 5 or more on Pittsburgh Sleep Quality Index (PSQI).
* Mentally and physically capable of administering music equipment, actigraph and self-report questionnaires.

Exclusion Criteria:

-

Primary outcomes:
measure: Sleep quality
timeFrame: Change from baseline to after the 14-days intervention period
measure: Objective sleep quality
timeFrame: Change from baseline to after the 14-days intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Stouby
country: Denmark
facility: Vejlefjord Rehabilitation
Study officials:
affiliation: Vejlefjord Rehabilitation
name: Mette Underbjerg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097469: Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.
Official title: Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Female Sexual Dysfunction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Dysfunction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Detailed description: Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic files.

Eligibility criteria: Inclusion Criteria:

* Negative urine analysis.
* Normal Pap smear test from the recent 3 years.
* No previous gynecological laser treatments.
* Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

* Active genital infection.
* Subject presenting abnormal Pap result from the last three years.
* Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year).
* Transvaginal mesh implant.
* Serious systemic disease or any chronic condition that could interfere with study compliance.
* Any vaginal bleeding of unknown reason.

Primary outcomes:
measure: Vaginal health index
timeFrame: From treatment up to 12 months post treatment
Secondary outcomes:
measure: Female sexual function index
timeFrame: From treatment up to 12 months post treatment
measure: Sexual intercourse
timeFrame: From treatment up to 12 months post treatment
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934869: Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity
Official title: Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metacarpal Shaft Fractures
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-07-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women with isolated metacarpal fractures

Brief summary: Rotational deformity or malunion causes the most significant functional deficit in these common fractures. The evaluation of the rotation may be performed with the metacarpophalangeal joints flexed although postoperative swelling may not enable this examination with flexion of the fingers. Furthermore, it has been shown that swelling may cause rotation of the digit itself. The investigators propose that the swelling may cause a mistake in the estimation of rotation, during surgery and early follow up period. This is of special importance when open reduction and rigid fixation is performed.

Methods:

Prospective analysis of XX isolated metacarpal fractures treated, in YY patients was performed. End-on view of the finger-nail was taken with a digital camera on the day of OR, at 2 weeks and at 1 year. The photos were taken on a standard apparatus and from a distance of XX cm and evaluated using ZZ software in comparison with photos taken of the other hand, according to the involved digit. Range of motion, type of fracture and type of fixation were compared.


Eligibility criteria: Inclusion Criteria:

1. isolated metacarpal fractures in one hand- fingers 2, 3, 4, 5
2. treated with cast or surgical treatment , closed or open reduction

Exclusion Criteria:

1. multiple fractures simultaneously
2. fractures in both hands
3. former fracture in one of the fingers, two palms,metacarpal,proximal phalanx (with exception of the thumb)
4. open fracture, open wounds, infection
5. pregnancy, inability performing full x-ray follow up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT01118169: Personal Values, Interpersonal Needs, and Suicidal Ideation in a Veteran Population
Official title: Examining the Relationship Between Personal Values, Interpersonal Needs, and Suicidal Ideation in a Veteran Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide Prevention
Keywords: Personal values
Suicidal thoughts
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2010-05-06
Enrollment: 122
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: Veterans receiving behavioral health services within the Denver VA Medical Center.

Brief summary: The primary aim of this study is to examine the relationship between personal values and suicidal thoughts in a sample of U.S. Veterans.


Eligibility criteria: Inclusion Criteria:

* Currently receiving care through the Denver VA Medical Center Behavioral Health Interdisciplinary Team
* Over the age of 18
* Willing to travel to the Denver VAMC to complete assessment measures.
* Provide informed consent to participate

Exclusion Criteria:

* Inability to adequately respond to questions regarding the informed consent procedure

Primary outcomes:
measure: Beck Scale for Suicide Ideation
timeFrame: One time
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System
name: Lisa Brenner, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04967469: Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
Official title: Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hypocalcemia
Hyperparathyroidism
End Stage Renal Disease (ESRD)
calcitriol
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2021-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy


Eligibility criteria: Inclusion Criteria:

* New End-stage renal failure patients and have iPTH\>800 pg/dl at least 6 months
* Patients who no response hyperphosphatemia with high dose vitamin D

Exclusion Criteria:

* Allergy vitamin D
* Pregnancy
* Patients who parathyroidectomy have less than 4 gland

Primary outcomes:
measure: Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
timeFrame: 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: