louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03316235: New, Easy and Efficient Ways to CLassify AcetabulaR Fractures
Official title: New, Easy and Efficient Ways to CLassify AcetabulaR Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fracture
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 35
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: patients with acetabular fracture surgery

Brief summary: Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one.

Five elements are considered and associated to five type of fracture. Even more, for orthopaedic surgeons with less experience with these fractures, correct classification can be more difficult.

So the the aim of this study is:

1. Evaluate the efficacy of four "special" 3D reconstruction: a 3D reconstruction of the pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis removed and an exopelvic view where the femoral head is removed according to the initial teaching of E. Letournel.
2. Evaluate the addition of teaching of non-experimented surgeon on the accuracy of classifying acetabular fractures.
3. Evaluate the addition of a digital algorithm (mobile application) on the accuracy of classifying acetabular fractures.

Detailed description: 12 reviewers will be given the different imaging of each case and will be divided in 4 groups: novice (junior ER and ortho residents), intermediate (non-experimented orthopedic surgeons), intermediate with a formation on classifying acetabular fractures and finally experts (acetabular fracture expert surgeons) . For each patient, representative CT scans are provided for each assessment. The study will be divided into 3 phases separated by 4-6 weeks of time. In the first phase, for each patient, representative CT scans are provided for each assessment with 2D and multiplanar reconstruction (MPR) without 3D views. In the second phase, 3D views are added. In the third phase, the cases are evaluated using the "Acetabular Diagnosis Tool" To note, the evaluation of the cases is done twice in each phase separated by 4-6 weeks and the order of the cases is changed, both in order to minimize recall bias

Eligibility criteria: Inclusion Criteria:

* acetabular fracture

Exclusion Criteria:

* no criteria

Primary outcomes:
measure: 3D reconstruction of pelvis CT scan
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT04477135: Upper Extremity paın and Ultrasound Use
Official title: Investigation of the Relationship Between Upper Extremity Pain and Ultrasound Use in Perinatologist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Upper Extremity Problem
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The relationship between perinatologists' ultrasound use and upper limb joint pain will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Those who have received specialization training in the branch of perinatology and have completed their specialty in the branch and worked as a perinatologist
* Those who want to participate in the study

Exclusion Criteria:

* Patients with discomfort and operation in the upper limb prior to perinatology training
* Physicians in other branches

Primary outcomes:
measure: Upper extremity pain in perinatologists
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sanlıurfa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT03858335: Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Official title: Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Hemiplegic
Keywords: constraint-induced movement therapy
hemiplegia
hand function
gross motor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Detailed description: This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Participants will be randomly assigned to either CIMT group or control group. Children of the CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected arm.

Eligibility criteria: Inclusion Criteria:

* spastic hemiplegic cerebral palsy patients
* 7\~36 months old

Exclusion Criteria:

* cognitive impairment severe enough to make participation impossible
* uncontrolled epilepsy
* visual or hearing impairment
* musculoskeletal disorders

Primary outcomes:
measure: Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test
timeFrame: baseline and 4 weeks
measure: Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test
timeFrame: baseline and 4 weeks
measure: Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test
timeFrame: baseline and 4 weeks
measure: Change From Baseline Gross Motor Function Measure (GMFM) at Post Test
timeFrame: baseline and 4 weeks
measure: Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test
timeFrame: baseline and 4 weeks
measure: Change From Baseline Accelerometers_Use Ratio at Post Test
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong-Yi Kwon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03313635: Evaluation of Prealbumin Levels in Men With Low-T
Official title: Prealbumin (Transthyretin) Levels in Men With Low-T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testosterone Deficiency
Keywords: Prealbumin
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-18
Enrollment: 19
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.

Brief summary: This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.


Eligibility criteria: Inclusion Criteria:

* Provide responses to standard questionnaires administered to subjects
* Written Informed Consent obtained
* Male sex at birth
* ≥ 40 and ≤ 75 years of age
* Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.
* Able and willing to provide blood specimens and follow study schedule
* A final diagnosis can be established (androgen deficient versus not androgen deficient)

Exclusion Criteria:

* Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)
* Use of opioid medication within 3 months prior to enrollment
* Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination
* Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)
* Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements
* Diagnosis of prolactinoma

Primary outcomes:
measure: Prealbumin Levels
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Men's Health Boston
state: Massachusetts
Study officials:
affiliation: Men's Health Boston
name: Abraham Morgentaler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948935: Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Official title: Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Cancer
Cholangiocarcinoma
Keywords: Biliary Cancer
Cholangiocarcinoma
Panitumumab
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 35
Sex: ALL
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 study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
* measurable disease
* available tumor tissue for investigational immunohistochemical evaluations
* ECOG PS 0-2
* No prior chemotherapy, biologic therapy or radiation therapy
* Age Eighteen and older
* Lab values per protocol

Exclusion Criteria:

* Life expectancy less than three months
* Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
* Prior therapy, which affects or targets the EGF pathway
* Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
* Recovery from major surgery within three weeks of the start of study treatment

Primary outcomes:
measure: Progression Free Survival Rate at Five Months
timeFrame: 5 months
Secondary outcomes:
measure: Response Rate From Combination Chemotherapy
timeFrame: 5 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson CC
name: Bruce Giantonia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sohal DP, Mykulowycz K, Uehara T, Teitelbaum UR, Damjanov N, Giantonio BJ, Carberry M, Wissel P, Jacobs-Small M, O'Dwyer PJ, Sepulveda A, Sun W. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol. 2013 Dec;24(12):3061-5. doi: 10.1093/annonc/mdt416. Epub 2013 Oct 20.
Clinical trial NCT03225235: Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer
Official title: Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer, SBRT, Ultrafractionation, CyberKnife
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 600
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.

Detailed description: Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.

Eligibility criteria: Inclusion Criteria:

* men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed \<180 days prior to the randomization date,
* completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;
* general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),
* belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),
* PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,
* no distant metastases,
* signing informed consent,
* morphological and biochemical blood parameters within the normal limits.

Exclusion Criteria:

* the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,
* surgical treatment (radical prostatectomy) or RT in the pelvic area,
* co-morbidities that may significantly affect the expectancy life of the patients
* do not meet the criteria for inclusion.

Primary outcomes:
measure: survival time without biochemical recurrence,
timeFrame: 5 years
Secondary outcomes:
measure: survival time specific for prostate cancer,
timeFrame: 5 years
Other outcomes:
measure: QoL-EORTC quality of life
timeFrame: 5 years
Locations:
city: Poznan
country: Poland
facility: Greater Poland Cancer Centre
state: Wielkopolska
Study officials:
affiliation: Greater Poland Cancer Centre
name: Piotr Milecki, PhD., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03067935: Individual Patient Expanded Access-Glembatumumab Vedotin
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Metastatic gpNMB Expressing Triple Negative Breast Cancer
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-03-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to glembatumumab vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.


Eligibility criteria: Inclusion Criteria:

1. The patient is 18 years of age or older.
2. The patient has histologically confirmed, gpNMB expressing, metastatic triple-negative breast cancer
3. Overexpression of gpNMB in at least one tumor sample as determined by a Sponsor approved laboratory using IHC methods
4. The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive glembatumumb vedotin.
5. The patient is not eligible for or cannot access ongoing glembatumumab vedotin clinical trials
6. The patient does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for triple negative breast cancer.
7. The patient is able to read and understand, and has signed a patient informed consent form, which outlines the nature of the proposed treatment and the anticipated benefits and risks of treatment with glembatumumab vedotin.

Exclusion Criteria:

1. History of allergic reactions attributed to compounds of similar composition to glembatumumab vedotin, MMAE, dolastatin or auristatin.
2. Pregnant or breast-feeding women, and women or men who are not willing to use effective contraception during the time from signing of informed consent through two months after the last dose of glembatumumab vedotin treatment.
3. The patient was previously treated with glembatumumab vedotin or previously enrolled on the METRIC trial (regardless of which arm they were randomized to).
4. Any underlying medical condition that, in the investigator's or Sponsor's opinion, will make the administration of Glembatumumab vedotin hazardous to the patient, or would obscure the interpretation of adverse events.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03261635: Ranibizumab Plus Indomethacin
Official title: Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
Primary purpose: TREATMENT

Brief summary: To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* provision of written informed consent and compliance with study assessments for the full duration of the study
* age \> 40 years
* presence of treatment-naïve neovascular AMD.

Exclusion Criteria:

* any previous intravitreal treatment
* previous laser treatment in the study eye
* myopia \> 7 diopters in the study eye
* concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
* concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
* known sensitivity to any component of the formulations being investigated.

Primary outcomes:
measure: Central Retinal Thickness (microns)
timeFrame: 12-month
measure: Visual Acuity (LogMAR)
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01119235: A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.
Official title: A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Keywords: Pharmacokinetics
tablet performance
healthy volunteers
open label
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.


Eligibility criteria: Inclusion Criteria:

* Young
* Healthy volunteers

Exclusion Criteria:

* Elderly volunteers
* Patients with any existing medical conditions considered likely to impinge on study execution

Primary outcomes:
measure: concentration of PF-04531083 in blood just before dosing on the 8th day of the study
timeFrame: Days 1 and 8 of the study
Secondary outcomes:
measure: pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.
timeFrame: Days 1, 8 and 14 of the study
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: