louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01502852: Identifying the Needs of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues
Official title: Identifying the Needs of OEF/OIF Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Co-Occurring Behavioral Health Issues
Keywords: OEF/OIF Veterans
Traumatic Brain Injury
Community Mental Health
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2012-01-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OEF/OIF Veterans with a history of TBI, their family members/friends, and community mental health providers working with these Veterans.

Brief summary: The purpose of this study is to explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health issues.

Detailed description: The focus of this project is on qualitative data collection to facilitate product development including assessment and treatment guidelines to improve non-VA community mental health care for OEF/OIF Veterans with TBI and co-occurring behavioral health issues within the state of Colorado. In addition to the development of assessment and treatment guidelines, other products developed through this study will include a training and accompanying toolkit, which may be used for annual educational training of mental health providers. As such, there are no hypotheses associated with this study. This statewide initiative may not only improve quality and access to non-VA community mental health care for persons with TBI and co-occurring behavioral health issues within Colorado, but also serve as a model for implementation across the country.

Eligibility criteria: Inclusion Criteria:

* Colorado Behavioral Health Organization (BHO) mental health providers
* OEF/OIF United States Veterans
* Family members and/or friends of OEF/OIF United States Veterans
* Ages 18-65

Exclusion Criteria:

- N/A

Primary outcomes:
measure: Focus Groups
timeFrame: One Time
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VISN 19 MIRECC, Denver VAMC
state: Colorado
Study officials:
affiliation: VISN 19 MIRECC; University of Colorado, School of Medicine, Dept. of Psychiatry
name: Lisa A Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05627752: Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
Official title: Docetaxel Alone or in Combination With Enzalutamide as First-line Treatment for Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone: a Single Center, Randomized, Open-label Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Castrate Resistant Prostate Cancer
Keywords: chemotherapy
Enzalutamide
Abiraterone
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: New androgen pathway targeting agents (ARTA), including Abiraterone acetate, Apalutamide and Enzalutamide, are approved and used in treatment of metastatic hormonal sensitive prostate cancer(mHSPC). However, the development of castration-resistance prostate cancer(CRPC) is only a matter of time. The use of sequential ARTAs in mCRPC showed limited benefit in retrospective series and prospective trials. Therefore this sequence should be avoided because of known cross resistance and the availability of chemotherapy and poly adenosine diphosphate-ribose polymerase(PARP) inhibitors (if a relevant mutation is present).

Recently, a randomized controlled trial(RCT), the ABIDO-SOGUG, indicated that compared with docetaxel, maintaining Abiraterone added to docetaxel in chemotherapy-naive patients who have experienced cancer progression to Abiraterone treatment could not improve radiographic progression-free survival or the other endpoints.However, another RCT, the PRESIDE trial, indicated that in patients who had progressed on Enzalutamide, continued Enzalutamide treatment in combination with docetaxel led to a significant improvement of PFS compared with placebo plus docetaxel.

The aims of this trial is to assess both the efficacy and safety of docetaxel in combination with Enzalutamide as first-line treatment in mCRPC patients progressed on Abiraterone.


Eligibility criteria: Inclusion Criteria:

* adenocarcinoma
* mCRPC
* Eastern Cooperative Oncology Group(ECOG) 0-1
* prior Abiraterone treatment

Exclusion Criteria:

* prior Enzalutamide or Docetaxel treatment

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: up to 6 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: up to 16 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhonghua Yang
state: Hubei
city: Wuhan
country: China
facility: Zhonghua Yang
state: Hubei
Study officials:
References:
Clinical trial NCT01184352: Glider PTCA Balloon Catheter Registry
Official title: Registry for PCI With the TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Lead sponsor: TriReme Medical, LLC
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated by Physicians using the Glider PTCA Balloon Catheter who are willing to participate in the Glider Registry.

Brief summary: The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing PCI who are at least 18 years old
* PCI procedure included the use of at least one Glider PTCA Balloon Catheter
* Patient has been informed, in accordance with local requirements, that their data will be used in the Glider Registry

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Technical Success
timeFrame: average of 1 hour
Secondary outcomes:
measure: Procedure Success
timeFrame: average of 2 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum Zum Friedrichshain
city: Coburg
country: Germany
facility: Klinikum Coburg Herzkatheterlabor
city: Essen
country: Germany
facility: Alfried Krupp Khs
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen Kardiologie
city: Muenster
country: Germany
facility: University Klinikum Muenster
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Carlo DiMario, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00958152: Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: VX-950
VX-222
STAT-C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive)
* Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight \> 50 kg

Exclusion Criteria:

* Women of child bearing potential
* Subjects positive for Hepatitis B, Hepatitis C, or HIV
* Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months

Primary outcomes:
measure: Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
timeFrame: Day 47 safety assessment
Secondary outcomes:
measure: Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state
timeFrame: Day 37 pharmacokinetic assessment
measure: Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state
timeFrame: Day 37 pharmacokinetic assessment
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02743052: Anticoagulation in Cancer Related Stroke
Official title: Optimal Anticoagulation Strategy In Stroke Related to CANCER (OASIS-CANCER Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients with active cancer

Brief summary: Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of cancer-related stroke, particularly in those without conventional stroke etiologies. Randomized clinical trials have investigated efficacy of vitamin K-dependent oral anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However, relatively little is known about the biological changes underlying intravascular coagulopathy and mechanisms of anticoagulation therapy in patients with cancer-related stroke. The aim of this study is to evaluate to determine the biological markers for intravascular coagulopathy causing stroke and for monitoring the effects of anticoagulation therapy, in patients with active cancer and stroke.


Eligibility criteria: Inclusion Criteria:

* Age 20 years and older
* Acute ischemic stroke presented within 7 days of symptom onset
* Cancer related stroke: active cancer (diagnosis of cancer within 6 months of stroke onset, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer) and ischemic stroke which could not be explained by conventional stroke mechanisms including large artery atherosclerosis, cardioembolism, lacunar infarction, or other etiologies (e.g., dissection)
* Signed informed consent or appropriate signed deferral of consent where approved

Exclusion Criteria:

* Primary intracranial malignancy
* Incomplete workup for stroke etiology (either vascular or cardiologic studies)
* Any signs of infectious or immunological diseases which may influence plasma D-dimer levels
* Patients with stroke suspected to be caused by the tumor itself (i.e., tumor emboli) or cancer treatment (i.e., chemotherapy-induced stroke)

Primary outcomes:
measure: Recurrent stroke or systemic embolism
timeFrame: up to 6 months
Secondary outcomes:
measure: 90-days modified Rankin Scale score
timeFrame: examined at 90 days after stroke symptom onset in each patients
measure: Effect of anticoagulation treatment
timeFrame: up to 14 days
measure: Symptomatic hemorrhagic transformation
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Samsung Medical Center
name: Oh Young Bang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04247152: Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery
Official title: Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Needed Correction for Low Toric Lens Correction in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2020-01-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

Detailed description: Based on preoperative keratometry and using the Baylor Nomogram and a standard factor for surgically-induced astigmatism, the investigators will calculate "keratometry-based total astigmatism" for each patient. This will be compared to "aberrometry-based total astigmatism", i.e. the total astigmatism measured by ORA in each case. With this information the investigators will determine in what portion of patients keratometry-based total astigmatism vs aberrometry-based total astigmatism predicts a need for astigmatism correction, (i.e., total astigmatism is greater than or equal to 0.5 D) during cataract surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent conventional (non-femtosecond) cataract surgery and whose "data to be collected" are accessible and available from the ORA database.
* Patients whose medical records show they did not exhibit any significant ocular morbidity that would be expected to influence outcome measures.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their visual outcome or ability to be refracted after.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
* Patients with previous refractive surgery.

Primary outcomes:
measure: Proportion of Patients requiring Astigmatism Correction
timeFrame: up to 3 months
Secondary outcomes:
measure: Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter
timeFrame: up to 3 months
measure: Patients with Postoperative residual astigmatism 1.0 to 1.5 diopter
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
Study officials:
References:
Clinical trial NCT01138852: Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
Official title: Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infections
Keywords: post-cesarean infections
ampicillin-sulbactam
cefuroxime
cesarean
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.

Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.

Detailed description: The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.

The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection.

A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.

Eligibility criteria: Inclusion Criteria:

- All patients undergoing a cesarean delivery were eligible.

Exclusion Criteria:

* Patients with known hypersensitivity to penicillin or cephalosporins.
* Patients who required concomitant antibiotic therapy during surgery.
* Patients who have received antibiotics during the 72 hours immediately preceding their enrollment.
* Patients whose postpartum fever was clearly associated with other known causes.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Williams MJ, Carvalho Ribeiro do Valle C, Gyte GM. Different classes of antibiotics given to women routinely for preventing infection at caesarean section. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD008726. doi: 10.1002/14651858.CD008726.pub3.
citation: Ziogos E, Tsiodras S, Matalliotakis I, Giamarellou H, Kanellakopoulou K. Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. BMC Infect Dis. 2010 Nov 30;10:341. doi: 10.1186/1471-2334-10-341.
Clinical trial NCT03962452: Mitochondrial Diseases - Long-read Genome and Transcriptome Sequencing in Cases Unresolved After Short-read Genomics
Official title: Mitochondrial Diseases - Long-read Genome and Transcriptome Sequencing in Cases Unresolved After Short-read Genomics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rare Diseases
Genetic Predisposition
Keywords: Rare Diseases
Genetic Predisposition
Epigenetic variation
Omics
Genetic variation
Mitochondrial disease
Next Generation Sequencing (NGS)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The MiDiSeq project will enroll 20 unresolved index patients with suspected mitochondrial disease prioritized for genomic analysis.

Detailed description: In the MiDiSeq (monocentric, prospective, open-label diagnostic) project, patients with suspected mitochondrial disease prioritized for i) high a priori probability for a genetic basis (e.g. positive family history) as well as availability of (ii) fibroblast cell lines with a biochemically defined phenotype, (iii) parental samples, (iv) short read whole genome and transcriptome datasets and (v) optional additional metabolomics and proteomics data.

The following questions will be leading the project:

i) to systematically benchmark different sequencing technologies to detect genetic and epigenetic variation and their impact on gene regulation.

(ii) to further develop algorithms for integrative analyses of different 'omics datasets.

(iii) to expand the analysis from coding Single-Nucleotide Variants (SNVs) and regulatory mutations to structural variants (SVs), repeat expansions and contractions, low complexity regions and epigenetic signatures.

(iv) to identify novel alterations and disease mechanisms. (v) to gain fundamental new insights into disease mechanisms and cellular biology.

(vi) to improve genetic diagnostics of future rare disease patients and to evaluate personalized therapeutic options.

Eligibility criteria: Inclusion Criteria:

Unclear diagnosis Suspected genetic cause of the disease

Exclusion Criteria:

Missing informed consent of the patient/ legal guardian

Primary outcomes:
measure: (Epi)Genetic variation
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Tobias Haack, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367652: Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted conditions.


Eligibility criteria: Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to letrozole or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: Alan Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References: