louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01293136: Retrospective Femoral Nerve Block Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Reconstructive Surgery
Keywords: knee
reconstructive surgery
femoral nerve block
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that had reconstructive knee surgery

Brief summary: This is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional anesthesia program. The investigators hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia and facilitates discharge home when compared to intravenous opioid use following reconstructive knee surgery.


Eligibility criteria: Inclusion Criteria:

* Patients that had reconstructive knee surgery between July 2009 to the present.

Exclusion Criteria:

* None

Primary outcomes:
measure: Duration of hospitalization
timeFrame: 1 Week
Secondary outcomes:
measure: Nausea and vomiting
timeFrame: 1 Week
measure: Total opioid use
timeFrame: 1 Week
measure: Postoperative pain score
timeFrame: 1 Week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT05802836: Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab
Official title: Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Hemophilia A
Severe Hemophilia A With Inhibitor
Severe Hemophilia A Without Inhibitor
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Chugai Pharma Germany GmbH
First posted: 2023-04-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to recruit 100 patients with severe hemophilia A from 15 study sites in germany.

Brief summary: The goal of this observational study is to learn about the changes of antibodies and inhibitors against the coagulation factor VIII in patients with severe hemophilia A receiving emicizumab therapy. No additional visits or procedures are planned. Patients in this study will continue to receive their routine care and analysis will be done from left over samples from routine visits.


Eligibility criteria: Inclusion Criteria:

* Severe congenital hemophilia A (CHA)
* Treatment with emicizumab irrespective of any other treatment
* Informed consent

Exclusion Criteria:

* No therapy with emicizumab
* Immunosuppressive therapy
* HIV-infection with CD4 (cluster of differentiation 4) cells \<200/µl

Primary outcomes:
measure: FVIII inhibitor development in inhibitor negative subjects
timeFrame: 3 years
measure: FVIII antibody development in inhibitor negative subjects
timeFrame: 3 years
measure: FVIII inhibitor disappearance in inhibitor positive subjects
timeFrame: 3 years
measure: FVIII antibody disappearance in inhibitor positive subjects
timeFrame: 3 years
Secondary outcomes:
measure: Anti-FVIII inhibitor development
timeFrame: 3 years
measure: Anti-FVIII antibody development
timeFrame: 3 years
measure: Time to negative inhibitor titers
timeFrame: 3 years
measure: Treatment of bleeds
timeFrame: 3 years
measure: Response to treatment
timeFrame: 3 years
measure: Quality of the antibody response (FVIII epitopes)
timeFrame: 3 years
measure: Quality of the antibody response (IgG subclasses)
timeFrame: 3 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt, Goethe University
state: Hessen
Study officials:
affiliation: Goethe University
name: Christoph Koenigs, PD Dr. Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04385836: Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Official title: Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Coronavirus
Lead sponsor: Ministry of Health, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2020-05-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin


Eligibility criteria: Inclusion Criteria:

1. Positive RT-PCR) assay for SARS-CoV-2
2. Age \>18 years
3. Hospitalized
4. Able to give informed consent

Exclusion Criteria:

1. Known allergy to AAT
2. imminent death within next 24 hours

Primary outcomes:
measure: clinical improvement
timeFrame: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Ministry of Health
Study officials:
affiliation: MOH
name: mohammed m othman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03432936: Prospective Use of Philips iSuite for Interventional Procedures
Official title: Prospective Use of Philips iSuite for Interventional Procedures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Tumor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2018-02-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.

Detailed description: The purpose of this study is to evaluate Philips Interventional iSuite software used for MRI guided procedures in the MRI suite. The real-time MRI Imaging software will be used during an MRI procedure to take continuous pictures.

The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on the use of this software as a clinical aid in performing interventional procedures within the MR suite. The primary evaluation will be weighted toward enhanced facilitation of ablation procedures. However, the software will not replace standard MR imaging for final confirmation of needle tip position and ablation margins.

Eligibility criteria: Inclusion criteria:

* Patients already scheduled for a percutaneous MR guided procedure

Exclusion criteria:

* Pregnant Women

Primary outcomes:
measure: Needle placement efficiency into target lesion
timeFrame: Will assess for 3 years with interval assessment each year
Secondary outcomes:
measure: Software ease of use in targeting lesion for treatment
timeFrame: Will assess for 3 years with interval assessment each year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David A Woodrum, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03770936: Effect of Some Drugs on Liver Fibrosis
Official title: Clinical Study Evaluating the Efficacy of Renin Angiotensin System Inhibitors on the Extent of Liver Fibrosis in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver Fibroses
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 45
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: Effect of Some Drugs on Liver Fibrosis

Detailed description: The study aimed at evaluating the effect of Some Drugs on Liver Fibrosis

Eligibility criteria: Inclusion Criteria:

* chronic hepatitis C

Exclusion Criteria:

* Acute hepatitis
* Thalassemia

Primary outcomes:
measure: Change in Fibroscan or APRI score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Clinical pharmacy Department- Tanta University
name: Gamal El-azab, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Department- Tanta University
name: Tarek Mostafa, Prof
role: STUDY_DIRECTOR
affiliation: National Hepatology Institute - Egypt
name: Gamal Badra, Prof
role: STUDY_CHAIR
affiliation: Clinical pharmacy Department-Tanta University
name: Abeer El-Motwally, Msc
role: STUDY_CHAIR
References:
citation: Mostafa TM, El-Azab GA, Badra GA, Abdelwahed AS, Elsayed AA. Effect of Candesartan and Ramipril on Liver Fibrosis in Patients with Chronic Hepatitis C Viral Infection: A Randomized Controlled Prospective Study. Curr Ther Res Clin Exp. 2021 Nov 12;95:100654. doi: 10.1016/j.curtheres.2021.100654. eCollection 2021.
Clinical trial NCT04817436: Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
Official title: Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.


Eligibility criteria: Inclusion Criteria:

1. Female
2. Patient \> 18 years
3. Follow-up in the department of clinical Nutrition of Rouen
4. BMI ≥15,0 and \<18,5 kg/m²
5. Diagnosis of anorexia nervosa according to DSM-V classification

Exclusion Criteria:

1. Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension
2. Patients with poor understanding of spoken or written French
3. Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults
4. Person subject to a safeguard of justice, guardianship or curatorship.
5. Pregnant or breastfeeding woman

Primary outcomes:
measure: To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate the effects of adapated physical activity program on anthropometric data.
timeFrame: 3 months
measure: To evaluate the involving of gut microbiota composition and diversity
timeFrame: 3 months
measure: To evaluate the effects of adapated physical activity program on quality of life
timeFrame: 3 months
measure: To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation
timeFrame: 3 months
measure: To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00574236: Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Official title: A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Millennium Pharmaceuticals, Inc.
First posted: 2007-12-17
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.


Eligibility criteria: Inclusion Criteria:

* Cytologically or histologically confirmed metastatic breast cancer
* Measurable or evaluable disease
* Age \> 18, PS 0,1,2
* MUGA \> 45%
* Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx.
* Must meet designated laboratory criteria within 14 days of enrollment

Exclusion Criteria:

* Doxorubicin for metatstatic disease.
* Pregnant or lactating.
* Active infections, no myocardial infarction within 2 months of enrollment.
* Investigational drugs within 14 days of enrollment.
* Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
* Neuropathy that is \> grade 2.
* Active brain mets.
* Hypersensitivity to bortezomib, boron, or mannitol.

Primary outcomes:
measure: Overall Response Rate
timeFrame: Every two cycles/42 days, up to 7 months
Secondary outcomes:
measure: Time to Progression
timeFrame: Up to one year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin PPC Comprehensive Cancer Center
name: James A Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193336: Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Official title: Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: NSCLC Lung Cancer
Non Small Cell Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status

Detailed description: Upon determination of eligibility, patients will be receive:

* ZD1839

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Biopsy proven non-small cell lung cancer
* Recurrent non-small cell lung cancer after previous surgery or radiation
* Advanced disease (stage IIIb or IV)
* No previous chemotherapy or biological therapy
* Require significant assistance with activities of daily living
* Measurable disease
* Adequate bone marrow, liver and kidney function
* Give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Brain metastasis
* Meningeal metastasis
* Other uncontrolled malignancies
* Women pregnant or lactating
* No measurable disease outside previous radiation therapy field

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Overall toxicity
measure: Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Hainsworth JD, Burkett ER, Burris HA, Yardley DA, Thomas M, Jones SF, Dickson NR, Scullin DC, Bradof JE, Rubinsak JR, Brierre JE, Greco FA. Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial. Clin Lung Cancer. 2005 Sep;7(2):127-32. doi: 10.3816/CLC.2005.n.028.
Clinical trial NCT01077336: Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
Official title: Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Stream Infections
Candida
Keywords: susceptibility testing
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-03-01
Enrollment: 450
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: This will be a retrospective cohort study of 400 hospitalized patients with bloodstream infections from January 2006 to January 2009 due to Candida species

Brief summary: Susceptibility testing is commonly employed in patients with bacterial infections in order to guide rational use of antibiotics; however, the use of antifungal susceptibility testing is limited due to lack of availability, costs, and delays in receiving results. The goals of antifungal susceptibility testing should mirror those of antibacterial susceptibility testing: to predict clinical response or failure. Additionally, susceptibility reports should be used as a guide for physicians when transitioning patients from parenteral to oral antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts treatment decisions in hospitals that routinely perform Candida susceptibility testing. The purpose of this study is to evaluate the changes in antifungal treatment based on in vitro susceptibility reports and how these decisions affect mortality, recurrence of infection, and length of hospital stay in candidemia patients.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with bloodstream infections due to Candida species

Exclusion Criteria:

* Patients will be excluded from this study if their medical charts contain incomplete outcome or susceptibility data. Patients treated empirically or definitively with amphotericin-based products will also be excluded

Primary outcomes:
measure: Assess empiric choice of antifungal therapy in hospitalized patients with candidemia.
timeFrame: Assessments made for 30-days after postivie blood culture
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02196636: A Phase 1 Study of RO6806127 in Healthy Male Volunteers
Official title: A Single-center, Randomised, Double-blind, Adaptative, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics or RO6806127 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants aged 18 to 45 years, inclusive
* A BMI between 18 to 30 kg/m2, inclusive
* Agreement to use highly effective contraception

Exclusion Criteria:

* Clinically significant abnormalities in laboratory test results
* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
* Significant disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
* Use of any prohibited medications and food before study start and during the study
* Dietary restrictions that would prohibit the consumption of standardized meals

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to Day 21
Secondary outcomes:
measure: Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine
timeFrame: Up to Day 21
measure: RO6806127 metabolite concentrations in selected plasma and urine samples
timeFrame: Up to Day 21
measure: Relative bioavailability (food effect): Area under the concentration-time curves [AUC]
timeFrame: Up to Day 21
Other outcomes:
Locations:
city: Marlton
country: United States
state: New Jersey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: