louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01038167: A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults
Official title: An Open-Label Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: VX-950
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2009-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.


Eligibility criteria: Inclusion Criteria:

* Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive)
* Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening.

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit.
* Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.

Primary outcomes:
measure: Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)
timeFrame: 33 days
measure: Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)
timeFrame: 33 days for Part A; 44 days for Part B
measure: Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)
timeFrame: 44 days
Secondary outcomes:
measure: Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations
timeFrame: 33 days for Part A; 44 days for Part B
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00186667: Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease
Official title: An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft vs Host Disease
Blood and Marrow Transplant (BMT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.

Detailed description: An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Eligibility criteria: Inclusion Criteria:- active chronic GvHD

* ANC \> 1000/mm\^3
* therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection
* elevated serum creatinine

Primary outcomes:
measure: Evaluate the efficacy of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
Secondary outcomes:
measure: Evaluate the safety of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Laura Johnston
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05267067: Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery
Official title: Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.

Detailed description: Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.

Eligibility criteria: Inclusion Criteria:

* Male patients
* underwent valve surgery (repair or replacement) for mitral valve stenosis;
* hemodynamically stable,
* ages ranged from 12 to 18 years old-
* BMI ranges from 18.5 to 24.9
* reduced MEP, MVV and complaining from shortness of breath with exertion.

Exclusion Criteria:

* Patients with previous cardiac surgery
* congenital heart disease
* neurological disorders
* type1 diabetes mellitus
* smoker
* pacemaker implantation
* atrial fibrillation
* utilization of mechanical ventilation longer than 24 hours.

Primary outcomes:
measure: Respiratory muscle strength
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sahar Abdalbary
state: Select State/province
Study officials:
affiliation: Nahda University, Faculty of Physical Therapy
name: Abdallaha Mohamed, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04753567: nCap Pain Relief Patch vs. Placebo
Official title: nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: pain, arthritis
Lead sponsor: nCap Medical
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether use of the nCap Medical Nano-Capacitive pain relief patch reduces subject pain as measured by subject pain scores, WOMAC scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.


Eligibility criteria: Inclusion Criteria:

* Meet Altman's clinical criteria for Knee Osteoarthritis
* Male and Female Adults age 40-79
* VAS pain score of \> 4 at the beginning of the study

Exclusion Criteria:

* Subject unable to walk unassisted. Participants must be able to stand/walk for 30 minutes
* Inability to read and understand English. Must be able to complete WOMAC scale and questionnaires
* Severe systemic disease limiting ability to ambulate for 30 minutes
* Use of a TENS unit for one week before study or during study
* History of total knee replacement on the affected knee
* Knee surgery on the affected knee in the last 12 months
* Injection into the knee in the last 6 months
* Knee pain \< 411
* Inability to cognitively understand consent form or research study, or inability to give consent
* Diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases.
* Malignancy
* Injury to knee within 6 months
* Concomitant use of opioids, NSAIDS or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen.
* Pregnant or lactating
* Poor general health (ASA classification of IV+)

Primary outcomes:
measure: Pain score using VAS scale
timeFrame: After 30 minutes of use
Secondary outcomes:
measure: WOMAC score
timeFrame: 3 weeks
measure: Sustained pain response
timeFrame: 3 weeks
measure: Global assessment question
timeFrame: 3 weeks
measure: Pain medication monitoring
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Knee Arthritis Clinical Trial Officew
state: Utah
Study officials:
References:
Clinical trial NCT01759667: DIT After RYGB - A Prospective Study
Official title: Diet-induced Thermogenesis After Roux-en-Y Gastric Bypass - A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Morbid Obesity
Bariatric Surgery
Keywords: Diet-induced Thermogenesis;
Respiratory Quotient;
Roux-en-Y Gastric Bypass;
Energy Expenditure.
Lead sponsor: Gastrocirurgia, Brazil
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese patients. This loss is a result of several factors that go beyond the simple anatomical abnormality of the gastrointestinal tract and may be the product of post-op energy expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are important components of energy expenditure and possible changes in them can perform an important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients, which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The objective of this study is to perform a prospective analysis of these same variables (RQ and DIT), evaluating them in the same patients, when pre and postoperatively.


Eligibility criteria: Inclusion Criteria:

* Pre-op: Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with associated co-morbidities. Age \> 18 years
* Post-op: Patients who underwent surgery ≥ 12 months by the Head Surgeon of the Gastrocirurgia de Brasilia Clinic;

Exclusion Criteria:

* Patients aged \> 65 years. Severe heart and/or respiratory problems; Pregnant women.

Primary outcomes:
measure: Post-op DIT increase
timeFrame: 2 months
Secondary outcomes:
measure: Post-op RQ increase
timeFrame: 2 months
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Gastrocirurgia de Brasilia
state: Distrito Federal
Study officials:
affiliation: Gastrocirurgia de Brasilia
name: Silvia L Faria, M.Science
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03193567: Study of High Efficient Killing Cell Therapy for Advanced NSCLC
Official title: Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Houchao Biotechnology Co., Ltd
First posted: 2017-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer

Detailed description: Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.

Eligibility criteria: Inclusion Criteria:

* Male or female patients' age from 18 years to 70 years.
* Patients who have a life expectancy of at least 3 months.
* pathologically confirmed non-small cell lung cancer.
* failed in previous standard chemotherapy and targeted therapy.
* Karnofsky performance status 0-1.
* adequate organ functions.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with T cell lymphoma, syphilis, AIDS or combination
* Patients with highly allergic or have a history of severe allergies
* Patients with severe hepatic or renal dysfunction
* Patients with severe autoimmune disease or who is being treated with immunosuppressive agents
* Patients with severe infection not controlled or High fever
* Patients with organ transplantation or waiting for organ transplantation.
* Patients with brain metastasis
* Patients with severe coagulopathy (e.g. hemophilia)
* Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.

Primary outcomes:
measure: safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
timeFrame: 2 years
Secondary outcomes:
measure: efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
timeFrame: 2 years
Other outcomes:
measure: Progression free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Imaging evaluation before and after treatment
timeFrame: 0 day and 60 day
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References:
Clinical trial NCT02691767: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors
Official title: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Solid Tumors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.


Eligibility criteria: Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* FGFR2 amplification ,Refractory solid tumor and/or specific sensitivity to by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, pazopanibPlatelets\>=100 x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with pazopanib

Primary outcomes:
measure: Progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall response rate
timeFrame: 24 months
measure: Time to progression
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Number of subjects with adverse events as a measure of safety
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00450567: Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy
Official title: Monitoring Targeted Lung Cancer Treatments With FDG-PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with non-small cell lung cancer (stage III B or stage IV) and will be treated with an experiemntal drug or a combination of chemotherapy and new drugs, as part of standarad of care or because of enrollment in a study protocol.

Brief summary: RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.

PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

Detailed description: OBJECTIVES:

* Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.

OUTLINE: This is a prospective study.

Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer
* Any disease stage allowed
* Undergoing targeted treatment

Exclusion Criteria:

None

Primary outcomes:
measure: Correlation of glucose metabolic response with progression-free survival, overall survival, and changes in tumor size as measured by fludeoxyglucose F 18 positron emission tomography/CT scan
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Johannes Czernin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00354367: Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
Official title: A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn Disease
Certolizumab pegol
Fistula
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.


Eligibility criteria: Inclusion Criteria:

* Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease

Exclusion Criteria:

* Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
* All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient.
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Primary outcomes:
measure: Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
Secondary outcomes:
measure: Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
Other outcomes:
Locations:
Study officials:
affiliation: UCB / Global Medical Affairs
name: Krassimir Mitchev, MD
role: STUDY_DIRECTOR
References: