louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01381289: VX-770 Expanded Access Program
Official title: VX-770 Expanded Access Program (EAP)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2011-06-27
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program is to provide VX-770 prior to its commercial availability to people with cystic fibrosis (CF) who have at least one copy of the G551D-CFTR mutation and who are in critical medical need and who are not eligible for participation in other Vertex-sponsored studies.

Detailed description: VX-770, a compound being developed by Vertex Pharmaceuticals Incorporated (Vertex) for the treatment of CF, is an orally bioavailable small molecule that targets the underlying defect in CF, the dysfunctional CFTR protein. In Phase 3 studies of VX-770 in patients with CF and a G551D CFTR mutation, improvements in CFTR function (measured by reduction in sweat chloride concentration) and improvements in lung function were observed.

Patients who are interested in the VX-770 Expanded Access should contact their CF physician about participation.

Physicians interested in participating as a site should contact 800-745-4484.

Eligibility criteria: Inclusion Criteria:

* Male or female with confirmed diagnosis of CF, with a sweat chloride \>60 mmol/L OR 2 CF-causing mutations AND chronic sinopulmonary disease OR gastrointestinal/nutritional abnormalities.
* Have the G551D-CFTR mutation in at least 1 allele
* Will be aged 6 years or older on the date of signed informed consent form
* Highest FEV1 in the 6 months prior to screening is ≤ 40% predicted value or patient is documented to be active on the lung transplant wait list

Exclusion Criteria:

* If female, currently pregnant
* Abnormal liver function, at screening on recent clinical laboratory testing, defined as \>3 × upper limit of normal (ULN), of any 3 or more of the following: AST, ALT, GGT, serum alkaline phosphatase, total bilirubin
* Is currently requiring invasive mechanical ventilation
* Is currently participating, or has participated in the past 30 days in another therapeutic or clinical study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05939089: Cardiovascular Assessment of Pediatric Cancer Survivors
Official title: Cardiovascular Assessment of Pediatric Cancer Survivors: Understanding Long-Term Effects and Risks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Dysfunction
Heart Failure
Keywords: Childhood Cancer Survivors
Cardiotoxicity
cancer treatment related heart diseases
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 54
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 who are less than 18 years-old, diagnosed and treated for any type of cancer.

Brief summary: The goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors.

Detailed description: All pediatric cancer survivors were evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cancer at pediatric age

Exclusion Criteria:

* Having cancer after 18 years of age

Primary outcomes:
measure: Rate of LV Dysfunction
timeFrame: From the first visit at cardio-oncology division through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Istanbul Faculty of Medicine
state: Istanbul
Study officials:
affiliation: Faculty member
name: Cafer Zorkun, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01343589: Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk
Official title: Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Type-2 Diabetes
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
name: The Danish Council for Strategic Research
First posted: 2011-04-28
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the effect of milk delivered from mountain-pasture grazing cows on risk markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish milk. The study should reveal the importance of phytanic acid content for these effects.


Eligibility criteria: Inclusion Criteria:

* sign written consent
* Age: 50-70
* BMI: 20-30
* increased risk of developing MS
* refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

* poor compliance
* if they suffering from any chronic or long lasting illness
* abuse of alcohol or medicine

Primary outcomes:
measure: Oral glucose tolerance test
timeFrame: before and after the intervention (12 weeks)
measure: LDL cholesterol
timeFrame: before and after the intervention (12 weeks)
measure: HDL cholesterol
timeFrame: before and after the intervention (12 weeks)
measure: Total cholesterol
timeFrame: before and after the intervention (12 weeks)
measure: Triacylglycerol
timeFrame: before and after the intervention (12 weeks)
measure: C-reactive protein
timeFrame: before and after the intervention (12 weeks)
measure: fatty acid composition in plasma
timeFrame: before and after the intervention (12 weeks)
Secondary outcomes:
measure: phytanic acid
timeFrame: before and after the intervention (12 weeks)
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Tine Tholstrup, lector
role: PRINCIPAL_INVESTIGATOR
References:
citation: Werner LB, Hellgren LI, Raff M, Jensen SK, Petersen RA, Drachmann T, Tholstrup T. Effects of butter from mountain-pasture grazing cows on risk markers of the metabolic syndrome compared with conventional Danish butter: a randomized controlled study. Lipids Health Dis. 2013 Jul 10;12:99. doi: 10.1186/1476-511X-12-99.
Clinical trial NCT01058889: Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus
Official title: Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Insulin Resistance
Keywords: Diabetes mellitus Type 2
Telemedicine
Insulin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2010-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to show if telemonitoring and automated feedback regarding glucose management, physical activity, blood pressure, and body weight improves treatment of patients with insulin dependent Type 2 Diabetes mellitus.

Detailed description: In this clinical trial 50 patients with insulin dependent type 2 diabetes will be randomised in two study arms: monitoring of blood glucose and blood pressure using a telemedical device or in an arm with treatment as usual. Patients will the following measurement devices: blood glucose, blood pressure. Both devices can communicate with a mobile phone, which will also be provided to the patients. The mobile phone will transfer the data to a central, safe server. Patients will receive automated reminder/feedback. Caregivers can evaluate the transferred data whenever necessary via a web-based access. Data will be presented in tables as well as trend figures.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 2, age 18-70 years, able to use a mobile phone

Exclusion Criteria:

* Pacemaker, intracardial defibrillator, no cure planned within the active study period.

Primary outcomes:
measure: System availability, acceptance, transmission rate
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Allgemeines Krankenhaus
Study officials:
affiliation: Medical University Vienna
name: Bernhard Ludvik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01880489: Multicomponent Intervention to Reduce Sexual Risk and Substance Use
Official title: Multicomponent Intervention to Reduce Sexual Risk and Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Infections
Substance Use
Keywords: transgender women
sexual risk
substance use
HIV prevention
behavioral intervention
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-06-19
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Identify as a transgender woman (assigned male at birth and currently identify as female)
* Report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days
* Report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30
* Provide contact information
* Reside in the NYC metropolitan area
* Able to complete a survey in English (Spanish-language assistance can be provided by bilingual staff)
* Provide informed consent

Exclusion Criteria:

* Unstable, serious psychiatric symptoms
* Current suicidal/homicidal ideation
* Evidence of gross cognitive impairment
* Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study

Primary outcomes:
measure: Number of Unprotected Sex Acts in the Past 90 Days
timeFrame: every 4 months over the course of 8 months
measure: Number of Days of Drug Use in the Past 90 Days
timeFrame: every 4 months over the course of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
state: New York
Study officials:
affiliation: Hunter College of City University of New York
name: H. Jonathon Rendina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00755989: Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds
Official title: A Phase 3, Single-Centered, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Trial of Morphine Sulfate Gel 0.1% in Patients With Stage 2-3 Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Wounds
Lead sponsor: Banner Health
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 100
Sex: ALL
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: Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.

Detailed description: Patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. Patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.

Eligibility criteria: Inclusion Criteria:

* Signed and dated consent form \& HIPAA
* \> 18 yo
* Single stage 2-3 wound
* No allergy to morphine
* Alert and oriented (thinking ability clear and intact, physician approval)
* English language proficiency

Exclusion Criteria:

* Allergy to morphine, codeine, or versa base, pts taking medications for acute condition, other than for the wound pain
* Patients with neuropathies
* Patients with respiratory conditions

Primary outcomes:
measure: Safety and efficacy with the use of morphine gel applied topically for pain control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
Study officials:
affiliation: Banner Health
name: Mary Whitmer, MSN,FNP, APRN BC-PCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02544789: Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
Official title: Phase II, Multi-center, and Pharmacokinetic Study of Efficacy, Safety and Pharmacokinetic of Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients with R/R ALL


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (younger than 21 years old) with acute lymphoblastic leukemia confirmed by histology
* Refractory or relapsed acute lymphocytic leukemia who had received at least two drugs treatment
* No prior chemotherapy within 2 weeks before entry and resolution of toxic effects from prior therapy
* Normal cardiac function, adequate hepatic function \[total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) alanine aminotransferase (ALT) ≤ 3ULN\] and renal function (serum creatinine ≤ 2 ULN)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy more than 3 months

Exclusion Criteria:

* AEs not recovered from prior therapy
* Within 3 months from allogeneic or autologous stem cell transplantation
* With central nervous involvement or uncontrolled infection
* Patients who used clofarabine before or allergic to fludarabine or cladribine

Primary outcomes:
measure: overall response rate
timeFrame: 8 weeks
Secondary outcomes:
measure: patients suffering adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pediatrics, Peking University People's Hospital
city: Beijing
country: China
facility: Department of Phase 1 Clinical Trial, Peking University People's Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital, Guangdong Academy of Medical Science
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
Study officials:
affiliation: Department of Pediatrics, Peking University People's Hospital
name: Jin Lu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05637489: Patient Initiated Note About Goals
Official title: Patient Initiated Note About Goals
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized controlled trial of the Patient-Initiated Note about Goals (PING).

Detailed description: The PING is a brief survey designed to elicit patients' goals, preferences, and preferred surrogate decision-maker. In the PING study, patients will be assigned to receive either a nurse-administered PING or usual care. Outcomes include PING completion, subsequent goals of care conversations with providers, and healthcare utilization.

Eligibility criteria: Inclusion Criteria:

* Patient referred for Annual Wellness Visit at participating clinic

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Number of participants with subsequent goals of care conversation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
Study officials:
affiliation: Duke Health
name: David J Casarett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914289: Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients
Official title: Comparison of Resection and Radiotherapy in the Prognosis of Intrahepatic Cholangiocarcinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Intrahepatic Cholangiocarcinoma
Prognosis
Resection
Radiotherapy
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.

Detailed description: Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies.

Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined.

This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 17 years and \<=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.

No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.

Karnofsky Performance Score performance over 60. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

* Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.

Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.

Patients would not sign the consent to the trial.

Primary outcomes:
measure: the overall survival rate of each group
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Li Aijun, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02351089: Probiotics in Radiation-treated Gynecologic Cancer
Official title: Probiotics in Radiation-treated Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Toxicity
Gynecologic Cancer
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy either as a primary or as a secondary treatment following surgery. Chemotherapy may or may not be part of the treatment regimen.
* Age, older than 18 years old.
* Agreement for participation in the study by signed written informed consent.

Exclusion Criteria:

* Previously treated with irradiation of the pelvic area.
* Reluctance to refrain from using other probiotic products during the participation in the study.

Primary outcomes:
measure: Change in incidence of loose/watery stools
timeFrame: Baseline and 10 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Dept of Oncology
Study officials:
References: