louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01429961: Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Official title: Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* ECOG performance score of two or less
* Child Pugh class A•
* Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL
* presence of extrahepatic measurable lesion
* no prior systemic therapy (excluding sorafenib)
* adequate marrow, liver, kidney function
* written informed consent

Exclusion Criteria:

* prior systemic therapy (excluding sorafenib)
* hypersensitivity to study drugs
* active gastrointestinal bleeding
* other malignancies within five years
* pregnant or breastfeeding female
* symptomatic brain or leptomeningeal metastasis
* clinically significant heart disease
* interstitial pneumonia
* peripheral neuropathy grade one or more
* uncontrolled infection
* renal impairment
* prior use of investigational drug or therapy within 4 weeks

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
measure: response rate
timeFrame: 2 years
measure: toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee DW, Lee KH, Kim HJ, Kim TY, Kim JS, Han SW, Oh DY, Kim JH, Im SA, Kim TY. A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma. BMC Cancer. 2018 Mar 5;18(1):252. doi: 10.1186/s12885-018-4039-9.
Clinical trial NCT04084561: Risk Communication in African American Smokers
Official title: Nicotine Dependence and Lung Cancer Genetics in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-10
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Participants will be given hypothetical personalized genetic risk results and ask to think about how they might respond to such information if they actually received such results.

Detailed description: The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Smokers will be randomized to receive hypothetical information about their genetic status and consider how they think they would respond if such results were actually presented to them. They will be randomly assigned to receive one of four sets of hypothetical genetic results: 1) High risk of lung cancer and high genetic African ancestry, 2) High risk of lung cancer and low genetic African ancestry, 3) Low risk of lung cancer and high genetic African ancestry, or 4) Low risk of lung cancer and low genetic African ancestry. After being given this hypothetical information, participants will complete brief questionnaires assessing perceived risk of lung cancer, worry about cancer, psychological distress, and motivation to quit smoking.

Eligibility criteria: Inclusion Criteria:

* 18 years of age minimum
* Self-report African American
* Report smoking at least 100 lifetime cigarettes

Exclusion Criteria:

* Report history of cancer

Primary outcomes:
measure: Motivation to Quit Smoking
timeFrame: 1 minute after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Camille Ragin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298761: Efficacy of I/v Nalbuphine v/s Iv Lignocain in Attanuation of Pressor Responseduring Laryngeoscopy and Intubation in Middle Age Patient Planned for Thyroid Surgery
Official title: Efficacy of IV Lignocaine Versus IV Nalbuphine for Attenuation of Pressor Response Diring Laryngoscopy and Intubation in Patients Planned for Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hemodynamic Stability
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2022-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at induction.


Eligibility criteria: Inclusion Criteria:

* middle age(18_40)
* Asa 1 and 2
* Non hypertensive
* Thyroid patients
* patient who gives consent

Exclusion Criteria:

* hypertensive
* Asa 3 and 4
* Patient refusal

Primary outcomes:
measure: Reduce stress response during intubation and hemodynamic stabilty
timeFrame: 10 minutes
measure: Achieve hemodynamic stabilty and smooth intubation
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Dr.amna
state: Punjab
Study officials:
affiliation: Sheikh zaied medical hospital
name: Dr.amna Sarwar, Fcps
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01140061: Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Official title: A 3-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-0873 Following Cumulative Patch and Repeated Max Area Applications in Healthy Subjects and Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plaque Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. The primary hypotheses of the study are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with psoriasis and 2) that the maximum plasma concentration of MK-0873 is \<20 nM in healthy participants and participants with psoriasis.


Eligibility criteria: Inclusion Criteria:

Part I, II and III:

* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
* In good general health;
* Nonsmoker;

Part III only:

* Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

Exclusion Criteria:

Part I, II and III:

* Has a history of stroke, chronic seizures or major neurological disease;
* Has a history of cancer;
* Is a nursing mother;

Part III only:

* Has nonplaque forms of psoriasis;
* Has current drug-induced psoriasis;
* Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
* Has used any systemic immunosuppressants or biologics within the past 4 weeks.

Primary outcomes:
measure: Number of Participants With an Adverse Event of Erythema in Part I of the Study
timeFrame: Up to Day 22 in Part 1
measure: Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days
timeFrame: Day 11
measure: Number of Participants With an Adverse Event
timeFrame: Up to 14 days after last dose of study drug (up to Day 42)
measure: Number of Participants Who Discontinued Study Medication Due to an Adverse Event
timeFrame: Up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00188461: Dose Reduction in Thoracic CT
Official title: Dose Reduction in Thoracic CT: A Comparison of on Line Automatic Dose Reduction and a 50% Reduction in Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis: Does a 50% reduction in radiation in dose significantly affect the diagnostic quality of chest CT

Detailed description: Patients with Lymphoma are recruited and have a follow up CT performed at 50% of the standard exposure parameters. The studies are compared for image quality with a recent (\<3 months) thoracic CT performed at standard exposure parameters.

Eligibility criteria: Inclusion Criteria:

* Patients with Lymphoma

Exclusion Criteria:

* No recent (\<3 months) thoracic CT

Primary outcomes:
measure: Evaluating the diagnostic quality of thoracic CT exams performed at 50% of standard dose parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846261: The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique
Official title: The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trauma
Orthopedic Surgery Complications
Keywords: infected
Ilizarov
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2009-02-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this retrospective study, the investigators evaluated the clinical and functional results of infected nonunion of the long bone with soft-tissue defects treated simultaneously with Ilizarov technique combining open dressing change in 22 patients. The investigators wanted to find out whether that the internal bone transport with external fixator combining open dressing change is a valuable method to treatment for those patients with infected bone nonunion and poor condition of the soft tissue such as sinus, skin defect.

Detailed description: From January 2002 to now, totally 22 patients (18 males, 4 females) were underwent internal bone transport for infected nonunion in the long bone with soft-tissue defects. The mean age of the patients was 36.5 years (range, 19 to 57). The infected nonunion occurred on the femur in 1 patients, the tibia in 21 patients. The hybrid mono-lateral limb reconstruction external fixator was used, combined with bone transport. The results were evaluated by the classification of the Association for the Study and Application of the Method of Ilizarov (ASAMI) which divided into bone and functional categories

Eligibility criteria: Inclusion Criteria:

* Patients with infected nonunion of long bone with soft tissue defects or sinus, without systemic illness that could affect their immunologic status (e.g., AIDS, diabetes mellitus, liver cirrhosis).

Exclusion Criteria:

* Patient noncooperation and an age of less than 18 years

Primary outcomes:
measure: Achive wounds close and bone union
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Orthopedics, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
name: Qiang Zheng, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00777361: Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
Official title: An Open, Two Period, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following Oral Administration of [14C]-AZD3480 and the Pharmacokinetics of AZD3480 Following Intravenous Administration to Healthy Male Volunteers With Different CYP2D6 Genotype
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Mass balance
AZD3480, Pharmacokinetics, Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 9
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.


Eligibility criteria: Inclusion Criteria:

* Physically healthy volunteers
* Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)

Exclusion Criteria:

* History of clinically significant diseases or illness.
* Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.

Primary outcomes:
measure: Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.
timeFrame: Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours.
measure: Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss)
timeFrame: 19 and 18 blood samples during 72 and 96 hours after iv (Visit 2) and po dosing (Visit 3) respectively. Urine collection for 72 hours and 168 hours (up to 2 weeks).
Secondary outcomes:
measure: identity of major metabolites in plasma and excreta
timeFrame: 4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks).
measure: Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.
timeFrame: From enrollment to follow-up
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research site
state: Cheshire
Study officials:
affiliation: AstraZeneca Södertälje, Sweden
name: Björn Paulsson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit @ Guy´s Hospital
name: Tim Mant, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167761: Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Official title: Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiovascular Diseases
Atherosclerosis
Type 2 Diabetes
Insulin Resistance
Keywords: Epicardial Adipose Tissue
SGLT2 Inhibitor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-11-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: in vitro experimental study with treated and control tissue samples
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.


Eligibility criteria: Inclusion Criteria:

* patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery
* history of Diabetes Mellitus Type 2 currently diet controlled, or on metformin or dpp4 inhibitors

Exclusion Criteria:

* allergy or intolerance to interventional medication
* currently taking insulin, glp-1 inhibitors, or sulfonylureas

Primary outcomes:
measure: Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples.
timeFrame: Time to collect tissue collected during surgery (up to 15 minutes)
Secondary outcomes:
measure: Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples.
timeFrame: Time to collect tissue collected during surgery (up to 15 minutes)
measure: Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples.
timeFrame: Time to collect tissue collected during surgery (up to 15 minutes)
measure: Distribution of adipose cell size in epicardial tissue.
timeFrame: Time to collect tissue collected during surgery (up to 15 minutes)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tracey McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01907061: Acute Renal Failure Post Liver Transplantation
Official title: Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Failure
Keywords: acute renal failure
post liver transplant
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant

Detailed description: 1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
2. To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
3. To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation

Eligibility criteria: Inclusion Criteria:

* First liver transplant
* Normal renal function before transplantation \[serum creatinine ≤ 1.5 mg / dl\]
* No requirements for dialysis before transplantation
* Age greater than 18 years

Exclusion Criteria:

* Re-transplant
* Renal dysfunction i.e. serum creatinine \> 1.5 mg/dl
* Need for dialysis before transplantation
* Presence of Hepatorenal or Hepatopulmonary syndrome\*
* Combined liver and kidney transplant
* Peptic ulcer disease
* Pregnancy

Primary outcomes:
measure: To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
timeFrame: 6 months
Secondary outcomes:
measure: To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
timeFrame: 6 months
measure: iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Yousri M. Barri, MD
role: PRINCIPAL_INVESTIGATOR
References: