louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00259987: Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
Official title: A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma
Keywords: relapsed adenocarcinoma
esophagus
tumors
GE junction
cancer
lapatinib
gastric cardia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 24
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: This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.


Eligibility criteria: Inclusion criteria:

* Has a histologically confirmed adenocarcinoma of the esophagus.
* GE (gastroesophageal) junction or gastric cardia.
* Must be of non-child-bearing potential or is of child-bearing potential.
* Have a negative serum pregnancy test and agree to an approved form of birth control.
* Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
* Have a life expectancy of at least 12 weeks.
* Have provided written informed consent.
* Investigator considers patient to be fit for study from lab test results and interview.

Exclusion criteria:

* Pregnant or lactating female.
* Prior resection of the small bowel.
* Received major surgery.
* Received prior radiation therapy to the mediastinum or abdomen.
* Has a known immediate or delayed hypersensitivity reaction.
* Idiosyncrasy to drugs chemically related to the study drug.

Primary outcomes:
measure: Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
timeFrame: daily throughout the study
Secondary outcomes:
measure: Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately.
timeFrame: throughout the study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: San Isidro
country: Peru
facility: GSK Investigational Site
state: Lima
city: Lima
country: Peru
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01514487: Comparison of Three Liraglutide Formulations in Healthy Volunteers
Official title: A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
* Body Mass Index (BMI) of 18-27 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
* metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
* that may interfere with the objectives of the study, as judged by the investigator
* Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
* Impaired renal function
* Uncontrolled treated/untreated hypertension
* Any clinically significant abnormal ECG
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunideficiency virus) antibodies
* Known or suspected allergy to trial product(s) or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* Prescription or non-prescription medication, except for paracetamol and vitamins
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator

Primary outcomes:
measure: Area under the Curve (0-t)
measure: Cmax, maximum concentration
Secondary outcomes:
measure: Area under the curve (0-infinity)
measure: tmax, time to reach Cmax
measure: t½, terminal half-life
measure: Terminal elimination rate constant
measure: Adverse events
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00769587: Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
Official title: Phase II Study of Thalidomide in Mastocytosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Neoplastic Condition
Precancerous Condition
Keywords: aggressive systemic mastocytosis
smoldering systemic mastocytosis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.

PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.

Detailed description: OBJECTIVES:

Primary

* Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.

Secondary

* Determine the tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of systemic mastocytosis

  * Aggressive or borderline (smoldering) disease (in first line or more)
  * Relapsed or progressive disease
* Measurable or evaluable disease
* Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs
* No nonsymptomatic mastocytosis

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment
* Bilirubin \< 2 times normal (unrelated to disease)
* Liver enzymes \< 2 times normal (unrelated to disease)
* Creatinine ≤ 300 mmol/L
* No central or peripheral neuropathy leading to psychiatric concerns
* No HIV positivity
* No active infection or other serious underlying illness that would preclude treatment
* No history of thromboembolism or deep vein thrombosis
* No geographical, social, or psychological reasons preventing medical monitoring

PRIOR CONCURRENT THERAPY:

* More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy)
* No other concurrent treatment specific for this disease
* No concurrent participation in another experimental drug trial

Primary outcomes:
measure: Objective reduction of the infiltration rate at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
Study officials:
affiliation: Centre Hospitalier Universitaire, Amiens
name: Gandhi Damaj
role: STUDY_CHAIR
References:
Clinical trial NCT00690287: A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients
Official title: A Dose-Ranging Study to Evaluate Fasting and Postprandial P-Glucose, Safety and Tolerability After Oral Single, B.I.D and Q.I.D Dosing of AZD6370 in Patients With Diabetes Mellitus: a Randomized, Single-Blind, Placebo-Controlled, Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
* Diabetes Mellitus diagnosis \<5 years

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results

Primary outcomes:
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Safety variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
measure: Pharmacokinetic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Research Site
city: Luleå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
name: Klas Malmberg, MD, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: Quintiles AB, Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
name: Wolfgang Kühn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ericsson H, Sjoberg F, Heijer M, Dorani H, Johansson P, Wollbratt M, Norjavaara E. The glucokinase activator AZD6370 decreases fasting and postprandial glucose in type 2 diabetes mellitus patients with effects influenced by dosing regimen and food. Diabetes Res Clin Pract. 2012 Dec;98(3):436-44. doi: 10.1016/j.diabres.2012.09.025. Epub 2012 Sep 23.
Clinical trial NCT02360787: The Effects of Including Almonds in a Weight Loss Trial
Official title: The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Almonds
Energy restriction
Obesity
Body weight
Body fat
Blood pressure
Cognitive function
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2015-02-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Detailed description: The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Eligibility criteria: Inclusion Criteria:

Adult participants

* Overweight or obese (BMI 25-40 kg/m2)
* Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples
* No nut allergies
* Willing to comply to study protocol and to eat test meals

Exclusion Criteria:

Those not meeting inclusion criteria.

Primary outcomes:
measure: Anthropometric measurements
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Post-lunch cognitive function
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting blood biochemistries
timeFrame: 12 weeks
measure: Dietary intake
timeFrame: 10 weeks
measure: Appetite ratings
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
citation: Dhillon J, Ferreira CR, Sobreira TJP, Mattes RD. Multiple Reaction Monitoring Profiling to Assess Compliance with an Almond Consumption Intervention. Curr Dev Nutr. 2017 Sep 6;1(9):e001545. doi: 10.3945/cdn.117.001545. eCollection 2017 Sep.
citation: Dhillon J, Tan SY, Mattes RD. Almond Consumption during Energy Restriction Lowers Truncal Fat and Blood Pressure in Compliant Overweight or Obese Adults. J Nutr. 2016 Dec;146(12):2513-2519. doi: 10.3945/jn.116.238444. Epub 2016 Nov 2.
Clinical trial NCT00089687: GBR 12909 Study in Cocaine Experienced African American Volunteers - 1
Official title: GBR 12909 Study in Cocaine Experienced African American Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.

Detailed description: Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.

Eligibility criteria: Inclusion Criteria:

* Must be within 20% of ideal body weight and must weigh at least 45 kg.
* Must understand the study procedures and provide written informed consent.
* Must meet DSM-4 criteria for abuse or dependence on cocaine.
* Must be non-treatment seeking at the time of the study.

Exclusion Criteria:

* Please contact the study site for more information.

Primary outcomes:
measure: pharmacokinetic assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016587: Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study
Official title: Symptom Clusters and Immune Markers in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: symptoms
dyspnea
pain
fatigue
anxiety
depression
sleeplessness
genetic markers
immune markers
COPD
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2009-11-19
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 308 COPD patients

Brief summary: COPD patients often have a wide range of physical (e.g., dyspnea, fatigue, pain) and psychological (e.g., depression, anxiety) symptoms and various other debilitating conditions that cause considerable suffering for the individual. Unfortunately, many of the symptoms and health problems in patients with COPD are unrecognized and untreated. Due to the irreversible nature of COPD, the aim is not to cure the disease, but to reduce symptoms and improve quality of life.

Therefore, the purpose of this project is to investigate the existence and nature of symptom clusters over time in patients with COPD and their effects on patient outcomes. Since this study aims to identify possible new subgroups of patients with COPD defined by the clustering of certain symptoms, the study also aims to investigate the relationship between the clinical presentation and certain immunologic and genetic factors.

Detailed description: The specific aims of this translational, interdisciplinary, multi-center, international research study will follow 308 COPD patients with repeated measures over 12 months, are to:

1. Explore COPD patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time; as well as the genetic markers for subgroups of patients with different symptom clusters.
2. Identify the occurrence of HGG and assess immune function in COPD patients.
3. Explore relationships between HGG and immune function, genetic markers, symptoms, symptom clusters, health and respiratory status, frequency of exacerbations and health-related QOL.

Eligibility criteria: Inclusion Criteria:

* degree 2-4
* above 18 years of age
* able to read/ write/ speak Norwegian

Exclusion Criteria:

* patients who are receiving treatment for cancer
* acute exacerbations of COPD

Primary outcomes:
measure: symptom clusters in patients with COPD
timeFrame: 5 times during 12 months
Secondary outcomes:
measure: Evaluate potential candidate genes in relation to symptom clusters and investigate the relationship between hypogammaglobulinemia and symptoms in COPD.
timeFrame: 2 times during 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT06042387: Genome Analysis Across Populations in Inflammatory Bowel Disease
Official title: Genome Analysis Across Populations in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Healthy
Crohn Disease
Inflammatory Bowel Diseases
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-09-18
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD or Healthy controls (non-IBD)

Brief summary: Objective:

To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD within affected populations.

Detailed description: Background:

Inflammatory bowel disease (IBD) is a chronic, and often disabling, disorder of the intestines characterized by dysregulation of mucosal immune response. Recent data suggests that the incidence and prevalence rates among all populations may be increasing due to constantly changing environmental exposures. The goal of the study is to identify susceptible genes that contribute to the pathogenesis of IBD in affected individuals.

Eligibility criteria: Inclusion Criteria:

* Subjects: diagnosed with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, IBD-undetermined)
* Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U))
* Healthy controls: no personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss
* Any age

Exclusion Criteria:

- Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy Control criteria

Primary outcomes:
measure: Genomics studies across populations
timeFrame: 2022-2027
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
Study officials:
affiliation: Sinai Health System
name: Mark Silverberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01452087: Health Benefits of Chronic vs. Acute Exercise in Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: insulin sensitivity
exercise
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-10-14
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index: 27-34 kg/m2;
* Regular exercisers(≥4 days/wk of aerobic exercise;
* 30-60min/session at moderate and vigorous intensities);
* Non-exercisers (no regularly planned exercise/physical activity);
* Women must have regularly occurring menses and must be premenopausal.

Exclusion Criteria:

* Pregnant or lactating;
* Evidence/history of cardiovascular or metabolic disease;
* Currently taking medications known to affect lipid or glucose metabolism.

Primary outcomes:
measure: oral glucose tolerance test
timeFrame: 2 hour
Secondary outcomes:
measure: Resting Metabolic Rate
timeFrame: 20-30 min
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Substrate Metabolism Laboratory
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: