louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02609711: Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 90
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin


Eligibility criteria: Inclusion Criteria:

* Adult healthy males 20 to 45 years at screening.
* BMI 18-29 kg/m2

Exclusion Criteria:

* History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
* Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
* Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
* Gastrointestinal disease affected the absorption of medications
* Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* AST or ALT \> 2 x normal range
* Total bilirubin \> 2.0 mg/dl
* CK \> 2 x normal range
* eGFR \< 60 mL/min/1.73m2
* Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
* Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
* Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
* Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
* History of drug abuse
* Genetic neuromuscular disorder or family history of neuromuscular disorder
* Unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subjects deemed ineligible by investigator based on other reasons

Primary outcomes:
measure: Cmax (Candesartan cilexetil)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
measure: Cmax (Atorvastatin)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours
measure: AUClast (Candesartan cilexetil)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
measure: AUClast (Atorvastatin)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha Univ. Hospital
Study officials:
affiliation: INHA UNIV. HOSPITAL
name: Chul Woo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03346811: Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer
Official title: Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer：a Single Arm，Multi-center，Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Plasma EGFR Mutation-positive Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 120
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: this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.
* Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS，any positive).
* unavailable of radical surgery or radical radiotherapy.
* not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.
* Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.
* Age 18-75 years old with performance status of 0 to 3.
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.
* Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
* Evidence of interstitial lung diseases
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
* Other situations researchers think not appropriate to enter the group

Primary outcomes:
measure: ORR
timeFrame: 12 weeks
Secondary outcomes:
measure: PFS
timeFrame: 12 months
measure: DCR
timeFrame: 12 months
measure: OS
timeFrame: 20 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital
state: Beijing
Study officials:
References:
citation: Xu J, Liu Z, Bai H, Dong G, Zhong J, Wan R, Zang A, Li X, Li Q, Guo J, Du N, Zhong D, Huang Y, Lv Q, Zhang J, Zhao Y, Gao L, Li L, Zhang C, Zhao J, Li B, Liu Z, Yang Z, Ji D, Wang T, Duan J, Wang Z, Wang J. Evaluation of Clinical Outcomes of Icotinib in Patients With Clinically Diagnosed Advanced Lung Cancer With EGFR-Sensitizing Variants Assessed by Circulating Tumor DNA Testing: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1328-1332. doi: 10.1001/jamaoncol.2022.2719.
Clinical trial NCT01400711: Enhanced Recovery After Surgery in Major Intrabdominal Procedures.
Official title: Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Surgical and Medical Care.
Keywords: Fast-tract surgery, Enhanced recovery after surgery, multimodal surgery.
Lead sponsor: St. Andrew's General Hospital, Patras, Greece
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating the stress response to surgery and enabling rapid recovery. There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of traditional treatment. However, few studies exist about the implication of ERAS programs in major upper abdominal surgery patients.

The aim of this study was to compare morbidity, mortality and length of stay in patients undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving either conventional postoperative care or an ERAS program.


Eligibility criteria: Inclusion Criteria:

* Elective surgery
* ASA grade \< 4

Exclusion Criteria:

* Emergency surgery
* ASA grade \> 3

Primary outcomes:
measure: Morbidity.
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Mortality.
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Patra
country: Greece
facility: St. Andrew General Hospital, Department of Surgery
Study officials:
References:
citation: Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
Clinical trial NCT05520411: Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
Official title: Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Distended
Bloating
Keywords: digestion
bloating
Lead sponsor: HUM Nutrition, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Flatter Me is a product that includes digestive enzymes in a way to support digestion of macronutrients and their constituents and provides herbs traditionally used for digestive health support. This trial aims to test Flatter Me against a placebo pill to examine differences in both subjective outcomes (feelings of bloating and indigestion) and changes in waist circumference (abdominal distension) after eating a test meal.


Eligibility criteria: Inclusion Criteria:

* Self Report bloating or stomach distension at least once per day after eating

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Currently taking any prescribed medication meant to treat gut health
* Currently taking any medication for fluid balance (i.e., Aldactone)
* Currently suffers from any pre-existing condition that would prevent them from adhering to the protocol.
* Currently suffers from any pre-existing condition that would prevent them from consuming cheese pizza.
* Use of an antibiotic in the previous 3 months.
* Taking an iron supplement with \> 65mg of iron in the last week.
* Diagnosed with any of IBS, chronic constipation, GERD, Crohn's Disease, ulcerative colitis, celiac disease, liver disease, kidney disease, heart failure.
* Lactose Allergy or Intolerance
* Any food allergies
* Current smoker
* Wears dentures

Primary outcomes:
measure: Perceived Changes in Bloating and Stomach Distention
timeFrame: 1 Week
Secondary outcomes:
measure: Visible changes in stomach distension.
timeFrame: 1 week
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02032511: Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)
Official title: Comparison of RAM Cannula NCPAP Versus Infant Flow NCPAP
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Deficiency
Prematurity
Assisted Ventilation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 19
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants less than or equal to 7kg with an order for nasal continuous positive pressure

Brief summary: This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.


Eligibility criteria: Inclusion Criteria:

* less than or equal to 7 kg
* order for nasal continuous positive pressure

Exclusion Criteria:

* patients greater than 7kg
* patients that do not have informed consent

Primary outcomes:
measure: Number of patients who achieve unassisted breathing
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00524511: Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
Official title: A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cesarean Section
Keywords: cesarean
wound
Dermabond
superglue
staples
wound complications
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 136
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.


Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria:

* Prisoners
* Insulin-requiring diabetics
* Vertical skin incision
* Allergy to Dermabond

Primary outcomes:
measure: Wound Complication Rate
timeFrame: within six weeks of study intervention
Secondary outcomes:
measure: Patient Satisfaction of Cosmesis of Surgical Wound
timeFrame: before hospital discharge after surgery
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Dawn S Tasillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497471: RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
Official title: The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malaria
Anemia
Keywords: Plasmodium Falciparum
Antimlarial chemoprophylaxis
Iron supplementation
Tanzania
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Agencia Española de Cooperación Internacional
name: World Health Organization
First posted: 2007-07-06
Enrollment: 832
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

Detailed description: 411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Eligibility criteria: Inclusion Criteria:

* Born in San Francis Designated District Hospital of Ifakara

Exclusion Criteria:

* Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
* Twins
* Birth weight \< 1,5 kg
* Clinical signs of cerebral asphyxia
* Clinical signs of neonatal or congenital infection
* Mother unreliable (deaf, mentally handicapped)

Primary outcomes:
measure: Clinical Malaria
timeFrame: During first year of life
measure: Severe Anemia (PCV < 25%)
timeFrame: During first year of life
Secondary outcomes:
measure: Clinical Malaria
timeFrame: After first year of life
measure: Severe Anemia (PCV < 25%)
timeFrame: After first year of life
measure: Outpatient visits
measure: Hospital Admissions
measure: Severe malaria
Other outcomes:
Locations:
city: Ifakara
country: Tanzania
facility: Ifakara Centre
Study officials:
affiliation: Centre for International Health, Hospital Clinic / Universitat Barcelona
name: Clara Menendez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
Clinical trial NCT01381471: Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 11060
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 40 years of age or older with at least one pharmacy claim for FSC during the index date range (July 1, 2005 through June 30, 2006). An index date was designated as the date of the first pharmacy claim for FSC. Patients were also required to have continuous medical and pharmacy eligibility for the 12 month pre-Index year and the 12 month Index year (referred to as the 24 month observation period), and the 3 month post-Index outcome period (referred to as the outcome period). Eligible patients were further required to have at least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an anticholinergic medication, both occurring during the12 month pre-index period.

Brief summary: The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.


Eligibility criteria: INCLUSION CRITERIA

* at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006).
* Continuous medical and pharmacy eligibility for the 12 month Pre-Index year and the 12 month Index year (referred to as the 24 month Observation Period), and the 3 month Post-Index period (referred to as the Outcome Period).
* At least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9 code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an Anticholinergic medication, both occurring during the12 month pre-index period.
* At least 40 years old at index date.

EXCLUSION CRITERIA

* any medical claim (ever) with a primary or secondary diagnosis of cystic fibrosis (ICD-9 code 277.0x).

Primary outcomes:
measure: Mean Number of Pharmacy Claims by Participants During the Post-Index Period
timeFrame: One Year
measure: Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01065571: Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Official title: Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: relapse
carrageenan
inflammation
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: The Broad Foundation
name: University of Chicago
First posted: 2010-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.

Detailed description: This study will evaluate the interval to relapse in patients with ulcerative colitis. The patients will be adults, who have been in remission for at least one month. They will have previously required corticosteroids to induce remission. Subjects will be instructed in a no-carrageenan diet and required to follow this diet for the duration of their participation in the clinical study. They will be randomized to receive either placebo capsules or capsules containing carrageenan 100 mg. In this way, the study will be a double blind study of no-carrageenan vs. carrageenan. Main study outcome is the interval to relapse. Since ulcerative colitis is associated with relapses, relapse is anticipated. Other outcome measures will include scores on questionnaires, including the SSCAI and the SIDBQ, and laboratory measurements of inflammation.

Subjects will participate for one year or until relapse, with study visits every three months and telephone contacts every two weeks. After three months, participants will increase to two capsules daily, of either placebo or carrageenan.

Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis
* Adult
* In remission
* Required corticosteroids to induce remission
* Able to make food choices and follow diet

Exclusion Criteria:

* Not able to make food choices

Primary outcomes:
measure: Number of Relapses by Group
timeFrame: up to one year of participation for each enrolled subject
Secondary outcomes:
measure: Fecal Calprotectin (Microgram/Gram Stool)
timeFrame: one year or relapse or withdrawal compared with baseline
measure: Serum Interleukin-6 (pg/ml)
timeFrame: change in IL-6 between baseline and up to one year of study participation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Joanne Tobacman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: