louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01322633: Risk of Cancer Among Pantoprazole Users
Official title: Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagitis
Keywords: Pantoprazole
proton pump inhibitor
gastric cancer
digestive system cancer
cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 61864
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: Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.

Brief summary: The primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.

Detailed description: All subjects who met the inclusion criteria were included in the study.

Eligibility criteria: Inclusion Criteria:

* Patients who have used pantoprazole or other proton pump inhibitors, enrollment in the health maintenance organization for at least 6 months, age 18 years or older.

Exclusion Criteria:

* Use of any proton pump inhibitor before study entry, any cancer diagnosis recorded in the medical history, diagnosis of Zollinger-Ellison Syndrome in medical history.

Primary outcomes:
measure: Incidence Rate of Gastric Cancer
timeFrame: 1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)
Secondary outcomes:
measure: Incidence Rate of Composite Gastrointestinal Cancers
timeFrame: 1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)
measure: Incidence Rate of Overall Cancer
timeFrame: 1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00647933: An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
Official title: An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Keywords: Females
Corifollitropin alfa
Antibodies
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.


Eligibility criteria: Inclusion Criteria:

* Good physical and mental health;
* Body Mass Index between 18 and 29 kg/m\^2;
* Good venous accessibility;

Exclusion Criteria:

* Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;
* Hypertension (sitting diastolic blood pressure \> 90 mmHg and/or systolic blood pressure \> 150 mmHg);
* Contraindications for the use of oral contraceptives or gonadotropins;
* PAP-smear (= III) according to the Papanicolaou classification;
* History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;
* Primary ovarian failure;
* Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;
* Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;
* Ovarian surgery;
* Smoking more than 10 cigarettes or equivalents a day;
* History (within 12 months) of alcohol or drugs abuse;
* Blood donation (\> 200 ml) within 90 days prior to screening;
* Administration of investigational drugs within 90 days prior to start Org 36286.

Primary outcomes:
measure: Maximum number of follicles >= 5 mm (nmax)
timeFrame: Days 2 - 35
measure: Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286
timeFrame: Days 1 - 15
measure: Mean dose-normalized area under the curve (AUC) post single dose Org 36286
timeFrame: Days 1 - 15
measure: Mean total plasma clearance (CL) post single dose Org 36286
timeFrame: Days 1 - 15
measure: Number of participants with an adverse event (AE)
timeFrame: Start of treatment up to day 28
Secondary outcomes:
measure: Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)
timeFrame: Days 2 - 35
measure: Total number of follicles >= 5 mm per day
timeFrame: Days 2 - 35
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00607633: Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH
Official title: Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Left Ventricular Hypertrophy
Keywords: essential hypertension
ARB
left ventricular hypertrophy
candesartan
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 686
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulant patient

Brief summary: The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..


Eligibility criteria: Inclusion Criteria:

* essential hypertension
* left ventricular hypertrophy
* under candesartan treatment

Exclusion Criteria:

Primary outcomes:
measure: to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index.
timeFrame: app. 3 monthly
Secondary outcomes:
measure: to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT
timeFrame: app. 3 monthly
measure: to gain further insight into the occurrence of unknown, unexpected and/or rarely occurring adverse events (AE) by estimating the incidence under naturalistic conditions.
timeFrame: app. 3 monthly
Other outcomes:
Locations:
Study officials:
affiliation: Cardiologist, Henstedt-Ulzburg
name: F. Sonntag, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MED Dep., AstraZeneca Germany
name: Andrea Pahor, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04645433: Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit
Official title: Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit: Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Intensive Care Unit
Keywords: covid 19
favipiravir
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to intensive care units (ICU) between March o 10thand May 10th 2020 due to COVID-19 infection were included to the study

Brief summary: Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience

Detailed description: Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.

Eligibility criteria: Inclusion Criteria:

* 18 Years and older

Exclusion Criteria:

* patients younger than 18 years old
* patients who have received both lopinavir-ritonavir and favipiravir sepuentially

Primary outcomes:
measure: Mortality for ICU
timeFrame: 14 days
measure: hospital stay
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SisliHamidiye Etfal Education and Training Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Education and Training Hospital
name: sultan acar sevinc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05265533: Measurement of Body Weight Using Shoe Insole Pressure Sensors
Official title: Measurement of Body Weight Using Smart Shoe Insole Pressure Sensors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Different Weights
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenient sample recruited within Tufts University

Brief summary: The purpose of this study is to create a dataset to help accelerate machine learning (ML) based solutions for applications such as activity recognition, detect changes in weight and predict weight of carried load. The research will further help in the development of novel machine learning-based algorithm for accurately predicting the body weight of an individual in real-time and within few ounces error margin, using sampled data from smart insole sensors.


Eligibility criteria: Inclusion Criteria:

* Age range of 18-70 years

Exclusion Criteria:

* Refusal to adhere to covid19 safety guidelines

Primary outcomes:
measure: Pressure readings
timeFrame: 1hr
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Susan Roberts
state: Massachusetts
Study officials:
References:
Clinical trial NCT04689633: Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy
Official title: Ultrasound-guided Bilateral Quadratus Lumborum Block Versus Erector Spinae Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 60
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 patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side. group(C):didn't received any block

Detailed description: on arrival to the operative room all patients were monitored with standared monitoring. then IV cannula were inserted. preoxygenation with 100% oxygen and induction of GA by 1mic/kg fentanyl and 2 mg/kg of 1%propofol. endotracheal intubation was facilitated by 0.5mg/kg of atracurium. isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg intermittent doses of atracurium to maintain adequate muscle relaxation. ventilation was controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100. after stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum and erector Spinae block were performed according to patient's group by the same anesthetist with the patient in lateral or prone position respectively.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia

Exclusion Criteria:

* Allergy to studed drugs
* morbid obesity
* patient refusal
* infection at the side of the bolck
* emergency laparoscopic cholecystectomy
* if laparoscopic procedure converted to open

Primary outcomes:
measure: time of first postoperative analgesic request
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Assistant professor
name: Abeer Hassaneen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00203333: Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
Official title: Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Epilepsy
Arrhythmia
Sudden Death
Keywords: Epilepsy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2005-09-20
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with refractory focal or generalized epilepsy.

Brief summary: People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP.

This study plans to determine:

1. the frequency and types of cardiac arrhythmias that occur in this population and
2. whether these are increased above the general population in the same age group.

Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

Detailed description: By employing long-term electrocardiographic monitoring, this study plans to determine:

1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
2. whether these are increased above the general population in the same age group.

The specific aims:

1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.
2. Correlate abnormal heart rates and rhythms to specific clinical data:

   1. seizure type,
   2. seizure frequency,
   3. probable location of seizure onset in the brain, when such data are available,
   4. duration of seizures, and
   5. type(s) and number of anticonvulsant medications being used.
3. Correlate cardiac arrhythmias to clinical symptoms

Eligibility criteria: Inclusion Criteria:

* Refractory epilepsy

Exclusion Criteria:

* Other pre-existing heart conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Maromi Nei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.
Clinical trial NCT02153333: Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
Official title: Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Human rotavirus (HRV) vaccine
Serologic response
Porcine circovirus type 1 (PCV-1)
Laboratory evaluations
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged 6 to 12 weeks from 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.

Brief summary: This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

Detailed description: Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Eligibility criteria: Inclusion Criteria:

Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:

* Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.
* Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed.
* Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points.

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Seropositivity rates for anti-PCV-1 antibodies.
timeFrame: At 1-2 months post dose 2 of HRV vaccine or placebo.
measure: Seroconversion rates for anti-PCV-1 antibodies.
timeFrame: At 1-2 months post dose 2 of HRV vaccine or placebo.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.
Clinical trial NCT03606733: Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
Official title: Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
Lead sponsor: Marashi Eye Clinic
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space
Primary purpose: TREATMENT

Brief summary: Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.

Detailed description: A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.

Eligibility criteria: Inclusion Criteria:

* 20 years and older
* Patients with macular edema or degeneration from various pathologies
* Central macular thickness more than 250 microns
* Patients who are able to come for all follow-up

Exclusion Criteria:

* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
* Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Primary outcomes:
measure: Proportion of patients achieved visual acuity improvement
timeFrame: 12 weeks
Secondary outcomes:
measure: Amount of Central macular thickness reduction in microns
timeFrame: 12 weeks
measure: Proportion of eyes with Increased intraocular pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Marashi Eye Clinic
Study officials:
References:
citation: Marashi A. Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle. Adv Ophthalmol Vis Syst. 2018;8(5):277-281. DOI: 10.15406/aovs.2018.08.00321