louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01799655: Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
Official title: Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized patient

Brief summary: Cardiovascular disease is the most common cause of mortality and morbidity worldwide. Recently, a growing body of evidence has identified Vitamin D deficiency as a potential risk factor for cardiovascular disease. Therefore, there is an increasing interest to explore the mechanism in which vitamin D deficiency affect the cardiovascular system.

The investigators want to examine the relationship between serum vitamin D levels and the coagulation status in the subjects. The applied the calibrated automated thrombogram (CAT) to assess thrombin generation in plasma as a measure of overall thrombotic activity, and thus to suggest a mechanism that may explain the link between vitamin D deficiency and cardiovascular disease.

Our study population are going to include 100 patients from the internal departments in Emek hospital, who present with chest pain but without acute coronary syndrome (ACS). The investigators will take blood samples from the subjects to measure the serum vitamin D levels and the generation of thrombin. The patients will be divided into four groups according to the level of vitamin D to evaluate the effect of vitamin D levels in the blood on coagulability and thrombotic activity in these patients.


Eligibility criteria: Inclusion Criteria:

•hospitalized patient with diagnosed of chest pain

Exclusion Criteria:

•recent Myocardial ischemia - (in the last 30 days)

Primary outcomes:
measure: thrombin generation levels and endogenous thrombin potentials
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
affiliation: haemek medical center
name: Mazen elias, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00400855: Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate
Official title: A Randomised, Double-blind, Placebo-controlled, Incomplete Block, 4-period Crossover, Study to Investigate the Effects of 5-day Repeat Inhaled Doses of Fluticasone Propionate (BID, 50-2000 mcg) on Airway Responsiveness to Adenosine 5-monophosphate (AMP) Challenge When Delivered After the Last Dose in Mild Asthmatic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
AMP challenge
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether 5-days of treatment with fluticasone propionate protects the lung from responding to the AMP in this way.

Detailed description: A randomised, double-blind, placebo-controlled, incomplete block, 4-period crossover study to investigate the effects of 5-day repeat inhaled doses of fluticasone propionate (BID, 50-2000 mcg) on airway responsiveness to adenosine-5'-monophosphate (AMP) challenge when delivered after the last dose in mild asthmatic subjects

Eligibility criteria: Inclusion Criteria:

* Female of non-childbearing potential
* Using appropriate contraception.
* Mild asthmatic, non (or ex) smokers.
* Has inflammatory response to AMP.
* Otherwise healthy, not using any steroids.

Exclusion Criteria:

* Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures.
* Have a known sensitivity to corticosteroids.
* Have a history of milk protein allergy.
* Test positive at the screening visit for hepatitis B or C or HIV

Primary outcomes:
measure: To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.
timeFrame: 5 days
Secondary outcomes:
measure: Safety following multiple AMP challenges: Adverse events
timeFrame: 5 days
measure: Plasma concentrations of FP and derived pharmacokinetic parameters
timeFrame: 5 days
measure: Exhaled nitric oxide concentrations
timeFrame: 5 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04212455: A Cohort Study on Biomarkers of Hypertension in Guangdong Province(GDP Study)
Official title: Establishing Biobank in a Cohort Study for Hypertensive Patients in Guangdong Province(GDP Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Cardiovascular Diseases
Keywords: Hypertension
Cardiovascular Diseases
Mortality
Biomarker
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 50000
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 hypertension

Brief summary: Hypertension is the most common chronic diseases and a most important risk factor for cardiovascular and cerebrovascular diseases, and also a substantial public health problem. The purpose of the study is to investigate the association between biomarkers and adverse outcomes in patients with hypertension.

Detailed description: Study population includes subjects who are hypertension, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide whole blood specimens at one or more study visits.

Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of all-cause and cardiovascular mortality will be investigated during follow-up.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* In accordance with the diagnosis of hypertension (including Blood pressure ≥140/90mmHg and/or taking antihypertensive drugs and/or self-reported hypertension)

Exclusion Criteria:

* \<18 years old
* Unsigned informed consent
* Pregnant Women and Lactation

Primary outcomes:
measure: All-Cause Mortality
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 1 year
Secondary outcomes:
measure: Cardiovascular Mortality
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 1 year
Other outcomes:
measure: Secondary outcomes of cardiovascular diseases
timeFrame: Through study completion, an average of 1 years
measure: Secondary outcomes of cerebrovascular diseases
timeFrame: Through study completion, an average of 1 years
measure: Secondary outcomes of kidney
timeFrame: Through study completion, an average of 1 years
measure: others
timeFrame: From date of inclusion until the date of first event, assessed up to 1 year
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Cardiovascular Institute
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Feng Ying-qing, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02340455: Effect of Oral Pregabalin on Hyperalgesia and Post-operative Pain in Patients Undergoing Nephrectomy Surgery: Sex Differential Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Living Kidney Donors Undergoing VAMS-nephrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the effective postoperative pain management and the prevention of hyperalgesia from pregabalin, GABA analogue, and the possible sex difference in such effects of pregabalin.


Eligibility criteria: Inclusion Criteria:

* 18, \<51 years

  * healthy patients accepted for video-assisted living donor nephrectomy

Exclusion Criteria:

* Female patients who are pregnant or menopause
* Patients undergoing hormonal therapy
* Patients having neurologic disease or already taking GABA related drugs (pregabalin, gabapentin), or taking opioid drugs
* Insulin resistant diabetes
* Renal deficiency (eGFR \< 60 ml/min/1.73 m2)
* Emergency operation, hemodynamically unstable patients
* Foreigner
* allergic to medication given in this study

Primary outcomes:
measure: Mechanical threshold
timeFrame: from 1 day before op to postop 48 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00005255: Ischemic Heart Disease Incidence and Indices of Body-fat Distribution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the association between ischemic heart disease incidence and anthropometric indices of body-fat distribution.

Detailed description: BACKGROUND:

Previous studies have demonstrated that abdominal obesity can be predictive of ischemic heart disease. These prospective cohort studies employed simple indices of body-fat distribution such as waist-to-hip circumference ratio or subscapular skinfold. Their similar results suggested that increased abdominal obesity conferred a two-fold increased risk of ischemic heart disease among middle-aged men. The two proposed studies permitted testing of alternative fat-distribution indices which might be stronger risk factors for ischemic heart disease incidence than the waist-to-hip-ratio or the subscapular skinfold.

DESIGN NARRATIVE:

Two parallel case-control studies were conducted. In both studies, subjects were measured for girth, skinfold, abdominal sagittal diameter, height, and weight. Analyses for both protocols considered men and women separately. Possible confounders of the association between fat-distribution indices and ischemic heart disease were considered and if required, adjusted for in multivariate analyses. Possible confounders included race, age, tobacco use, alcohol use, diabetes, social class, hypertension, cholesterol levels, and physical activity levels.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kahn HS, Williamson DF. Abdominal obesity and mortality risk among men in nineteenth-century North America. Int J Obes Relat Metab Disord. 1994 Oct;18(10):686-91.
citation: Kahn HS. Choosing an index for abdominal obesity: an opportunity for epidemiologic clarification. J Clin Epidemiol. 1993 May;46(5):491-4. doi: 10.1016/0895-4356(93)90027-x.
citation: Kahn HS, Simoes EJ, Koponen M, Hanzlick R. The abdominal diameter index and sudden coronary death in men. Am J Cardiol. 1996 Oct 15;78(8):961-4. doi: 10.1016/s0002-9149(96)00479-1.
citation: Kahn HS. The accumulation of visceral adipose tissue may be influenced by intra-abdominal temperature. Obes Res. 1996 May;4(3):297-9. doi: 10.1002/j.1550-8528.1996.tb00550.x.
citation: Kahn HS, Austin H, Williamson DF, Arensberg D. Simple anthropometric indices associated with ischemic heart disease. J Clin Epidemiol. 1996 Sep;49(9):1017-24. doi: 10.1016/0895-4356(96)00113-8.
Clinical trial NCT01291355: Maternal Positioning and Occipitoposterior Fetal Position
Official title: Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Distress in Labor
Persistent Occipitoposterior or Occipitoanterior Position
Dystocia
Fetal Position and Presentation Abnormalities
Keywords: Maternal position
Occipitoposterior position
Labor
Dystocia
Fetal presentation Abnormalities
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
name: Swiss National Science Foundation
First posted: 2011-02-08
Enrollment: 438
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of a specific maternal position to correct fetal position in occipito-posterior during the labor.

The investigators hypothesize that the maternal position described by the Dr de Gasquet facilitate the rotation in occipito-anterior during the labor.

The calculated sample size is 438 participants (219 in each group)

Detailed description: Randomized clinical trial

Eligibility criteria: Inclusion Criteria:

* singleton
* primiparous and multiparous
* Term ≥ 37 weeks
* Labor in dilatation phase (cervix effaced, permeable finger 2 to 9 cm)
* Diagnosis of occipitoposterior variety confirmed by ultrasound

Exclusion Criteria:

* Maternal age below 18 years old
* Misunderstanding the French Language
* Full dilatation of the cervix
* Posture evaluated already adopted by the woman during labor

Primary outcomes:
measure: Fetal presentation after the intervention compare to control group
timeFrame: One hour after the randomization for the study
Secondary outcomes:
measure: Maternal comfort and pain sensation
timeFrame: During the hour after the randomization
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Maternity of University Hospitals
city: Geneva
country: Switzerland
facility: University Hospitals - Maternity
Study officials:
affiliation: University Hospitals of Geneva-Switzerland
name: Marie-Julia GUITTIER, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guittier MJ, Othenin-Girard V, Irion O, Boulvain M. Maternal positioning to correct occipito-posterior fetal position in labour: a randomised controlled trial. BMC Pregnancy Childbirth. 2014 Feb 24;14:83. doi: 10.1186/1471-2393-14-83.
citation: Guittier MJ, Othenin-Girard V. [Correcting occiput posterior position during labor: the role of maternal positions]. Gynecol Obstet Fertil. 2012 Apr;40(4):255-60. doi: 10.1016/j.gyobfe.2011.05.006. Epub 2011 Nov 17. French.
Clinical trial NCT02063555: Phase I Trial of DAR-901
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Keywords: Tuberculosis
BCG
HIV
TB Vaccines
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Aeras
First posted: 2014-02-14
Enrollment: 59
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: PREVENTION

Brief summary: This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.


Eligibility criteria: Inclusion Criteria:

All subjects: age 18-65, prior BCG vaccine (scar)

56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA)

21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA)

Exclusion Criteria: pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness

-

Primary outcomes:
measure: Safety
timeFrame: 10 months
Secondary outcomes:
measure: Immunogenicity
timeFrame: 10 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Charles F. von Reyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Masonou T, Hokey DA, Lahey T, Halliday A, Berrocal-Almanza LC, Wieland-Alter WF, Arbeit RD, Lalvani A, von Reyn CF. CD4+ T cell cytokine responses to the DAR-901 booster vaccine in BCG-primed adults: A randomized, placebo-controlled trial. PLoS One. 2019 May 23;14(5):e0217091. doi: 10.1371/journal.pone.0217091. eCollection 2019.
citation: Craig SR, Lahey T, Dixit A, Fordham von Reyn C. Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial. BMC Public Health. 2018 Apr 23;18(1):535. doi: 10.1186/s12889-018-5460-3.
citation: von Reyn CF, Lahey T, Arbeit RD, Landry B, Kailani L, Adams LV, Haynes BC, Mackenzie T, Wieland-Alter W, Connor RI, Tvaroha S, Hokey DA, Ginsberg AM, Waddell R. Safety and immunogenicity of an inactivated whole cell tuberculosis vaccine booster in adults primed with BCG: A randomized, controlled trial of DAR-901. PLoS One. 2017 May 12;12(5):e0175215. doi: 10.1371/journal.pone.0175215. eCollection 2017.
Clinical trial NCT00000255: Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7
Official title: Differential Acute Tolerance Development to Effects of Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
acute tolerance
subjective effects
analgesia
psychomotor
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine differential acute tolerance development to effects of nitrous oxide in humans.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Pain intensity, pain bothersomeness
timeFrame: 25, 70, & 115 min of inhalation and 40 min post
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zacny JP, Cho AM, Coalson DW, Rupani G, Young CJ, Klafta JM, Klock PA, Apfelbaum JL. Differential acute tolerance development to effects of nitrous oxide in humans. Neurosci Lett. 1996 May 10;209(2):73-6. doi: 10.1016/0304-3940(96)12626-4.
Clinical trial NCT05482555: Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
Official title: Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patientes operated for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Brief summary: A single-center prospective study. Patients undergoing surgery for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.


Eligibility criteria: Inclusion Criteria:

* Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.

Exclusion Criteria:

* Non-femoral arterial cannulation
* Concomitant femoro-femoral bypass
* Conversion to ECMO with arterial inflow in the previously cannulated femoral artery
* Death within 30 days from procedure
* Loss to follow-up

Primary outcomes:
measure: Femoral access site complication
timeFrame: During the first 8 weeks after surgery
Secondary outcomes:
measure: Femoral artery complication
timeFrame: During the first 3 years after surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Cardiothoracic Surgery, Karolinska University Hospital
Study officials:
References: