louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00593216: Diagnosis Of Vertigo With New Imaging
Official title: New Diagnosis Of Vestibular Vertigo With Functional MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo
Keywords: functional magnetic Resonance Imaging
vertigo
vestibular
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study is to determine the potential usefulness of new functional MRI in diagnostic assessment of patients presenting with vertigo.

Detailed description: The incidence of vertigo has been reported to be as high as 1.5% in the general population and some reports suggest that more than 5% of adults experience some kind of vertigo each year. In 80% of affected individuals, this symptom resulted in a medical consultation, interruption of daily activities, or sick leave. Therefore, vertigo can have a significant impact on health and well being. Unfortunately, there is not yet any satisfactory objective method for diagnosis of vertigo. At present, the diagnosis usually depends on medical history, vestibular function tests, Dix-Hallpike positioning tests done in the office, and, to some extent imaging studies doen to look for such abnormalities such as acoustic tumor, brain tumor, and evidence of multiple sclerosis. A number of recent studies support the possibility of using functional MRI (fMRI), particularly a new diffusion tensor fiber tracking (DTT) technique, as a new tool for diagnosis of disorders that can cause vertigo. In this study, our hypothesis is that there is an alteration in the activity in neural pathways of patients with vertigo that can be detected by fMRI. To test this assumption, our objective in this study is to determine whether there is a difference between the fMRI images obtained in normal subjects versus those in patients with vertigo.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer or patient with symptom of vertigo

Exclusion Criteria:

* Evidence of mental impairment
* Any type of bioimplant or any type of ferromagnetic bioimplant
* Pregnant females
* Exhibit noticeable anxiety and/or claustrophobia
* History of serious disease in central nervous and cerebrovascular systems.

Primary outcomes:
measure: Activation of target sites on the functional MRI images during the vestibular response
timeFrame: Not specific
Secondary outcomes:
measure: Differences in the fiber tracking of central nervous system specifically involved in the vestibular response
timeFrame: Not specific
Other outcomes:
Locations:
Study officials:
affiliation: Department of Otolaryngology- Head and Neck surgery of Boston University Medical Center
name: Kenneth Grundfast, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935216: Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection
Official title: Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection: Results of 105 Consecutive Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Surgery
Pancreas
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra

Brief summary: Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. The objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies.

Detailed description: The investigators conducted a retrospective study using a prospective database of laparoscopic resections performed between 2000 and 2020. Data were collected on age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, type of surgery, histologic type, operative time, hospital stay, postoperative complications, degree of severity and hospital readmission

Eligibility criteria: Inclusion Criteria:

* A retrospective study was carried out using data from a prospective database of all consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Correlation of Gender, Age, body mass index with the outcomes
timeFrame: 20 years
measure: Readmission
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01498016: Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Official title: Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Leukemia
Keywords: acute leukemia
allogeneic stem cell transplantation
busulfan
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. Though the pharmacokinetics data are available for population from America, Europe and Japan or Korea in Asia, there are no data in Chinese population. It is shown that high Bu concentration are associated with the toxicity such as veno-occlusion disease and lower concentration is correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct the pharmacokinetic study in Chinese population.

Detailed description: All patients received intravenous Busulfan based conditioning regimen for allogeneic stem cell transplantation.

Intravenous Busulfan (iv-Bu) was given 1.6mg/kg twice daily for 4 days as in the conditioning regimen.

Blood samples were obtained after first and 7th dose of iv Bulsulfan.

Eligibility criteria: Inclusion Criteria:

* patient with acute myeloid or lymphoblastic leukemia in 1st or second remission
* age 18-55 years
* with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA matched related (6/6) or unrelated donors (at least 8/10)

Exclusion Criteria:

* age less than 18 years or over 56 years
* HLA mismatched related donor
* liver function/renal function damage (over 2 X upper normal range)
* with mental disease

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
Study officials:
affiliation: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
name: Jiong HU, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04309916: Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Official title: A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erosive Reflux Disease
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.

Detailed description: This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)

Eligibility criteria: Inclusion Criteria:

1. Subjects aged between 19 and 75 years
2. Subjects who have erosive reflux disease

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy
2. Symptoms of primary or secondary esophageal movement disorders
3. Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)

Primary outcomes:
measure: Time to first nighttime heartburn-free interval (days))
timeFrame: 2 week
Secondary outcomes:
measure: Percentage of days without nighttime heartburn during the 2-week dosing period
timeFrame: 2 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Sang Kil Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004416: Randomized Study of Botulinum Toxin Type A for Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Achalasia
Keywords: achalasia
gastrointestinal disorders
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of achalasia.

II. Compare the safety of these two doses in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, dose response study. Patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type A.

All patients undergo a flexible upper gastrointestinal endoscopy. Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. Some patients may receive a second treatment, depending on response and/or time of relapse.

Patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of achalasia by esophageal manometry and upper endoscopy
* Symptomatic including dysphagia, regurgitation, etc.
* No esophageal ulcers, Barrett's esophagus, significant esophagitis, or esophageal varices

--Patient Characteristics--

* Hematopoietic: Platelet count at least 50,000/mm3
* Hepatic: PT no greater than 3 seconds No severe hepatic problems
* Renal: No severe renal problems
* Cardiovascular: No recent myocardial infarction No unstable angina No decompensated congestive heart failure
* Pulmonary: No severe pulmonary disease with dyspnea at rest
* Other: No altered mental status No serious systemic disease Not pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Pankaj Jay Pasricha
role: STUDY_CHAIR
References:
Clinical trial NCT05509816: A Study of Imlunestrant (LY3484356) in Healthy Women
Official title: The Effect of Repeat Dosing of Imlunestrant on CYP3A Activity in Healthy Women of Non-childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of non-childbearing potential. This study will last up to approximately 6 weeks for each participant including the screening period.


Eligibility criteria: Inclusion Criteria:

* Women not of childbearing potential
* Participants who are overtly healthy as determined by medical assessment
* Participants with body mass index (BMI) of 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

* Have known allergies to imlunestrant, related compounds or any components of the formulation or midazolam
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Use or intend to use medications that are substrate drugs of P-glycoprotein

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
timeFrame: Predose up to 48 hours postdose
measure: PK: Maximum Observed Concentration (Cmax) of Midazolam
timeFrame: Predose up to 48 hours postdose
Secondary outcomes:
measure: PK: AUC[0-∞] of 1'-hydroxymidazolam
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of 1'-hydroxymidazolam
timeFrame: Predose up to 48 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve From Zero to 24 hours at steady state (AUC[0-24], ss) of Imlunestrant
timeFrame: Predose up to 24 hours postdose
measure: PK: Maximum Observed Concentration at steady state (Cmax, ss) of Imlunestrant
timeFrame: Predose up to 24 hours postdose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: LabCorp CRU, Inc.
state: Florida
city: Dallas
country: United States
facility: LabCorp CRU, Inc.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005316: White Coat Hypertension and Antihypertensive Treatment Effect - SCOR in Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
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 investigate the mechanisms of white coat hypertension and study it further as a risk factor for heart damage.

Detailed description: BACKGROUND:

The multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on white coat hypertension began in December of 1985.

DESIGN NARRATIVE:

In the longitudinal study, eighty patients with white coat hypertension were compared with 40 age- and sex-matched normotensives, and with 80 patients with sustained hypertension. The protocol consisted of (a) clinic blood pressure measurements made both by a physician and a nurse, (b) self-monitoring at home, (c) noninvasive ambulatory monitoring, (d) reactivity testing (cold pressor test, mental arithmetic, and isometric exercise) and (e) Korotkoff signal recording. Patients were also tested for early markers of disease (echocardiography and urine albumin).

The 80 patients in each of the two hypertensive groups were randomized to one of four treatment protocols (20 patients each); an alpha blocker, a beta blocker, a combined alpha- and beta-blocker, or an ACE inhibitor. The doses of medication were adjusted to produce similar reductions of clinic blood pressure in the different groups. The test battery (a-e) was reported during treatment.

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: Liu JE, Roman MJ, Pini R, Schwartz JE, Pickering TG, Devereux RB. Cardiac and arterial target organ damage in adults with elevated ambulatory and normal office blood pressure. Ann Intern Med. 1999 Oct 19;131(8):564-72. doi: 10.7326/0003-4819-131-8-199910190-00003.
citation: Cavallini MC, Roman MJ, Pickering TG, Schwartz JE, Pini R, Devereux RB. Is white coat hypertension associated with arterial disease or left ventricular hypertrophy? Hypertension. 1995 Sep;26(3):413-9. doi: 10.1161/01.hyp.26.3.413.
citation: Pickering TG, Devereux RB, Gerin W, James GD, Pieper C, Schlussel YR, Schnall PL. The role of behavioral factors in white coat and sustained hypertension. J Hypertens Suppl. 1990 Dec;8(7):S141-7.
citation: Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988 Jan 8;259(2):225-8.
Clinical trial NCT02423616: Correlation Between Maximal Inspiratory Pressure and Hand Grip Force
Official title: Correlation Between Maximal Inspiratory Pressure and Hand Grip Force in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: MIP
Hand Grip
Correlation
Inspiratory Pressure
Hand Grip Force
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study aimed to examine the possible relationship between hand grip strength (HGS) and maximum inspiratory pressure (MIP) in healthy individuals.

Detailed description: This study aimed to examine the possible relationship between hand grip strength (HGS) and maximum inspiratory pressure (MIP) in healthy individuals. All individuals underwent assessment of inspiratory muscle strength by maximum inspiratory pressure, and evaluation of hand grip strength. MIP was measured using a U-type water manometer calibrated in centimetre of water (cmH2O), while the HGS was measured with hydraulic hand dynamometer calibrated in Kg.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* age \<20 years old,
* pregnancy,
* official diagnosis with lung disease such as Chronic obstructive pulmonary disease (COPD),
* body mass index (BMI) \> 40,
* known pre-existing causes of neuromuscular weakness,
* median entrapment neuropathy such as carpal tunnel syndrome

Primary outcomes:
measure: CORRELATION BETWEEN MAXIMAL INSPIRATORY PRESSURE AND HAND GRIP FORCE
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Univercity of Athens
name: Apostolos Armaganidis, M.D
role: STUDY_CHAIR
affiliation: Attikon Hospital
name: Eirine Maurou, MD
role: STUDY_DIRECTOR
affiliation: Attikon Hospital
name: Konstantinos Grigoriadis, PT, MSc
role: STUDY_DIRECTOR
affiliation: Attikon Hospital
name: Ioannis Efstathiou, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital
name: Eirini Maurou, MD
role: STUDY_DIRECTOR
References:
citation: Larson JL, Covey MK, Vitalo CA, Alex CG, Patel M, Kim MJ. Maximal inspiratory pressure. Learning effect and test-retest reliability in patients with chronic obstructive pulmonary disease. Chest. 1993 Aug;104(2):448-53. doi: 10.1378/chest.104.2.448.
citation: Efstathiou ID, Mavrou IP, Grigoriadis KE. Correlation Between Maximum Inspiratory Pressure and Hand-Grip Force in Healthy Young and Middle-Age Individuals. Respir Care. 2016 Jul;61(7):925-9. doi: 10.4187/respcare.04319. Epub 2016 Apr 19.
Clinical trial NCT01197716: German Chest Pain Unit (CPU)-Register
Official title: Deutsches CPU-Register. Unterstützt Durch Die Deutsche Gesellschaft für Kardiologie.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Keywords: Chest Pain Unit
Myocardial infarction
Register
Admission to a Chest Pain Unit for any reason
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 34470
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to a chest pain unit in a primary care clinic

Brief summary: The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a Follow-up via telephone is conducted after 3 months.

Detailed description: The aim of a Chest Pain Unit (CPU) is to clarify unclear chest pain quickly and specifically. Present data from Germany, the USA and England prove that the organisation models of a CPU lead beside a drastic reduction of mortality also to a cost reduction as well as a shortening of the average inpatient hospital stays.

Therefore it seems reasonable to assign a minimum standard to CPUs. Although there are internationally already standards for CPUs up to complete certification programmes, it is an explicit wish of the German society for cardiology (DGK) to create an own standard which considers on the national circumstances.

The aim of the CPU register is the internal and external validation of the care quality of CPU including Benchmark reports and risk-adjusted comparisons.

Eligibility criteria: Inclusion Criteria:

All patients that are admitted to a Chest Pain Unit are included in this register.

Exclusion Criteria:

Missing informed consent (informed consent can NOT be given in the acute phase of the disease, if consciousness is limited at that time; instead the patient will be asked for his consent at a later point of time, when he is fully conscious).

Primary outcomes:
measure: Internal and external validation of the medical care quality in the field of Chest Pain Units
timeFrame: hospital stay
Secondary outcomes:
measure: Documentation of CPU complications
timeFrame: up to 30 hours on average
measure: Documentation of long-term mortality and serious but non-fatal complications
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Bethanien Krankenhaus
Study officials:
affiliation: Vivantes Clinic Neukölln
name: Harald Darius, MD
role: STUDY_CHAIR
References: