louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00484913: Effects of Abdominal Hot Compresses on Indocyanine Green Elimination in Healthy Subjects
Official title: Effects of Abdominal Hot Compresses on Indocyanine Green Elimination - a Randomized Cross Over Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2007-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system increase hepatic blood flow.

Detailed description: Abdominal hot compresses are traditionally used by patients with liver diseases as self help. This study investigated the effect of abdominal hot compresses on hepatic blood flow measured by elimination of indocyanine green (ICG), a non-toxic green dye. It was presumed, that abdominal hot compresses increase hepatic blood flow either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system.

In healthy volunteers ICG elimination was measured with and without hot compress at two investigations in a weekly interval. At each investigation ICG was injected as bolus after a rest period of 10 minutes. After the injection blood was taken in regular intervals for analysis of ICG concentration over a period of 40 minutes and half life was calculated.

The time interval between the investigations was 8 days, the sequence was randomly assigned.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* iodine allergy
* any acute or chronic disease \[with exception of pollinosis because it is common\]
* elevated levels of alanine amino transferase \[ALT\], aspartate amino transferase \[AST\], gamma glutamyltransferase \[GGT\] or bilirubin
* heat urticaria
* pregnancy
* alcohol intake \>30 g/d
* any medication except contraceptives
* body mass index (BMI) \>30 kg/m2

Primary outcomes:
measure: Indocyanine green half life
timeFrame: 40 minutes
Secondary outcomes:
measure: heart rate, blood pressure
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Internal Medicine II, Freiburg University Hospital
state: Baden Württemberg
Study officials:
affiliation: Department of Internal Medicine II, Freiburg University Hospital, Germany
name: Roman Huber, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huber R, Weisser S, Luedtke R. Effects of abdominal hot compresses on indocyanine green elimination--a randomized cross over study in healthy subjects. BMC Gastroenterol. 2007 Jul 10;7:27. doi: 10.1186/1471-230X-7-27.
Clinical trial NCT04388813: Predictors of Severe COVID-19 Outcomes
Official title: Predictors of Severe COVID-19 Outcomes (PRESCO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
COVID-19
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 494
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: Participants confirmed positive for COVID-19.

Brief summary: This is a longitudinal, multi-center, observational study collecting diverse biological measurements and clinical and epidemiological data for the purpose of enabling a greater understanding of the onset of severe outcomes, primarily acute respiratory distress syndrome (ARDS) and/or mortality, in patients presenting to the hospital with suspicion or diagnosis of COVID-19. We seek to understand whether there are early signatures that predict progression to ARDS, mortality, and/or other comorbid conditions. The duration of the study participation is approximately 3 months.


Eligibility criteria: Inclusion Criteria:

* Participant or legally authorized representative willing and able to provide informed consent
* Receiving care at a participating site
* Age 18 years old or older
* U.S. Resident
* Confirmed positive for COVID-19
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Self reported pregnancy

Primary outcomes:
measure: Performance (discrimination / calibration) of models
timeFrame: From date of study enrollment until the date of first documented ARDS diagnosis or date of death from any cause, whichever comes first, assessed up to study end (estimated at 3 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
Study officials:
affiliation: Verily Life Sciences LLC
name: Charlie Kim, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05983536: The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
Official title: The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Seropositivity
Cancer
Blood Disease
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients and blood disease patients with age over 18 and have an HIV test in that very day.

Brief summary: To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.

Detailed description: First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of tumor Disease or blood disease
* Blood samples must meet the test requirements

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The HIV Ab/Ag results
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: Xia Zhao, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alali M, Carlucci JG, Christenson J, Prather C, Skiles J. Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. J Pediatric Infect Dis Soc. 2022 Aug 30;11(8):383-385. doi: 10.1093/jpids/piac028.
citation: Lu X, Zhang M, Liu W, Sheng N, Du Q, Zhang M, Guo X, Wang G, Wang Q. A method to alleviate false-positive results of the Elecsys HIV combi PT assay. Sci Rep. 2021 Jan 13;11(1):1033. doi: 10.1038/s41598-020-80047-0.
Clinical trial NCT03746236: Transpulmonary Pressure Under Stressing Conditions
Official title: Transpulmonary Pressure Under Conditions of Increased Intra-abdominal Pressure From Pneumoperitoneum and Steep Trendelenburg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator-Induced Lung Injury
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent laparoscopic or robotic assisted radical prostatectomy

Brief summary: Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.


Eligibility criteria: Inclusion Criteria:

* ASA (american society of anesthesiologists) score ≤ III
* Patients underwent laparoscopic prostatectomy

Exclusion Criteria:

* BMI (body mass index) ≥ 30
* Impossibility to insert nasogastric tube
* Anatomic rib cage alterations

Primary outcomes:
measure: Incidence of postoperative acute complications
timeFrame: 24 hours
measure: Dosage of inflammatory mediators
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena National Cancer Institute
state: Rm
city: Rome
country: Italy
facility: Regina Elena National Cancer Institute
Study officials:
References:
Clinical trial NCT04129736: Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis
Official title: Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Pharmacokinetics
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pharmacokinetic
Primary purpose: TREATMENT

Brief summary: Serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting multiple sclerosis treated with teriflunomide tablets 14 mg daily

Detailed description: Teriflunomide concentration in cerebrospinal fluid and serum will be determined in 12 patients with multiple sclerosis. They have been treated for at least 6 months and the sampling from blood and by spinal tap is done before dose at 8 am in 10 patients and at 12 am in 10 patients. The dependence from age, sex, and blood-brain barrier (BBB) integrity will be evaluated.The ratio between serum and cerebrospinal fluid will determine the passage over the BBB.

Eligibility criteria: Inclusion Criteria:

* patients with multiple sclerosis treated with teriflunomide 14 mg for at least 6 months

Exclusion Criteria:

* other immunosuppressive or immunomodulating drugs, other CNS diseases

Primary outcomes:
measure: Concentration of teriflunomide in cerebrospinal fluid
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: MS Centre
state: Vastra Gotaland
Study officials:
References:
Clinical trial NCT02074813: Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD
Official title: Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Inspiratory muscle training
COPD
dyspnea
Multidimensional Dyspnea Profile questionnaire (MDP).
pulmonary rehabilitation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD stage 3 or 4
* Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course;

Exclusion Criteria:

* FEV ≥ 50%
* Pneumonectomy, Lobectomy less than 6 months
* Patient with risk of spontaneous pneumothorax or rib fracture

Primary outcomes:
measure: Dyspnea measure
timeFrame: 21 - 4 days / +7 jours
Secondary outcomes:
measure: PI max variation
timeFrame: 21 - 4 days / +7 days
measure: CI variation
timeFrame: 21 - 4 days / +7 days
measure: Dyspnea measure
timeFrame: 21 - 4 days / +7 days
Other outcomes:
Locations:
city: Briançon
country: France
facility: Centre des maladies respiratoires et allergiques - Les Acacias
city: Morlaix
country: France
facility: Brest University Hospital
Study officials:
References:
citation: Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
Clinical trial NCT00973336: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?
Official title: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteoporosis?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Hyperparathyroidism
Bone Metabolism
Keywords: postoperative follow-up
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.

Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Male patients
* Biochemically proven PHPT, PTX planned
* No evidence for osteoporosis

Exclusion Criteria:

* Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
* Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma \>1cm)
* Persisting or recurrent PHPT (postoperative hypercalcemia)
* Four-gland hyperplasia
* Multiple endocrine neoplasia (MEN) or hereditary PHPT
* Familial hypercalciuric hypercalcaemia (Ca/creatinine ratio \< 0.01)
* Phenylketonuria
* Renal impairment (creatinine clearance \<30ml/h)
* Severe hepatic disorder
* Severe systemic disorder
* Thyroid dysfunction
* Immobilisation
* Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
* Intake of drugs containing digoxin or digitoxin
* Known allergy against any component of the study medication

Primary outcomes:
measure: Parathyroid hormone
timeFrame: 1 year
Secondary outcomes:
measure: BMD of lumbar spine, femoral neck and radius
timeFrame: 1 year
measure: Adverse effects calcium or vitamin D
timeFrame: 1 year
measure: Other biochemical markers of bone metabolism
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Surgery
name: Bruno Niederle, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04964336: An Observational Study to Investigate the Role of B Cells in Multiple Sclerosis
Official title: Decoding the B Cell Response in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients under diagnostic work-up for multiple sclerosis.

Brief summary: Multiple sclerosis (MS) typically afflict young people in their twenties, when they start a career and establish a family. The disease thus imposes a severe impact on quality of life and heavy economic burdens on society. Critical barriers to progress in the field are the lack of knowledge of relevant immune cell subsets driving the pathology and the targets of the immune response within the central nervous system. In this project, we will test the hypothesis that a subgroup of MS patients is defined by a genetically determined B cell response against specific antigenic epitopes. The hypothesis is based on our recent, pioneering results showing that approximately half of MS patients have a restricted population of B cells in the cerebrospinal fluid defined by polymorphisms in the constant heavy-chain of the immunoglobulin B cell receptor, the G1m1 allotype. Here, we aim to characterize the G1m1 B cells, to disentangle the genetic basis of the B cell response, and to identify the molecular targets.


Eligibility criteria: Inclusion Criteria:

* Symptoms and brain MRI scans strongly suggestive of multiple sclerosis according to the 2017 McDonald revisions
* Intrathecal immunoglobulin G synthesis
* Age \> 18 years

Exclusion Criteria:

* Treatment with immunomodulatory drugs

Primary outcomes:
measure: The transcriptome of B cells from blood and cerebrospinal fluid
timeFrame: 1 day (subject inclusion)
measure: The immunglobulin receptors of B cells from blood and cerebrospinal fluid
timeFrame: 1 day (subject inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo
name: Andreas Lossius
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04708236: A Study of ORTD-1 in Patients Hospitalized With COVID-19 Related Pneumonia
Official title: A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: COVID-19 pneumonia
SARS-CoV-2
COVID-19 drug treatment
theta-defensins
Lead sponsor: Oryn Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be allocated into 1 of 3 sequential escalating dose cohorts and randomized to ORTD-1 treatment versus vehicle control within each cohort.
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.

Detailed description: This is a randomized, blinded, vehicle-controlled dose-escalation study. Initial enrollment and treatment will be conducted as an inpatient study. Patients will be randomized 2:1, ORTD-1 treatment versus vehicle control. Patients will be allocated into 1 of 3 sequential escalating dose cohorts. Blinded study drug will be infused intravenously once daily for 5 consecutive days.

Eligibility criteria: Inclusion Criteria:

* Positive RT-PCR assay for SARS CoV-2 in a respiratory tract sample
* Hospitalized for COVID-19
* Radiographic diagnosis of pneumonia
* Respiratory insufficiency
* Receiving pharmacologic thromboprophylaxis

Exclusion Criteria:

* Premorbid abnormal pulmonary function or disease
* Concurrent or prior intubation or ventilated support for COVID-19
* Receiving systemic corticosteroids or other immunomodulators or immunosuppressant drugs
* Previous hospitalization for COVID-19

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through Day 65
measure: Incidence of laboratory abnormalities
timeFrame: Through Day 65
measure: Incidence of anti-drug antibodies
timeFrame: Through Day 65
Secondary outcomes:
measure: Proportion of patients requiring intubation
timeFrame: Day 1-65
measure: Percentage of days requiring supplemental oxygen
timeFrame: Day 1-65
measure: Overall survival (OS)
timeFrame: Day 1-65
Other outcomes:
measure: Peripheral blood oxygen levels (SpO2)
timeFrame: Day 1-Day 7, Day 14, Day 21, Day 28, Day 35, Day 65
measure: IL-6
timeFrame: Through Day 65
measure: TNF-alpha
timeFrame: Through Day 65
measure: C-reactive protein
timeFrame: Through Day 65
measure: Serum ferritin
timeFrame: Through Day 65
measure: D-dimer
timeFrame: Through Day 65
measure: Serum concentration of ORTD-1 (Pharmacokinetics)
timeFrame: Day 1-Day 6, Day 14, Day 21, Day 35, Day 65
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
affiliation: Professor & Chair, Department of Medicine University of California, Irvine
name: Alpesh Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: