louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00657865: Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Official title: Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake.

This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Male
* Healthy defined as absence of relevant disease
* Caucasian
* Aged 18-45 years
* BMI: 18-28 kg/m2
* Signed informed consent
* Blood pressure between 110/45 and \<140/90 (twice at screening)

Exclusion Criteria:

* History of renal artery stenosis

  * angioneurotic edema
  * psoriasis
  * relevant renal diseases
* RR at screening \< 110/45 mmHg.
* Diabetes, history of hypertension, RR \> 140/90 at screening, cardiovascular disease
* Known Diabetes mellitus of parents
* HIV or Hepatitis B/C positive virology
* Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain
* Contraindications against the use of the drug according to the SmPC, history of angioedema
* Any drug intake 3 weeks prior to first study day
* History of excessive bleeding tendency / hemophilia
* Presence of relevant illness within the last 3 weeks
* Suspected non-compliance with study instructions and life-style requirements
* Alcohol or drug abuse
* Blood/Plasma donation within 4 weeks prior to study day
* Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril
* Current smoking (any quantity), (at least 6 months of non-smoking required)

Primary outcomes:
measure: Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Clinical Pharacology
Study officials:
affiliation: Medical University of Vienna, Dep. of Clinical Pharmacology
name: Markus Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05496465: Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares
Official title: A Single-Dose, Randomized, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urticaria
Lead sponsor: ARS Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine the effect of ARS-1 on a patient reported pruritus/hive score


Eligibility criteria: Inclusion Criteria:

* 1. Male or female subject between the ages of 18 and 65 years.
* 2. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.
* 3. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².
* 4. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
* 5. At screening, has stable vital signs.
* 6. If female, is not pregnant or breastfeeding.
* 7. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug.

  8. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.

Exclusion Criteria:

* 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
* 2. Patients receiving beta blocker due to potential interaction with the study drug.
* 3. Prior nasal fractures, severe nasal injuries or history of nasal disorders.
* 4. Clinically significant medical condition or physical exam finding.
* 5. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
* 6. Mucosal inflammatory disorders.
* 7. Significant traumatic injury or major surgery within 30 days prior to study screening.
* 8. Has donated blood or had an acute loss of blood (\>50 mL) during the 30 days before study drug administration.
* 9. Known hypersensitivity to any compound in the test product.
* 10. Participated in a clinical trial within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score
timeFrame: Assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
Study officials:
affiliation: ARS Pharmaceuticals, Inc.
name: Sarina Tanimoto, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01995565: Regional Cerebral Hemodynamics Related to Global Hemodynamics
Official title: Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill Patients
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients mechanically ventilated patients

Brief summary: This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.

Detailed description: Cerebral blood flow velocity (as an index of regional perfusion), dynamic cerebral autoregulation and regional cerebral oxygen saturation should be monitored if disturbances of cerebral perfusion and oxygenation have to be suspected. Noninvasive monitoring techniques are established. When detected early, disturbed perfusion and oxygenation may be treated promptly and permanent damage of brain tissue can be avoided.

In critically ill patients, hemodynamic changes occur due to the disease itself but also as a function of diagnostic and therapeutic procedures. Systemic hemodynamic changes can be monitored using PiCCO® system (pulse contour cardiac output, Pulsion Medical Systems, Munich, Germany) that combines transpulmonal thermodilution and pulse contour analysis. PiCCO® continuously monitors cardiac output (CO), as well as static parameters like global enddiastolic blood volume index (GEDVI), and dynamic parameters as difference in pulse pressure (dPP) and stroke volume variation (SVV), respectively. CC Nexfin® (BMeye, Amsterdam, The Netherlands) is a noninvasive hemodynamic monitor.

This study investigates the effects of changes in cardiac output on cerebral blood flow velocity and regional cerebral oxygen saturation in intensive care patients that underwent major abdominal surgery.

Eligibility criteria: Inclusion Criteria:

* critically ill
* mechanically ventilated
* needing advanced hemodynamic monitoring (PiCCO)

Exclusion Criteria:

* \<18years
* \> 80years
* rhythm other than sinus

Primary outcomes:
measure: cerebral blood flow velocity
timeFrame: 1 hour
Secondary outcomes:
measure: Cerebral oxygen saturation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg University Mainz
Study officials:
References:
Clinical trial NCT04916665: Bridging Intestinal Failure With Teduglutide - a Case Report
Official title: Bridging Intestinal Failure With Teduglutide - a Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: case report

Brief summary: In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.


Eligibility criteria: Inclusion Criteria:

short bowel syndrome

Exclusion Criteria:

* \<18 years

Primary outcomes:
measure: enteral autonomy (complete discontinuation of parenteral support)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT06714565: The Value of Near-infrared Spectroscopy and Blood Pressure Measurements in Estimating Future Fall Risk in Older Adults
Official title: The Value of Near-infrared Spectroscopy and Blood Pressure Measurements in Estimating Future Fall Risk in Older Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Falls
Orthostatic Hypotension
Older Adults (65 Years and Older)
Keywords: falls
orthostatic hypotension
blood pressure
NIRS
Older adults
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 141
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 65 years and over referred to the outpatient (fall) clinic who have experienced a fall in the past 12 months.

Brief summary: The investigators aim to study which measurements/definitions from continuous blood pressures measurements (using a Finometer) and from cerebral oxygenation measurements (using near-infrared spectroscopy (NIRS)) are associated with future fall incidents in older adults at risk of falls.

Detailed description: Patients aged 65 years and over with a fall in the last 12 months are eligible for inclusion. After being informed about the study, all participants giving written informed consent will perform the active stand procedure (5min lying, 5 min standing). The hemodynamic measurements that will be performed during this procedure simultaneously consist of:

1. Volume-clamp photoplethysmography on the finger in the digital artery (Finapres medical systems, Enschede, The Netherlands) for continuous blood pressure measurements.
2. PortaLite MKII (Artinis medical systems, Elst, The Netherlands) for continuous cerebral oximetry (NIRS).

After completing the measurements, participants will receive a falls calendar and will be instructed to record falls, fall-related injuries, and fall-related healthcare use on a weekly basis for 12 months.

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* History of a fall (in the past year)
* Ability to perform supine-to-stand manoeuvres.
* Ability to sign informed consent.
* a Mini-Mental State Examination (MMSE) score of 21 points or higher or a Montreal Cognitive Assessment (MOCA) - Dutch score of 16 points or higher.
* Sufficient command of the Dutch language

Exclusion Criteria:

* Physically not able to perform sit-to-stand and supine-to-stand manoeuvres.
* Estimated life expectancy of less than one year.

Primary outcomes:
measure: Falls during follow-up
timeFrame: From enrollment to 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center, location Meibergdreef
Study officials:
References:
Clinical trial NCT02978365: Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability
Official title: Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability - Cross Sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Instability of Joint
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
Collaborators: name: Wolfson Medical Center
First posted: 2016-11-30
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability.

Detailed description: In this study the investigators will try to find correlations between different factors and functional abilities of patients 6 months post shoulder surgery.

Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs and functional abilities.

Functional abilities will be examined using two validated questionnaires:

1. The Western Ontario Shoulder Instability index (WOSI)
2. Disabilities of the Arm, Shoulder and Hand (DASH)

Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)

Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system, model 4.

Eligibility criteria: Inclusion Criteria:

* 26-28 weeks s/p surgical repair of shoulder instability
* At least 1 shoulder dislocation prior to surgery

Exclusion Criteria:

* Previous surgery in either shoulders
* Any injury in the non-operated shoulder in the last 6 months
* Any history of shoulder dislocation or subluxation in the non-operated shoulder
* Any tendon repair during the surgery.

Primary outcomes:
measure: Western Ontario Shoulder Instability index (WOSI)
timeFrame: 26-28 weeks post surgery
Secondary outcomes:
measure: Fear avoidance belief questionnaire (FABQ)
timeFrame: 26-28 weeks post surgery
measure: Isokinetic strength
timeFrame: 26-28 weeks post surgery
measure: Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: 26-28 weeks post surgery
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: IDF Medical Corp
Study officials:
affiliation: Medical Corp, Israel Defense Forces
name: Arnon Gam, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gottlieb U, Springer S. Translation and validation of a Hebrew version of the Western Ontario Shoulder Instability index. J Orthop Surg Res. 2019 Aug 1;14(1):245. doi: 10.1186/s13018-019-1289-4.
Clinical trial NCT06442865: AMNIODERM+ Medical Device Clinical Study
Official title: Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-healing Wound
Diabetic Foot
Keywords: medical device
AMNIODERM+
non-healing wounds
DFU
Lead sponsor: BioHealing s.r.o.
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 20
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: Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.

Brief summary: This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.


Eligibility criteria: Inclusion Criteria:

1. Males and females over 18 years of age
2. Type 1 or Type 2 diabetes mellitus
3. Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
4. History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
5. Size of a wound to be evaluated 2 to 16 cm2
6. Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
7. The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
8. The subject is able to understand the clinical trial information
9. Signed informed consent form
10. Data on previous wound care are available in the subject medical documentation

Exclusion Criteria:

1. Necrotic wound requiring surgical treatment
2. Pregnancy or breastfeeding
3. Venous etiology of ulceration
4. Burns or chemical burns
5. Clinical manifestations of systemic infection
6. Undermined wound edges
7. The wound involves deeper structures (bone, tendons, joints)
8. Inadequately controlled diabetes mellitus with HbA1c \> 12 % (DCCT) diabetes mellitus
9. Renal insufficiency with eGF \< 30ml/min/1.73m2
10. Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP \>10
11. Topical treatment with any growth factor-based products

Primary outcomes:
measure: Non-healing wounds measuring
timeFrame: 6 + 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lubochna
country: Slovakia
facility: Národní Endokrinologický a Diabetologický ústav
Study officials:
References:
Clinical trial NCT00934765: Effect of Weight Loss on Reproductive Function in Overweight Men
Official title: Effect of Weight Loss on Reproductive Function in Overweight Men.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight
Obesity
Keywords: overweight, obesity, male, fertility
Lead sponsor: Oslo University College
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: The Hospital of Vestfold
name: Tartu University Hospital
First posted: 2009-07-08
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese and overweight men that are planing to loss weight by diet and/or lifestyle changes or gastric by-pass surgery.

Brief summary: Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. The purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* BMI \> 27 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: weight, height, % body fat, sperm (volume, concentration, motility, morphology, vitality), sperm DNA integrity, steroid hormones, gonadotropins, blood glucose, HbA1c, mCRP, lipids, adiponectins, fatty acid composition in serum and sperm phospholipids
timeFrame: minimum three months
Secondary outcomes:
measure: genetic variations in genes involved in metabolism and reproduction
timeFrame: no time frame
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University College
Study officials:
affiliation: Oslo University College
name: Trine B. Haugen, PhD
role: STUDY_CHAIR
affiliation: Oslo University College
name: Oliwia Witczak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01072565: Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring
Official title: Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
A1c
Continuous Glucose Monitoring
Blood Glucose
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Abbott Diabetes Care
First posted: 2010-02-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects ≥18 and ≤75 years of age
* Clinical diagnosis of diabetes
* Diabetes duration ≥ 1 year
* HbA1c ≥7.2%
* Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy

Exclusion Criteria:

* Taken prednisone or cortisone medications in the previous 30 days
* Currently pregnant or planning pregnancy during the study period
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* Unable to follow the study protocol
* Unable to speak, read and write in English

Primary outcomes:
measure: Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
timeFrame: Three, six and nine months.
Secondary outcomes:
measure: Determine the incremental benefit of CGM for clinical decision-making.
timeFrame: Three, six and nine months.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Roger S Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Elinor S Strock, APRN, BC
role: PRINCIPAL_INVESTIGATOR
References: