louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03928197: Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)
Official title: Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe - Trial) - Pilootstudie: definiëren Van Duidelijke Afkapwaarden Omtrent Oedeem Ter Hoogte Van de Onderste Ledematen te Gevolge Van Veneuze insufficiëntie.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema Leg
Venous Insufficiency of Leg
Nocturia
Bio-Impedance Measurements
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. This will lead to a higher voiding frequency during the night.

With this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).


Eligibility criteria: Inclusion Criteria:

* Age between 25 years and 60 years
* For the volunteers with venous insuffiency: clearly visual venous insufficiency (CEAP 1 and 2)
* BMI between 24 and 30

Exclusion Criteria:

* Volunteers using medication (exception for contraception)
* Volunteers having comorbidities
* Pregnant women
* Women who menstruate on the test date
* Volunteers with an implanted elektronical device (IPG, Pacemaker)

Primary outcomes:
measure: Leg swelling measured in cm
timeFrame: 25 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Department of Urology, Ghent University
state: Oost-Vlaanderen
Study officials:
References:
Clinical trial NCT04558697: Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
Official title: Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Specific Vaginitis
Lead sponsor: University of Sarajevo
Sponsor class: OTHER
Collaborators: name: Institution for Health Protection of Women and Motherhood
name: University of Tuzla
First posted: 2020-09-22
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical picture of vaginitis by patients themselves, but also by healthcare professionals. Plant species, St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are well known for there anti-inflammatory, antimicrobial and wound healing activity. This paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of above mentioned plant species, were investigated for their effectiveness on non-specific vaginitis.

This was randomized controlled clinical study that included 210 women with diagnosed non-specific vaginitis. Patients were divided into two basic groups, women in reproductive stage and postmenopausal stage. Three subgroups, containing approximately 30 patients each, received one of three vagitorie formulations for 5 days during which the effects on subjective and objective symptoms were monitored.


Eligibility criteria: Inclusion Criteria:

* adult women who already had sexual intercourse
* diagnosis of non-specific vaginal inflammation by medical examination.

Exclusion Criteria:

* microbiologically confirmed bacterial vaginosis,
* treatment with antibiotic therapy according to official protocols and guidelines
* allergies to one of the plant species included in the vaginal test,
* diabetes mellitus,
* pregnancy,
* lactation,
* immunodeficiency disorder,
* severe chronic illness,
* previous radiotherapy, chemotherapy and biological therapy

Primary outcomes:
measure: Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination
timeFrame: 1 day after treatment completion
Secondary outcomes:
measure: Change in subjective symptoms of non-specific vaginitis, assessed by the valuation of subjective parameter of vaginitis reported by patients during gynecological examination
timeFrame: 1 day after treatment completion
measure: Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Kemal Duric
state: Canton Sarajevo
Study officials:
affiliation: Universiyt of Sarajevo Faculty of Pharmacy
name: Fahir Becic, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00178997: Realistic Models of Gastrointestinal Bioelectromagnetism
Official title: Realistic Models of Gastrointestinal Bioelectromagnetism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Keywords: Blood supply
Mesentery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The purpose of this study is to look at the electrical activity present in healthy and diseased smooth muscle of the intestines; and develop both mathematical and computer models.

Detailed description: The Superconducting QUantum Interference Device (SQUID)is a large cylinder machine located in a large shielded room that measures magnetic activity of the intestines. Subjects will be asked to lie underneath and get recordings of the electrical activity of their intestines. They will also be asked to have a CT scan done. From these two procedures, the mathematical and computer models will be developed to determine the difference between normal bowels and those that do not have adequate blood supply.

Eligibility criteria: Inclusion Criteria:

* Normal subjects and those with diseased bowel

Exclusion Criteria:

* Subjects with claustrophobia

Primary outcomes:
measure: To observe a difference in the electrical activity between normal and diseased smooth muscle of the intestines.
timeFrame: 2011
Secondary outcomes:
measure: To create both mathematical and computer models of the electrical activity of the intestines.
timeFrame: 2011
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt UNiversity Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Leo Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696605: Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion
Official title: Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoosmolality
Hyperosmolality
Renal Failure
Keywords: Hypoosmolality
Hyperosmolality
Copeptin
Vasopressin
Lead sponsor: Hospital Centre Biel/Bienne
Sponsor class: OTHER
Collaborators: name: Brahms AG
First posted: 2008-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers; patients with chronic renal failure

Brief summary: The are 2 principal goals in this study:

1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.
2. To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.


Eligibility criteria: Inclusion Criteria:

* chronic renal failure grade I through IV
* healthy age-matched controls

Exclusion Criteria:

* chronic renal failure grade V
* heart failure
* liver disease
* nephrotic syndrome
* anemia (hemoglobin level \< 100 g/L)
* uncontrolled hypertension (systolic BP \> 160 mmHg; diastolic BP \> 95 mm Hg)
* coexisting severe disease
* known thyroid disease
* known hypocortisolism
* known hypercortisolism
* known diabetes insipidus
* pregnancy
* lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Biel/Bienne
country: Switzerland
facility: Clinic of Internal Medicine, Hospital Center
Study officials:
References:
citation: Balanescu S, Kopp P, Gaskill MB, Morgenthaler NG, Schindler C, Rutishauser J. Correlation of plasma copeptin and vasopressin concentrations in hypo-, iso-, and hyperosmolar States. J Clin Endocrinol Metab. 2011 Apr;96(4):1046-52. doi: 10.1210/jc.2010-2499. Epub 2011 Feb 2.
Clinical trial NCT02356705: Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Official title: Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Lead sponsor: Bassett Healthcare
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration


Eligibility criteria: Inclusion Criteria:

1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia
2. American Society of Anesthesiologists (ASA) Class 1 or 2
3. Parent willing and able to provide written informed consent
4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)

Exclusion Criteria:

1. ASA Class 3 or greater
2. History of allergy to midazolam or xylocaine
3. Presence of acute respiratory infection at time of surgery
4. Parent unwilling or unable to provide informed consent
5. Parent unwilling or unable to complete the OBD VAS

Primary outcomes:
measure: Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement
timeFrame: 25 minutes
Secondary outcomes:
measure: Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room
timeFrame: 20 minutes
Other outcomes:
measure: Time to Discharge
timeFrame: approximately 3 hours
measure: Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home
timeFrame: approximately 3 hours
measure: Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)
timeFrame: 1 minute
measure: Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet)
timeFrame: 5minutes
Locations:
city: Cooperstown
country: United States
facility: Bassett Healthcare Network
state: New York
Study officials:
affiliation: Bassett Healthcare
name: david Ullman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03993405: Cut-off Values of Muscle Thickness Ratio for Sarcopenia
Official title: Cut-off Values and Adjustments for Diagnosing Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: older people
muscle
ultrasound
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The loss of muscle mass is one of the major diagnostic criteria for sarcopenia. Many methods are also used for the definition of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.

Detailed description: Decreases in total skeletal muscle mass are accepted to be necessary for confirming the diagnosis of sarcopenia. Many methods are also used for the definition of sarcopenia.

However, ultrasound measurements has a high sensitivity and specify for confirming the diagnosis of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.

Eligibility criteria: Inclusion Criteria:

* To be a volunteer to participate
* To be an aged 18-90 years old.

Exclusion Criteria:

* Walking with assist device
* Having a visual deficits
* Having an undergone orthopedic surgery
* Having a cardiac pacemaker
* Having a hypothyroidism, diabetes mellitus, renal/hepatic failure

Primary outcomes:
measure: Muscle thickness
timeFrame: 30 minutes
measure: Skeletal muscle mass
timeFrame: 2 minutes
Secondary outcomes:
measure: Muscle strength
timeFrame: 15 minutes
measure: Peripheral strength
timeFrame: 1 minutes
measure: Physical function
timeFrame: 5 minutes
measure: Anthropometric assessments
timeFrame: 5 minutes
measure: Balance
timeFrame: 1 minute
measure: Body mass index
timeFrame: 1 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ozden Ozkal
Study officials:
References:
Clinical trial NCT03405805: Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules
Official title: The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunogenicity, Vaccine
Immunologic Memory
Lead sponsor: Aghia Sophia Children's Hospital of Athens
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants 2-15 months of age living in Athens, Greece

Brief summary: The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.


Eligibility criteria: Inclusion Criteria:

* 2-15 months of age

Exclusion Criteria:

* previously recorded allergy to PCV
* intravenous immunoglobulin (IVIG) given within the previous 6 months
* primary or secondary immunodeficiency
* any chronic medical condition

Primary outcomes:
measure: immunoglobulin G (IgG) antibody serum titers (measured by ELISA)
timeFrame: 28 days post last vaccine dose
measure: switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)
timeFrame: 28 days post last vaccine dose
measure: immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)
timeFrame: 28 days post last vaccine dose
Secondary outcomes:
measure: Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)
timeFrame: 7 days post last vaccine dose
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 'Aghia Sophia' Children's Hospital
state: Attiki
Study officials:
affiliation: "Aghia Sophia" Children's Hospital
name: Vana Spoulou, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00877305: Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiac Surgery
Keywords: Ischemic Preconditioning
Cognitive function
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
First posted: 2009-04-07
Enrollment: 180
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: The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cognitive function in patients undergoing cardiac surgery compared to control intervention.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

* Emergency cases
* Myocardial infarction up to 7 days prior to enrollment
* Stroke up to 2 months prior to enrollment
* Ejection fraction less than 30%
* Previous psychiatric and neurological illness
* Inability to give informed consent

Primary outcomes:
measure: The primary outcome measure is postoperative neurocognitive dysfunction.
timeFrame: Preoperative, 1 week and 3 months after surgery
Secondary outcomes:
measure: New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study).
timeFrame: Within 24-48 hours after surgery
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Patrick Meybohm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Schleswig-Holstein
name: Berthold Bein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zitta K, Meybohm P, Bein B, Gruenewald M, Lauer F, Steinfath M, Cremer J, Zacharowski K, Albrecht M. Activities of cardiac tissue matrix metalloproteinases 2 and 9 are reduced by remote ischemic preconditioning in cardiosurgical patients with cardiopulmonary bypass. J Transl Med. 2014 Apr 8;12:94. doi: 10.1186/1479-5876-12-94.
citation: Meybohm P, Renner J, Broch O, Caliebe D, Albrecht M, Cremer J, Haake N, Scholz J, Zacharowski K, Bein B. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study. PLoS One. 2013 May 31;8(5):e64743. doi: 10.1371/journal.pone.0064743. Print 2013.
Clinical trial NCT01275105: A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
Official title: A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Eye Therapies, LLC
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2011-01-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.

It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* If female, cannot be not pregnant or nursing
* Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;
* Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;

Exclusion Criteria:

* Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
* Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
* Have a presence of active ocular infection;
* Use specified disallowed medications during the study or appropriate pre-study washout period;
* Have any significant illness;
* Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
* Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
* Be a female who is currently pregnant or nursing.

Primary outcomes:
measure: Conjunctival Redness
timeFrame: at specified timepoints for up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora, Inc.
state: Massachusetts
Study officials:
References: