louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04338477: Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers
Official title: Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urine Specimen Collection
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.

Detailed description: To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in healthy volunteers, all participants in this open-label study will be asked to record their fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement. Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1 and 29.

Eligibility criteria: Inclusion Criteria:

* Willingness and ability to record urine volume and fluid consumption over 3 days.
* Written consent to participate in the study.

Exclusion Criteria:

* Disease or comprehension problems (language) that affect the accurate collection and measurement of urine levels over 3 days.
* Taking diuretic drugs, teas, herbal supplements, or systemic corticosteroids.
* Chronic nephropathy (such as glomerulonephritis, analgesic nephropathy, interstitial nephritis).
* Pregnancy or lactation.
* Psychiatric disorders that include suicidality.
* Surgical intervention in the 3 months prior to enrollment or scheduled surgery during the study.
* Known chronic diseases such as dementia, progressive systemic diseases.
* Known alcohol and/or drug addiction.
* Known allergies to goldenrod or birch leaves.
* Participation in one or more other clinical trials in the last 30 days

Primary outcomes:
measure: Tolerability as assessed by the treating physician
timeFrame: day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Arbon
country: Switzerland
facility: Privat practice of Dr. med. Bruno Haug, Medizinisches Zentrum Arbon
state: Thurgau
city: Freidorf
country: Switzerland
facility: Private Practice Dr. med Bernhard Waelti
state: Thurgau
Study officials:
name: Bernhard Waelti, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831777: CareTaker Self-Calibration Validation
Official title: CareTaker Self-Calibration Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: non-invasive blood pressure
Lead sponsor: CareTaker Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
First posted: 2016-07-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be UVA patients/staff, \> 18 years of age, who are able and willing to participate and have given verbal assent

Brief summary: The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration.

The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.

Detailed description: The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings.

The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff \> 18 years of age and who were able to give verbal consent.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age, who are able and willing to participate and have given verbal assent

Exclusion Criteria:

* Unable to give verbal assent
* \<18 years of age
* No or poor finger pulse, as determined through visual inspection for ischemic hands

Primary outcomes:
measure: Performance comparison
timeFrame: 8 minutes for 3 paired readings
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CareTaker Medical LLC
name: Martin C Baruch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270477: Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury
Official title: Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound (Morphologic Abnormality)
Keywords: Frost injury
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage.

The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment.

Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.


Eligibility criteria: Inclusion Criteria:

* Age 18-70. Frost damage grade II-IV. Inclusion is needed within 48 hours from time of damage.

Exclusion Criteria:

* Pregnancy. Ventilator treatment. Problems with equalizing. High grade heart failure. Chronic obstructive lung disease of high grade. Treatment over 3 days after time of damage. Serious claustrophobia/psychiatric illness.

Primary outcomes:
measure: Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.
timeFrame: From incusion of a patiant through a follow up after 1 year.
Secondary outcomes:
measure: First: The number of surgeries is reduced with hyperbaric oxygen treatment.
timeFrame: One year from the enrollment of a patient.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Hyperbaric section Oslo University hospital
Study officials:
affiliation: Oslo University Hospital
name: Knut Ar Kirkeboen, MD Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00160277: Efficacy and Safety of Moxonidine in Indian Patients
Official title: Open Label, Multi-Center, Force-Titration Study to Evaluate the Efficacy and Safety of Moxonidine in Ambulatory Subjects With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Efficacy and safety of moxonidine in Indian hypertensives
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.


Eligibility criteria: Inclusion Criteria:

Hypertension

Exclusion Criteria:

Severe concomitant diseases, CHF, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina

Primary outcomes:
measure: Systolic blood pressure reduction
Secondary outcomes:
measure: Piggy-back pharmacoeconomic evaluation; Safety and tolerability
Other outcomes:
Locations:
city: Jubillee Hills Hyderabad
country: India
facility: Site 1
city: Mangalore
country: India
facility: Site 2
city: New Delhi
country: India
facility: Site 3
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT00049777: A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-11-15
Enrollment: 2000
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 relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.


Eligibility criteria: Inclusion Criteria

* Adults greater than or equal to 18 years of age
* Receiving inpatient treatment for severe sepsis
* Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled

Exclusion Criteria

* Contraindicated for heparin treatment
* Require a higher dose of heparin than defined in the trial
* Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min
* Weigh more than 135 kg (297 pounds)
* Are not expected to survive 28 days given their medical condition.

Primary outcomes:
measure: Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality.
Secondary outcomes:
measure: Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6
measure: and 28. Evaluate the safety profile of drotrecogin alfa (activated) and prophylactic heparin co administration by the incidence of intracranial hemorrhage and other serious bleeding events through study day 28.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Levi M, Levy M, Williams MD, Douglas I, Artigas A, Antonelli M, Wyncoll D, Janes J, Booth FV, Wang D, Sundin DP, Macias WL; Xigris and Prophylactic HepaRin Evaluation in Severe Sepsis (XPRESS) Study Group. Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated). Am J Respir Crit Care Med. 2007 Sep 1;176(5):483-90. doi: 10.1164/rccm.200612-1803OC. Epub 2007 Jun 7.
Clinical trial NCT00421577: Technique for Localization of Caries Associated Bacteria on Tooth Surfaces.
Official title: Usage of Laboratory Technique for Localization of Caries Associated Bacteria on Tooth Surfaces as Clinical Measurement to Caries Diagnosis and Treatment Efficiency.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caries
Keywords: Caries Diagnosis
Replica technique
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: There is a simple laboratory technique for localization of caries associated bacteria on tooth surfaces by taking an impression of the teeth with a material containing sucrose.

The purpose of this study is to check whether the technique can be incorporated into dental clinics as diagnostic tool comparing to other diagnostic methods available.


Eligibility criteria: Inclusion Criteria:

* adult/ patient of the student clinic in Hadassa, Jerusalem.

Exclusion Criteria:

* children/ antibiotic taken in the last month.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shay Levi, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenberg M, Weiss E, Eli I. A novel replica technique for localization of caries-associated bacteria on tooth surfaces: development and initial experience. Caries Res. 1988;22(1):42-4. doi: 10.1159/000261081. No abstract available.
Clinical trial NCT03178877: The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors
Official title: The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBS - Irritable Bowel Syndrome
Keywords: IBS, Rome IV criteria, anxiety
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 350
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Medical student from first grade to fifth grade

Brief summary: A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016. This study used stratified randomized sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview was applied to all subjects.

Detailed description: A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016. This study used stratified randomized sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview was applied to all subjects. A bivariate analysis was done to know the relationship between IBS and its related factors using chi-square, unpaired t-test, and their alternatives. Multivariate analysis was done using logistic regression test

Eligibility criteria: Inclusion Criteria:

* Age of participant \>= 15 years
* Volunteer to participate in study

Exclusion Criteria:

* Red flag symptoms: febrile, vomiting, rectal bleeding, weight lost
* Diagnosed as having Inflammatory bowel disease
* Peptic ulcer drug consumption
* History of gastrointestinal surgery

Primary outcomes:
measure: Anxiety and depression
timeFrame: 1 month
Secondary outcomes:
measure: Sleep Quality
timeFrame: 1 month
measure: Spiritual status
timeFrame: 1 month
measure: Academic Stress
timeFrame: 6 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT00920777: Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Official title: A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Fatigue
Pain
Keywords: CBT
Fukuda criteria
Mental functioning
Physical functioning
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2009-06-15
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.


Eligibility criteria: Inclusion Criteria:

* Patients referred to St.Olav Hospital, Trondheim
* fulfil the FUKUDA criteria for CFS/ME.

Exclusion Criteria:

* Pregnant patients

Primary outcomes:
measure: Mental and physical function
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Egil Fors, prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasouli O, Gotaas ME, Stensdotter AK, Skovlund E, Landro NI, Dastol P, Fors EA. Neuropsychological dysfunction in chronic fatigue syndrome and the relation between objective and subjective findings. Neuropsychology. 2019 Jul;33(5):658-669. doi: 10.1037/neu0000550. Epub 2019 Jun 6.
citation: Gotaas ME, Stiles TC, Bjorngaard JH, Borchgrevink PC, Fors EA. Cognitive Behavioral Therapy Improves Physical Function and Fatigue in Mild and Moderate Chronic Fatigue Syndrome: A Consecutive Randomized Controlled Trial of Standard and Short Interventions. Front Psychiatry. 2021 Apr 12;12:580924. doi: 10.3389/fpsyt.2021.580924. eCollection 2021.
Clinical trial NCT06717477: Streamlining Care for Patients With Compression Neuropathies: The Carpal Tunnel Plus Pathway
Official title: Streamlining Care for Patients With Compression Neuropathies: The Carpal Tunnel Plus Pathway
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: Carpal Tunnel Syndrome
Patient Satisfaction
Care Pathway
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective: Patients age 18 or over seen by study surgeons for CTS. Prospective: patients age 18 or over with carpal tunnel syndrome seen at SPH or Vancouver Hospital EMG lab.

Brief summary: The goal of this clinical trial is to assess the impact of a new care pathway (the Carpal Tunnel Plus Pathway) in patients with carpal tunnel syndrome. The main questions it aims to answer are:

1. What was the effect of the Carpal Tunnel Plus Pathway on wait times between each step of the care pathway (e.g. from referral to initial consult, from initial consult to surgical consult, etc.)?
2. How satisfied are patients with the care they received through the Carpal Tunnel Plus Pathway?

Researchers will compare wait times pre- and post- Pathway implementation to see if there was any change.

Participants will be asked to complete a short patient satisfaction survey.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Referred to the Vancouver General Hospital Neuromuscular Disease Unit or St. Paul's Hospital with a confirmed diagnosis of carpal tunnel syndrome
* Ability to understand English

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Wait times
timeFrame: From initial referral to surgery/injection (variable, but approximately 9 months)
measure: Patient satisfaction
timeFrame: Immediately after surgery/injection appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kristine Chapman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04276077: Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
Official title: Effects of Different Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electric Stimulation Therapy
Frailty
Women
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to determine the effects of different electrical muscle stimulation protocols on muscle stiffness and functional capacity in post-menopausal women. A randomized controlled clinical trial will be carried out. A total sample of 27 post-menopausal women will be recruited and divided into 3 groups which received high-frequency electrical muscle stimulation during 8 weeks, low-frequency electrical muscle stimulation during 8 weeks or no-intervention (control group). Outcome measurements will be stiffness assessed by sonoelastography and functional capacity assessed by the 30 seconds Chair-Stand Test before and after 8 weeks interventions.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women

Exclusion Criteria:

* Arrhythmias
* Diabetes
* Smokers

Primary outcomes:
measure: Stiffness
timeFrame: Change from Baseline stiffness at 8 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: Change from Baseline functional capacity at 8 weeks
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
References: