louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04697862: Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil
Official title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: hypoxia
exercise
blood markers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: mean pulmonary artery pressure (mPAP) / cardiac output (CO)
timeFrame: 4 hours
Secondary outcomes:
measure: Differences in pulmonary arterial pressure
timeFrame: 4 hours
measure: Differences in cardiac output
timeFrame: 4 hours
measure: Differences in pulmonary vascular resistance
timeFrame: 4 hours
measure: Differences in pulmonary artery wedge pressure
timeFrame: 4 hours
measure: Differences in right atrial pressure
timeFrame: 4 hours
measure: Differences in mixed venous oxygen saturation
timeFrame: 4 hours
measure: Differences in heart rate
timeFrame: 4 hours
measure: Differences in blood pressure
timeFrame: 4 hours
measure: Differences in oxygen saturation
timeFrame: 4 hours
measure: Differences in arterial blood gases
timeFrame: 4 hours
measure: Differences in mixed venous blood gases
timeFrame: 4 hours
measure: Differences in cerebral tissue oxygenation
timeFrame: 4 hours
measure: Differences in muscle tissue oxygenation
timeFrame: 4 hours
measure: Differences in symptoms (Borg dyspnoea)
timeFrame: 4 hours
measure: Differences in symptoms (Borg leg effort)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversityHospital Zurich, Department of Pulmonology
Study officials:
affiliation: UniversityHospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03761862: Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts in Patients Who Undergo Bilateral Tubal Ligation
Official title: Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts and Gynecologic Symptoms in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Neural Therapy of Huneke
Dysmenorrhea
Dyspareunia
Sterilization, Tubal
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 113
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo bilateral tubal ligation admitted to the training and research hospital.

Brief summary: The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any possible links between the clinical changes and pathophysiologic mechanisms. One hundred and thirteen patients were randomly divided into two groups (neural therapy and control). Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one year after the treatment. The visual analog scale (VAS) were noted in both groups, also discomfort and gynecologic symptoms are recorded.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo bilateral tubal ligation

Exclusion Criteria:

* Previous abdominal surgery
* Patients with diseases that could have neurologic complications (DM, SLE ...)

Primary outcomes:
measure: Pain scores
timeFrame: 1 year later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05982262: Naturopathic-pharmacological Consultation in Hematology
Official title: Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Diseases
Keywords: Dietary supplements
Herbal supplements
Hematology
Safety
Consultation
Naturopath
Clinical pharmacist
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this cross-sectional study is to learn about the effect of a naturopathic-pharmacologic consultation in patients with hematologic conditions. The main question it aims to answer is whether such consultation can improve the safety of dietary and herbal supplements' use among these patients.

Participants will be asked to answer basic questions and fill-out questionnaire before and after meeting the consultation team. Some patients will be prescribed dietary and herbal supplements that may help relief some of the symptoms they describe, in a safe way and without interacting with the drugs they are taking.


Eligibility criteria: Inclusion Criteria:

1. Followed up for a hematological condition
2. Ability to fill simple questionnaires in Hebrew, Russian or Arabic
3. Indication for consultation:

   1. Patient's request to expand knowledge about the use of DHS
   2. Patient using DHS
   3. Patient's desire to start using DHS
   4. Patient that is interested in hearing about the use of DHS for his/her health condition
   5. Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment.

Exclusion Criteria:

None

Primary outcomes:
measure: Safety of the use of DHS in patients with a hematological disease through naturopathic counseling
timeFrame: From enrollment to the end of intervention, up to 1 year
Secondary outcomes:
measure: Efficacy of prescribed dietary and herbal supplements (DHS)
timeFrame: From enrollment to the end of intervention, up to 1 year
measure: Patient-physician communication around the use of DHS
timeFrame: From enrollment to the end of intervention, up to 1 year
measure: Patient satisfaction
timeFrame: From enrollment to the end of intervention, up to 1 year
measure: Compliance with hematological treatment
timeFrame: From enrollment to the end of intervention, up to 1 year
measure: Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling
timeFrame: From enrollment to the end of intervention, up to 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Ilana Levy Yurkovski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02264262: Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers
Official title: Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sympathetic Nerve Activity
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Activation of the sympathetic nervous system is associated with increased risk of ventricular arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable tools to measure sympathetic outflow in human subjects is therefore highly desirable.

Microneurography is the current gold standard measurement technique, whereby multiunit postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is considered extremely safe, and has been used successfully for decades in human translational physiology experiments, it has not been adopted for routine clinical assessment due to the requirement for sophisticated equipment and specific technical training and skills. Alternatively, many have adopted heart rate variability as a simple, noninvasive technique for assessing sympathetic nerve activity. However, heart rate variability does not directly measure sympathetic nerve activity, and there is much debate in the literature as to the exact source of sympathetic nerve traffic. For example, many believe it is an accurate reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in muscle or skin sympathetic nerve activity.

To address these limitations, the investigators have developed a simple, noninvasive technique to measure sympathetic nerve activity using surface electrodes.

Despite its great promise, this new approach has not yet been directly validated. The purpose of this study is therefore to validate this new technique (refered to as EKG-NA) against the current gold standard measurement technique, microneurography.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years of age
* BMI \< 35 kg/m2

Exclusion Criteria:

* History of hypertension, diabetes, pulmonary disease, metabolic disease or heart failure
* Cardiac rhythm disorder, specifically: rhythm other than sinus
* Use of any medications other than common supplements
* Unable to perform handgrip exercise
* Pregnant

Primary outcomes:
measure: Chane in Sympathetic nerve activity
timeFrame: Change from baseline in sympathetic nerve activity at 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald Victor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141362: Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain.
Official title: An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Chronic Neuropathic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 325
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: Evaluate long-term safety and efficacy of pregabalin in patients with chronic neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Must have met the inclusion criteria for the preceding double-blind BID study in diabetic neuropathy or postherpetic neuralgia.
* Must have received study medication under double-blind conditions.

Exclusion Criteria:

* Patients cannot participate if they experienced a serious adverse event during the previous double-blind BID study which was determined to be related to the study medication.

Primary outcomes:
measure: Safety and efficacy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT07002762: Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Official title: Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperuricemia or Gout
Lead sponsor: OMNIFARMA LLC
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicentre, double-blind, randomized, placebo-controlled trial of the clinical efficacy of burdock root extract in patients with asymptomatic hyperuricemia, with the primary objective to assess the efficacy of the use of burdock root extract in patients with asymptomatic hyperuricaemia versus placebo


Eligibility criteria: Inclusion Criteria:

* Hyperuricaemia confirmed by a laboratory, uric acid level from 360 to 540 μmol/L in women and from 420 to 540 μmol/L in men;

  * Age from 35 to 65 years at the baseline;
  * Patients examined by an experienced specialist not revealing any clinical evidences of gout or other somatic consequences of hyperuricaemia;
  * Not taking any other nutritional additives;
  * Women of reproductive age having negative pregnancy test at the baseline and at the end of the trial;
  * Not taking any diuretics, or their administration based on a regimen usual for a patient, without changes;
  * Not taking part in any other clinical trials;
  * Consent and voluntarily signed informed consent form for participation in the clinical trial.

Exclusion Criteria:

* Age \<35 or \>65 years;
* Fever (above 36.8 оС);
* Pregnancy and lactation;
* Patients with any somatic evidences of hyperuricaemia including gout taking antigout drugs during or within 6 months before the trial;
* Patients with mental disorders / taking antipsychotics or antidepressants;
* Patients not giving (informed) consent to participate in the trial;
* Patients causing doubts of the study doctor as to their motivation to comply with the trial;
* Presence of any concomitant decompensated diseases or acute conditions able to influence results of the trial;
* Alcohol abuse and drug addiction;
* Changes in taking diuretics within a month before and during the trial;
* Participation in any other clinical trial;
* Taking any nutritional additives.

Primary outcomes:
measure: Body temperature
timeFrame: 0 - 60 days
measure: Body weight
timeFrame: 0 - 60 days
measure: Body mass index
timeFrame: 0 - 60 days
measure: Purpouse of the trial
timeFrame: Till end of 2025 year
Secondary outcomes:
measure: Uric acid
timeFrame: 0 - 60 days
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Study officials:
References:
Clinical trial NCT02621762: Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
Official title: Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Vascular Calcification
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 111
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.


Eligibility criteria: Inclusion Criteria:

* Male or female hemodialysis patients ≥ 18 years of age
* Negative pregnancy test of female patients in child-bearing age
* The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
* Start of chronic hemodialysis treatment ≥ 3 months ago
* HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
* Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
* T50 ≥ 200 minutes.

Exclusion Criteria:

* Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment

Primary outcomes:
measure: Effect of treatment on serum calcification propensity, measured by T50
timeFrame: 7 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern Inselspital
state: BE
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Dominik Uehlinger, Prof Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.
Clinical trial NCT00171262: Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Official title: Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Dyslipidemia, chronic renal disease, fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years Patients that give their inform consent

Exclusion Criteria:

* Pregnant women Diabetic patients Treated with statins for the year prior to study inclusion Patients with contraindications listed in fluvastatin prescribing information

Other protocol-defined in and exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in serum inflammatory markers after 52 weeks
Secondary outcomes:
measure: Change from baseline in fibrosis parameters and endothelial function after 52 weeks
measure: Adverse events and serious adverse events after 52 weeks
measure: Change from baseline in laboratory tests of kidney function after 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00533962: IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
Official title: Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Intraocular Pressure
Keywords: Glaucoma
Anecortave Acetate
Intraocular pressure
Advanced glaucoma cases with uncontrolled IOP
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2007-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.


Eligibility criteria: Inclusion Criteria:

* Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg)
* Patients should be under maximum tolerated medication
* Low best corrected visual acuity (worse than 20/100)

Exclusion Criteria:

* Under 18 or over 80

Primary outcomes:
measure: Intraocular pressure
timeFrame: Procedure
Secondary outcomes:
measure: Visual Acuity; side effects (biomicroscopy exam)
timeFrame: Post treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Tiago Prata
role: STUDY_DIRECTOR
References: