louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01768507: Reresveratrol Administered to Healthy Male Subjects
Official title: The Effects of the Dietary Supplement Trans-resveratrol on Heme Oxygenase-1 (HO-1) and Sirtuins Expression in PBMCs in Healthy Male Subjects: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Heme Oxygenase
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 10
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: Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to evaluate the HO-1 stimulation of resveratrol in healthy humans.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male patient aged between 18 and 45 years (inclusive) at screening.
* No clinically significant findings on the physical examination at screening.
* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
* Non-smoker (for at least 1 month)
* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to resveratrol or any excipients of the resveratrol formulation.
* Treatment with any investigational drug within 3 weeks prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of resveratrol.
* Smoker
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Regularly intake of resveratrol rich food
* Positive results from the hepatitis serology at screening.
* Positive results from the HIV serology at screening.
* Presumed non-compliance.
* Legal incapacity or limited legal capacity at screening.

Primary outcomes:
measure: The maximal HO-1 and sirtuin mRNA expression in PBMCs
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02192307: Effectiveness of Two Water-Based Potassium Oxalate Desensitizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent to participate in the study
* Be at least 18 years of age
* Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
* Agree to refrain from participating in any other oral/dental product studies for the duration of the study
* Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
* Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
* Agree to comply with study/product usage instructions; and
* Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

* Gross oral neglect or urgent dental treatment needs
* Severe periodontal disease and/or generalized mobility
* Active treatment for periodontitis
* Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
* Self-reported pregnancy or nursing

Primary outcomes:
measure: Change From Baseline Air Challenge
timeFrame: 30 days
Secondary outcomes:
measure: Change From Baseline Visual Analog Scale
timeFrame: 30 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
References:
Clinical trial NCT00186407: Autologous Stem Cell Rescue for Primary Amyloidosis
Official title: High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyloidosis
Blood and Marrow Transplant (BMT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.

Detailed description: To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.

Eligibility criteria: Inclusion Criteria:1. Primary amyloidosis

2. Age \< 75 years.

3. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.

4. Patients who have undergone bone marrow transplantation previously will not be eligible.

5. Patients must have a Karnofsky performance status greater than 70%.

6. Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction \>45% on echocardiography, cardiac index \> 1.8 liters/min/m\^2 and pulmonary function tests demonstrating FEV1 and DLCO \> 60%.

7. Patients must be HIV negative.

8. Pregnant or lactating women will not be eligible to participate.

9. Patients must provide signed informed consent.

10. Patients with multiple myeloma and amyloid are eligible.

Exclusion Criteria:1. prior blood or marrow transplant

Primary outcomes:
measure: To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sally Arai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882707: The Effectiveness of Neurodynamic Mobilization in Carpal Tunnel Syndrome
Official title: The Effectiveness of Neurodynamic Nerve Mobilization in Addition to Physical Therapy on the Median Nerve and Abductor Pollicis Brevis Muscle in Patients With Mild and Moderate Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Median Nerve
Keywords: carpal tunnel syndrome
median nerve mobilization
abductor pollicis brevis
boston carpal tunnel questionnaire
hand grip
ultrasonography
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized, clinical, single-blinded, controlled study will initially planned to include 86 patients diagnosed with carpal tunnel syndrome who applied to Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital, Physical Medicine and Rehabilitation outpatient clinic and Kutahya City Hospital.Patients aged 20-55 years who were diagnosed with mild and moderate carpal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study. The patients were randomized into two groups using the computer-assisted randomization method. Median nerve mobilization and ultrasound therapy will be given to the study group, and only ultrasound therapy will be given to the control group. All the patients were evaluated with the Visual Analog Scale (VAS), Hand and Pinching Grip Test, Boston Carpal Tunnel Questionnaire (BCTQ) and Median Nerve and Abductor Pollicis Brevis Muscle ultrasonography before the intervention and at the third week of intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with mild-to-moderate CTS on the dominant hand, based on the electrodiagnostic examination.
* Aged 20-55 years.
* Consent to receive the described treatment.
* Lasting symptoms at least 3 months

Exclusion Criteria:

* A systemic inflammatory disease.
* Any disease that can cause polyneuropathy, for example, diabetes mellitus.
* A cognitive disorder.
* Receiving psychotherapy.
* A pacemaker.
* Any disease that can affect the central nervous system.
* Carpal tunnel syndrome surgery history

Primary outcomes:
measure: Ultrasound assessment
timeFrame: Change from Baseline at 3th weeks
Secondary outcomes:
measure: Hand and pinching grip measurement
timeFrame: Change from Baseline at 3th weeks
measure: Symptom severity and functional status
timeFrame: Change from Baseline at 3th weeks
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Merve Akdeniz LEBLEBİCİER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030807: Pulmonary Hypertension in Hypersensitivity Pneumonitis
Official title: Recognition of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Institute for Lung Vascular Research
First posted: 2017-01-25
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed Hypersensitivity Pneumonitis

Brief summary: The investigation serves the identification of pulmonary hypertension (PH) among patients with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data from South America indicate that the prevalence of pre-capillary PH amongst patients with HP is higher than 20%. There are no reliable data from Europe so far. According to the investigators previous analysis, more than 400 HP patients have participated in pulmonary rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is to be invited to participate in the study.

A diagnostic algorithm will be applied in the clinical trial, in the case of clinical suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the determination of the prevalence of PH in patients with HP the investigators aim to assess the reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed Hypersensitivity Pneumonitis
* written consent
* Age: 18-90 years

Exclusion Criteria:

* severe impairment of the general health condition
* pregnancy

Primary outcomes:
measure: Prevalence of pulmonary hypertension
timeFrame: 4 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276507: Multisystem Shortness of Breath Evaluation Study
Official title: Multisystem Shortness of Breath Evaluation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspnea
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing evaluation for dyspnea in a specialized clinic (Pulmonary and/or Cardiology)

Brief summary: The MUSE study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related questionnaires. Follow up will continue for at least one year.


Eligibility criteria: Inclusion Criteria:

* Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea.

Exclusion Criteria:

* Patients with a known cause of dyspnea such as established cardiopulmonary disease

Primary outcomes:
measure: Dyspnea etiology
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundación Jimenez Díaz
Study officials:
affiliation: Fundación Jimenez Díaz
name: German Peces-Barba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342107: Effect of FID 114675A on Lens Wettability
Official title: The Effect of Alcon Multi-Purpose Disinfecting Solution (MPDS) on Lens Wettability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wettability
Keywords: Contact Lenses
Contact Lens Care
Multi-Purpose Solution Wettability
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.


Eligibility criteria: Inclusion Criteria:

* 18 years or age or older with normal eyes, other than correction for refractive error.
* At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
* Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
* Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Participation in any investigational study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Lens Wettability
timeFrame: 16 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT04105907: Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.
Official title: Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Root Canal Treatment
Keywords: GentleWave
Multisonication
Sonendo
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Sonendo, Inc.
First posted: 2019-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo


Eligibility criteria: Inclusion Criteria:

* Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.

Exclusion Criteria:

* Teeth with root fractures or previously root canal treated teeth.
* Teeth with severe loss of structure
* Children

Primary outcomes:
measure: Visualization of the amount of pulp tissue left behind after GentleWave procedure
timeFrame: at the time of tooth extraction(immediately after GentleWave procedure)
Secondary outcomes:
measure: Number of participants with the presence of bacteria inside the root canal and inside the dentinal tubules as assessed by observation under the light microscope
timeFrame: at the time of tooth extraction(immediately after GentleWave procedure)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David E Jaramillo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04035707: Serum Tryptase Concentration During General Anaesthesia With Rocuronium
Official title: Serum Tryptase Concentration During General Anaesthesia With Rocuronium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity Reaction
Keywords: general anaesthesia
mast cell
rocuronium
tryptase
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study included 126 women given a general volatile anesthesia: group I - 66 - using the rocuronium and group II - 60 - without neuromuscular relaxants. Informations about perioperative fluid therapy and doses of rocuronium were noticed. The blood samples were collected to perform tryptase concentration analysis: preoperatively - before anesthesia and postoperatively - after recovery from anesthesia.
Primary purpose: TREATMENT

Brief summary: Rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents (NMB). Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. No studies have been performed to explain specific role of rocuronium doses on serum tryptase values. The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations.

Detailed description: The greatest risk of hypersensitivity occurs during anesthesia for female patients and it is connected with the induction phase using skeletal muscle relaxants . Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Due to the multiple advantages reports of triggering allergic or hypersensitivity reactions caused by rocuronium create doubts about the safety of application .

Eligibility criteria: Inclusion Criteria:

* ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia

Exclusion Criteria:

* steroid therapy, allergy in medical history, mastocytosis

Primary outcomes:
measure: tryptase
timeFrame: up to 40 minutes after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University in Bialystok
name: Urszula Kosciuczuk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kosciuczuk U, Knapp P, Jakubow P. Effect of body mass index and rocuronium on serum tryptase concentration during volatile general anesthesia: an observational study. Clinics (Sao Paulo). 2020;75:e1701. doi: 10.6061/clinics/2020/e1701. Epub 2020 Aug 10.
Clinical trial NCT03349307: Thin-EBUS in Ex-vivo Human Lungs
Official title: Feasibility of the Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) System for Lymph Node Staging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lobectomy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) in human resected lobes. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to visualize lung tumors from an intra-bronchial view. The secondary objective is to evaluate the insertion ability, operability, endoscopic image and ultrasound image compared to that of the convex probe EBUS.


Eligibility criteria: Inclusion Criteria:

* Any patients scheduled for lobectomy or anatomical segmental resection for malignant lung tumors.
* 18 years of age or older

Exclusion Criteria:

* Any patients with inability to give informed consent.

Primary outcomes:
measure: To clarify the feasibility of using the thin convex probe EBUS scope to visualize lung tumors from an intra bronchial view.
timeFrame: Within an hour of resection.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References: