louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06505967: Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels
Official title: Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels: A Randomized Double-Blind Parallel Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAD+ Levels in the Blood
Lead sponsor: Qualia Life Sciences
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to determine if Qualia NAD+ effectively increases NAD+ levels in the blood and to evaluate its safety.

Researchers will compare Qualia NAD+ to a placebo (a look-alike substance that contains no active drug) to assess its efficacy in increasing NAD+ levels in the blood.

Participants will:

Take Qualia NAD+ or a placebo every day for 4 weeks. Undergo blood tests before and after the trial.


Eligibility criteria: Inclusion criteria:

Provide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text.

Healthy male and female participants between the ages of 40-65 years of age. Willingness to complete questionnaires, records, and diaries associated with the study.

Willing to not consume any supplements, energy drinks/shots, or other products containing any form of supplemental vitamin B3 (e.g., niacin, niacinamide, nicotinamide ribosome, NMN) starting about 2 weeks prior to the baseline NAD fingerstick test and continuing through the intervention period.

Willing to not begin taking any new supplements during the study period, and to continue taking any supplements they are currently using regularly (with the exception of vitamin B3 containing supplements).

Willingness to self-administer the intracellular NAD fingerstick test kit at home for both a baseline and post-intervention blood sample, and to complete a release form that gives researchers access to the results of these tests.

Exclusion criteria:

Women who are pregnant, breastfeeding, or planning to become pregnant during the trial Known food intolerances/allergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent

Primary outcomes:
measure: NAD+ Levels in the Blood
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Qualia Life Sciences
state: California
Study officials:
References:
Clinical trial NCT00563940: Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema
Official title: Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
OCT
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2007-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical significant macular edema

Brief summary: Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation, extension and increased permeability of the vessels. The aim of our study was to examine the short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone on visual acuity and central retinal thickness in patients with clinically significant diabetic macular edema (CSME).


Eligibility criteria: Inclusion Criteria:

* clinical significant macular edema

Exclusion Criteria:

* retinal thickness \< 250 µm

Primary outcomes:
measure: Central retinal thickness
timeFrame: 4, 8, 12, 24, 72, and 168 hours
Secondary outcomes:
measure: BCVA
timeFrame: 4, 8, 12, 24, 72, and 168 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Klinik und Poliklinik für Augenheilkunde
Study officials:
affiliation: University of Bern
name: Ute Wolf-Schnurrbusch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Sebastian Wolf, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02863640: Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Macular Degeneration, Senile
Keywords: Senile macular degeneration
Parkinson's disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-11
Enrollment: 13
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of patients followed at Rothschild's Ophthalmologic Foundation for Parkinson's disease.

The study is proposed to patients aged of 70 years old and more and with a cumulative dose of L-DOPA above the 59 th percentile of the population or with with a cumulative dose of L-DOPA below the 41th percentile of the population

Brief summary: Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to validate the hypothesis stating that he L-DOPA would play a protective role against age related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Patients aged of 70 years old and more
* Parkinson's disease

Exclusion Criteria:

* Opposition to participate in this trial
* Patient under a measure of legal protection
* Absence of affiliation to social security or universal health coverage (CMU)

Primary outcomes:
measure: Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging
timeFrame: Diagnosis of ARMD made during a single consultation lasting about an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Martine MAUGET FAYSSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03722940: Role of Magnesium in Pediatric Cochlear Implant
Official title: Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Bahteem Specialized Hospital
First posted: 2018-10-29
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery. Also its effects on the intraoperative evoked stapedial reflex thresholds (ESRT) and the intraoperative anesthetic requirements were evaluated.

Detailed description: Sixty-six ASA I and II children (1-6 years) undergoing cochlear implantation under general anesthesia were enrolled in this double blind, randomized study. Children were randomly allocated into two equal groups. Children in Group M (magnesium sulphate group) received an iv bolus dose of magnesium sulfate 40 mg Kg-1 over 5 minutes before induction of anesthesia followed by 15mg Kg-1 h-1 infusion until the start of skin closure. Children in Group C (Control group) received equivalent volumes of isotonic saline solution over the same period instead of magnesium sulphate. Haemodynamic variables, quality of surgical field, ESRT and the intraoperative anesthetic requirements were recorded

Eligibility criteria: Inclusion Criteria:

* ASA I and II children

Exclusion Criteria:

* uncontrolled hypertension,
* diabetes mellitus,
* liver disease,
* kidney disease,
* heart disease,
* allergy to magnesium sulphate,

Primary outcomes:
measure: Quality of surgical field
timeFrame: at the end of the surgey
Secondary outcomes:
measure: The operative time
timeFrame: Intraoperative
measure: The anesthesia time.
timeFrame: Intraoperative
measure: ESRT responses
timeFrame: After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),
measure: Heart rate
timeFrame: baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.
measure: Mean arterial blood pressure
timeFrame: Intraoperative
measure: Anesthetic consumption
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03767140: Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD
Official title: Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Instituto de Ciências Biomédicas Abel Salazar
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture.

The method used to randomized was flipping a coin, when got heads they went to verum group and when got tails they went to sham group.
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world and it´s expected to become the 3rd cause of death in 2020 and the majority cause of morbidity. Besides that, in Portugal COPD patients become more dependents each day.

Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM) diagnose that will allowed to identify the acupoints.

The investigators are interested in to assess acupuncture efficacy on physical exercise tolerance in COPD patients.An experimental, controlled, randomized, double blind study was done. Patients were recruited according TCM diagnose to optimize potential therapeutic effects.


Eligibility criteria: Inclusion Criteria:

* COPD GOLD III,IV;
* able to walk;
* Informed consent signed;
* stable medication during last 3 days
* exacerbation during 3 months;
* Chinese diagnose opening principle;
* blood pressure "90"180 mmhg/ "100mmhg; respiratory rate "10"30 cpm

Exclusion Criteria:

* smoker;
* metastasis;
* hepatic,
* renal or cardiovascular disease;
* pulmonary hypertension;
* COPD symptoms exacerbation during the therapy;
* previous acupuncture treatments;
* unstable vital signs;
* pulmonary rehabilitation in the last 6 months;
* needle phobia.

Primary outcomes:
measure: six minute walk test (6MWT)
timeFrame: 6 minutes
Secondary outcomes:
measure: Oxygen peripheral saturation (SPO2)
timeFrame: 6 minutes
measure: Rating of perceived exertion (Borg Scale)
timeFrame: 6 minutes
measure: Blood pressure
timeFrame: 6 minutes
measure: heart rate
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Marco de Canaveses
country: Portugal
facility: Carla Manuela Loureiro Barros
state: Porto
Study officials:
affiliation: Abel Salazar Institute of Biomedical Sciences, University of Porto
name: Henry Greten, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06113640: Montelukast in Parkinson Disease
Official title: Clinical Study to Investigate the Possible Efficacy and Safety of Montleukast in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 60
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: Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease (AD). Clinical manifestations of PD can vary, but a formal diagnosis relies on the presence of bradykinesia with rigidity and/or rest tremor according to Movement Disorder Society (MDS) criteria for PD. Non-motor symptoms, such as hyposmia, constipation, depression, and rapid eye movement (REM) sleep behavior disorder, are common and can in many cases manifest before classical motor symptoms. In later years, more emphasis has been put on non-motor symptoms, especially in the early stages of PD and which is evident in the proposed prodromal PD criterion by MDS.

Detailed description: Leukotrienes are along with prostaglandins, lipoxins, and thromboxanes included in a group of long-chain fatty acids known as eicosanoids. They are known to play important parts in the inflammatory response such as leukocyte chemotaxis, vascular leakage, and astrocyte proliferation, and were first described by Bengt Samuelsson and colleagues in 1983. Leukotrienes (LT) are synthesized from free arachidonic acid (AA) by the enzyme 5-lipoxygenase (5-LOX) into LTA4, which is then further metabolized into LTB4, C4, D4, and E4. LTC4, D4, and E4 are grouped by their molecule structure to form the cysteinyl leukotrienes and they mainly activate two receptors, CysLT1 and CysLT2. CysLT1 is a Gq/11 family G-protein-coupled receptor with signaling through phospholipase C and Ca2+ mobilization

Eligibility criteria: Inclusion Criteria:

- Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

- Secondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications

Primary outcomes:
measure: Change in unified parkison disease rating scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References:
Clinical trial NCT01488240: The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Official title: The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Scar
Keywords: burn
scar
laser
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects (good or bad) of pulsed dye laser treatment in burn scar height, texture, redness and pliability in acute burn injury.

Detailed description: While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our research group is proposing the commencement of two randomized controlled trial pilot studies assessing the effects of pulsed dye laser (PDL) on burn scars. The objectives of this project will be to determine the effectiveness of pulsed dye laser therapy on burn scar vascularity, pliability, height and texture. It has been hypothesized that the PDL works on acute injury to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. Therefore the investigators are proposing to study both acute injury and late burn scars. This project will compare the effects of each laser type, and will either help support or refute the assertion that laser therapy can be used to improve burn scars.

Objectives:

To determine the benefit of pulsed dye laser treatment in improving burn scar height, texture, vascularity and pliability in acute burn injury.

Eligibility criteria: Inclusion Criteria:

* burn scar
* living in Winnipeg
* scar age one to 6 months
* Fitzpatrick I-III skin type

Exclusion Criteria:

* open wound
* active infection
* previous scar treatment with steroid injection or interferon
* established disposition towards keloid scarring

Primary outcomes:
measure: Scar Characteristics
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: S Logsetty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782440: The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy
Official title: The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 20
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effect of a telerehabilitation approach to patients with Duchenne Muscular Dystrophy and evaluate patients' motor function, parents' anxiety and depression levels before and after the intervention


Eligibility criteria: Inclusion Criteria:

* Patients with Duchenne muscular dystrophy

Exclusion Criteria:

* Patients without the ability of independent ambulation

Primary outcomes:
measure: Quick motor function test
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01939340: Prevalence of Cachexia in Patients Undergoing Chemotherapy
Official title: Prevalence and Impact of Cachexia in Cancer Patients Undergoing Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Cachexia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected in primary care clinics.

Brief summary: Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing chemotherapy. The purpose of this study is to assess prevalence of cachexia and low nutritional intake and the impact on quality of life, fatigue and mortality in patients undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and chemotherapy, respectively.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing chemotherapy at least in the second cycle.
* Patients who have signed a written Informed Consent.

Exclusion Criteria:

* Patients with implanted pacemaker or defibrillator.

Primary outcomes:
measure: Nutritional intake
timeFrame: 1 day
Secondary outcomes:
measure: Cachexia
timeFrame: 1 day
measure: Quality of life and fatigue
timeFrame: 1 day
measure: Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dept. of Gastroenterology, Infectiology and Rheumatology (including workspace nutrition medicine), Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jörg-Dieter Schulzke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: