louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06812416: Effectiveness of Qualia NAD+ Supplementation on NAD Levels
Official title: Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels: a Randomized Double-Blind Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracellular NAD+ Levels
Keywords: NAD
Lead sponsor: Qualia Life Sciences
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 92
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 current study is designed as a randomized double-blind placebo-controlled parallel trial. It aims to investigate the efficacy of Qualia NAD+ on intracellular NAD levels in blood samples (primary outcomes) and health-related quality of life (secondary outcomes) in an adult population experiencing moderate to severe joint pain between ages of 40 and 65 years.


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).

Willing 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 NHC 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: Intracellular NAD+ Levels
timeFrame: Baseline and day 28
Secondary outcomes:
measure: Aging Male/Female Symptom scale
timeFrame: Baseline, day 14, and day 28
measure: RAND SF-36
timeFrame: Baseline, day 14, and day 28
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Remote Study
state: California
Study officials:
References:
Clinical trial NCT04738916: Vibration Training in Healthy Individuals
Official title: The Impact of Low-intensity Whole-body Vibration Training on Extensor Muscles Strength, and Mechanical Properties of Lower Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vibration; Exposure
Muscle Strength
Lower Limb
Keywords: muscle mechanical properties
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Bitlis Eren University
First posted: 2021-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.

Detailed description: The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.

Eligibility criteria: Inclusion Criteria:

* Volunteering
* Weight less than 120 kg

Exclusion Criteria:

* The presence of a history of trauma in the lower extremity in the last six months
* Limitation of movement in the lower extremity
* A history of cardiovascular, neurological, orthopedic disease

Primary outcomes:
measure: Muscle mechanical properties
timeFrame: at 6-week
Secondary outcomes:
measure: Muscle Strength
timeFrame: at 6-week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University Sports Laboratory
Study officials:
References:
Clinical trial NCT02647216: Mindfulness for Breast Cancer
Official title: Mindfulness Training to Improve Well-being in Post-Treatment Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Breast Cancer
Keywords: Mindfulness Based Cognitive Therapy (MBCT)
anxiety
depression
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 30
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 primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Investigators will examine whether MBCT-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2). Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom MBCT is most effective (Aim 3).


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Able to speak and read English
* Diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years

Exclusion Criteria:

* Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program;
* Major psychiatric disorder (e.g., psychosis, personality disorder)
* Current suicidal ideation or suicide attempt within past 3 months
* Past participation in an MBCT group

Primary outcomes:
measure: Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
timeFrame: 3 Months
measure: Change in level of Depression using the Beck Depression Inventory-II (BDI-II)
timeFrame: 3 Months
Secondary outcomes:
measure: Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)
timeFrame: 3 Months
measure: Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):
timeFrame: 3 Months
measure: Change in Physical Health Symptoms
timeFrame: 3 Months
measure: Change in Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI):
timeFrame: 3 Months
measure: Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: 3 Months
measure: Change in Rumination using the Ruminative Responses Scale (RSS):
timeFrame: 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Tanya Spruill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00754416: S.E.S Shoulder Arthroplasty Data Collection
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Keywords: Shoulder Replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet France SARL
First posted: 2008-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive series of patients received S.E.S prostheses

Brief summary: This observational study intends to collect efficacy and safety data on S.E.S shoulder system

Detailed description: The S.E.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Eligibility criteria: Inclusion Criteria:

* A pre-operative level of pain and function the same as for conventional joint replacement
* A likelihood of obtaining relief of pain and improved function
* Full skeletal maturity
* Ability to follow instructions
* Good general health for age
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Glenohumeral joint infection, osteomyelitis
* Neuro-muscular complications
* Inability to co-operate with and complete the study

Primary outcomes:
measure: Constance and oxford Scores
timeFrame: 6m, 1yr, 2yr, 3yr, 4yr and 5 yr
Secondary outcomes:
measure: Complication
timeFrame: Any time
measure: Patient Satisfaction
timeFrame: 6m,1yr,2yr,3yr,4yr and 5yr
Other outcomes:
Locations:
city: Schilde
country: Belgium
facility: De Dreef Van Zonnebos 13
city: Annecy
country: France
facility: Clinique Générale
city: Chambery
country: France
facility: Clinique St Joseph
city: Dax
country: France
facility: Centre Hospitalier Général
city: Maxeville
country: France
facility: Clinique Chirurgicale Orthopédique A.D.R.
city: Montpellier
country: France
facility: Clinique St Jean
city: Paris
country: France
facility: IRCOS
city: Pessac
country: France
facility: Clinique St Martin
city: Saint Herblain
country: France
facility: Polyclinique de l'Atlantique
city: St Etienne
country: France
facility: Clinique Mutualiste
city: St Laurent du Var
country: France
facility: Institut A. Tzanck
city: St Laurent du Var
country: France
facility: Institut Calot
Study officials:
affiliation: Centre hospitalier Bellevue
name: Laurent BEGUIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128216: Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia
Official title: Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Istituti Ospitalieri di Cremona
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 48
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: Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years;
* ASA score I - II - III;
* patients undergoing elective inguinal hernia repair;
* signed informed consent;

Exclusion Criteria:

* chronic therapy with opioids/ antidepressants;
* urgent/emergent surgery;
* postoperative transfer to the intensive care unit;
* known allergy to any drug medication;
* local skin infection;
* epilepsy;
* alcohol or drug abuse;

Primary outcomes:
measure: Hospital discharge
timeFrame: First 6 post-operative hours
Secondary outcomes:
measure: Intraoperative Pain Control
timeFrame: Intraoperative period
measure: Post-operative Pain
timeFrame: Post-operative period for 6 hours, every 30 min
measure: Side effects
timeFrame: intra-operative and post-operative period (6 hours)
measure: Chronic Pain
timeFrame: at 1 week and 3 months in post-operative period
Other outcomes:
Locations:
city: Creom
country: Italy
facility: ASST Cremona
state: Cremona
Study officials:
References:
Clinical trial NCT01572116: Effect of Sufentanil on the Rate of Anesthesia
Official title: Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irreversible Pulpitis
Keywords: sufentanil
irreversible pulpitis
intra ligament injection
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.


Eligibility criteria: Inclusion Criteria:

* patients in the age group of 18-65 years old
* healthy (ASA I, II)
* patients with first or second mandibular molars who need endodontic treatment
* vital tooth without a history of past endodontic treatment
* patients with clinical evidence of irreversible Pulpits with moderate to severe pain
* patients who signed consent form
* patients numbness at the lateral edge of the lips after inferior alveolar injection (INA) and those with positive respond to maximum output of pulp tester after INA.

Exclusion Criteria:

* pregnant or nursing
* necrotic tooth
* patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
* Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
* patient with infectious diseases
* patient with moderate to sever periodontal disease
* those without numbness at the lateral edge of the lips after inferior alveolar injection (INA), and those do not respond to maximum output of pulp tester after INA.

Primary outcomes:
measure: depth of anesthesia
timeFrame: in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment
Secondary outcomes:
measure: intensity of the pain
timeFrame: before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dental School of Azad University
Study officials:
affiliation: Dental School of Azad University
name: Mandana Abedi Tari, Dentist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817816: Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.

This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.


Eligibility criteria: Inclusion Criteria:

* first-ever stroke, with spasticity within 3-months (MAS=2\~3)
* independent walking 10 meters (with assistive devices)

Exclusion Criteria:

* recurrent stroke, cognition impaired
* lower limb fracture
* received anti-spasticity injection in the past

Primary outcomes:
measure: Change in the muscle tone in upper and lower extremity
timeFrame: 4 weeks after injection
Secondary outcomes:
measure: Change in the gait pattern as walking
timeFrame: 4 weeks after intervention
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
Study officials:
References:
Clinical trial NCT03574116: Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?
Official title: Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Keywords: Sarcopenia
jejunostomy
oesogastric adenocarcinoma
scanography
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with Stage IB Gastric Cancer and having benefited from the placement or not of a feeding jejunostomy and a control CT performed at the HUS, after the end of the courses of chemotherapy and / or before the surger

Brief summary: The study of sarcopenia is a subject that is the subject of numerous research and publications, particularly because of its link with a poor prognosis for many cancers.

In an article published by the digestive surgery team, the role of feeding jejunostomy has been demonstrated: it allowed more patients to reach the 2nd stage of surgery and a better tolerance of chemotherapy.

Investigators wanted to study retrospectively the impact of feeding jejunostomy on radiological sarcopenia. Is the positive effect of jejunostomy in gastric cancers associated with a decrease in sarcopenia?


Eligibility criteria: Criteria for inclusion:

* Age 18-80 years
* Sex: H or F
* Subject giving their consent for their participation
* Gastric cancers
* stage\> IB
* whether or not a feeding jejunostomy
* CT scan performed at the HUS, after the end of the courses of chemotherapy and / or before the surgery.

Exclusion criteria:

* antecedent level L3 surgery,
* psoas hematoma
* No CT performed at HUS at the end of chemotherapy and / or before surgery
* Impossibility of giving the subject informed information
* Subject under the protection of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Evaluate muscle status by CT evaluation of sarcopenia in patients
timeFrame: 24 hour after the realization of the MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
References:
Clinical trial NCT04506216: Eating Disorders in Type 1 Insulin-dependent Diabetes Patients
Official title: Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Eating Disorders
Keywords: diaboulimia
insulin pump treatment
DT1
Lead sponsor: Icadom
Sponsor class: INDUSTRY
Collaborators: name: AGIR à Dom
First posted: 2020-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cohort prospective monocentric
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

Detailed description: The risk of developing an eating disorder is increased in type 1 diabetes patients and associated with a poor prognosis in terms of glycemic control, metabolic complications, degenerative complications, and mortality.

Therefore the terminology diaboulimia has emerged to characterize an eating disorder specific to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of losing or controlling weight and that can contribute to a deterioration of the body composition.

The purpose of this study is to determine the prevalence of eating disorders in an adult cohort with type 1 insulin-dependent diabetes.

Eligibility criteria: Inclusion Criteria:

* Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump
* Patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (Agir à Dom group).
* Beneficiary of social security coverage.

Exclusion Criteria:

* Patient with type 2 diabetes or MODY diabetes
* Patient wearing a pacemaker
* Breastfeeding or pregnant woman
* Deprived of liberty by judicial or administrative decision
* Legal guardianship

Primary outcomes:
measure: Eating disorders in men and women
timeFrame: at inclusion
Secondary outcomes:
measure: Eating disorders in cohort
timeFrame: at inclusion
measure: Auto declared insulin under dosage
timeFrame: at inclusion
measure: Overall glycemia
timeFrame: at inclusion
measure: Basal/Bolus insulin ratio
timeFrame: at inclusion
measure: Boluses performed per day
timeFrame: at inclusion
measure: Body composition
timeFrame: at inclusion
measure: Continuous glycemic control
timeFrame: at inclusion
measure: Glycemic variability
timeFrame: at inclusion
measure: Adherence to the sensor
timeFrame: at inclusion
measure: Blood glucose monitoring
timeFrame: at inclusion
Other outcomes:
Locations:
city: Meylan
country: France
facility: AGIR à dom.
Study officials:
affiliation: CHU Grenoble Alpes
name: Cécile Bétry, PhD
role: PRINCIPAL_INVESTIGATOR
References: