louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05627843: Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Official title: Effects of Curcumin on Inflammation and Oxidative Stress in Paediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pediatric Patients Having Renal Failure and on Regular Hemodialysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The study will be a randomised, double blinded, placebo controlled design.
* It will include 2 groups : trial group and placebo group
* Patients in both groups are children on regular hemodialysis
* The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo capsule for 3 months
* All patients will be evaluated clinically, and laboratory at baseline, at 3 months after end of supplementation.


Eligibility criteria: Inclusion Criteria:

* Male or female pediatric patients with weight of at least 30 kilograms.
* Undergoing regular hemodialysis for at least 6 months.

Exclusion Criteria:

* Bleeding disorders.
* Chronic liver disease.
* Diabetes mellitus.
* Autoimmune diseases.
* Receiving drugs that are contraindicated, or have major interactions with curcumin, and can't be discontinued or replaced.
* Receiving corticosteroids, or immune-suppressants.
* Patients taking any antioxidant supplements including vitamin E, ascorbic acid, omega -3 fatty acid, or L-carnitine within 3 months prior to enrollment in our study.

Primary outcomes:
measure: inflammatory marker
timeFrame: 3 months
Secondary outcomes:
measure: Oxidative stress markers
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Iman Mohamed Naguib Alagamy
Study officials:
References:
Clinical trial NCT03186443: Pregabalin Treatment and Prevention Post-herpetic Neuralgia
Official title: Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Herpetic Neuralgia
Keywords: herpetic neuralgia
post-herpetic neuralgia
pregabalin
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Nanjing PLA General Hospital
name: Air Force Military Medical University, China
First posted: 2017-06-14
Enrollment: 342
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group is to oral gabapentin 0.4 tid； experiment group is to oral pregabalin 300mg q 12h
Primary purpose: PREVENTION

Brief summary: Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.

Detailed description: Pregabalin has been recommended as the first-line drug for post-herpetic neuralgia (PHN) therapy currently due to its efficacy and safety. However,there was no valuable report at present on the clinical efficacy of pregabalin for acute and subacute herpetic neuralgia (SHN), expect for a smaller study which included 29 outpatients who had acute zoster pain for a period of 7-1 4 days. And it is not clear whether early application of pregabalin can reduce the incidence of PHN.

Therefore, this study was rational designed to evaluate the efficacy and safety of pregabalin in the treatment of herpetic neuralgia，and follow-up to the 8 months, evaluation whether impacting the accidence of PHN.

It is the first time in the international that treating acute herpetic neuralgia (AHN) and SHN with pregabalin as a large sample size clinical trial. The results of this study will be great significance for guiding the clinical medication.

Eligibility criteria: Inclusion Criteria:

1. Pain occurs within 90 days of rash onset
2. Numerical rating scale (NRS) greater than 50 mm

Exclusion Criteria:

1. Patient with nervous system disorders which impair completing the pain diaries
2. Patient with history of illicit drug or alcohol abuse within the last 2 years

Primary outcomes:
measure: the changes of numerical rating scale (NRS)
timeFrame: from the date of start to 8 month
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: baseline and 8th month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: National drug clinical trial fundation
state: Guangdong
Study officials:
affiliation: The Second Affiliated Hospital, Guangzhou Medical University
name: Li Wan, Ph.D.,M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03274843: Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation
Official title: Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 9
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: A non-randomized, monocentric, pilot study comparing the level of independence for each individual with significant resumption of activity in adult patients with stroke


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Primary stroke or recurrence on stroke having no previous sequelae
* Stroke older than 3 weeks
* Ability to understand treatment and sufficient motivation
* Problem Activity Indicated in CMOP (Canadian Measure of Occupational Performance)
* Barthel Index \> 60
* Patient who received oral and written information about the protocol and who did not show opposition to participate in the study

Exclusion Criteria:

* Dermatological pathology with wounds on the unhealed upper limbs
* Patient in contact and droplet isolation
* A psychiatric history requiring hospitalization in specialized settings for more than 2 months
* Any condition that may limit participation or interfere with analysis of results

Primary outcomes:
measure: Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3
timeFrame: Day 0, Week 3
Secondary outcomes:
measure: Evaluation of the patient's quality of life
timeFrame: Day 0, Week 3
measure: Evaluation of the patient's self-esteem
timeFrame: Day 0, Week 3
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT02540343: Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"
Official title: Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"-Translation and Validation of a Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Keywords: Translation
Validation
Orebro-G
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2015-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute and chronic neck pain patients Healthy volunteers

Brief summary: The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire into German.

Detailed description: Participants will fill out all questionnaires at baseline and again after three days. If the questionnaires have not been returned by day four the participant receives a reminder telephone call. Patients that do not return the questionnaires by day seven are dismissed. The baseline measurement is done at the practice the second measurement will be done by the patient at home. To send the questionnaire back the participant receives a prepaid envelope.

Eligibility criteria: Inclusion Criteria:

Acute:

* Recently diagnosed with neck pain (\< 30 days)
* Must be able to speak, read and write German

Chronic:

* Neck problems for a longer period of time (\> 90 days)
* Must be able to speak, read and write German

Healthy volunteers:

* No neck pain
* Must be able to speak, read and write German

Exclusion Criteria:

* Does not speak, read and write German
* "Red Flags" e.g. acute trauma
* Medical knowledge

Primary outcomes:
measure: Pain, on the German Version of the Orebro Musculoskeletal Pain Screening Questionnaire
timeFrame: For every patient the average study length is one week.
Secondary outcomes:
measure: Disability, on the Neck Disability Index (NDI-G)
timeFrame: For every patient the average study length is one week.
measure: Pain, on Visual Analogue Pain Rating Scale (VAS)
timeFrame: For every patient the average study length is one week.
Other outcomes:
measure: Voice Handicap, on the Voice Handicap Index (VHI-9)
timeFrame: For every patient the average study length is one week.
measure: Movement restriction, on self-reported measurements of the Range of motion of the cervical spine
timeFrame: For every patient the average study length is one week.
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langenfeld A, Bastiaenen C, Brunner F, Swanenburg J. Validation of the Orebro musculoskeletal pain screening questionnaire in patients with chronic neck pain. BMC Res Notes. 2018 Mar 2;11(1):161. doi: 10.1186/s13104-018-3269-x.
Clinical trial NCT03959943: Nerve Coaptation in LTP Flap Breast Reconstruction
Official title: Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast reconstruction
LTP flap
Sensory recovery
Breast sensation
Nerve coaptation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this prospective study, patients who underwent an innervated or non-innervated LTP flap breast reconstruction between December 2014 and August 2018 at Maastricht University Medical Center in the Netherlands were included if they returned for follow-up between February 2016 and April 2019.

Brief summary: The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.


Eligibility criteria: Inclusion Criteria:

* Female patients 18 years or older
* Unilateral or bilateral LTP flap breast reconstruction
* Returned for follow-up between February 2016 and April 2019
* Informed consent

Exclusion Criteria:

* In case of a total flap loss
* Flaps that required a take-back
* Follow-up less than six months postoperatively

Primary outcomes:
measure: The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments
timeFrame: Through study completion up to 27 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: René van der Hulst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00530543: Effects of Gait Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Robot
Gait
Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-09-17
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the effects of robot-assisted gait training on active walking in the patients with stroke.


Eligibility criteria: Inclusion Criteria:

* 1st-ever-stroke
* hemiplegic patient after stroke
* who can stand independently, but cannot walk more than 10 meters independently
* whose muscle powers of hip and knee are more than poor on manual muscle test

Exclusion Criteria:

* previous gait difficulty before stroke onset
* arthralgia on lower extremity
* uncontrolled hypertension or hypotension
* severe medical illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyung Hoon Jeong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03495843: The Influence Body Position and Axial Load on Spinal Stiffness
Official title: Assessing Normative Data, Reliability and the Influence of Body Position and Axial Load on Spinal Stiffness by Electromechanical Measurements in Young Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy adults

Brief summary: The objective of this study is to examine the influence of body position and additional axial load on spinal stiffness in young healthy adults.

Detailed description: Spinal stiffness plays an important role in the assessment of the spine in the clinical daily routine. It is often performed as a manual PA-pressure test in the prone position. The spinal stiffness is the result of the resistance from the active, passive and neurological subsystems, like muscles (active), ligaments, joint capsule and the skin (passive). Further research had shown, that the spinal stiffness depends also from other factors. It is increased by axial compression. A better understanding of spinal stiffness leads to novel insights into spinal stabilization mechanisms.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* Acute backpain (thoracal or lumbar)
* History of significant backpain (thoracal or lumbar) or radiating pain down the leg
* Contraindications to PA mobilisation/manipulation
* Spinal fractures
* Spinal tumors
* Surgical intervention in the thoracic and lumbar spine
* Local infections of the spine or the surrounding tissue

Primary outcomes:
measure: Spinal stiffness
timeFrame: Day one of the study
Secondary outcomes:
measure: Pain during measuring spinal stiffness
timeFrame: Day one of the study
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257243: Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
Official title: Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cough
Keywords: cough
symptoms
cold
flu
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

Detailed description: STUDY DESIGN

* Open-label, superiority, prospective, parallel group, intent to treat trial
* Experiment duration: 7 days
* 3 visits (days 1, 2 and 7)
* Reduction cough symptoms
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
3. Cough score superior to 3.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation.
3. Fever above 38º C.
4. Patients with bacterial infections of the upper respiratory tract.
5. Any pathology or past medical condition that can interfere with this protocol.

Primary outcomes:
measure: Reduction/improvement of cough symptoms
timeFrame: DAY 7
Secondary outcomes:
measure: Tolerance
timeFrame: DAY 7
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro
Study officials:
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05361343: First Line Prevent Age Study
Official title: First Line Prevent Age Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Healthy Lifestyle
Healthy Diet
Lead sponsor: Prevent Age Resort "Pervaya Liniya"
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To prove the effectiveness of complex wellness programs in terms of maintaining active longevity, including motivational counseling, high-intensity training, intermittent fasting, hypoxic training, as well as practices for achieving healthy sleep and mental well-being.

Clinical-instrumental, single-centre, prospective, open-label, non-randomized, sequential enrollment study with blinded endpoint analysis


Eligibility criteria: Inclusion Criteria:

* Men and women over 18;
* No significant (affecting the functional state) "active" diseases: acute diseases and exacerbations of chronic diseases;
* Interest in active longevity and willingness to participate in research.
* Signed informed consent.

Exclusion Criteria:

* Age up to 18 years;
* Severe or moderate comorbidities;
* Rheumatological (systemic / autoimmune) diseases of any severity;
* Intestinal infections (within 3 months);
* SARS / pneumonia, other diseases accompanied by systemic inflammation during the last 2 months;
* Chronic inflammatory bowel disease;
* Major surgery within the last 3 months
* Intoxication (alcohol, drugs, other toxins);
* Oncological disease (except for basalioma) out of remission;
* Persons with mental illness;
* Diabetes;
* Syndrome of obstructive sleep apnea of moderate and severe severity;
* Low adherence to lifestyle interventions, including physical activity of less than 150 minutes of aerobic activity per week (at least two days per week) or 75 minutes of vigorous exercise (at least 3 days per week).

Primary outcomes:
measure: improved endothelial function
timeFrame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
measure: improved quality of night sleep
timeFrame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
measure: Reducing the degree of anxiety
timeFrame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Secondary outcomes:
measure: increased self-esteem
timeFrame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
measure: improved quality of night sleep
timeFrame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Line Health Care Resort
Study officials:
References:
Clinical trial NCT00745043: Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
Official title: Do Beta-blockers Affect the Use of Beta-agonist Inhalers in COPD?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Betablockers
bronchodilator
exercise capacity
methacholine challenge
Lead sponsor: Waikato Hospital
Sponsor class: OTHER
Collaborators: name: Waikato Hospital Research Fund
First posted: 2008-09-01
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD
* \> 40 years of age
* \> 15 pack year smoking history

Exclusion Criteria:

* Contra-indication to beta-blocker use
* Severe COPD FEV1 \< 30% or 1 L
* Not responsive the methacholine

Primary outcomes:
measure: Bronchodilator response to salbutamol after beta-blockers
timeFrame: 7-10 days
measure: Incremental Shuttle Walk Test Result after taking beta-blockers
timeFrame: 7-10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: New Zealand
facility: Department of Respiratory Medicine
state: Waikato
Study officials:
affiliation: Waikato Hospital Research Unit
name: Bob Hancox, MD FRACP
role: STUDY_DIRECTOR
References: