louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05296642: Exercise Induced Hypoalgesia Diabetes
Official title: Exploring the Use of Blood Flow Restriction in Addition to Aerobic Exercise as a Modality to Produce Exercise Induced Hypoalgesia in Participants With Painful Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

1. Subjects between the ages of 18 - 65.
2. Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose \> 126 mg/dL, or an oral glucose tolerance test \> 200 mg/dL.
3. Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
4. Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
5. Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.

Exclusion Criteria:

1. Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
2. Subjects with current or history of central nervous system disorders.
3. Subjects with resting hypertension (HTN) \>/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
4. Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
5. Subjects with Reynaud's disease or cold urticaria.
6. All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.

Primary outcomes:
measure: Change in Pain Pressure Threshold (PPT)
timeFrame: Baseline, 20 minutes
Secondary outcomes:
measure: Change in Heat Pain Threshold (HPT)
timeFrame: Baseline, 20 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Marlon L. Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06809842: Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries
Official title: Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Vastus Lateralis Nerve Block
Lateral Femoral Cutaneous Nerve Block
Knee Surgeries
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 80
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: This study aims to compare the analgesic efficacy and functional outcomes of blocking the nerve to the vastus lateralis (NVL) muscle versus the lateral femoral cutaneous nerve (LFCN).

Detailed description: Knee surgeries are associated with significant postoperative pain, which can impede early mobilization and prolong recovery. Recent advancements in ultrasound-guided regional anesthesia have enabled more targeted nerve blocks, such as the blockade of the nerve to the vastus lateralis (NVL) and the lateral femoral cutaneous nerve (LFCN)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status from I to III.
* Underwent knee surgeries under spinal anesthesia.

Exclusion Criteria:

* Pregnancy.
* Coagulopathy.
* Neuromuscular disorders.
* Hematological disorders.
* Mental disorders.
* History of multiple traumas or anesthesia drug allergies.
* Local skin infection at the block site.
* Body mass index (BMI) greater than 40.
* Opioid analgesics or abusing opioids.

Primary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to first request for analgesia
timeFrame: 24 hours postoperatively
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
measure: Block performance time
timeFrame: Intraoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Length of hospital stay
timeFrame: Till the discharge from hospital (Up to one week).
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT01453842: Diet Oil Induced Stimulation of GLP-1
Official title: Diet Oil Induced Stimulation of GLP-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Glucagon-like peptide-1
Glucose-dependant insulinotropic polypeptide
Glucagon
Peptide PYY
2-oleyl glycerol
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone.

Detailed description: Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone. The aim of the study is to elucidate the effect of 2-OG, 'diet oil' on GLP-1 secretion in patients with type 2 diabetes and to explain the mechanism behind the known stimulation of GLP-1 release by dietary fat.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus according to the WHO criteria
* caucasians
* age above 18 years
* BMI 20-30

Exclusion Criteria:

* kidney disease
* liver disease
* retinopathy
* anaemia
* use of insulin
* use of GLP-1 analogues
* use of DPP-4 inhibitors

Primary outcomes:
measure: Plasma GLP-1
timeFrame: 3 hours
Secondary outcomes:
measure: Plasma insulin
timeFrame: 3 hours
measure: Plasma glucose
timeFrame: 3 hours
measure: Plasma GIP
timeFrame: 3 hours
measure: Plasma glucagon
timeFrame: 3 hours
measure: Plasma PYY
timeFrame: 3 hours
measure: Plasma paracetamol
timeFrame: 3 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Clinical Physiology
Study officials:
affiliation: University of openhagen
name: Katrine B Hansen, MD
role: STUDY_CHAIR
affiliation: University of Copenhagen
name: Jens J Holst, Professor
role: STUDY_CHAIR
affiliation: University of Copenhagen
name: Harald S Hansen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06818942: Nomogram for Predicting Difficult Laparoscopic Appendectomy
Official title: Nomogram for Predicting Difficult Laparoscopic Appendectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergencies
Keywords: Laparoscopic appendectomy
Surgical difficulty
Training program
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed acute appendicitis, were willing to and suitable to undergo laparoscopic appendectomy (LA). Patients were well informed about the surgical procedure and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.

Brief summary: No prior studies have stratified the difficulty of laparoscopic appendectomy (LA). The investigators aimed to investigate preoperative factors as indicators of difficult LAs based on the experience of surgical trainees and to develop a predictive model accordingly.

Detailed description: Acute appendicitis is the most common cause of surgical emergencies and laparoscopic appendectomy (LA) is usually attempted by surgical trainees. This study aim to explore the preoperative and intraoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in training programs.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute appendicitis
* Participants who underwent laparoscopic appendectomy

Exclusion Criteria:

* Participants refused or could not tolerate laparoscopic appendectomy
* Incomplete preoperative examination or missed information

Primary outcomes:
measure: Operative time
timeFrame: During surgery
measure: Number of participants with postoperative complications
timeFrame: through study completion, an average of 1 year
measure: Hospitalization
timeFrame: 1 day of discharge
measure: Degree of pain
timeFrame: approximately 4 hours after surgery and on postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06750042: Analysis of Motor Performance in Children with Duchene's Muscular Dystrophy
Official title: Analysis of Motor Performance in Children with Duchene's Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Duchene&#39;s Muscular Dystrophy
Keywords: Duchene's muscular Dystrophy
Pulmonary Functions
Pediatrics
motor performance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 ages ranging from 6 to 16 years, diagnosed with Duchene's muscular Dystrophy will participate in this study. They were selected from Pediatric rehabilitation center of Deraya university out-patient clinic in El-Minia district, Minia,

Brief summary: 25 boys, ages ranging from 6 to 16 years, diagnosed with Duchene's muscular Dystrophy (DMD) will participated in the study. They will be selected from the Pediatric Rehabilitation Center of Deraya University's outpatient clinic in El-Minia district, Minia-Egypt. The outcome will be assessed motor performance will be assed by Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2) : balance, running speed and agility, bilateral coordination and strength and by Blue Cherry; Geratherm Respiratory. It is used to measure vital capacity (VC), forced expired volume in one second (FEV1), FEV1/FVC, FEV1/VC, and peak expiratory flow (PEF) to provide objective information for monitoring lung health.


Eligibility criteria: Inclusion Criteria:

* the diagnosis is Duchene's muscular Dystrophy only not other types,
* ambulated with or without assistance,
* oriented and endurance enough to understand orders to perform ventilation on the Blue Cherry; Geratherm Respiratory device.

Exclusion Criteria:

* any cognitive or neurological condition (other than Duchene's muscular Dystrophy),
* history of previous surgical operations that can affect pulmonary functions, and structural scoliosis

Primary outcomes:
measure: motor performance
timeFrame: measured for one time
measure: respiratory function
timeFrame: measured for only one time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04120142: Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients
Official title: Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in Chronic Obstructive (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
IMT
6MWT
Dyspoea
SGRQ
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 34
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress.

The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. The investigators aimed to demonstrate that, in patients with obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement of dyspnoea and exercise tolerance.

Detailed description: The purpose of this study is to evaluate the effect of the inspiratory muscle training (with incremental load every two weeks in two months) performed during pulmonary rehabilitation on dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory questionnaire (SGRQ) in COPD patients.

Eligibility criteria: Inclusion Criteria:

* Were COPD diagnosed by pulmonary function testing
* Clinically stable
* Abscence of other obstructive diseases
* Signed written consert

Exclusion Criteria:

* Were previous pneumonectomy or lobectomy in the past 6 months
* spontaneous risk of pneumothorax or rib fracture
* Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
* The absence of written informed consent.

Primary outcomes:
measure: Dyspnoea
timeFrame: Baseline, After 2 months
measure: Inspiratory muscle strength
timeFrame: Baseline, After 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Bilel TOUNSI
Study officials:
References:
citation: Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
citation: Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
citation: Ambrosino N. Inspiratory muscle training in stable COPD patients: enough is enough? Eur Respir J. 2018 Jan 25;51(1):1702285. doi: 10.1183/13993003.02285-2017. Print 2018 Jan. No abstract available.
Clinical trial NCT04040842: International Low Anterior Resection Score Evaluation
Official title: Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Anterior Resection Syndrome
Keywords: Rectal cancer
low anterior resection
low anterior resection syndrome
Lead sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
Collaborators: name: King's College London
name: National Cancer Institute (NCI)
First posted: 2019-08-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.

Brief summary: * Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
* Primary outcome measure: LARS score before surgery and 1 year after the surgery.
* Primary comparison: Between average LARS score before and after curative surgery and also comparing these with publish LARS score on normal population.

Detailed description: All patients undergoing treatment for rectal rectal will be included in the study. Before any treatment all the included patients will be asked to fill the LARS score (5 question questionnaire with differently weighted answers for assessing the low anterior resection score). One year after the low anterior resection (without the stoma) or following the stoma take down patients will be reassessed. The LARS score will be filled one again. Patient characteristics, age, cancer stage, level of anastomosis will be assessed aswel.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing rectal cancer surgery on curative intent.
* Elective surgery patients.
* Laparoscopic, laparoscopic-converted, robotic, TaTME (transanal total mesorectal excision) and open cases will be included.
* Patients aged 18 years and over should be included.

Exclusion Criteria:

* Patients undergoing a procedure purely for diagnosis or staging should be excluded.
* Patients with palliative treatment.
* Patients with recurrence should be excluded.
* Patients with dementia
* Patients who do not complete their treatment within 12 months of primary surgery e.g. including reversal of stoma, chemotherapy etc

Primary outcomes:
measure: LARS score change comparing before surgery and 1 year after the surgery.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
affiliation: King's College
name: Joseph Nunoo-Mensah, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01513642: Respiratory Physiotherapy After Cardiac Surgery
Official title: Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Disturbance Following Cardiac Surgery
Keywords: physiotherapy
cardiac surgery
breath Stacking
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period.

Objective: To compare inspiratory volume and electromyographic activity of respiratory muscles during breath stacking technique and incentive spirometry in patients undergoing cardiac surgery.

Detailed description: The purpose of the present study are:

1. to evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.
2. to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques.

Eligibility criteria: Inclusion Criteria:

* patients submitted to myocardial revascularization surgery

Exclusion Criteria:

* cognitive impairment or incoordination to perform IS
* face mask intolerance during BS
* level of consciousness incompatible to perform IS
* hemodynamic complications \[arrhythmia, intraoperative myocardial infarction, major blood loss (defined as a loss of ≥20% of total blood volume), mean arterial pressure \<70 mmHg and reduce cardiac output requiring the use of an intra-aortic balloon pump or vasoactive drugs)
* intubation for more than 72 h after admission to the Intensive Care Unit
* the need for reintubation.

Primary outcomes:
measure: Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients
timeFrame: Within 2 days after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal Bonsucesso Hospital
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Cristina Dias, PhD
role: STUDY_DIRECTOR
References: