louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06495099: Effect of Core Stability Exercises and Russian Electrical Stimulation in Non-specific Low Back Pain
Official title: Effect of Core Stability Exercises and Russian Electrical Stimulation in Non-specific Low Back Pain (Randomized Control Trail)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brief Summary: Low back pain (LBP) is an important public health problem due to the increasing world population and aging. In chronic LBP, exercise therapy is among the first-line treatments. Core stabilization exercises (CSE), one of the motor control exercises, focus on the activation and control of the deep spinal muscles. Recently, some studies have shown that Russian electrical stimulation alone or combined with exercise can provide contraction in deep stabilizer muscles and significantly reduce pain in patients with LBP


Eligibility criteria: Inclusion Criteria:

* The duration of the disease is more than 3 months with pain scores greater than four in the VAS disability score of 19% or greater as evident from the modified oswestry disability.

Exclusion Criteria:

* Neurological or musculoskeletal diseases that affect lumbar spine (e.g: lumbar spondylosis, spondylolisthesis, and lumbar disc injuries)
* women during pregnancy and lactation.
* History of lumbar spine surgery.
* Signs of lumbar radiculopathy or myelopathy.
* Signs of serious pathology (e.g., malignancy, inflammatory disorders, infection

Primary outcomes:
measure: Pain scoring
timeFrame: 6 weeks
measure: Quality of life by using Oswestry Disability Index (OID)
timeFrame: 6 weeks
Secondary outcomes:
measure: Muscle thickness assessment
timeFrame: 6 weeks
measure: Stability and mobility of spine
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Deraya university
Study officials:
References:
Clinical trial NCT01672099: Effects of Dairy on Vitamin K-status
Official title: The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin K-status
Vascular Health
Keywords: vitamin K2
menaquinone-7
vascular health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health.

Detailed description: In earlier studies, cardiovascular disease and osteoporosis were found to be associated with K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new product will be investigated on vitamin K status and on general health markers.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy men and postmenopausal women between 45 and 65 years old
* Subjects of body weight and height according to BMI between 23 and 30 kg/m2
* Subjects of Caucasian race
* Subject has given written consent to take part in the study
* Low vitamin K-status

Exclusion Criteria:

* Subjects with hypertension
* Subjects with hypercholesterolemia
* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects with (a history) of diabetes mellitus
* Abuse of drugs and/or alcohol
* Subjects receiving corticosteroϊd treatment
* Subjects using oral anticoagulants and subjects with clotting disorders
* Subjects using blood pressure lowering medication
* Subjects using cholesterol-lowering medication
* Subjects using multivitamins or vitamin K supplements
* Subjects consuming high amounts of vitamin K-containing food products
* Subjects with cow's milk allergy and lactose intolerance

Primary outcomes:
measure: undercarboxylated and carboxylated matrix-gla protein
timeFrame: 12 weeks
Secondary outcomes:
measure: undercarboxylated and carboxylated osteocalcin
timeFrame: 12 weeks
Other outcomes:
measure: markers of vascular health and inflammation
timeFrame: 12 weeks
Locations:
city: Maastricht
country: Netherlands
facility: Vitak BV / Maastricht University Medical Center
Study officials:
affiliation: VitaK BV Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04351399: Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
Official title: Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Rheumatic Diseases
Rheumatoid Arthritis
Chronic Pain
Keywords: Psychological impact
COVID-19
Rheumatoid arthritis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patient will be interviewed par internet questionnaire (patient association / ANDAR)

Brief summary: Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration.

In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression.

During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients.

The present study is an "emergency" being realize before the end of the quarantine.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis Quarantine

Exclusion Criteria:

* Non adult patient RA patient without quarantine

Primary outcomes:
measure: Frequency of RA patients with emotional impact (feeling of isolation)
timeFrame: maximum 1 week from baseline on
Secondary outcomes:
measure: self-reported questionnaire for painful
timeFrame: maximum 1 week from baseline on
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: René-Marc FLIPO, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564199: Phase I Pharmacokinetic Study (SALBLOCK)
Official title: Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the extent to which the charcoal prevents the absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 18-60
* Normal weight at least 50 kg

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
* Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
* Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
* Known hypersensitivity to the active substance(s) or to the excipients of the drug.
* Pregnant or lactating females.

Primary outcomes:
measure: The pharmacokinetic parameter Area Under Curve (AUC) time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose.
timeFrame: 24 hours
Secondary outcomes:
measure: The pharmacokinetic variables Cmax and tmax time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: CRST (Clinical Research Services Turku)
Study officials:
affiliation: Clinical Research Services Turku Finland
name: Mika Scheinin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04363099: Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.
Official title: Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: ambulatory
outpatients
COVID 19
Oise, France
Lead sponsor: Maison de Sante Pluridisciplinaire de Creil
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 1000
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ambulatory patients

Brief summary: Since December 2019, a new agent, the coronavirus SARS-Cov-2, has spread from China to the rest of the world causing an international epidemic of respiratory diseases called COVID-19. Oise was one of the first clusters in France, with more than 4,000 confirmed cases. A significant proportion (80%) of patients with COVID-19 are ambulatory. However, few data are available for this particular population in France. Thus, few clear recommendations are available.

We propose to conduct a large cohort of observation of suspected or confirmed COVID-19 patients on an ambulatory basis in the Oise region. This observatory will make it possible to describe the epidemiological characteristics and initial management of COVID-19 patients and to identify early severity factors.


Eligibility criteria: Inclusion Criteria:

* patients with covid 19 symptoms
* patients who had a contact with a person PCR Covid 19+

Exclusion Criteria:

* none

Primary outcomes:
measure: clinical description of covid 19 ambulatory cases.
timeFrame: 3 months
Secondary outcomes:
measure: Biological and radiological description of ambulatory cases
timeFrame: 3 months
measure: Prevalence of positive cases (PCR and/or serological positive)
timeFrame: 3 months
Other outcomes:
Locations:
city: Creil
country: France
facility: Msp de Creil
Study officials:
References:
Clinical trial NCT01558999: A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 150
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: The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Have provided written informed consent
* Have dry eye in both eyes

Exclusion Criteria:

* Use of contact lenses
* Have an uncontrolled systemic disease
* Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
* Women who is pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Mean change from baseline in TFBUT
timeFrame: Day 27
measure: Mean change from baseline in symptom score
timeFrame: Day 21 - 27
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: SKK Investigational Site
state: Massachusetts
Study officials:
References:
Clinical trial NCT05436899: A Pilot Study on Training Simulator Efficacy
Official title: Training Simulator Efficacy in Developing Thoracic and General Surgical Skills in an Academic Residency Program: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Surgery
Medical Education
Simulation Training
Keywords: Education
Simulation
Virtual reality
Laparoscopic surgery
Learning curve
Endoscopic surgery
Thoracoscopic surgery
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 36
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.

Detailed description: All thoracic and general surgery trainees at the first and second year of residency will be randomized in two groups: A) trainees undergoing an intensive (twice a week) virtual training program and B) those undergoing a non-intensive virtual training program (once a week).

The virtual training program will be organized in 4 modules, each of 12 weeks and, according to the training simulator instructions, for each surgical skill there are predetermined goals to be achieved by the trainee. Data about duration of surgical maneuvers and type and number of mistakes made by the trainee at each training session will be collected and compared with those of the same trainee at the previous session; this will assess the number of training sessions required to achieve the training simulator predetermined goals. Moreover, the same data will be registered at the beginning and at the end of each courses to compare the two groups of trainees (intensive vs non-intensive program).

Eligibility criteria: Inclusion Criteria:

* Trainees at the first and second year of residency in thoracic or general surgery

Exclusion Criteria:

* Fully trained surgeons
* Persons who are not trainees at year of specialization higher than the second

Primary outcomes:
measure: Learning curves of time, errors and economy of motion for each training tasks
timeFrame: 48 weeks
Secondary outcomes:
measure: Intensive vs non-intensive training group
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Università degli Studi dell'Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Andrea Imperatori
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654299: Biliary Externalization After Pancreaticoduodenectomy
Official title: Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: Pancreaticoduodenectomy
Pancreatic postoperative fistula
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergo elective pancreaticoduodenectomy

Brief summary: Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.

Detailed description: n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Patient age \> 18 years old;
* Elective pancreaticoduodenectomy performed for primary pancreatic disease.

Exclusion Criteria:

* Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
* Patients with peritoneal or liver metastases found during surgery.

Primary outcomes:
measure: Postoperative complications
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Extremadura
name: Gerardo Blanco-Fernández, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Blanco-Fernandez G, Jaen-Torrejimeno I, De-Armas-Conde N, Rojas-Holguin A, Naharro JS, Castillo-Tunon JM, Lopez-Guerra D. Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy. J Gastrointest Surg. 2021 Nov;25(11):2881-2888. doi: 10.1007/s11605-021-04983-6. Epub 2021 Mar 25.
Clinical trial NCT03274999: Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use
Official title: Randomized, Controlled, Single-Center, Cross-Over Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).


Eligibility criteria: Inclusion Criteria:

* Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"
* In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
* History of nasal or sinus surgery
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
* Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

Primary outcomes:
measure: Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
timeFrame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
measure: Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
timeFrame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
measure: Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
timeFrame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
measure: Change From Pre-application in Protective Index (PI)
timeFrame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
measure: Change From Pre-application in Exposed Area (EA)
timeFrame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Ocular Technology Group International
Study officials:
affiliation: Allergan, plc
name: Clinical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00391599: Enemas Before Elective Cesarean Section
Official title: Are Enemas Given Before Elective Cesarean Section Useful?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complications After Cesarean Section
Keywords: Cesarean Section,
Enema
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-10-24
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Enemas are not anymore used routinely before vaginal deliveries.The intention of this study is to elucidate whether there is a benefit in routine use of enema before cesarean section.


Eligibility criteria: Inclusion Criteria:

* Cesarean Section, Elective

Primary outcomes:
measure: Number of Participants With Bowel Sounds
timeFrame: On postoperative day 1
measure: Number of Participants With Gas Passage
timeFrame: On postoperative day 1
measure: Number of Participants Had Spontaneous Feces
timeFrame: On postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Edith Wolfson Medical Center
name: Samuel Lurie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lurie S, Baider C, Glickman H, Golan A, Sadan O. Are enemas given before cesarean section useful? A prospective randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):27-9. doi: 10.1016/j.ejogrb.2012.03.034. Epub 2012 Apr 17.