louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01932723: Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain
Official title: Effect of Functional Lumbar Stabilization Exercises on Pain, Disability and Kinesiophobia in Women With Menstrual Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Stabilization exercises, Pain, Disability, Menstruation
Lead sponsor: University of Social Welfare and Rehabilitation Science
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may be attributed to the spinal instability resulting from ligament laxity due to hormonal change. The purpose of this study was to investigate the effect of functional lumbar stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.

Detailed description: Pain intensity using Numeric Pain Scale (NPS), Oswestry disability index (ODI), Roland-Morris questionnaire (RMQ) and Tampa scale of kinesiophobia (TSK) were collected at base line and at the end of treatment (after three months) in both groups.

Eligibility criteria: Inclusion Criteria:

* Having low back pain LBP during menstrual phase (days 1-6) of the menstrual cycle.
* Suffering from low back pain during all menstrual cycles in the year before the study.
* No back pain or low back paiun at times other than the menstrual phase.
* Pain intensity during menstrual LBP greater than 5 in Numeric Pain Scale

Exclusion Criteria:

* History of spinal surgery, spinal or pelvic fracture and hospitalization for severe trauma or car accident, urinary tract infection, vaginal infection and known neurological disorders.
* Pain intensity lesser than 5 in Numeric Pain Scale

Primary outcomes:
measure: Pain
timeFrame: one year
Secondary outcomes:
measure: Disability
timeFrame: One year
Other outcomes:
measure: Kinesiophobia
timeFrame: One year
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: University of Social Welfare and Rehabilitation Sciences
Study officials:
affiliation: University of Social Welfare and Rehabilitation Sciences
name: Amir M Arab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05024123: Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects
Official title: Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects: A Randomized, Double-blind, Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Absorption of Amino Acids and Peptides
Keywords: AstraGin
arginine
pharmacokinetic
nitric oxide
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: AstraGin increases the absorption of amino acids and peptides in Caco-2 cells and in normal and TNBS-induced rats. Given the potential beneficial applications of AstraGin for health, the effects on L-arginine uptake and nitric oxide production are investigated. The study is the L-arginine pharmacokinetic study: A randomized, double-blind, crossover trial. This study performed in healthy human subjects. The knowledge gained from this study will provide valuable information for the development of novel and effective natural food supplements.


Eligibility criteria: Inclusion Criteria:

* Healthy adults and age 20 years and above, subdivided into three groups, Early-life (younger than 45 years, midlife (45--65 years), and later-life (older than 65 years), respectively.
* Subject has provided written and dated informed consent to participate in the study.
* The subject is willing and able to comply with the study.

Exclusion Criteria:

* The subject is participating in another clinical trial thirty days prior to enroll-ment.
* Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kid-ney disease, current infections, and smoking were exclusion criteria.
* Subject has any medical condition or uses any medication, nutritional product, amino acids supplement or program which might interfere with the conduct of the study or place the subject at risk.
* Subjects lost to follow-up, non-compliance, concomitant medication.

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 3 hours
measure: Maximum Time [Tmax]
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References:
Clinical trial NCT04121923: Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Official title: Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Belun Technology Company Limited
Sponsor class: OTHER
Collaborators: name: Clinimark, LLC
First posted: 2019-10-10
Enrollment: 50
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: SCREENING

Brief summary: The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during standard polysomnography sleep study conditions. The primary outcome metric is the Apnea-Hypopnea Index (AHI).

The goal, in its entirety, is to evaluate the performance of the Belun Ring Pulse Oximeter during a standard polysomnography sleep study and its ability to compare to the determined Apnea-Hypopnea Index (AHI) of the subjects. It is expected that the Belun Ring Pulse Oximeter will adequately record SpO2, pulse rate, body position and heart rate variability throughout the duration of the study.


Eligibility criteria: Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent.
* Subject is 18 to 90 years of age.
* Subject must be willing and able to comply with study procedures and duration.
* Male or female of any race.

Exclusion Criteria:

* Subject requires oxygen therapy or noninvasive ventilation.
* Subject has a current diagnosis of chronic obstructive pulmonary disorder (COPD), neuromuscular disease, periodic limb movement, or narcolepsy.
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
* Subject is on medication known to interfere with heart rate, such as beta blockers, digoxin, or calcium receptor agonists.
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
* Unwillingness or inability to remove colored nail polish from test digits.
* Other known health condition, which should be considered.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Mountain Sleep Diagnostics
state: Colorado
Study officials:
References:
citation: Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.
Clinical trial NCT03262623: Radial Nerve Block for Treatment of Tennis Elbow
Official title: Localized Radial Nerve Block for Treatment of Tennis Elbow: a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Elbow
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 50
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: Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.

Objectives: The primary objective of this study is to assess the effectiveness of nerve stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.

Methods: This is a prospective randomized, double blind clinical trial. Patients will be randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will receive placebo through radial nerve block. Patients will be followed up for 2 weeks.

Detailed description: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. It is a major arm disorder which occurs commonly in adults between 30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral epicondylitis results from the overuse of the extensor muscles, causing inflammation or irritation of the tendon insertion. It is common in workers whose job requires manual and repetitive work .

Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.

To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block for the treatment of lateral epicondylitis.

Eligibility criteria: Inclusion Criteria:

* 18 years and above
* presenting with refractory elbow pain

Exclusion Criteria:

patients with:

* osteoarthritis,
* rheumatoid arthritis,
* olecranon bursitis,
* radial nerve entrapment

Primary outcomes:
measure: Pain score
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Zoher Naja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791838: Experience in Borderline Ovarian Tumors
Official title: Borderline Ovarian Tumors: Results of a Retrospective, Single-center Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Borderline Ovarian Tumor
Keywords: Conservative surgery
Micropapillary patterns
Surgical staging
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients surgically treated for borderline ovarian tumors (BOT)

Brief summary: Borderline ovarian tumors (BOTs) comprise 15-20% of primary ovarian neoplasms and represent an independent disease entity among epithelial ovarian cancers. The present study aimed to report the 8-year experience of a single center on the management and outcomes of consecutive BOTs patients. From January 2010 to December 2017, all patients with BOTs undergoing surgical treatment were included. Demographic, clinical, and pathological data were reviewed retrospectively.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* Patients affected by borderline ovarian tumors (BOT) of any histological type and any FIGO stage,
* Women undergoing surgical treatment with both laparoscopic and laparotomic approaches.

Exclusion Criteria:

- Women affected by ovarian cancers

Primary outcomes:
measure: Oncological outcome
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Catania
name: Basilio Pecorino, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Catania
name: Paolo Scollo, M.D. Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D. Ph.D.
role: STUDY_CHAIR
affiliation: University of Palermo
name: Andrea Etrusco, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01295138: Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
Official title: Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Abdominal Pain
Nausea
Vomiting
Keywords: Constipation
Caesarean section
Abdominal Pain
Nausea
Vomiting
Lead sponsor: NHS Fife
Sponsor class: OTHER_GOV
First posted: 2011-02-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation.

1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).


Eligibility criteria: Inclusion Criteria:

* All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS

Exclusion Criteria:

* Unable to give informed consent
* A basic level of literacy sufficient to complete postoperative form.
* History of constipation
* Regular opiate use
* Previous bowel surgery or bowel adhesions
* Lactose intolerant
* Diabetic
* Any patient unable to have spinal Anaesthesia
* Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose
* Patients receiving injury to bowel intraoperatively
* Patients receiving additional opiates perioperatively

Primary outcomes:
measure: Time in hours to passage of first stool post Caesarean Section.
timeFrame: First 5 days post Caesarean section.
Secondary outcomes:
measure: Frequency of abdominal pain between lactulose and non-lactulose groups.
timeFrame: First 5 days post Caesarean section.
measure: Frequency of nausea and vomiting between lactulose and non-lactulose groups
timeFrame: First 5 days post-Caesarean
Other outcomes:
Locations:
city: Kirkcaldy
country: United Kingdom
facility: Forth Park Hospital
state: Fife
Study officials:
affiliation: NHS Fife
name: Anthony Davis, MBCHB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04630938: Effects of Anaesthesia on Inflammatory Markers
Official title: Effects of Anesthetics on Inflammatory Markers in Patients Undergoing Abdominal Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.


Eligibility criteria: Inclusion Criteria:

* Adult patients aging 18 - 55 years old
* Patients scheduled for abdominal surgeries
* Patients with American Society of Anesthesiologists (ASA) I, II physical status

Exclusion Criteria:

* Patients' refusal.
* Critically ill patients.
* Patients who have contraindications to regional anesthesia.

Primary outcomes:
measure: Visual analogue score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Esam A. Hamed
Study officials:
References:
Clinical trial NCT00910338: Efficacy and Safety of Extracorporeal Biofeedback
Official title: Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Urinary Incontinence
Keywords: Pelvic Floor Muscle Training
Extracorporeal Biofeedback
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Furun Medical
First posted: 2009-05-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.


Eligibility criteria: Inclusion Criteria:

* Women with stress urinary incontinence
* Standard pad test \> 2gram

Exclusion Criteria:

Women with:

* Mixed urinary incontinence of which urgency incontinence is dominant
* True incontinence
* Overflow incontinence
* Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
* Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
* Pelvic organ prolapse which the stage is at least 2
* Proven urinary tract infection during screening period
* Pacemaker
* Pregnant women
* Neurogenic voiding dysfunction

Primary outcomes:
measure: Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.
timeFrame: After 12 weeks of treatment
measure: Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Irwon-dong
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Ulsan College of Medicine
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02792738: Effect of Hypnosis on Dyspnea
Official title: Effect of Hypnosis on Dyspnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Dyspnea
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.

Detailed description: This is a study of permissive suggestion in two laboratory models of dyspnea ("work/effort", "air hunger"). Breathing discomfort rating induced by laboratory models of dyspnea will be assessed before, during and after hypnosis.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* ongoing pain
* respiratory disease
* high levels of depression, panic disorder, or other significant mental health problems
* not fluent in french

Primary outcomes:
measure: Subject rating of Breathing Discomfort (affective component of dyspnea)
timeFrame: continuous measurement for 5 minutes
measure: Subject rating of dyspnea intensity (sensory component of dyspnea)
timeFrame: continuous measurement for 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Pneumologie et Réanimation Médicale
Study officials:
References:
Clinical trial NCT03789838: Effect of Sepsis Response Team in the Emergency Department
Official title: Prospective Cohort Study Examining the Effect of a Sepsis Rapid Response Team in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 245
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: Adult patients with suspected sepsis in emergency department

Brief summary: Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour?

Detailed description: Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour? The time from the patients arrive at the emergency department to an adequate antibiotic is given, before and after introduction of a sepsis response team, was registered.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected sepsis

Exclusion Criteria:

* Patients who was consider not to need antibiotics

Primary outcomes:
measure: Time from arrival the emergency department to antibiotic is given.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Aleksander Holten, Phd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trydal E, Martinsen AB, Beisland F, Jacobsen D, Holten AR. [Structured evaluation on arrival of patients with sepsis and initiation of antibiotics]. Tidsskr Nor Laegeforen. 2019 May 27;139(9). doi: 10.4045/tidsskr.18.0216. Print 2019 May 28. Norwegian.