louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04650295: Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Official title: Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Muscle Cramp
Ascites
Keywords: Liver disease
Nutrition
quality of life
sleep
non-pharmaceutical intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 82
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 clinical trial is evaluating the feasibility of using a non-pharmaceutical treatment to improve the symptoms and severity of muscle cramps in patients with cirrhosis.

Eligible participants will be randomized to the treatment arm or control group. The treatment phase of the study will last 28 days. Information about participants will be collected including surveys and assessments throughout the study. Please note that only the participants randomized to experimental intervention group (Household Remedy) will be told what the treatment is during the study period. At the conclusion of the study (time of the final follow-up assessments), all participants will be debriefed on the use of concealment in this study as outlined in the protocol regarding the intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cirrhosis (criteria per protocol will be used)
* History of painful muscle spasms, cramps, or charley horses that come on while resting (they had to have happened 4 times in the past month and bother the participant)

Exclusion Criteria:

* Non-English speaking
* Unable or unwilling to provide consent
* History of liver transplant
* History of multiple sclerosis
* History of cerebral palsy
* History of stroke with paralysis

Primary outcomes:
measure: Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps
timeFrame: 28 days
Secondary outcomes:
measure: Number of cramp-days per person
timeFrame: 28 days
measure: Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps
timeFrame: 28 days
measure: Number of cramps during study
timeFrame: 28 days
measure: Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 28 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elliot Tapper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03620695: Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps
Official title: Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Polyps
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients undergoing surveillance or screening colonoscopies will be recruited in this study at Qilu Hospital, Shandong University.

Brief summary: Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.


Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies.

Exclusion Criteria:

* Contraindications to CV (such as allergy);
* Pregnancy or breastfeeding;
* Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;
* Inability to provide informed consent.

Primary outcomes:
measure: The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
timeFrame: 5 months
measure: Number of diagnostic agreement between pCLE with topical CV and histopathological results
timeFrame: 5 months
measure: Number of participants with procedure-related adverse events
timeFrame: 5 months
measure: Number of pCLE imaging failure with topical CV
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02077595: Effects of Transcutaneous Electrical Nerve Stimulation on Cortical Excitability in the Primary Motor Cortex in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation
Keywords: transcutaneous electrical nerve stimulation
transcranial magnetic stimulation
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. About DC stimulation, the change of polarity could modulate the spontaneous neuronal activity and make effect on decision making, language, memory, sensory perception, and pain. In spite of that the concept of transcranial alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches have revealed that AC might potentially have the effect on the cortical excitability. However, there are still many areas about AC stimulation which remain unknown, such as mechanism, application, and potential influence on cortical excitability.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Primary outcomes:
measure: Motor evoked potential
timeFrame: Baseline
measure: Intracortical inhibition, ICI
timeFrame: Baseline,2 hours, 2.5 hours,and 3 hours
measure: intracortical facilitation, ICF
timeFrame: Baseline,Baseline,2 hours, 2.5 hours,and 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT04972695: Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
Official title: Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Suspect
Glaucoma
Ocular Hypertension
Keywords: Deep Learning
Diagnoses Disease
Glaucoma
retinographies
Lead sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 615
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ocular hypertensive patients or patients with diagnosis of Glaucoma.

Brief summary: Clinical, cross-sectional and prospective study to assess the images of the posterior pole of the retina of patients from the Glaucoma Unit of the IOBA and the Hospital Clínico Universitario de Valladolid during the period between May and December 2021.

The aim of the project is to provide a sufficient number of images from posterior pole retinographies in patients with suspected glaucoma or with diagnosis of glaucoma in order to determine the sensitivity and specificity of an automatic glaucoma screening algorithm developed by the company Transmural Biotech S.L.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension
* Signed informed consent
* Visual field examination within the last 12 months

Exclusion Criteria:

* Ocular or systemic pathologies that may interfere with the quality of the retinographic image or the results of the visual field
* Congenital anomalies of the papilla that seriously alter its structure
* High ametropia (\> 10 diopters)
* Pharmacological Mydriasis contraindication.

Primary outcomes:
measure: Sensitivity and Specificity of an automated classification system for retinographies
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: IOBA - Universidad de Valladolid
Study officials:
References:
Clinical trial NCT06509295: Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. .
Official title: Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intervention
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.


Eligibility criteria: Inclusion Criteria:

1. Systematically healthy patient (ASA I, II).
2. Age between 20 and 55 years
3. Male or female.
4. Mandibular premolar teeth having single canals diagnosed with pulp necrosis with asymptomatic apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software showing mandibular premolars with (0-2 mm) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Teeth with:

   * Immature roots
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated
   * Deep periodontal pockets more than 4 mm
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Primary outcomes:
measure: Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps.
timeFrame: measured at 6, 12, 24, 48 hours after single visit treatment
Secondary outcomes:
measure: Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.
timeFrame: T0=Baseline immediate after access preparation . T1=Post-instrumentation. T1(within an hour)
measure: Number of analgesic tablets taken by the patient after endodontic treatment
timeFrame: Up to 48 hours postoperative.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06063395: Study of the Size of the Operating Fields Depending on the Morphology of the Patients
Official title: Study of the Size of the Operating Fields Depending on the Morphology of the Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Surgery on the Abdominal Aorta
Keywords: Abdominal aorta
Open surgery
Vascular surgery
Lead sponsor: Geprovas
Sponsor class: NETWORK
First posted: 2023-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing open surgery on the abdominal aorta by laparotomy.

Brief summary: This is a prospective, single-centre, observational clinical study.

Patients who have not expressed their non-opposition, who are of age and who are undergoing open surgery on the abdominal aorta by laparotomy will be included.

The aim is to mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict the surgical risk.

To meet this objective, the dimensions of the working volume of open abdominal aortic surgery will be measured using a camera to create an algorithm by associating them with the preoperative images and morphometric data of the patient.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patient undergoing open surgery on the abdominal aorta by laparotomy.
* Patient who has been informed of the terms of the study and who has not expressed non-opposition.

Exclusion Criteria:

* Emergency surgery
* Patient without preoperative CT scan

Primary outcomes:
measure: Mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict surgical risk.
timeFrame: During surgery
Secondary outcomes:
measure: Find a correlation between work volume and BMI du patient.
timeFrame: During surgery
measure: Validate the algorithm for predicting the volume of work in abdominal aortic abdominal aortic surgery.
timeFrame: During surgery
measure: Evaluation of how the algorithm helps to deal with surgery
timeFrame: During surgery
measure: Correlate results with surgical complications
timeFrame: During the procedure until patient discharge
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Nabil Chakfe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03777995: A New Designed Balance Platform for Children
Official title: Reliability and Validity of a New Designed Balance Platform for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Keywords: Balance
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 108
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children who have a typical development will be recruited from various kindergartens in Cyprus.

Brief summary: People always come across with different floors which gradually affect dynamic balance. Dynamic balance is important in activities of daily life of all people. There are various reliable and valid tests for both children and adults, but no test design which includes different floor materials has been developed. Thus, this study aimed to describe a new designed balance test platform and investigate its reliability and validity in 3-5 years old children.

Detailed description: Children whose families signed consent form will be included. Height and weight will be measured. Then they will be taken to the balance measurements. Design will firstly be shown to child and one trial will be permitted before starting the test. Timed-up and Go test will also be used as a reliable and valid test for dynamic balance in this age group. Single leg standing will also be used to investigate the discrimination feature of the dynamic balance tested by new design platform.

All tests will be done without socks and shoes. Timing will be the only results for all tests. Calibrated chronometers will be used for this aim. After all measurements complete, statistical analysis will be conducted.

Eligibility criteria: Inclusion Criteria:

* Chid aged 3-5 years (birth date: December 2013 - December 2015)
* Parents who signed consent form.

Exclusion Criteria:

* Children who have problem about musculoskeletal system, neurological disorder, vestibular system disorders.
* Children who mention painful situations which may possibly prevent to walk on the platform
* Children who have visual problems

Primary outcomes:
measure: New designed test
timeFrame: at baseline
Secondary outcomes:
measure: Timed-up and go test
timeFrame: at baseline
measure: Single leg standing
timeFrame: at baseline
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Zehra Güçhan Topcu
Study officials:
affiliation: Eastern Mediterranean University
name: ZEHRA GÜÇHAN TOPCU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004795: Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Northwestern University
First posted: 2000-02-25
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701) in women with prednisone-dependent systemic lupus erythematosus.

II. Describe the pharmacokinetics of GL701.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo, administered daily for a minimum of 7 months. A prednisone taper is attempted each month in patients with stable or improving disease. Therapy continues until a successful prednisone taper is achieved and sustained for at least 2 months, or until a maximum of 9 months.

Patients are followed for 1 year after entry.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Systemic lupus erythematosus by American College of Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose (or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior to entry No prior participation in double-blind dehydroepiandrosterone (DHEA) study at Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No concurrent participation in other clinical studies No investigational agents within the longer of 30 days or 10 half lives of the agent At least 3 months since the following: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin Other immunosuppressants At least 1 month since any change in dose of concurrent nonsteroidal anti- inflammatory drugs or hydroxychloroquine --Patient Characteristics-- No hypersensitivity to DHEA or inactive ingredient in DHEA, i.e.: Cornstarch Lactose Magnesium stearate No condition that would prevent adequate compliance with study No history of breast cancer or reproductive tract malignancy Negative pregnancy test required within 2 weeks prior to entry Reliable contraception required of fertile women No estrogen-containing oral contraceptive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Rosalind Ramsey-Goldman
role: STUDY_CHAIR
References:
Clinical trial NCT03264495: Measuring the Quantities of Food Consumed by Patients Hospitalised in a Geriatric Centre
Official title: Recording Food Consumption in Patients Hospitalised in a Geriatric Centre
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age ≥ 65 Years
Hospitalisation in the Champmaillot Geriatric Centre
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly persons hospitalised at the Champmaillot Geriatric Centre

Brief summary: The objective of the study is to measure the quantities of food consumed at each meal by a representative part of the population of patients hospitalised in each department of the Champmaillot Geriatric Centre.

To do so, the quantity eaten will be quantified by weighing the amounts served and subtracting the weight of the left-overs. These measurements will allow us to provide more appropriate meals in the second step.


Eligibility criteria: Inclusion Criteria:

* Persons aged ≥ 65 years
* Persons hospitalised in the Champmaillot Geriatric Centre

Exclusion Criteria:

* Persons at the end of life

Primary outcomes:
measure: Weigh the food served and the left-overs
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: