louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02114983: General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis
Official title: Precision and Diagnostic Accuracy of General Practitioner-performed Compression Ultrasound for Proximal Symptomatic Deep Vein Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Keywords: deep vein thrombosis
diagnostic accuracy
general practitioner
test
compression ultrasonography
ultrasound
Lead sponsor: Azienda Sanitaria Locale ASL 6, Livorno
Sponsor class: OTHER_GOV
First posted: 2014-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All outpatients evaluated at home or at office by the GP with a first episode of suspected DVT of the lower limbs will be screened with CUS. GP may use his/her own ultrasound, or take advantage of the equipment of the Vascular Service of the Hospital. Shortly afterward, (i.e., within 2 hours), all outpatients will be re-evaluated by a doctor with expertize in vascular ultrasound

Brief summary: Numerous studies have demonstrated excellent diagnostic accuracy of Compression Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology.

Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners (GP) can perform reliable ultrasound to increase the speed and improve the quality of clinical management of various clinical conditions. To date, in the medical literature there are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision and the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case will be the standard of reference.


Eligibility criteria: Inclusion Criteria:

* first episode of DVT of lower limbs

Exclusion Criteria:

* previous episodes of DVT
* ongoing anticoagulation
* age younger than 18 years
* pregnancy

Primary outcomes:
measure: Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT
timeFrame: Up to 2 h hours after ambulatory admission
Secondary outcomes:
measure: Precision of CUS performed by General Practitioner for the diagnosis of DVT
timeFrame: Up to 2 h hours after ambulatory admission
Other outcomes:
measure: To assess the prevalence of DVT in patients with a high pre-test probability and/or a positive D-dimer
timeFrame: Up to 2 h hours after ambulatory admission
Locations:
city: Livorno
country: Italy
facility: Azienda USL 6 Livorno
state: Tuscany
Study officials:
affiliation: Section of Vascular Medicine - Livorno Hospital, Italy
name: Nicola Mumoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05323383: The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain
Official title: The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Chronic Pain
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2022-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, three-arm, parallel-group randomized design
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effects and mechanisms of 1 x 20-min training in mindfulness meditation and self-hypnosis relative to an inert control. Participants will be randomly assigned to condition. The dual primary outcomes will be pre- to post-training changes in current pain intensity and pain unpleasantness. The active treatments are hypothesized to produce greater reductions in pain outcomes than the control. It is also hypothesized that change in mindfulness will be a mediator specific to mindfulness meditation, while change in affect and decentering will be mediators of the hypnosis condition. Moderators of response will also be explored.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age;
* Experience chronic or recurrent pain;
* Have access to a computer, phone or tablet with internet capability; and
* Be able to read and understand English.

Primary outcomes:
measure: Current pain intensity
timeFrame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
measure: Current pain unpleasantness
timeFrame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Secondary outcomes:
measure: Mechanism: Mindfulness
timeFrame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
measure: Mechanism: Positive Affect
timeFrame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
measure: Mechanism: Decentering
timeFrame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The University of Queensland
state: Queensland
Study officials:
References:
Clinical trial NCT00755183: Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction
Official title: A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian Gland Dysfunction
Dry Eye Syndrome
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

Detailed description: Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.

Eligibility criteria: Inclusion Criteria (subjects must):

* Be ≥ 60 years of age
* Have a corrected visual acuity of LogMAR +0.5 (ETDRS)
* Have a documented history of Meibomian Gland Dysfunction
* Have a TFBUT ≤ 5 seconds
* Have an ocular discomfort score ≥ 1
* Have an IOP ≤ 25 mmHg at Visit 1 in both eyes
* Report use of and/or desire to use an artificial tears

Exclusion Criteria (subjects may not):

* Have contraindications to the use of the study medications
* Have a known allergy or sensitivity to the study medications
* Have any ocular infections, or active ocular inflammation
* Have used ocular medications within 24 hours prior to Visit 1
* Be a current contact lens wearer
* Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial
* Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study
* Have a history of prostate cancer

Primary outcomes:
measure: Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
timeFrame: 168 days
measure: Ocular Discomfort Score at Visit 4
timeFrame: 168 days
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ophthalmic Research Associates
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: H. Jerome Crampton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333983: Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Official title: Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-06-06
Enrollment: 62
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 compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Detailed description: A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
* Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
* A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Exclusion Criteria:

* Subjects unable to give informed consent
* Serious complicating medical illness
* Contracture or orthopedic problems limiting the range of joint movement in the study arm
* Visual loss
* Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
* Botox treatment within 3 months of enrollment

Primary outcomes:
measure: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
timeFrame: Baseline to Final Training (6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Christopher Bever, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.1016/j.apmr.2011.06.016. Epub 2011 Aug 17.
Clinical trial NCT02356783: Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain
Official title: Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2015-02-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can be used to measure efficacy of pain interventions.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month).
* Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study.
* Patient who used web-based communication frequently, e.g. Email.
* Patients who can speak, understand, and write in English.
* Prior MRI or an appointment to obtain an MRI prior to the procedure.

Exclusion Criteria:

* Workers' compensation cases.
* Patient does not have a computer at home.
* Non-ambulatory patients.
* Patients who have received a lumbar epidural steroid injection in the past 6 months.
* Nursing or pregnant women.

Primary outcomes:
measure: Percentage of Patients With Available Step Count Data at Baseline.
timeFrame: A week pre-procedure.
measure: Percentage of Patients With Available Step Count Data Post-procedure.
timeFrame: Duration of 60 days after procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital For Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Robert Griffin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen SP, Bicket MC, Jamison D, Wilkinson I, Rathmell JP. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med. 2013 May-Jun;38(3):175-200. doi: 10.1097/AAP.0b013e31828ea086.
citation: MacVicar J, King W, Landers MH, Bogduk N. The effectiveness of lumbar transforaminal injection of steroids: a comprehensive review with systematic analysis of the published data. Pain Med. 2013 Jan;14(1):14-28. doi: 10.1111/j.1526-4637.2012.01508.x. Epub 2012 Oct 30.
Clinical trial NCT04560283: HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
Official title: Randomized Clinical Trial to Assess the Efficacy and Safety of HYDEAL-D® Application in Promoting the Restoration of Sexual Function in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vagina; Anomaly
Puerperium; Disease
Sexual Dysfunction
Keywords: Puerperium
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women.

This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function in the postpartum period.


Eligibility criteria: Inclusion Criteria:

* Women from 18 to 40 years old;
* Women in the puerperium period (after vaginal delivery or cesarean section);
* Women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially;

Exclusion Criteria:

* Allergy to hyaluronic acid gel;
* Women non-Italian speaking;
* Women with signs of vaginal infection;
* Women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney;
* Women who are attending or have attended other clinical trials within previous two weeks;
* Women with mental disorder and no insight

Primary outcomes:
measure: Evaluation of sexual function by FSFI
timeFrame: At baseline; 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
Study officials:
affiliation: Ospedale San Martino
name: Fabio Barra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustavino C, Sala P, Cusini N, Gravina B, Ronzini C, Marcolin D, Vellone VG, Paudice M, Nappi R, Costantini S, Ferrero S, Barra F. Efficacy and safety of prolonged-release hyaluronic acid derivative vaginal application in the postpartum period: a prospective randomised clinical trial. Ann Med. 2021 Dec;53(1):1589-1597. doi: 10.1080/07853890.2021.1974083.
Clinical trial NCT05039983: Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer
Official title: Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Obstruction
Keywords: EGCG
Esophageal obstruction
Supportive and Symptomatic Management
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main symptom of patients with advanced esophageal cancer is eating obstruction. In clinical practice, patients need to wait for a long time before anti-tumor treatment, which will lead to a rapid decline in the quality of life and nutritional status of patients, and severe patients sometimes need to place nasointestinal feeding tubes or endoscopic stents. EGCG has been shown to have antioxidant, anti-inflammatory and anti-tumor effects . The complex effects of EGCG may improve esophageal obstruction during the waiting period before antineoplastic therapy. The purpose of this phase I study was to explore the safety, recommended dose and preliminary efficacy of EGCG solution in the treatment of esophageal obstruction.


Eligibility criteria: Inclusion Criteria:

* confirmed pathological esophageal squamous cell carcinoma
* ≥18 years old
* the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* no previous anti-tumor treatment
* no esophageal bleeding or fistula
* adequate hemocyte count, normal hepatic and renal functions
* Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score

Exclusion Criteria:

* lactating or pregnant women
* known hypersensitivity or allergy to any kind green tea extract
* placement of small intestinal feeding tube or endoscopic stent treatment
* unable or refusing to take oral liquids

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: baseline and up to 7 days post-treatment
measure: Maximum tolerated dose (MTD)
timeFrame: baseline and up to 7 days post-treatment
measure: Recommended phase 2 dose (RP2D)
timeFrame: baseline and up to 7 days post-treatment
Secondary outcomes:
measure: Imaging objective response rate
timeFrame: Change from Baseline esophageal stenosis size at 7 days
measure: Symptom objective response rate
timeFrame: baseline and up to 7 days post-treatment
measure: change in blood biochemical indicators
timeFrame: baseline and up to 8 days post-treatment
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shan Dong cancer hospital and institute
state: Shandong
Study officials:
References:
Clinical trial NCT05325983: Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation
Official title: Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Thirst
Saliva
Keywords: Heart Failure
Thirst
Saliva stimulation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will screening period to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomize in a double-blind manner (participant and researcher) in a 1:1 ratio to experimental group (lemonade ice cubes) or the control group (water ice cubes).

Eligibility criteria: Inclusion Criteria:

* 1. Hospital stay for more than 24 hours;
* 2. NYHA III-IV;
* 3. Oral mucosa is intact, without ulcers or wounds;
* 4. Consciousness and normal cognitive function;
* 5. Those who are more than 20 years old and can answer the questionnaire in Chinese or Taiwanese verbally or in writing;
* 6. Normal swallowing function;
* 7. Stable vital signs and maintain systolic blood pressure above 90mmHg;
* 8. Those who need to limit water according to doctor's advice

Exclusion Criteria:

* 1. Those with endotracheal tube and respirator;
* 2. Those with indwelling nasogastric tube;
* 3. Those who fasted according to the doctor's advice;
* 4. Those who were diagnosed with dry syndrome

Primary outcomes:
measure: Thirst intensity measured using an Visual Analogue Scale (VAS)
timeFrame: baseline and 180 second
measure: Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF)
timeFrame: baseline and 180 second
measure: Change from Baseline in Measure Saliva Amount at 45 seconds.
timeFrame: baseline and 45 second
measure: Change from Baseline in Measure Saliva Amount at 90 seconds.
timeFrame: baseline and 90 second
measure: Change from Baseline in Measure Saliva Amount at 135 seconds.
timeFrame: baseline and 135 second
measure: Change from Baseline in Measure Saliva Amount at 180 seconds.
timeFrame: baseline and 180 second
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Guishan
Study officials:
affiliation: Self
name: LI-JU Chen
role: STUDY_CHAIR
References: