louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04415463: Esophageal Multisegmented FCSEMS for Malignant Strictures
Official title: EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oesophageal Cancer
Esophageal Stent Stenosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2020-06-04
Enrollment: 23
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: Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.

Study design: Prospective observational nonrandomized clinical study.

Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study.

Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS.

Primary end points:

* Safety: complications and adverse events during follow-up with special attention to stent migration rates;
* Efficacy: technical success of stent placement.

Secondary end points:

* Recurrent dysphagia including its cause;
* Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
* Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
* Pain related to esophageal stent.


Eligibility criteria: Inclusion criteria:

* Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
* Requiring treatment for dysphagia (Ogilvie score of 2-41);
* Life expectancy of less than 12 months.

Exclusion criteria:

* Stenosis after laryngectomy;
* Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
* Esophageal fistula;
* Tumor length of more than 14 cm;
* Previous stent placement for the same condition;
* Inappropriate cultural level and understanding of the study;
* Coagulopathy;
* Patients with eosinophilic esophagitis or an esophageal motility disorder;
* Nickel titanium (Nitinol) allergy.

Primary outcomes:
measure: Adverse events
timeFrame: 6 months
measure: Technical success of stent placement
timeFrame: 1 day
Secondary outcomes:
measure: Recurrent dysphagia
timeFrame: 6 months
measure: Functional outcome
timeFrame: 6 months
measure: Tissue ingrowth or overgrowth
timeFrame: 6 months
measure: Pain related to esophageal stent
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References:
Clinical trial NCT04355663: Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity
Official title: Neuroproprioceptive Facilitation and Inhibition Physical Therapy Activates Adaptive and Plastic Changes in the Central Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
physical therapy
white matter integrity
neuroproprioceptive "facilitation, inhibition"
functional recovery
network reorganization
neurohormones
dehydroepiandrosterone
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates whether neuroproprioceptive "facilitation, inhibition" physical therapy induces plastic and adaptive processes of the CNS (white matter integrity changes), if they relate to clinical improvement, and whether therapeutic effect differs between different kinds of therapies.

Detailed description: In the Multi-Arm Parallel-Group Exploratory Trial, patients with multiple sclerosis were divided into three groups by an independent study coordinator, and underwent three kinds of neuroproprioceptive "facilitation, inhibition" physical therapy. At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from DTI .

Eligibility criteria: Inclusion Criteria:

* prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist,
* Expanded Disability Status Scale score (EDSS) max. 7.5

Exclusion Criteria:

* other neurological disease or conditions disabling movement

Primary outcomes:
measure: White Matter Integrity
timeFrame: 2 months
Secondary outcomes:
measure: Berg Balance Scale, BBS
timeFrame: 2 months
measure: Timed up and go Test, TUG
timeFrame: 2 months
measure: the 12-item Multiple Sclerosis Walking Scale, MSWS - 12
timeFrame: 2 months
measure: the 29-item Multiple Sclerosis Impact Scale, MSIS -29
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Third Faculty of Mecicine, Charles Univerzity
name: Kamila Řasová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasova K, Buckova B, Prokopiusova T, Prochazkova M, Angel G, Markova M, Hruskova N, Stetkarova I, Spanhelova S, Mares J, Tintera J, Zach P, Musil V, Hlinka J. A Three-Arm Parallel-group Exploratory Trial documents balance improvement without much evidence of white matter integrity changes in people with multiple sclerosis following two months ambulatory neuroproprioceptive "facilitation and inhibition" physical therapy. Eur J Phys Rehabil Med. 2021 Dec;57(6):889-899. doi: 10.23736/S1973-9087.21.06701-0. Epub 2021 Feb 10.
Clinical trial NCT00533663: Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
Official title: Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-09-21
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To study if Healing Touch is effective during chemotherapy treatment for breast cancer

Detailed description: To study the effectiveness of Healing Touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.

Eligibility criteria: Inclusion Criteria:- Stage I or II breast cancer

* Post-operative
* Concurrent enrollment on a treatment protocol of 8 weeks of adriamycin + cyclophosphamide given every other week followed by 8 weeks of paclitaxel given every other week
* ECOG Performance Status: 0 to 2
* Speak and read English

Exclusion Criteria:- Previous chemotherapy exposure

- Concomitant energy-work interventions (HT, Reiki, QiGong, acupuncture).

Primary outcomes:
measure: FACT-B summary score
timeFrame: Baseline, 6 wks, 14 wks
Secondary outcomes:
measure: Domain scores for FACT-B; BSI-18; FACIT-Fatigue; nausea measured on a Likert scale
timeFrame: Baseline, 6 wks, 14 wks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kathy Turner, RN, NP
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Alice "Ellie" Guardino, RN, NP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02317263: A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: MS
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96 weeks duration on whole brain atrophy in men with MS.


Eligibility criteria: Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria

Primary outcomes:
measure: Whole Brain Atrophy
timeFrame: 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01893463: Prospective Evaluation of the iTClamp50 to Provide Temporary Wound Closure
Official title: Prospective Study to Evaluate the Safety and Effectiveness of the iTClamp50 to Provide Temporary Wound Closure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemorrhage
Wound Closure
Bleeding
Keywords: hemorrhage control
wound closure
Lead sponsor: Innovative Trauma Care Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-hospital or emergency department patients requiring wound closure for hemorrhage control

Brief summary: Early and effective control of severe bleeding is critical to survival of trauma patients. The iTClamp™50 is a Health Canada approved medical device for temporary wound/skin closure that quickly controls bleeding by sealing the skin. Similar to a clip, the device seals the skin edges within a pressure bar, enabling the creation of a hematoma where blood collects under pressure to form a stable clot until definitive repair. The iTClamp50 is indicated for use as a skin closure device for short-term soft tissue approximation, including use in trauma wounds, lacerations, junctional bleeds or surgical incisions. The purpose of this prospective clinical study is to evaluate the effectiveness and safety of the iTClamp50 in the ambulance (pre-hospital) and emergency department setting. This will be accomplished by observing patients with the device applied from the pre-hospital through to patient discharge. The hypothesis is that the iTClamp50 will be safe and effective at providing temporary wound closure to control hemorrhage in the pre-hospital and emergency department setting.


Eligibility criteria: Inclusion Criteria:

* The device is indicated for use to control external hemorrhage from all compressible areas and to close wounds on the torso (chest and abdomen). The final decision to apply the device will be left with the care provider; however, their rationale will be reviewed in the post-use questionnaire.

Exclusion Criteria:

* The device is contraindicated for application to specific regions (e.g., eyes and genitals), application on patients less than the size of maturity, and wounds in which the skin edges cannot be approximated.

Primary outcomes:
measure: Effectiveness of the iTClamp50 to control hemorrhage
timeFrame: Patient discharge (Varies)
measure: Number of Adverse Events
timeFrame: Until patient discharge
Secondary outcomes:
measure: Pain associated with application and removal of the iTClamp50
timeFrame: Patient discharge (varies)
Other outcomes:
measure: Location of Application of the iTClamp50
timeFrame: Immediate
measure: How long did it take for the iTClamp50 to be applied?
timeFrame: immediate
measure: Anatomical Location of application of the iTClamp50
timeFrame: immediate
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT05351463: Papilla Suture Design Affects Papillary Postsurgical Dimensions
Official title: Papilla Suture Design Affects Papillary Postsurgical Dimensions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Surgery
Oral Surgery
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: RCT parallel study
Primary purpose: TREATMENT

Brief summary: The current prospective, randomized, controlled clinical trial aimed at comparing the impact of papillae suture technique on interdental papilla dimensions after periodontal surgery using a novel 3D intraoral scanning technique.

Detailed description: Scientific rationale for study: Choosing the appropriate suture design for periodontal surgery may affect post-surgery tissue dimension. This is a critical issue in periodontal surgery due to the grave impact papilla play on soft tissue esthetics.

Principal findings: using the novel 3D scanning of the gingiva tissue show that simple interrupted suture negatively affect post-surgery papillary height and recession adjacent to the suture compared with vertical internal mattress suture.

Practical implications: the study provide evidence that allows the clinician to better choose the suture design that will allow optimal healing of the papilla. Furthermore, the study presents a novel 3D scanning method to analyzed dimensional changes in the soft tissue.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Systemically healthy (based on health questionnaire prior to treatment)
* Willingness to participate in the study
* Clinical requirement for periodontal\\ implant surgery

Exclusion Criteria:

* Diagnosis of diabetes/heart disease, thrombocytopenia\\ coagulation factors deficiency
* Chronic use\\abuse of drugs\\ alcohol
* Pregnancy Smoking more than 10 cigarettes per day Antibiotic consumption in the last 3 months.

Primary outcomes:
measure: papilary volume
timeFrame: 12 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
Clinical trial NCT05333263: A Study to Validate Treadmill Parameters
Official title: Validation of Treadmill Disturbance Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the accuracy with which a microprocessor-controlled treadmill delivers controlled postural disturbances.


Eligibility criteria: Inclusion Criteria:

* Healthy adults with no medical conditions or previous injuries, trauma, or surgeries that reduce your balance, mobility or strength.
* Able to follow simple directions.
* Willingness to participate in the study.
* No restriction will be placed on gender, race, or ethnicity.

Exclusion Criteria:

* Current or chronic pain in your shoulders, elbows, hips, knees, ankles, feet, neck or back.
* Use of assistive device such as walker or cane.

Primary outcomes:
measure: Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: belt displacement.
timeFrame: Duration of participant test session (approximately 2 hours)
measure: Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: peak velocity.
timeFrame: Duration of participant test session (approximately 2 hours)
measure: Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: average initial acceleration.
timeFrame: Duration of participant test session (approximately 2 hours)
Secondary outcomes:
measure: Kinetic loading exerted on treadmill during perturbations: treadmill force.
timeFrame: Duration of participant test session (approximately 2 hours)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenton Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00661063: Diabetic Neuropathy Topical Treatment
Official title: Diabetic Neuropathic Pain Topical Treatment- Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Neuropathy
Pain
Keywords: neuropathic pain
ketamine
clonidine
association
Lead sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 200
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: Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus type I or II
* Mono or polyneuropathy
* Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
* Preserved cognition

Exclusion Criteria:

* Ulcerative or infection or vesicle lesion in pain site
* Pregnancy
* Breast feeding

Primary outcomes:
measure: pain evaluation by visual analogue scale
timeFrame: 12 weeks
Secondary outcomes:
measure: pain evaluation by amount of rescue medication required
timeFrame: 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Casa de São Paulo
Study officials:
affiliation: Santa Casa de São Paulo
name: Judymara L Gozzani, Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3.
Clinical trial NCT00151463: QEQ Treatment Responsiveness Evaluation Study
Official title: An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Quality of Erection Questionnaire (QEQ) is a new questionnaire that was developed to assess erectile attributes in men with erectile dysfunction. The study objective is to validate the Quality of Erection Questionnaire (QEQ) through the evaluation of subject responses to the QEQ regarding the quality and hardness of erections at baseline compared to subject responses post 6 and 10 weeks dosing with Viagra (sildenafil citrate).


Eligibility criteria: Inclusion Criteria:

* Subjects must have documented clinical diagnosis of erectile dysfunction based on a screening SHI-M score of \<21 and the subject fulfilling the NIH definition of erectile dysfunction
* Subjects must be either PDE-5 inhibitor naive; i.e. have never used sildenafil, tadalafil or vardenafil, or have been previously treated with no more than six doses of a PDE-5 inhibitor (sildenafil, tadalafil, vardenafil) and must have taken their last dose no less than 4 weeks prior to the screening visit

Exclusion Criteria:

* Subjects who are currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis

Primary outcomes:
measure: Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
Secondary outcomes:
measure: Change from baseline to week 6 of the QEQ total score
measure: Change from baseline to week 6 in the 5 IIEF domain scores
measure: Change from baseline in scores of QEQ individual question
Other outcomes:
Locations:
city: Bondi Junction
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Spring Hill
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Malvern
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Mentone
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01421563: Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers
Official title: A Randomized, Open-label, Two-Sequence, Two-Period Crossover Study to Assess the Pharmacokinetic Characteristics of Sarpogrelate HCl Controlled Release Tablet Compared With Sarpogrelate HCl Immediate Release Tablet in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after oral administration in healthy male volunteers.

Detailed description: The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)first, DP-R202(Sarpogrelate HCL 300mg, qd) Second or DP-R202(Sarpogrelate HCL 300mg, qd) first, anplag tablet(Sarpogrelate HCL 100mg, tid) second.

Eligibility criteria: Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Primary outcomes:
measure: Cmax, AUClast
timeFrame: 24h
Secondary outcomes:
measure: tmax, t1/2, AUC0-∞
timeFrame: 24h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: JaeWook Ko, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: