louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02732548: MIRODERM™ for Complex Wounds in an Inpatient Setting (MIRODERM CLOSure)
Official title: MIRODERM™ for Complex Wounds in an Inpatient Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complex Wound
Lead sponsor: Miromatrix Medical Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 0
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 study is being conducted to collect data on the performance of Miromatrix Wound Matrix (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Have a complex study wound which will require an autograft or delayed primary closure procedure and which may or may not include tunneling and/or undermining
* Have a study wound with a total post-debridement surface area ≥50cm2 and ≤250cm2 with no dimension \>25cm, and a minimum depth of ≥0.5cm
* Have a study wound which is expected to take at least 4 weeks to reach autograft or delayed primary closure using standard care and NPWT
* Have a study wound that will be treated with NPWT regardless of study participation
* Be in an inpatient setting
* Be able and willing to sign the consent form and comply with all study visits and procedures

Exclusion Criteria:

* Be pregnant or be planning to become pregnant during the study
* Be contraindicated for NPWT (necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, exposed organs)
* Be immunocompromised or at risk of immunosuppression (e.g. be HIV positive, be experiencing organ rejection, be a recent, current, or anticipated chemotherapy recipient) as determined by the Investigator
* Be taking a Tumor Necrosis Factor (TNF) blocker
* Be participating in another research study
* Have a sensitivity to porcine material
* Have a life expectancy of less than 1 year
* Have a study wound which is a third degree burn wound
* Have a study wound that is infected
* Have a study wound that is a pressure ulcer/wound
* Have a study wound with sinus tract(s) leading to other open area(s)
* Have a wound that is being treated or expected to be treated with either HBOT or topical wound oxygen therapy
* Have a study wound which has been treated with a cellular and/or tissue-based product within last 30 days

Primary outcomes:
measure: The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05743348: COVID-19 e Telepsychotherapy: Which Variables Affect Therapeutic Experience?
Official title: COVID-19 e Telepsychotherapy: Which Variables Affect Therapeutic Experience?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telepsychotherapy
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study addresses both licensed and currently practicing psychotherapists and their patients, namely individuals currently undergoing a psychotherapy

Brief summary: COVID-19 pandemic forced a widespread adoption of telemedicine, including telepsychotherapy.

Telepsychotherapy has been proven to be effective before COVID-19 breakout (Poletti et al., 2020); however, both patients and therapists were skeptical about this modality.

The aim of this study is to probe the experience of telepsychotherapy in both patients and therapists, during the COVID-19 lockdown. Thus, when the adoption of online colloquia was mandatory and not an option.

Crucially, studying the experience of telepsychotherapy during the COVID-19 pandemic allows i) investigating also the experience of those patients and therapists that were not favorable to this kind of intervention and ii) comparing the experience of therapy in the online and face-to-face modality, in the same patients and therapists. Furthermore, we collect several psychological variables that possibly influence the experience and efficacy of telepsychotherapy (e.g., personality traits, attachment state of mind, previous traumatic experiences) to define the psychological profile behind a favorable or negative experience of telemedicine in both patients and therapists. As crucial novelty, this information is collected in both patients and their therapists, allowing the direct comparisons between the experience of the therapeutic relationship (e.g., empathy, alliance) from two different point of views.

The results of the present study may help in the definition of possible subgroups of patients who may be sufficiently responsive to telepsychotherapy and those who may benefit - exclusively - of face-to-face interventions.


Eligibility criteria: Inclusion Criteria:

* Licensed and currently practicing psychotherapists
* Individuals currently undergoing a psychotherapy

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: Telepsychotherapy perception
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT00496730: A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Official title: A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Metabolic Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 256
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
* No history of diabetes and 100 \<=LDL-C \<=250 mg/dl

Exclusion Criteria:

* Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
* Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Uncontrolled hypertension
* Unstable angina

Primary outcomes:
measure: Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.
timeFrame: Baseline and Week 8
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02802930: Test the Phototoxicity of Sunscreen Products
Official title: A Randomized Study to Assess the Potential for Phototoxicity of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27-104 in Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study was to evaluate the potential for phototoxicity of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a negative control (0.9% sodium chloride \[NaCl\]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

The secondary objective of this study was to evaluate the safety of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring adverse events (AEs) throughout the study.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 18 to 65 years
* Good general health, as assessed by medical history and brief visual examination of the skin
* Fitzpatrick skin Type I IV, determined by interview at screening
* Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
* Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
* Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study

Primary outcomes:
measure: Skin irritation
timeFrame: up to 1 week
Secondary outcomes:
measure: Number of adverse event as a measure of safety and tolerability
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Pinellas Park
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00425230: Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain
Official title: Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Phantom Limb Pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2007-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.


Eligibility criteria: Inclusion Criteria:

1. Chronic PLP \> 6 months
2. Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
3. Age ≥ 18 years old
4. Inpatient or Outpatient
5. Able to come to all appointments, in the opinion of the investigator
6. Able to give informed consent, in opinion of investigator

Exclusion Criteria:

1. Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
2. Substance abuse or dependence within the last six months, as assessed by the MINI
3. Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
4. History of coronary artery disease, hepatic disease, renal disease
5. Other pain syndromes
6. Any unstable medical conditions in the opinion of the investigator
7. Other psychotropic medications excluding hypnotics

Primary outcomes:
measure: McGill Short Form Pain Questionairre
Secondary outcomes:
measure: Fiser Side effect scale
measure: visual analog pain scale
measure: Present Pain intensity
measure: Tylenol # 3 consumption
Other outcomes:
Locations:
city: Houston
country: United States
facility: Micheal E. DeBakey Veterans Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Asif Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04583930: Clinical and Health-related Outcome of rFVIIIFc Prophylaxis
Official title: Clinical and Health-related Outcome of rFVIIIFc Prophylaxis in Patients With Haemophilia A
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia A
Lead sponsor: University of Wuppertal
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 48
Sex: MALE
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: Patients with moderate or severe Haemophilia A will be included in this study consecutively, who will be switched from FVIII prophylaxis on rFVIIIFc prophylaxis.

Brief summary: Current standard therapy for patients with haemophilia (PwH) in the prevention of bleeding episodes is a prophylactic intravenous treatment with recombinant coagulation factor (F) VIII (Haemophilia A) or rather FIX (Haemophilia B) two to three times weekly. With the development of recombinant factor VIII Fc fusion protein (rFVIIIFc) the conventional routine prophylaxis regime is complemented by an extended half-life (EHL) factor replacement prophylaxis with the potential of improved bleed prevention and reduced injection frequency at similar factor consumption. Aim of this longitudinal multicentre study is to evaluate the influence of an EHL factor replacement regime with rFVIIIFc on haemophilic specific parameters (annual bleeding rate, bleeding localisation), joint status, pain, functional parameters, treatment adherence and health-related quality of life in PwH A.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from moderate to severe haemophilia A
* Age ≥ 18-years
* Treatment with FVIII prophylaxis
* Submitted written informed consent

Exclusion Criteria:

Patients suffering from other bleeding diseases

* Patients with inhibitors
* Patients without written informed consent
* Age \< 18-year-old
* Any surgeries up to 6 months before the examination date
* Suffering from different rheumatologic diseases like M. Bechterew, Psoriasis or other local or generalized joint infections (Borreliosis, septic arthritis)

Primary outcomes:
measure: total annual bleeding rate
timeFrame: one year
measure: orthopaedic joint status (Haemophilia health joint score)
timeFrame: one year
measure: pressure pain thresholds
timeFrame: one year
Secondary outcomes:
measure: spontaneous joint ABR
timeFrame: one year
measure: subjective quality of life (SF-36)
timeFrame: two years
measure: subjective physical performance (HEP-Test-Q)
timeFrame: two years
measure: self-perceived functional abilities (Haemophilia Activities List)
timeFrame: two years
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Department of Sports Medicine, University of Wuppertal
state: North Rhine-Westphalia
city: Wuppertal
country: Germany
facility: Department of Sports Medicine
state: Northwest
Study officials:
affiliation: Head of Department
name: Thomas Hilberg, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00382330: Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Official title: Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vulvar Cancer
Keywords: Vulva
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2006-09-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages 18 and 75 years.
* Patients may be carriers of the Human Immunodeficiency Virus (HIV).
* Patients must have been diagnosed with precancerous lesion(s) of the vulva by tissue sampling (biopsy-proven vulvar intraepithelial neoplasia grade II or III)
* Patients must be able to come to University Hospital for their initial appointment in Gynecologic Oncology Clinic, and for the eight follow-up visits in that Clinic required by the protocol.

Exclusion Criteria:

* Pregnant or patients who are breast feeding a baby.
* Patients who have been diagnosed with a vaginal yeast infection.
* Patients who have undergone prior surgery for precancerous lesion(s) of the vulva.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Medicine and Dentistry of NJ
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Bernadette Cracchiolo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04144530: MRI Repository for Acute Stroke Clinical and Research Applications
Official title: MRI Repository for Acute Stroke Clinical and Research Applications
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke, Acute
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted at Hopkins Stroke center with the diagnosis of acute brain stroke

Brief summary: Stroke is one of the leading causes of death and long-term disability. A major unresolved problem in MRI-based stroke assessment is to relate image features to brain function in a way that can properly guide stratification for treatment and rehabilitation. This requires extracting meaningful and reproducible models of brain function from stroke images, a daunting task severely hindered by the great variability of lesion frequency and pattern. Large datasets are imperative to uncover possible lesion-function relationships.

In this project the investigators will create a large database of acute strokes MRIs. The investigators will retrospectively archive an estimated 3,000 MRIs of patients with acute stroke, acquired at the Johns Hopkins Hospital, 2009-2019. This dataset will include 1.5 and 3 Tesla scans, diverse protocols and sequences (e.g., diffusion and perfusion weighted images (DWI/b0, PWI), T1, T2, FLAIR, susceptibility weighted images), with typical clinical low voxel resolution (4-7 mm3). Lesions will be initially delineated on DWI/b0, the most informative MRI sequence for acute stroke. After anonymization and defacing, two trained evaluators will perform the manual lesion segmentation. Two expert neuroradiologists will create consensual structured radiological reports with information about stroke type and location according to different criteria (e.g., 34 brain structures and 11 vascular territories). The investigators will also archive structured information from discharge (demographics, laboratory, and neurological evaluation of patients, including NIH stroke scale and modified Rankin scale, mRS), as well as the 90-days follow-up mRS.


Eligibility criteria: Inclusion Criteria:

* patients admitted at Hopkins Stroke center with the diagnosis of acute brain stroke

Exclusion Criteria:

* Not performed MRI

Primary outcomes:
measure: Demographic and clinical data obtained via chart review
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Andreia V Faria, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05651230: Seaweed-derived Rhamnan Sulfate and Vascular Function
Official title: Seaweed-derived Rhamnan Sulfate and Vascular Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Konan Chemical Manufacturing
First posted: 2022-12-14
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim of the proposed investigation is to examine the hypothesis that a relatively short period of rhamnan sulfate supplementation would improve key markers of vascular dysfunction in middle-aged and older adults with at least one risk factors for cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* at least one risk factor for cardiovascular disease (e.g., dyslipidemia, hypertension, obesity, impaired fasting glucose)
* a BMI of \<40 kg/m2

Exclusion Criteria:

* gastrointestinal disorders and/or renal disease
* pregnancy or lactation
* strenuous physical activity (\>3 times/week)
* alcohol abuse

Primary outcomes:
measure: Vascular function
timeFrame: Before the 3-week intervention
measure: Vascular function
timeFrame: After the 3-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Cardiovascular Aging Research Lab at UT Austin
state: Texas
Study officials:
References:
Clinical trial NCT05834530: Comparison of Conventional Versus 3-D Printed Complete Denture Regarding Retention, Accuracy, Elctromyographic Activity and Patient Satisfaction.
Official title: Electromyographic Activity, Accuracy, Patient Satisfaction and Retention of Conventional Versus 3-D Printed Maxillary Complete Denture: A Cross-over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques.


Eligibility criteria: Elligibility Criteria:

Inclusion Criteria:

* Completely edentulous patients were selected to have their ridges covered with firm, thick and compressible mucosa
* All patients accepting prosthodontic treatment by an removable denture.

Exclusion Criteria:

* TMJ disorder.
* Limited mouth opening or mandibular movement
* Muscle spasm or tenderness
* Mandibular deviation

Primary outcomes:
measure: Change of Retention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Accuracy
timeFrame: up to 1 week
measure: Electromyography Change
timeFrame: 3 months
measure: Change of Patient satisfaction
timeFrame: 3 months
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, AlAzhar University for Girls
Study officials:
References: