cyrilzakka/clinical-trials huggingface dataset:
Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain

The main goal of this study to integrate techniques producing images of the brain (also called neuroimaging techniques) with non-invasive brain stimulation to investigate factors that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).

Trigeminal neuropathic pain (TNP) disorders, such as classical trigeminal and post-surgical neuralgia, are debilitating chronic conditions with pain that is either spontaneous or that can be intensely evoked by light touch to the facial skin. Although neuroimaging techniques have provided insights into some brain mechanisms of experimental trigeminal pain in humans (DaSilva et al., 2002; Borsook et al., 2003), it is not well understood how structural and molecular mechanisms are affected during the course of TNP, and how they can be safely modulated for therapeutic and research purposes. Understanding these processes is crucial to determine the structures engaged in the development and persistence of TNP.

We will test the hypothesis that chronicity of TNP is sustained by changes at cellular and molecular levels in neural circuits associated with pain perception and modulation, rather than by the initial peripheral etiology, and that this dysfunction can be safely targeted and modulated as a therapeutic approach by transcranial direct current stimulation (tDCS). To achieve this goal we will use a neuroimaging technique, PET, employing a mathematical model that permits the quantification of opioid receptor availability in vivo.

Eligibility Criteria:
Patient Inclusion Criteria:

* Daily chronic TNP for at least 6 months not adequately controlled by pervious medicine therapies;
* minimal average baseline pain score of 4 (moderate to severe) in the visual analogue scale (VAS);
* unilateral pain
* orofacial allodynic region to mechanical (light touch or palpation) or thermal stimulation (head or cold);

Patient Exclusion Criteria:

* pregnancy or planning to become pregnant
* local pathology (e.g. orofacial lesion)
* history of systemic disorders (e.g. MS)
* history of other chronic pain disorder (e.g. back pain)
* recent orofacial surgery or trauma (\< 6 months)
* history of central origin disorders (e.g. stroke)
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age

Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.

As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, in good health or medically stable
* Able to understand and comply with planned study procedures
* Provide written informed consent
* Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)

Exclusion Criteria:

* Prior serious or severe reaction to influenza vaccine
* Known contraindication to either study vaccine
* Receipt of any other influenza vaccine within 180 days prior to enrollment
* Plan to receive another licensed influenza or other vaccine during the duration of this study
* Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
* Underlying disease or therapeutic intervention that might adversely affect the immune response
* Plans to participate in any investigation involving an investigational product during this study.
* Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
* Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses
* Three or more months have elapsed since the last abortion
* Postmenstrual period
* No other therapy allowed during our treatment course

Exclusion Criteria:

* Concomitant use of organic nitrites, or nitrates
* Severe hepatic, renal, or cardiovascular impairment
* History of stroke or myocardial infarction
* Patients with retinitis pigmentosa.
Acupuncture Treatment for Improving Alzheimer's Dementia

Evaluate cognitive improvement pre amd post acupuncture treatment in patients with probable alzheimer's dementia as measured by MOCA score and also per form A( measure of patient's personal information). Also caregiver input.

Patient's with diagnosis of probable mild to moderate AD will be enrolled in this study. Patient will undergo neurological examination including MOCA. Examiner will also fill out Form A at the time of initial evaluation.

Patient will then undergo series of acupuncture treatments 2 per week for 6 weeks(12 acupuncture treatment). At end of this intervention patients will be reassessed using same testing(MOCA and form A) Data collected will be assessed via statistical analysis to see if there is any statistically significant improvement.

Acupuncture points used in this trial will stay the same for all subjects and throughout the course. The points will be Si Shen Chong, ST36, 37, LV 2,3,6, GB 34, 39, Xia San Huang, LI 11, LI 4.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate AD

Exclusion Criteria:

* Severe AD
Improving Depression Treatment for Older Minority Adults

The purpose of this study is to improve access to quality depression care for older, low-income, minority adults in public sector health care. The study will examine current depression care in a public sector geriatric clinic that serves mostly Spanish-speaking Latinos and pilot study assessments and treatments in order to lay the groundwork for a large study of quality improvement for depressed older minorities

Depressive disorders affect 5-10% of older primary care patients, although rates may be higher among Latinos, especially among immigrants and those less acculturated. Late-life depression may be chronic and recurrent and results in significant morbidity and mortality. Despite a growing evidence base for the treatment of geriatric depression, only half of depressed older adults receive mental health care; fewer than 10% receive specialty services. Treatment rates are even lower for low-income, ethnic minorities who may be more ill and disabled, may lack adequate insurance and have different treatment preferences, and who frequently face barriers to accessing care. Recent quality improvement interventions for geriatric depression have targeted primary care, the location where older patients and ethnic minorities are most likely to receive mental health services. A recent multi-site, randomized trial of collaborative care for geriatric depression in primary care offered patients their choice of treatments, including antidepressant medication or 6-8 sessions of a structured psychotherapy. Although the intervention had few cultural accommodations, both processes and outcomes of care improved for depressed older minorities. However, because the study only included Latinos who were English-speaking and mostly high school graduates, these results may not generalize to a large proportion of ethnic minorities.

This study first examines current rates of depression and patterns of depression treatment in a public-sector geriatric clinic that serves mostly Spanish-speaking Latinos. Then depressed patients are identified and their depression treatment preferences and barriers to care are assessed. Patients are enrolled in a 6-month patient-centered, evidence-based intervention, and they, family members, and clinic medical providers are interviewed at program end to assess the feasibility, acceptability, and possible effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the LAC+USC Medical Center Geriatric Clinic
* English- or Spanish-speaking
* Positive for depression on the Geriatric Depression Scale
* Current major depressive disorder or dysthymia
* All adult family members, especially caregivers, and all regular clinic providers eligible for interviews

Exclusion Criteria:

* History of bipolar disorder or psychosis
* Significant cognitive impairment (score less than 24 on the Mini-Mental Status Examination, adjusted for age and education)
* Acute suicidal ideation
2019-06 TRISCEND Study

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.

Eligibility Criteria:
Key Inclusion Criteria:

* Functional or degenerative TR moderate or greater
* Symptomatic despite medical therapy or prior HF hospitalization from TR
* The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

Key Exclusion Criteria:

* Tricuspid valve anatomic contraindications
* Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
* Hemodynamic instability
* Refractory heart failure requiring advanced intervention
* Currently participating in another investigational study in which the patient has not reached a primary endpoint
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in people with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the efficacy and safety of VX-661 in combination with Ivacaftor (IVA, VX-770). The active treatment regimen comprised of a morning dose of a fixed-dose combination (FDC) tablet of 100 milligram (mg) VX-661/150 mg IVA once daily (qd) and an evening dose of IVA 150 mg to be taken approximately 12 hours after the morning dose. The placebo regimen was visually matched tablets to be taken with the same schedule as the active treatment.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening Visit
* Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis
* Forced expiratory volume at one second (FEV1) ≥40% and ≤90% of predicted normal for age, sex, and height during screening
* Stable CF disease as judged by the investigator
* Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug)
* Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Day 1)
* Sexually active participants of reproductive potential who are not willing to follow the contraception requirements
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)

The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants will have the opportunity to receive intravenous (IV) delandistrogene moxeparvovec in either Part 1 or Part 2.


Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of DMD based on documented clinical findings and prior genetic testing.
* Cohort 1 only: Non-ambulatory per protocol-specified criteria.
* Cohort 2 only: Ambulatory per protocol-specified criteria and ≥8 to \<18 years of age at the time of Screening.
* Ability to cooperate with motor assessment testing.
* Stable daily dose of oral corticosteroids for at least 12 weeks prior to Screening, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight).
* Recombinant Adeno-Associated Virus Serotype rh74 (rAAVrh74) antibody titers are not elevated as per protocol-specified requirements.
* A pathogenic frameshift mutation or premature stop codon in the DMD gene, except for any deletion mutations in exon 8 and/or 9.

Exclusion Criteria:

* Exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression within protocol specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests.
* Presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risk for gene transfer.

Other inclusion or exclusion criteria could apply.
Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children.

Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.

Fever: a single oral temperature of \>/= 38.3 degrees C; or \>/= 38.0 degrees C for \>/= 1 hour.

Neutropenia: neutrophil count, \< 500/cu mm or \<1,000/cu mm with a predicted decrease to \<500/mm3.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1 year - 14 years
* A single oral temperature of \>/= 38.3 degrees C; or \>/= 38.0 degrees C for \>/= 1 hour.
* Neutropenia: neutrophil count, \< 500/cu mm or \<1,000/cu mm with a predicted decrease to \<500/mm3.
* During the course of chemotherapy

Exclusion Criteria:

* History of amikacin or cloxacillin allergy
* Creatinine clearance \< 30 ml/min/m2
* Central nervous system infection: meningitis or brain abscess
* History of hearing abnormality
* Severely ill: shock
* Chronic liver diseases or SGPT \> 10 times of upper normal limit
* Received aminoglycoside within 14 days prior to enrolment
* Received any intravenous antibiotics within 7 days
* Cancer which is newly diagnosed or relapsed
Bilateral; Flank Study With Crown Cooling Insert

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.

This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
* No weight change exceeding 5% of body weight in the preceding month.
* Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed the study written informed consent form.

Exclusion Criteria

* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
* Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
* Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject has a history of hernia in the areas to be treated.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo.

VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestous, drug induced ILD, unclassified ILD)
* Dyspnea corresponding to Medial Research Councils (MRC) dyspnea score ≥ 3
* Written consent
* Age ≥ 18 years
* Competent
* For fertile women: Negative pregnancy test
* For fertile and sexually active participants: Use of safe anti-conceptionals

Exclusion Criteria:

* Ongoing infection
* Decreased lung function to a degree which makes any form of respiratory depression life threatening
* Treatment with morphine or morphine analogues
* Allergy towards morphine hydrochloride
Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. However, one of the concerns with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients undergoing total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3
* scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

* Allergy or intolerance to any of the drugs used in the study
* Hepatic or renal insufficiency
* Opioid dependency
* Coagulopathy
* Pre-existing neurologic or anatomic deficits in the lower extremities
* Severe psychiatric illness
Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory or hospitalized patients
* patients over 50 years old
* one or more venous leg ulcer, lasting for 1 month or more
* wound area more than 1 cm2
* clinical findings consistent with established venous disease (skin hyperpigmentation, varicose veins, lipodermatosclerosis), confirmed by venous Doppler duplex ultrasonography performed during the preceding 6 months
* absence of significant arterial insufficiency assessed by clinical findings (intermittent claudication or resting pain, necrotic or distal foot wound) and by an ankle brachial index (ABI) ≥0.8
* ability to give informed consent
* ability to be followed for 24 weeks

Exclusion Criteria:

* ongoing systemic diseases known to be associated with pyoderma gangrenosum or necrotizing vasculitis
* corticosteroid, cytotoxic or immunosuppressant drug use during the preceding 3 months
* hypertensive leg ulcer
* foot ulcer
* ABI \< 0.8