Kornimate/medical-research-clean huggingface dataset:
ata-200 dose-escalation gene therapy trial in patients with lgmdr5

Conditions: LGMD2C

Summary: the purpose of ata-003-gsar study is to evaluate the safety and tolerability of a single intravenous infusion of ata-200 in pediatric patients with limb girdle muscular dystrophy type 2c/r5 (lgmd r5). patients will be treated sequentially in 2 dose-cohorts.

this is a multicenter phase 1b assessing the safety and tolerability of 2 doses of ata-200 for the treatment of lgmdr5. the dose escalation phase will enroll ambulant patients with lgmdr5. two dose cohorts (c1) and (c2) will be enrolled sequentially and enrollment will be staggered with at least 4-week interval between 2 patient treatments. an initial cohort c1 of three (3) patients will receive a potentially effective dose corresponding to the minimum effective dose (med) in preclinical studies. enrollment of three (3) patients in the 2nd higher dose cohort c2 (with a 7-fold safety margin relative to the highest safe dose in the glp toxicology study) will be initiated following review of the one-month safety data post-administration in cohort c1 by an independent data safety monitoring board (dsmb). time point of primary interest for safety evaluation and dose selection for future studies is at 6 months. all subjects will be followed up for an additional 4.5 years after completion of the evaluation period.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of lgmdr5 before age of 10, based on clinical presentation and genotyping * ambulant male or female patients aged 6 to less than 12 years of age at screening * able to perform the 10-meter walk test (10mwt) in less than 15 sec and to rise from chair with or without arm support exclusion criteria: * detectable neutralizing antibodies against aav8 * cardiomyopathy with left ventricular ejection fraction (lvef) \&lt; 50% * respiratory assistance * concomitant medical condition that might interfere with lgmdr5 evolution * acute illness within 4 weeks of anticipated imp administration * current participation in another clinical trial with investigational medicinal product * previous participation in gene and cell therapy trials * any condition that would contraindicate immunosuppressant treatment * presence of any permanent items (e.g., metal braces) precluding undergoing mri * any vaccination 1 month prior to planned imp administration * serology consistent with hiv exposure or active hepatitis b or c infection * grade 2 or higher lab abnormalities for liver function tests, creatinine, hemogram and coagulation
a micro/nano device for exhaled breath analysis

Conditions: Lung Cancer; Pulmonary Disease

Summary: use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds (vocs) in human exhaled breath for quantitative analysis of vocs.

will use fourier transform mass spectrometry (ft-ms) and gas chromatography-mass spectrometry (gc-ms) to analyze concentrated vocs. the purpose of this study is to search for disease-related markers in the breath in subjects with known or suspected lung or other cancer, or pulmonary disease.

Eligibility criteria:
inclusion criteria: * for controlled (healthy) subjects - we are seeking persons who do not have a known history of cancer or pulmonary disease. * both smokers and nonsmokers are invited to participate as control subjects. * for experimental subjects, we are seeking persons with pulmonary disease but no known history of cancer, as identified by the investigators during routine clinic or office visits. * additionally for experimental subjects, we are seeking persons with known or suspected lung or other cancers, as identified by the investigators during routine clinic or office visits. exclusion criteria:

Keywords: lung cancer pulmonary disease
prevention of stroke and sudden cardiac death by recording of 1-channel electrocardiograms

Conditions: Sinus Rhythm; Atrial Fibrillation; Atrial Premature Complexes; Ventricular Premature Complexes; Ventricular Tachycardia, Nonsustained

Summary: single-channel electrocardiograms (lead i of 12-lead surface ecg; 30 seconds) will be collected from subjects/patients at 11 clinical centers in germany to train an artificial intelligence in the automatic diagnosis of regular and irregular heart rhythms. heart rhythms of interest are normal sinus rhythm (sr), atrial fibrillation (af), atrial premature beats (apbs), ventricular premature beats (vpbs), and nonsustained ventricular tachycardia (vt). per diagnosis, 20,000 ecgs are required, for a total of 100,000 ecgs to be obtained from approximately 10,000 subjects/patients.

in phase 1 of a research project titled 'prevention of stroke and sudden cardiac death by recording of 1-channel electrocardiograms' (price), a total of 100,000 30-sec single-channel ecgs (lead i of 12-lead surface ecg) will be collected from approximately 10,000 subjects/patients at 11 participating clinical centers in germany. relevant baseline clinical patient characteristics will also be recorded. the ecgs, diagnosed by an experienced electrophysiologist (diagnostic gold standard), will be fed into an artificial intelligence (ai) for the automatic detection of normal sinus rhythm (sr), atrial fibrillation (af), atrial premature beats (apbs), ventricular premature beats (vpbs), and nonsustained ventricular tachycardia (vt). it is expected that the overall diagnostic accuracy of the ai against an experienced electrophysiologist will be on the order of 95%. in price phase 2, ecg diagnosis by the ai will be compared with the diagnosis by 3 general cardiologists of the same ecgs. it is expected that the ai will surpass the general cardiologists in terms of diagnostic accuracy. the final clinical phase of the price project will comprise a randomized controlled community trial of risk patients to establish the superiority in stroke prevention of ai detection of af on smart-watch ecgs vs. no af detection.

Eligibility criteria:
inclusion criteria: * heart rhythm of interest present on ecg exclusion criteria: * patient incapable of or not willing to sign informed consent form

Keywords: automated ecg diagnosis
effect of lavender inhalation on dysmenorrhea

Conditions: Dysmenorrhea

Summary: this study was planned to determine the effect of lavender inhalation on primary dysmenorrhea and its symptoms.

the research is a randomized controlled trial and an experimental research design will be used. the research will be carried out with two groups as experimental (lavender) and control (placebo) groups.

Eligibility criteria:
inclusion criteria: * having primary dysmenorrhea (degrees ii and iii), * single, * who have never been pregnant before, * having a regular menstrual cycle * without any genital organ disorder (such as fibroids, fibroadenoma, endometriosis, metrorrhagia, ovarian cyst, pelvic inflammatory disease, chronic pelvic pain, other pelvic pathologies) * not using contraceptive method, * having a normal sense of smell * people who can smell odors and are not allergic to odors will be included in the study. exclusion criteria: * married, * having a disease that causes dysmenorrhea, * regularly using a pharmacological and non-pharmacological method to relieve * dysmenorrhea pain during the study, * having a previous or unconcluded pregnancy, * having a chronic disease (diabetes, endometriosis, uterine congenital anomalies, epilepsy, etc.), * using drugs that affect the menstrual cycle or dysmenorrhea, * persons who fill in the data collection form incompletely or not at all will not be included in the study.
observational cohort of hiv infected adults and children in the phpt network hospitals in thailand

Conditions: HIV Infections

Summary: since 2004, the thai ministry of public health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80,000 patients with partial support of the global fund to fight aids, tuberculosis and malaria (gfatm). as access to hiv care continues to expand under the universal health coverage system, it is important to document and analyze the efficacy, tolerance, toxicity and acceptability of antiretroviral therapy within pilot treatment programs, to provide evidence based feedback and recommendations to the national program and policy makers.

as thailand is rapidly expanding access to antiretroviral treatments under the universal health coverage system, it is crucial to document and learn from pilot antiretroviral treatment programs, in particular the medical outcomes and logistical, and organizational issues faced by hospital teams and patients in order to adapt the arv delivery and monitoring system to various local settings. specific objectives 1. analyze data collected in patients participating in the phpt antiretroviral treatment program, in accordance to national and international guidelines, with no experimental interventions. 2. to determine factors associated with treatment outcome including immune status, virologic factors and antiretroviral drugs levels 3. to study the operational aspects of integrating comprehensive hiv care into the existing care system with regards to new activities generated at the hospital level (counseling, referral systems, biological monitoring), the impact on other health activities, mobilization of human and financial resources, affordability and sustainability. the population of the study consists of approximately 2,000 consenting hiv-infected patients, including one-third of children, receiving hiv care as part of the gf-atm or oxfam access to antiretroviral programs, presenting at any of the phpt network hospitals.

Eligibility criteria:
inclusion criteria: * adults and children (children are defined as less than 18 years old) patients are eligible for the inclusion in the cohort if they meet all the following inclusion criteria: * participation in the gfatm or oxfam access to antiretroviral programs * for adults, consent to have their clinical or biological data used for this research study, and willingness to be followed at one of the phpt network hospitals. for children, caregiver's consent to participate, willingness to bring the child to the scheduled visits for the duration of the treatment, and to have the child's clinical or biological data used for this research study. exclusion criteria: * this is an observational study of an access to treatment program, therefore all patients who require treatment and are willing to be followed by the medical team and have their data collected can be enrolled in the study. the only exclusion criteria would be refusal to participate and the discontinuation criteria would be withdrawal of consent.

Keywords: highly active antiretroviral therapy hiv viral load hiv drug resistance thailand
treatment of huntington's chorea with amantadine

Conditions: Chorea; Huntington's Disease

Summary: huntington's disease is a chronic disorder passed on through genetic autosomal dominant inheritance. the condition usually begins between the ages of 30 and 50 years and it is characterized by involuntary movements in the face and extremities, (chorea), accompanied by changes in behavior and gradual loss of the mental function. the disease typically ends in a state of disorientation, impaired memory, judgement, and intellect (dementia). the objective of this study is to test the effectiveness of the drug amantadine for the treatment of chorea associated with huntington's disease. amantadine is an antiviral drug that has been used to treat a variety of illnesses including parkinson's disease. amantadine works by attaching to special sites called nmda (n-methyl-d-aspartate) receptors and blocking the normal activity of glutamate there. glutamate is an amino acid released by brain cells and has been associated with the symptoms of parkinson's disease.

the objective of this study is to evaluate the acute effects of the putative nmda-receptor antagonist amantadine on chorea of patients with huntington's disease (hd). participants in this study will have mild to moderate hd associated with chorea.

Eligibility criteria:
all patients will carry a diagnosis of huntington's disease confirmed by dna testing. patients will have mild to moderate disease with associated significant chorea. ability to comply with study requirements and to report on their condition by telephone. males and females between the ages of 18 and 82. no patients with the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. no patients with renal impairment (serum creatinine exceeding the upper limit of normal). no patients with a history of intolerance to previous exposure to amantadine. no patients with an mmse of less than 18/30. no patients receiving other anti-chorea therapies (such as haldol). those receiving other anti-chorea therapies must stop taking these medications for at least 4 weeks prior to the study to be eligible. no pregnant women. patients must practice effective means of birth control.

Keywords: amantadine chorea glutamate antagonist
early intervention for suicide risk among immigrant youth

Conditions: Family Conflict; Suicidal Ideation

Summary: the purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant latino/a adolescents. the intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child communication. the investigators will first develop the 8-session preventive intervention with quantitative data from analysis of existing longitudinal studies and qualitative feedback from latino youth and their caregivers, clinicians, administrators, and research consultants, as well as results from initial pilot testing of the intervention. the investigators will then conduct a pilot randomized trial with 40 adolescents and their families to test feasibility, acceptability, and impact on intervention targets. successful development of the intervention would improve mental health outcomes for a growing and underserved portion of the u.s. population.

suicide is the second-leading cause of death among adolescents, with rates increasing between 1999 and 2014. family-based preventive interventions demonstrate promise for reducing suicide risk among adolescents, and are particularly relevant for addressing suicide risk factors specific to immigrant youth, who comprise one-fourth of the u.s. population under 18. the purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant latino/a adolescents. in the first phase of intervention development, quantitative and qualitative data will be used to develop and if necessary refine a new family based preventive intervention (early intervention for suicide risk among immigrant youth, eisr-i). the investigators will then test the intervention in a pilot case series in order to finalize assessment and intervention protocols. in the second phase, the investigators will pilot test the preventive intervention, delivered by mental health clinicians to 1st and 2nd generation latino/a early adolescents and their families, in order to assess feasibility, acceptability, and impact on the intervention targets (i.e. a positive signal of the intervention) on the study population. twenty families will be randomized to receive the 8-session intervention and twenty will receive enhanced usual care including a safety planning and feedback session.

Eligibility criteria:
inclusion criteria: * latino * first generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant * 12 to 15 years old * speaks english or spanish * reports current suicidal ideation with no plan, past-year suicidal ideation, or a suicide plan more than three months prior or has a cat-ss score\>34 exclusion criteria: * suicide attempt in the past three months * endorses psychotic symptoms on a pre-study screener * has severe major depressive disorder * has a prior diagnosis of severe intellectual disability * receiving individual or family therapy

Keywords: suicidal ideation mental health adolescent latino immigrant
catheter extension trial for early vesicovaginal fistula repair failures

Conditions: Vesico Vaginal Fistula

Summary: this study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). both groups will be examined for outcomes at 3 months post-repair.

at present, there is no standard of care nor consensus for the proper management of repaired vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter removal. in the past, extension of time with catheterization has been tried, with patients becoming fully healed by the time of catheter removal. however, some patients who are discharged with a fistulous leak later return at follow up completely dry, with a closed and healed fistula. this study will compare, in a prospective, randomized manner, extension of catheterization vs no intervention, to see if in such patients extending catheterization will improve their likelihood of complete fistula healing.

Eligibility criteria:
inclusion criteria: * women who present with a vesicovaginal fistula for surgical repair and who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test exclusion criteria: * hiv infection, * concomitant bladder stone(s), * one or more ureters outside of the bladder, * urethrovaginal fistula, * multiple fistulas (more than one), * dye leak / fistulous leak present at end of surgical procedure, * radiation-induced fistula, * fistula caused by cancer or infection (such as lymphogranuloma venereum), * continence procedures being performed (such as pubovaginal sling), * rectovaginal fistula, * pregnancy, * fistula breakdown of greater than 2cm identified on postoperative dye test.

Keywords: vesicovaginal fistula urinary catheter catheter extension
lymphopilot test for limb lymphedema

Conditions: Lymphedema, Secondary; Lymphedema of Upper Limb; Lymphedema Arm; Lymphedema of Leg; Lymphedema, Lower Limb

Summary: the present study is a first-in-man, single arm, open-label, single center study to assess feasibility and safety of a novel implantable device, lymphopilot, in patients suffering from secondary upper limb or lower lymphedema.

the study consists in a first-in-man clinical investigation for lymphopilot, an investigational implantable medical device. lymphopilot is composed of an implanted part and an external wearable device. the implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm or leg and drains excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. the external part consists in a wearable controller used to activate the implanted pump. the subcutaneous implantation of the device is performed in loco-regional or general anesthesia, in ambulatorial settings, and the patient is dismissed from the hospital on the same day of the procedure. the device is activated in the postoperative room by placing the external wearable device on patient's limb, in proximity of the implanted pump. patients are required to wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. follow-up visits are planned 1, 4 and 8 weeks after device implantation. the implanted device is removed with a surgical procedure in local anesthesia 8 weeks after device implantation, and 2 additional follow-up visits are planned after device removal.

Eligibility criteria:
inclusion criteria: * female patients, 18 years and older * patients with unilateral secondary upper or lower limb lymphedema. exclusion criteria: * active cellulitis/infection * lymphedema associated with active cancer requiring chemotherapy or radiotherapy * motor and sensitive neurological deficiency * post-operative edema (i.e. acute edema following breast cancer related surgery) * any contraindication to surgery or to loco-regional or general anesthesia * patient participating in any other clinical study * patient unable to provide informed consent * patient with pacemaker * pathologies associated with an overload of the cardiac system * poor wound healing * pregnancy or breastfeeding * known intolerance to implantable devices * known allergies to silicone * patient needing magnetic therapy * any other condition that according to the principal investigator makes the patient unsuitable for the participation in the trial * patient refusing to receive information about incidental findings on her health status discovered during the clinical investigation * l-dex score lower than 6.5 at screening

Keywords: lymphedema
relationship to dose of triamcinolone acetonide and methylyprednisolone to improvement in subacromial bursitis

Conditions: Subacromial Bursitis; Shoulder Pain

Summary: it is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. this study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.

background: subacromial bursitis is a common site for patients to report shoulder pain. in some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or nsaids. subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects. methods: our hypothesis is that both methylprednisolone and triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. subjects will be enrolled in this trial which lasts 6 weeks. subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. no placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection. outcomes: primary outcome with be the improvement in a functional measure of the shoulder, the quickdash ®, at 6 weeks. secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).

Eligibility criteria:
inclusion criteria: * age 18 years or older * history and physical examination consistent with shoulder pain and subacromial bursitis * at least 2 weeks of shoulder pain and subacromial bursitis exclusion criteria: * known allergies to lidocaine, marcaine, methylprednisolone, and/or triamcinolone * history or examination suspicious for a humeral head fracture * history or examination consistent with adhesive capsulitis (normal x-ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side * history or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint * any shoulder surgery involving the affected arm within the last 6 months

Keywords: subacromial bursitis triamcinolone methylprednisolone shoulder pain