Kornimate/medical-research-clean huggingface dataset:
boosting the hrqol among hiv+ mothers and children

Conditions: HIV; Perinatal HIV Infection

Summary: the goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (hrqol) among perinatally infected hiv positive children and their hiv positive mothers in china. the main questions it aims to answer are: 1. whether baseline resilience and treatment adherence are associated with the hrqol; 2. whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of hrqol, and dyadic level outcomes such as dyadic coping; 3. whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of hrqol, and dyadic level outcomes such as dyadic coping; 4. whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups; 5. whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups. participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions.


Eligibility criteria:
inclusion criteria: 1. the child is hiv positive and perinatally infected, and receives haart; 2. the biological mother of the child is hiv positive and receives haart; 3. the mother is a primary caregiver of the child. exclusion criteria: 1. cannot complete the assessment due to a low education level or physical constraints; 2. have been diagnosed with another life-threatening disease (e.g., cancer); 3. have experienced a traumatic event (e.g., a severe car accident or bereavement) in the past 12 months.
efficacy, safety, and tolerability of topical terbinafine in patients with mild to moderate toenail fungus of the big toenail

Conditions: Onychomycosis

Summary: this study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. this trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.


Eligibility criteria:
inclusion criteria: * male and females 12 - 75 years of age * fungal toenail infection of one or both of the large (great) toenails * the nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed) exclusion criteria: * target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. other topical treatments for athlete's foot may be recommended at the discretion of the investigator. * subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved * no administration of systemic antifungal medications within 6 months prior to screening visit * no application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit * no professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit * known pregnancy or lactation at time of enrollment other protocol-defined inclusion/exclusion criteria may apply

Keywords: toenail fungus onychomycosis nail fungus toenail fungal infection tinea unguium dermatophytes foot dermatoses
long-term fasting: multi-system adaptations in humans

Conditions: Fasting

Summary: the aim of this trial is to investigate the effects of long-term fasting on size, mass, composition and function of metabolic active tissues in several organs that reexpand possibly rejuvenated after 1-4 months. additionally, the lipid metabolism is investigated in depth.

fasting displays numerous positive effects on metabolism, health and aging. surprisingly, few considerations are given to long-term fasting periods. the metabolic switch from food-derived glucose to adipose tissue-derived fatty acids and ketones as primary cellular fuel is the key to fasting metabolism. fasting has been shown to improve cardiovascular risk factors and gut microbiota in humans. it provokes profound changes in lipid metabolism. however, many questions are still open concerning the mobilization, exchange, and function of lipids during long-term fasting. furthermore, recent results show the ability of periodic restrictive nutritional strategies to trigger organ regeneration. this promising regenerative power has not been investigated comprehensively in humans. in addition, the knowledge about the role of human faecal microbiota in health and disease is increasing. only little is known about its composition and function during fasting. we found indications that the gut microbiome could influence energy metabolism and consequently could influence the dynamic of the metabolic switch. long-term fasting under medical supervision according to the buchinger wilhelmi fasting program has been demonstrated to be safe and well-tolerated. the current project investigates the effects of a 9±3 days fasting period by a multi-systemic approach focusing on lipid metabolism and the gut microbiome in 100 subjects. additionally, the body composition in combination with muscle performance will be analyzed in-depth in a subgroup of 32 subjects.

Eligibility criteria:
inclusion criteria: * bmi between 22 - 35 kg/m2 exclusion criteria: * intake of medication (cardiovascular diseases, lipid and glucose metabolism) * chronic manifest psychical and psychiatric diseases * participation in another study * pregnancy or breastfeeding * in the mri/mrs sub-study, any mri contraindication (claustrophobia, pacemakers, mr-incompatible prosthetic valves, metallic implants, foreign metallic body) * active uncontrolled gastrointestinal disorders including ulcerative colitis, crohn's disease, indeterminate colitis, severe irritable bowel syndrome, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, recurrent clostridium difficile infection * major surgery of the gi tract, in the past five years. any major bowel resection at any time * intake of antibiotics in the last 2 months

Keywords: long-term fasting buchinger wilhelmi program magnetic resonance imaging (mri) magnetic resonance spectroscopy (mrs) hdl efflux capacity fatty acid profile in erythrocyte membrane gut microbiota metabolomics hydrogen sulfide and transsulfuration pathway
a post market study on drg stimulation in fbss (sympathy)

Conditions: Failed Back Surgery Syndrome

Summary: the purpose of this post market observational study is to monitor the effect of the axium® scs system in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment with the axium® scs system.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject is able and willing to comply with the follow-up schedule and protocol 3. chronic pain following surgical lumbar discectomy for at least 6 months 4. failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. minimum baseline pain rating of 60 mm on the vas in the subjects' primary area of pain 6. subject is able to provide written informed consent exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study 2. escalating or changing pain condition within the past month as evidenced by investigator examination 3. subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. subject has had radiofrequency treatment of an intended target drg within the past 3 months 5. subject currently has an active implantable device including icd, pacemaker, spinal cord stimulator or intrathecal drug pump 6. subject is unable to operate the device 7. subjects with indwelling devices that may pose an increased risk of infection 8. subjects currently has an active infection 9. subject has participated in another clinical investigation within 30 days 10. subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. subject has been diagnosed with cancer in the past 2 years. 12. subject has an anatomical spinal abnormality which is anticipated to require further surgery
a clinical study to assess the efficacy and safety of vildagliptin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study was not conducted in the united states. the purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * patients who have been placed on diet and exercise therapy without achievement of glycemic control * outpatients exclusion criteria: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * significant cardiovascular diseases * significant diabetic complications * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hba1c
steroid treatment for meatal stenosis

Conditions: Meatal Stenosis

Summary: the goal of this observational study is to learn about the efficacy of topical steroid treatment for meatal stenosis. the main question it aims to answer is: is steroid therapy effective for treatment of meatal stenosis? participants already treated for meatal stenosis will be included.


Eligibility criteria:
inclusion criteria: * presence of meatal stenosis exclusion criteria: * presence of any anatomical problem or history of surgery
do young triathletes have a greater predisposition to suffer running injuries

Conditions: Gait Retraining; Kinematics

Summary: in running 70% of the lower limb, injuries are produced in the running segment. the vast majority of sports-related musculoskeletal injuries in young athletes are caused by overuse. previous research has shown a clear association between running-related injuries and kinematic patterns, showing the existence of a causal relationship between biomechanical alterations and injures. according to the evidence, that real-time visual and auditory feedback based on gait retraining should be considered to treat injured runners or prevent injuries. however, no previous studies have been carried out on whether gait retraining decreases running-related injuries incidence in young triathletes. the investigators propose a study to determine the effect of gait retraining on the decrease in the number of running-related injuries and improve the running efficiency in young triathletes.


Eligibility criteria:
inclusion criteria: * triathletes included in the triathlon plan in high performance of the valencian community in spain. * reported running a minimum of 2 days per week for the last 3 months with no reported injury. * worst pain rated a minimum of 3 out 10 on a numerical rating scale (nrs) for pain (0=no pain, 10=worst possible pain) exclusion criteria: * previous musculoskeletal surgery. * neurological impairment * structural deformity in the knee. * pain suffered by trauma or sports activity, having stopped running or receiving additional treatment outside the study.

Keywords: gait analysis triathlon running gait retraining
corevalve viva study evaluation of the clinical outcomes of corevalve in degenerative surgical aortic bioprosthesis.

Conditions: Aortic Valve Stenosis

Summary: this observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the medtronic corevalve® system for transcatheter aortic valve implantation (tavi).

to collect real-world (post-approval use) data regarding the clinical utility and performance of the medtronic corevalve® system for tavi in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.

Eligibility criteria:
inclusion criteria: * patient is \> 18 years old * patient has a symptomatic degeneration of aortic bioprosthesis * acceptable candidate for elective treatment with the medtronic corevalvetm system (according to the most recent version of the medtronic corevalvetm instructions for use) and in conformity with the local regulatory and reimbursement context * logistical euroscore \> 20% or sts \> 10% or presence of comorbidities responsible of contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or patients in whom heart team has assessed the redo surgery at high risk * the patient or legal representative has been informed of the nature of the procedure and the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("patient informed consent form") * the patient is willing and able to comply with requirements of the study, including the 24 months follow-up * patient will receive the corevalvetm device in a degenerated surgical bioprosthesis exclusion criteria: * patients in whom anti-platelet and/or anticoagulant therapy is contraindicated * patient in whom heart team considers that risk of tavi is too high with a particular attention for the risk of coronary occlusion * patient with prior endocarditis on failed bioprosthesis * patient has other medical illness associated with a limited life expectancy (i.e., less than 1 year) * patient with lvef \<20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices * patient with severe mitral disease associated with severe pulmonary hypertension * acute coronary syndrome less than 7 days before intervention * currently participating in another investigational drug or device study. * patient with significant paravalvular regurgitation * patient in whom internal diameter prosthesis is equal to 17 mm
post-marketing surveillance study on the safety and efficacy of cymbalta (duloxetine) on diabetic peripheral neuropathic pain among filipino patients

Conditions: Pain

Summary: primary objective: to estimate the frequency of adverse events, serious and non-serious in filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once daily within the study duration of approximately 6-8 weeks in a naturalistic clinical setting. secondary objective: to evaluate the change from baseline to endpoint in the brief pain inventory (bpi) and neuropathic pain questionnaire (npq) assessed by the investigators in duloxetine use in the treatment of diabetic peripheral neuropathic pain among filipino patients within the study duration of approximately 6-8 weeks in a naturalistic clinical setting.


Eligibility criteria:
inclusion criteria * are of filipino race * are male or female outpatients at least 18 years of age * provide written consent to the release of their data after being informed of the study * are known diabetics and have been clinically diagnosed by the investigator to have diabetic peripheral neuropathic pain * are judged by the investigator to be reliable, and agree to keep appointments for clinic visits, complete tests and procedures as may be required by his/her attending physician in the course of routine clinical care * treated with duloxetine according to the approved product information as prescribed by the investigator in the routine care of the patient, without the concomitant conditions and medications specified therein as contraindicated exclusion criteria * are the investigators or their immediate families. immediate family was defined as the investigator's spouse, parents, naturally or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. employees of investigators are also not eligible * are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug * are hypersensitive to duloxetine or any of its components * are pregnant and/or nursing mothers * have concomitant conditions contraindicated for duloxetine treatment, as described in the product information (e.g. liver disease resulting in hepatic impairment, severe renal impairment) * are concomitantly taking contraindicated medications, as described in the product information (e.g. fluvoxamine, ciprofloxacin)
the interest of the ani in the monitoring of peroperative analgesia in bariatric surgery

Conditions: Surgery; Obese

Summary: the intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.

the intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. currently, this assessment is based on hemodynamic changes, although hypertension or tachycardia is neither sensitive nor specific. an overdose in opioids exposes to many side effects ranging from respiratory depression to phenomena of post-operative hyperalgesia. conversely, an under-dosage in opioids is at the origin of a nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative morbidity or promote the occurrence of implicit memorization. nociceptive influx can not be detected directly. however, its ascent to the somesthetic area of the cerebral cortex leads to physiological reactions that can be evaluated. in particular, there are numerous anatomical and functional interactions between the autonomic nervous system and the nociceptive tract in the brain stem. these interactions are mainly at the level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the solitary tract nucleus and the hypothalamus. the nociceptive influx thus leads to changes in the activity of the ans. the study of changes in the ans would therefore be a method of assessing the intensity of the nociceptive influx. this objective method can be used in the non-communicating or unconscious patient to evaluate the pain and to adapt the analgesic treatment to the best. obese patients who receive surgical management often have comorbidities such as restrictive syndrome, or obstructive sleep apnea syndrome. they thus represent a target of choice in perioperative analgesic optimization in order to avoid respiratory complications that may be related to over or under assay of morphine such as atelectasis, alveolar hypoventilation. it is hypothesized that this device is more effective for the intraoperative evaluation of analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized patients for bariatric surgery.

Eligibility criteria:
inclusion criteria: * major patient age ≥ 18 years * adult patients candidate for planned surgery with bmi\> 30. * affiliation to social security. * patients who were clearly informed and signed consent. exclusion criteria: * patient with a heart rhythm disorder. * respiratory rate less than 9 cycles / min. * irregular spontaneous ventilation. * perioperative use of a drug acting on the sinus node (eg atropine, etc.) * history of neuropathic pain. * patient under morphine until the day before surgery. * patients under guardianship or curatorship or deprived of liberty

Keywords: analgesia per-operative
extension study of ag-348 in adult participants with pyruvate kinase deficiency previously enrolled in ag-348-006 or ag348-c-007

Conditions: Pyruvate Kinase Deficiency

Summary: this is a multicenter, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with ag-348 in participants who were previously enrolled in study ag348-c-006 or study ag348-c-007.


Eligibility criteria:
inclusion criteria: * be willing and able to comply with study visits and procedures; * have signed written informed consent prior to participating in this extension study; * have completed either antecedent study ag348-c-006 or ag348-c-007 through the part 2 week 24 visit; * cohorts 2 and 3: have demonstrated clinical benefit from ag-348 treatment in the antecedent study, in the opinion of the investigator; * for women of reproductive potential, have a negative pregnancy test during screening; * for women of reproductive potential as well as men with partners who are women of reproductive potential, be abstinent as part of their usual lifestyle, or agree to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of giving informed consent, during the study, and for 28 days following the last dose of study drug for women and 90 days following the last dose of study drug for men. exclusion criteria: * have a significant medical condition (including clinically significant laboratory abnormality) that developed during his/her antecedent ag- 348 study that confers an unacceptable risk to participating in this extension study, that could confound the interpretation of the study data, and/or that compromises the ability of the participant to complete study visits and procedures. * are currently pregnant or breastfeeding. * have a splenectomy scheduled during the study treatment period. * meet the withdrawal criteria of his/her antecedent ag-348 study during screening of this extension study. * are currently receiving medications that are strong inhibitors of cytochrome p450 (cyp)3a4 that have not been stopped for a duration of at least 5 days or a time frame equivalent to 5 half-lives (whichever is longer) before start of study drug; or strong inducers of cyp3a4 that have not been stopped for a duration of at least 28 days or a time frame equivalent to 5 half-lives (whichever is longer) before start of study drug on this extension study. * have received anabolic steroids, including testosterone preparations, within 28 days prior to start of study drug on this extension study. * have received hematopoietic stimulating agents (eg, erythropoietins, granulocyte colony stimulating factors, thrombopoietins) within 28 days prior to start of study drug on this extension study. * have exposure to any investigational drug other than ag-348, device, or procedure within 3 months prior to start of study drug on this extension study.