Kornimate/medical-research-clean huggingface dataset:
vr-act after stroke: a feasibility study

Conditions: Chronic Pain; Stroke

Summary: this exploratory project aims to develop and pilot test, in a parallel group randomized controlled trial (rct) design, the feasibility, acceptability, and preliminary efficacy of a self-management virtual reality (vr) 8-week program for pain management and mental health in patients with chronic post-stroke pain (cpsp), in two assessment moments (pre- to post-intervention).

this project has three objectives: o1) to develop and test the feasibility and acceptability of a 8-week vr act program (vr-act) in a sample of cpsp patients; o2) to pilot test the efficacy of vr-act in improving pain, mental health, and adaptive psychological processes and skills, and in reducing the functional connectivity of the triple network (dmn, sn, and fpn); o3) to examine the cost-effectiveness of the vr-act. the current project will conduct a parallel group design randomized controlled trial (rct) and will follow a multi-method approach (qualitative and quantitative assessment).

Eligibility criteria:
inclusion criteria: * medical diagnosis of cpsp; * age between 18 and 80; * implicit de facto internet and computer literacy; * willingness to comply with the study procedures. exclusion criteria: * currently with active malignancy; - * severe cognitive impairment; * currently undergoing any psychological intervention or vr-delivered pain management program; * current severe psychiatric symptoms (i.e., psychosis; severe depression; non-suicidal self-injury; suicide attempt in the last month); * language impairment with severe comprehension deficit; * history of photosensitive epilepsy or previous experience of severe simulator sickness; * other neurological conditions (e.g., dementia; parkinson´s).

Keywords: chronic post-stroke pain contextual-behavioral approaches virtual reality acceptance and commitment therapy
virtual world training for community health workers (chw)

Conditions: Diabetes Mellitus Risk

Summary: standard, effective, and scalable training models are needed to help equip community health workers in their community-based diabetes prevention awareness efforts. this study will tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to remotely deliver a diabetes prevention awareness training program to community health workers.

standard, effective, and scalable training models are needed to help equip community health workers in their community-based diabetes prevention awareness efforts. this study will tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to remotely deliver a diabetes prevention awareness training program to community health workers. a sequential mixed-methods design is used to address these specific aims: 1. use community-based participatory research methods to guide the overall study and inform tailoring and adaptation of our virtual world model to deliver the chw training program; 2. conduct a randomized pilot study to compare change in primary outcomes (0, 12 weeks) after the in-person versus virtual world delivery of the program; and 3. conduct summative focus groups to gather information to refine the program and study methodology.

Eligibility criteria:
inclusion criteria: * community health worker * 18-65 years old * female * of african american/black/african ancestry * not getting 150 minutes of physical activity weekly and/or overweight * residing in chicago/driving distance to chicago study site * regular access to internet and computer exclusion criteria: • does not meet inclusion criteria
pilot study of a novel 532nm ktp laser for the treatment of fresh surgical scars

Conditions: Scar; Surgical Scar; Cicatrix; Cicatrix, Hypertrophic; Keloid

Summary: the purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (ktp) laser in comparison with the 595nm pulsed-dye laser (pdl) for the treatment of fresh surgical scars.

randomized, controlled, open-label pilot study of a novel 532 nm ktp laser for the treatment of fresh surgical scars. this is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm ktp laser in comparison with the 595nm pulsed-dye laser (pdl) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.

Eligibility criteria:
inclusion criteria: * fitzpatrick skin type i - iv * has postoperative linear scar(s) which is one to twelve months post-surgery. * having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length. * be in good health. * must agree not to undergo any other procedure for the treatment of scar during the study. * willing to refrain from excess sun exposure and willing to wear sunscreen on the treated scar during the study (including the follow-up period). * able to read, understand and sign the informed consent form. * willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions. * willingness to have digital photographs taken of the treated scar. * post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study. exclusion criteria: * participation in a study of another device or drug within 6 months prior to enrollment or during the study. * having received any prior treatment for the target surgical scar. * pregnant and/or breastfeeding. * significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy. * current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medication. * history of abnormal or delayed wound healing, keloid formation or pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. * history of malignant skin disease, immune deficiency disorders, coagulation disorders, seizure disorders due to light, or diseases stimulated by heat, unless prophylactic measures taken prior to treatment. * systemic use of isotretinoin within 6 months or corticosteroids within 12 months of study participation. * anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. * current smoker or history of smoking within 12 months of study participation.

Keywords: scar scars surgical scar surgical scars cicatrix hypertrophic cicatrix keloid hypertrophic scar surgical incision scarring abdominoplasty tummy tuck augmentation mammoplasty breast augmentation thyroidectomy
internet-based emotional awareness and expression therapy for somatic symptom disorder

Conditions: Somatic Symptom Disorder

Summary: the main purpose of the study is to conduct an initial feasibility evaluation of the new internet-based eaet treatment manual. we will include 50 patients with somatic symptom disorder to take part of the treatment for nine weeks through the internet. a within-subject design will be used. self-report measures of symptom level and mechanisms of change will be conducted weekly. feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. linear mixed models will be used to investigate trajectories of change in symptoms and processes.


Eligibility criteria:
inclusion criteria: * age over 18 years * a total score ≥10 on the phq-15 * a diagnosis of ssd according to the dsm-5, i.e ≥1 of the 3 of: disproportionate thoughts about the somatic symtom, persistently high level of anxiety, or excessive time and energy devoted in regard to symptoms or health concerns * symptom duration ≥6 months * written statement from a medical professional that states that a medical evaluation has been conducted. exclusion criteria: * alcohol or substance addiction * a diagnosis of a psychological condition that might require other treatment (e.g., psychosis, suicidality, etc) * other severe medical condition that might require other treatment * ongoing psychological intervention or psychotherapy that may interfere with the psychological treatment * ongoing medical treatment that may interfere with the psychological treatment
the value of using platelet rich plasma after hysteroscopic lysis of severe intrauterine adhesions

Conditions: Intrauterine Adhesion

Summary: the aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.

research question: in women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions? research hypothesis: in women undergoing hysteroscopic adhesiolysis for asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.

Eligibility criteria:
inclusion criteria: * infertility due to asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to american fertility society. exclusion criteria: * hb \< 11 g/dl, platelets \< 150.000/mm3 * patient taking anticoagulant. * patient taking nsaid in the 10 days before procedure. * any significant comorbidity or psychiatric disorder that would compromise patient's consent. * active cervical or uterine infection.
predict 5-year survival in elderly gastric cancer

Conditions: Gastric Cancer; Machine Learning

Summary: in this study, elderly patients with gastric cancer who underwent radical gastrectomy in union hospital affiliated to fujian medical university from 2012 to 2018 were included as a derived cohort, and the training set and internal validation set were randomly divided by 4:1. machine learning strategies of random forest, decision tree and support vector machine are used to construct survival prediction model. each model was tested in an internal validation set and an external validation set consisting of patients from two other large medical centers.

this is a retrospective, supervised learning, data mining study.

Eligibility criteria:
inclusion criteria: * (1) gc diagnosis confirmed by abdominal computed tomography (ct) or biopsy; (2) age ≥65 years at diagnosis; (3) underwent radical surgical resection without evidence of distant metastasis; and (4) availability of complete clinical and pathological data. exclusion criteria: * (1) postoperative pathology confirming non-gastric primary tumors; (2) distant metastasis; (3) incomplete clinical data; and (4) other concurrent malignancies within five years.

Keywords: gastric cancer elderly oxidative stress machine learning overall survival
effect of traditional chinese medicine on in vitro fertilization (ivf) success rates

Conditions: Primary Female Infertility; Secondary Female Infertility

Summary: the purpose of this study is to determine the value of combining traditional chinese medicine (tcm) protocols including acupuncture with in vitro fertilization (ivf).


Eligibility criteria:
inclusion criteria: 1. subject is able to understand and provide consent 2. subject is female, 21-42 years of age at time of screening and has at least one l ovary 3. subject bmi is \> 18 and \< 32 4. subject is experiencing primary or secondary infertility 5. subject may receive sperm from donated source 6. subject's partner has sperm in the ejaculate 7. subject's serum basal fsh is \< 11 iu/l 8. subject's serum basal estradiol level is between 20-80 pg/ml 9. subject's tsh level is \< 3.0 mv/ml 10. subject's prolactin level is \< 24 ng/ml 11. subject will agree to limit caffeine intake to one cup (76.5 ml/day) by the time of randomization 12. subject agrees not to make alterations in diet and lifestyle practices other than those that their medical practitioner deems necessary in the best interest of the subject 13. subject agrees not to participate in any other research opportunities for the duration of the study exclusion criteria: 1. subject is pursuing sex selection 2. subject is undergoing treatment with an egg donor 3. subject experienced more than 2 previous failed cycles 4. subject is undergoing a heparin or lovenox-based protocol 5. subject is currently taking herbal therapy (1 week wash-out) 6. subject is currently taking co-interventions of moxibustion and cupping 7. subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,) 8. subject is diagnosed with severe endometriosis defined as endometriomas \> 4cm 9. subject is currently receiving acupuncture therapy (subject must agree to a 30 day washout period prior to randomization) 10. subject has history of recurrent spontaneous abortions defined as \> 3 11. subjects with a beck depression inventory (bdi-ii) of 29 or higher at screening, indicative of severe depression, will be excluded from the study and referred for further psychological evaluation by our in-house licensed mental health professional.

Keywords: infertility ivf acupuncture
treatment of freckles by intradermal tranexamic acid versus q switched ktp laser.

Conditions: Therapeutic Efficacy

Summary: comparative split face study in which 30 patients with freckles are recruited.one side of the face will be treated with q switched (qs)ktp 532nm, and the other side will be treated with intradermal tranexamic acid (txa).

one side of the face will receive qs ktplaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5j/cm2 and the clinical end point is just frosting.sessions will be every month for 2 months. the other side of the face will be assigned to txa intradermal microinjection in the same session using kapron 500mg/5ml ampoules (amoun pharmaceutical company), the dose of 1 ml syringe with 100mg/ml. txa will prepared under sterile conditions. injections will be applied intradermally on freckles area at. the sessions of txa will be every 2 weeks for 2 months. postoperatively, topical antibiotic ointment and steriod will be applied. sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations. follow up after treatment monthly for 2 month.

Eligibility criteria:
inclusion criteria: * both genders * age group \> 18years old. exclusion criteria: * pregnant and lactating females. * keloid and scarring tendancy * usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study. * oral isotretinoin 6 months prior to the study. * active herpetic lesions. * any concurrent active skin disease within the treated area. * photosensitive skin conditions such as systemic lupus erythematous. * history of delayed wound healing. * bleeding diathesis. * medical conditions such as autoimmune diseases.
treatment of breast fibroadenoma with high intensity focused ultrasound (hifu)

Conditions: Breast Fibroadenoma

Summary: this is a monocenter, open-label, uncontrolled study in accordance with §23b mpg to evaluate the efficacy of the hifu-treatment of fibroadenoma using the th-one device.


Eligibility criteria:
inclusion criteria: * female patients 18 years or older with at least one diagnosed breast fibroadenoma. diagnosis of fibroadenoma must be based on: * clinical examination, * women ≤ 40 years of age: ultrasound image alone; women \> 40 years of age: ultrasound image and mammogram, * histological confirmation of fibroadenoma of the breast. patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm. women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to hifu treatment. patient must be able to understand the nature and the extent of the study and the procedures required and be willing and able to complete the screening and study procedures. patient must give written informed consent (personally signed and dated) before completing any study-related procedure. exclusion criteria: * patient who is pregnant or breast-feeding. * patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion. * patient with implant on the treated breast. * patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for hifu. * patient's fibroadenoma not clearly visible on the ultrasound images (in b mode) at the inclusion visit. patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
migalastat food effect study

Conditions: Fabry Disease

Summary: a 5-period crossover study to evaluate the effect of meal type and timing on migalastat hcl pharmacokinetics in healthy male and female subjects. subjects will be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.

this is a phase 1, randomized, open-label, 5-period crossover study to evaluate the effect of meal type and timing on migalastat hcl pharmacokinetics in healthy male and female subjects between the ages of 18 and 65 years. a total of 20 subjects will be enrolled such that approximately 14 evaluable subjects complete dosing and critical assessments. subjects will be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the course of 5 successive weekly periods including a single dose of migalastat hcl 150 mg in the fasting state as the reference treatment. there will be at least a 7-day washout period between each dose of migalastat hcl and a follow-up visit approximately 7 to 10 days after the last dose in period 5. all subjects will be screened within 28 days of admission to the clinical unit. in each period, subjects will check in to the clinical unit the day prior to drug administration and have relevant assessments to ensure continued eligibility for dose administration. on day 1 of each period, subjects will receive a single dose of migalastat hcl within 1 of the following 5 treatment regimens as follows: * 150 mg migalastat hcl in the fasting state (reference arm) * 150 mg migalastat hcl with simultaneous consumption of a glucose drink * 150 mg migalastat hcl 1 hour before consumption of a high fat meal * 150 mg migalastat hcl 1 hour before consumption of a light meal * 150 mg migalastat hcl 1 hour after consumption of a light meal subjects will be confined to the clinical unit for 24 hours after dosing with serial blood samples collected for pk analysis. safety will be assessed throughout the study by monitoring clinical laboratory tests, ecgs, physical examinations, vital signs, and aes.

Eligibility criteria:
inclusion criteria: * male or female aged 18 to 65 years inclusive * healthy, as determined by study physician * capable of giving informed consent exclusion criteria: * positive for hiv or hepatitis b and/or c viruses * history of drug or alcohol abuse or addiction within 2 years * smoker or consumes tobacco products * participation in a clinical trial within 30 days of scheduled first dose

Keywords: food effect gr181413a at1001 migalastat hydrochloride lysosomal storage disorders pharmacokinetics
exercise intervention in liver transplant candidates

Conditions: Liver Diseases

Summary: the aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.


Eligibility criteria:
inclusion criteria: * liver transplant candidates, accepted in the waiting list of the surgical department of transplantation a.u.th., general hospital of thessaloniki "ippokratio". exclusion criteria: * recent (\<12 months) acute myocardial infraction * recent (\<12 months) brain strokes * uncontrolled and/or untreated arrythmia * hepatic encephalopathy * bed-bound patient * liver transplantation * death
an extension study of abt-199 in subjects with advanced non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this is a phase 1, open-label, multicenter, extension study. subjects with non-hodgkin's lymphoma (nhl) (excluding chronic lymphocytic lymphoma \[cll\], small lymphocytic lymphoma \[sll\], and mantle cell lymphoma \[mcl\]) who completed a prior abt-199 study, or were active and assigned to abt-199 when the study was completed, may roll over into this extension study. subjects will receive abt-199 during this study.


Eligibility criteria:
inclusion criteria: * subject has completed a prior abt-199 study (and had met the criteria for a diagnosis of nhl and all other eligibility criteria for the previous study) and the investigator believes that treatment with abt-199 is in the best interest of the subject. exclusion criteria: * subject discontinued abt-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other). * subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. * subject has not recovered to ≤ grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy. * subject has been diagnosed with post-transplant lymphoproliferative disease (ptld), burkitt's lymphoma, burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), or mantle cell lymphoma (mcl).

Keywords: abt-199 cancer gdc-0199 non-hodgkin's lymphoma relapsed refractory safety