Kornimate/medical-research-clean huggingface dataset:
image guided targeted photoablation for the treatment of localized hyperhidrosis

Conditions: Hyperhidrosis

Summary: hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. commonly affected areas in primary hyperhidrosis include axillae, palms and soles. secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life. the investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.


Eligibility criteria:
inclusion criteria: 1. subjects of ages between 18 and 65 years. 2. subjects with any fitzpatrick skin type. 3. subjects who are proficient in the english language. 4. willingness to participate in the study. 5. willingness to undergo experimental procedure. 6. informed consent agreement signed by the subject. 7. willingness to follow the follow-up schedule. 8. willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, botox, miradry). 9. patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (hdss, see below). 10. subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat. 11. no known allergy to iodine or potato starch exclusion criteria: 1. pregnancy 2. subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks. 3. subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis. 4. subjects with an underlying disorder, such as neurologic injury or disease affecting the autonomic system, vascular disorders and metabolic disorders (e.g. hyperthyroidism, diabetes mellitus) that can produce hyperhidrosis 5. subjects with a history of coronary artery disease. 6. subjects with a history of poor compliance or psychosis 7. subjects taking ssris, snris, tcas, or maois 8. subjects with known hypersensitivity to methylene blue 9. subjects with cardiac pacemaker or any other electrically powered implantable device. 10. subjects not proficient in the english language. 11. subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat. 12. known allergy to iodine or potato starch.
a trial comparing hr17031 with insulin glargine in patients with type 2 diabetes

Conditions: Adult Patients With Type 2 Diabetes

Summary: to compare the efficacy and safety of hr17031 injection and insulin glargine, including the changes of efficacy indicators such as hba1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18-75 years at the time of signing the informed consent (both ends included) 2. body mass index (bmi) of 20.0-40.0 kg/m2 (both ends included) 3. diagnosed with type 2 diabetes for at least 90 days prior to screening 4. tested by local laboratory, hba1c is 7.5%-10.5% (including both ends) 5. before screening, the daily basal insulin dose had been stabilized at 20-40u/ day (including both ends) for at least 60 days 6. stable treatment with metformin alone or in combination with another oad for ≥60 days prior to screening. metformin dose ≥1500 mg/ day or maximum tolerated dose. 7. ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen. exclusion criteria: 1. known or suspected allergy to the investigational drug product or its components or excipients; 2. systemic glucocorticoid use within 3 months prior to screening 3. use of weight loss drugs within 3 months prior to screening 4. insulin therapy other than basal insulin was used within 3 months prior to screening 5. cardiovascular disease, defined as congestive heart failure (nyha iii-iv), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; and/or coronary, carotid, or peripheral arterial revascularization is planned at screening 6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg) 7. proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening; 8. patients diagnosed with mental disorders; mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate; 9. known or suspected abuse of alcohol or narcotics; 10. previous history of pancreatitis (acute or chronic) 11. during pregnancy or lactation;fertile women (wocbp) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product; 12. any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
study of preoperative management of angiotensin converting enzyme inhibitor (acei) and angiotensin receptor blocker (arb) medications

Conditions: Hypertension

Summary: patients on a stable dose of ace inhibitor or arb medication who are scheduled for elective surgery will be randomized to take their ace inhibitor or arb up to and including the morning of surgery, or to hold them a day prior to the surgery. the patients will be followed for 30 days after surgery to assess any adverse health outcomes.


Eligibility criteria:
inclusion criteria: * currently taking an acei, arb or both * no change in these medications during the two weeks prior to study enrollment * scheduled for non-cardiac surgery requiring regional or general anesthesia * minimum overnight anticipated length of stay * age ≥18 years. exclusion criteria: * explicit instructions provided to patient by surgical team regarding the perioperative management of acei or arb * significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg) * significant hypotension in pre-operative assessment clinic (systolic blood pressure \< 90 mmhg) * prior enrollment in the study * participation in another research study of antihypertensive medications

Keywords: ace inhibitor arb non-cardiac surgery perioperative preoperative hypotension congestive heart failure hypertension angiotensin-converting enzyme inhibitors angiotensin ii type 1 receptor blockers perioperative care
correlation of cervical lordosis degree detected on cervical x-ray image with clinical, demographic and mri findings

Conditions: Neck Pain; Cervical Lordosis; Disk, Herniated

Summary: in this study we are investigating whether there is a relationship between the lordosis angle measured on cervical x-ray images on the severity and level of cervical disc herniation detected by cervical mri, demographic characteristics and the duration and posture of the person's daily life activities.

at least 125 patients between the ages of 18-65 who meet the inclusion criteria with cervical cervical x-ray and cervical mris taken in the last 3 months will be included in the study. the demographic characteristics of the patients such as age, gender, bmi, job, education level, marital status, as well as the time they spend on head flexion posture, and their screen time will be questioned. the presence of active trigger points in the cervical muscles will be determined by examination (levator scapula, trapeze, longus colli, splenius capitis). neck disability index will be filled in order to evaluate activities of daily life. symptom duration and pain level will be evaluated by vas. tangent and cobb angles will be measured on cervical x-ray images. presence of effective lordosis will be recorded. in cervical mr, disc herniation level, number, degree (bulging, protrusion, extruded disc) its level will be recorded.

Eligibility criteria:
inclusion criteria: * 18-65 years old * axial neck pain and / or upper extremity radicular symptoms * existing mr and x-ray radiographs taken within the last 3 months for cervical disc pathologies exclusion criteria: * a history of trauma, * patients with rheumatoid / autoimmune diseases such as rheumatoid arthritis or ankylosing spondylitis, * a history of cervical fracture or cervical spine surgery * history of cancer history, neurological disease * muscle weakness * presence of scoliosis

Keywords: neck pain cervical sagittal balance trigger points flex head posture
an evaluation of pdi-192 0.1% in comparison to pdi-192 0.15% in the treatment of mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study will compare the safety and efficacy of three test article foams (pdi-192 0.1% foam, pdi-192 0.15% foam, and vehicle foam) such that a final commercial product may be selected for future development.


Eligibility criteria:
inclusion criteria: * subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis. * subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study. exclusion criteria: * subject is pregnant, lactating or is planning to become pregnant during the study. * subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period. * subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start. * subject has used ultraviolet light therapy (puva, uvb, etc.) within 30 days prior to study start. * subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin d preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, within 14 days prior to study start. * subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study. * subject has used systemic (oral, iv, etc.) antibiotic therapy within seven days prior to study start. * subject is currently enrolled in an investigational drug or device study. * subject has used an investigational drug or investigational device treatment within 30 days prior to study start.

Keywords: atopic dermatitis eczema pdi-192 precision
hop-2a - intratesticular hormone levels

Conditions: Healthy; Male Infertility; Prostate Disease

Summary: the purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

we will collect a very small amount of fluid from each testicle. participation will last up to 12 weeks. the study involves a minimum of 4 visits, the screening visit and procedure day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).

Eligibility criteria:
inclusion criteria: * males between 18 and 50 years of age * sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology * in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline t, lh, and fsh levels) * body mass index ≥18 and ≤32 kg/m2 * must agree not to participate in another research study involving drug exposure for the duration of the study exclusion criteria: * men in poor general health, with abnormal blood results * sperm counts \<20 million/ml on two tests * chronic, ongoing alcohol or drug abuse * participation in a long-term male contraceptive study within the past three months * history of testicular or scrotal surgery * history of infertility * abnormal testicular exam * abnormal dre * chronic pain syndrome * use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids * known bleeding disorder * use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)

Keywords: fine needle aspiration male health male contraception
skilljoy clinical trial

Conditions: Generalized Anxiety Disorder

Summary: this study is a randomized controlled trial comparing a smartphone-delivered savoring intervention (skilljoy) for generalized anxiety disorder to an active treatment control.

the current study seeks to determine if the positivity intervention skilljoy, a smartphone-based, ecological momentary intervention (emi), can reduce worry and generalized anxiety disorder (gad) symptoms, increase positive emotion and wellbeing, improve reinforcement and probabilistic learning, increase savoring and reduce kill-joy thinking, and decrease avoidance of negative emotional shifts relative to an active treatment control in a gad sample. skills for generating positive emotion may reduce symptoms and increase well-being for those with gad. to test this approach, participants with gad were randomly assigned to either a savoring treatment or a self-monitoring control.the savoring treatment consisted of an ecological momentary intervention (emi) for learning and practicing savoring skills-skilljoy. skilljoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. the active self-monitoring control emi consisted of similar activities, but they all omitted savoring practices. these activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. both emis were delivered by apps on participants' smartphones for seven days with 30th day follow-up. secondarily, the current study will assess differences between those with gad and non-anxious controls on a computerized probabilistic reinforcement learning task and baseline savoring questionnaires.

Eligibility criteria:
inclusion criteria: * meet clinical criteria for generalized anxiety disorder on the gad-q-iv and the gad section of the mini-international neuropsychiatric interview (mini). * must be at least 18 years old to participate. * pregnant women will be allowed to participate. exclusion criteria: * they do not meet criteria for gad on the gad-q-iv and the ini or do not fall one standard deviation below the subject pool mean on the gad-q-iv (i.e., they fall between these two scores). * they are younger than 18 years of age. * they do not speak english. * they are adults unable to consent.

Keywords: worry savoring ecological momentary intervention generalized anxiety disorder positive emotion
long term follow-up for safety of avr-rd-02

Conditions: Gaucher Disease

Summary: the goal of this observational study is to assess the safety and tolerability of avr-rd-02 treatment in subjects who previously received avr-rd-02 treatment (single dose administration).

subjects who received avr-rd-02 in the preceding treatment study (nct04145037) and who meet all eligibility criteria may participate. subjects will be asked to return for study visits annually for 14 years to assess measures of safety and persistence of avr-rd-02 treatment.

Eligibility criteria:
inclusion criteria subjects must meet all of the following inclusion criteria for participation in this study: 1. subject must be willing and able to provide written informed consent for the jab-gd-001 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures. 2. subject must have been enrolled in the preceding avrobio avro-rd-02-201 treatment study and have received avr-rd-02 treatment exclusion criteria subject has any medical, psychological, or other condition that, in the opinion of the investigator: * might interfere with the subject's participation in the study (including consenting to procedures); and/or * poses any additional risk to the subject; and/or * might confound the results of any study-required assessments.
preventing impaired driving among adolescents

Conditions: Substance-Related Disorders

Summary: the primary goal of this project is to evaluate the efficacy of webchat, a single-session web-intervention, on reducing impaired driving among adolescents receiving behind-the-wheel training at driver education programs.

alcohol and marijuana (am) are the most commonly used substances among adolescents in the u.s. the consequences of am use are significantly higher relative to use of either substance alone. this study builds on effective interventions that have demonstrated reductions in alcohol and/or marijuana use and reduced consequences one year later, and proposes to adapt one of those interventions, chat, to the web (web-chat). the investigators will evaluate the efficacy of web-chat among 15.5-17-year-old adolescents (n=150) recruited when teen participants are attending behind-the-wheel training. the study has the potential to promote public welfare by improving adolescent health outcomes and reducing risky driving behaviors that can have substantial monetary and social costs, as well as by providing unique insight into what mediates reduced risky driving attitudes behaviors among those in the intervention. the study is innovative because it is for both youth who are at risk for substance use as well as those who are not, and it is delivered during a teachable moment when adolescents receive driver's education. finally, this study can provide unique insights about the efficacy of web-chat to reduce marijuana initiation, use, and risky driving attitudes in the context of a changing marijuana policy climate. a 3-year study is proposed to test the feasibility of research procedures in a driver education setting and pilot the efficacy of web-chat. the investigators will test whether web-chat reduces alcohol and/or marijuana initiation or use compared to teens in uc, at three and six-month follow-up.

Eligibility criteria:
inclusion criteria: * 15.5-17 year olds enrolled in driver education school * access to a computer or smartphone * within one month of taking their driver's licensing exam exclusion criteria: * under 15.5 or over 17 years old * not enrolled in one of the participating schools * non-english speaking

Keywords: impaired driving
investigation of short course, high dose primaquine treatment for liver stages of plasmodium vivax infection

Conditions: Plasmodium Vivax

Summary: this study specifically seeks to provide data on the safety, tolerability and pilot efficacy of short course, high dose primaquine treatment in papua new guinean children aged 5-10 years, in a cross-sectional study design. community screened asymptomatic cases and/or cases of clinically diagnosed malaria admitted to the out-patient units of the health center, will be screened for glucose-6-phosphate dehydrogenase deficiency (g6pd) and malaria illness by rapid diagnostic test and p. vivax infection confirmed by light microscopy. following treatment with artemether-lumefantrine (coartem), g6pd normal children will be enrolled into the study and followed for 2 months. primaquine treatment will be allocated to study participants in a step-wise design; firstly receiving the current 14 day treatment regimen of 0.5 mg/kg total dose (n=40); secondly, a 7 day treatment regimen receiving a total dose of 1.0 mg/kg/day; then thirdly, receive 1.0 mg/kg twice daily dose (bd) for a total of 3.5 days, should the 7 day treatment prove to be safe and well tolerated. in addition to this dose-escalation study, the pharmacokinetic profiles of single doses of 0.5 mg/kg and 1.0 mg/kg will be determined using an intensive sampling protocol, in children aged 5-10 years. the pharmacokinetic profiles obtained by this sub-study will be essential for modeling the population pharmacokinetic data obtained from the dose-escalation study. as there is currently no data on the safety, tolerability and efficacy of primaquine in children, the present study will validate previous observation and contribute to the knowledge of primaquine as a treatment for liver stages of plasmodium vivax infection.


Eligibility criteria:
inclusion criteria: * permanent resident in study area * absence of history of hypersensitivity reactions to pre-treatment drugs * positive for p. vivax infections on blood smear or pcr * normal g6pd enzyme activity exclusion criteria: * features of severe malaria * clinical evidence of nonmalarial illness * severe malnutrition (weight for age nutritional z score \<60th percentile) * moderate to severe anemia (hb \<8g/dl) * permanent disability which prevents or impedes study participation
pn-943 in adults with moderate to severe active ulcerative colitis (uc)

Conditions: Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe

Summary: the purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of pn-943 450 mg twice daily \[bid\] and pn-943 150 mg bid, compared with placebo bid, in subjects with moderate to severe active ulcerative colitis (uc).

the study consists of a 12-week double-blind, placebo-controlled treatment period. participants will be randomized in a 1:1:1 ratio to pn-943 450 mg bid, pn-943 150 mg bid, or matching placebo bid. participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.

Eligibility criteria:
key inclusion criteria: 1. male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years. 2. subject understands the study procedures and agrees to participate in the study by giving written informed consent. 3. diagnosis of uc supported by appropriate documentation of biopsy results consistent with uc. 4. moderate to severe active uc. 5. demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-asas), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab). key exclusion criteria: 1. subject with a current diagnosis of crohn's disease (cd), indeterminate colitis (ic), microscopic colitis, ischemic colitis, radiation colitis. 2. history of colonic dysplasia other than completely removed low-grade dysplastic lesion. 3. history of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or iv antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening. 4. prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study. 5. positive stool test for c. difficile. 6. chronic recurrent or serious infection. 7. known primary or secondary immunodeficiency. 8. pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication. 9. history of any major neurological disorders.

Keywords: inflammatory bowel disease (ibd)