Kornimate/medical-research-clean huggingface dataset:
the use of onexton in moderate acne vulgaris for patients with skin of color

Conditions: Acne Vulgaris; Post Inflammatory Hyperpigmentation

Summary: this is a single-center, open label pilot study. the study is comprised of 5 study visits; screening, baseline, and weeks 4, 8, and 16. all subjects will receive onexton at baseline and be instructed to apply the gel once daily to the face. the investigators will evaluate investigator global assessment of acne (iga), total lesion count, inflammatory lesion count, non-inflammatory lesion count, investigator global assessment of post-inflammatory hyperpigmentation and distribution of post-inflammatory hyperpigmentation, adverse events and concomitant medications.


Eligibility criteria:
inclusion criteria: i. outpatient, subjects of skin of color, age 12 or older. female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study; a female is considered of childbearing potential unless she is: * postmenopausal for at least 12 months prior to study drug administration * without a uterus and/or both ovaries; or * has been surgically sterile for at least 6 months prior to study drug administration reliable methods of contraception are: * intrauterine device in use ≥ 90 days prior to study drug administration; * barrier methods plus spermicide in use at least 14 days prior to study drug administration; or * vasectomized partner \[exception: female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. these subjects may be enrolled at the investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\] ii. facial acne vulgaris in patients with skin of color (fitzpatrick type v \& vi supplement vi) characterized by the following: * iga score for acne vulgaris 3 * iga score for pih 3 iii. able to understand and comply with the requirements of the study and sign informed consent /hipaa authorization forms exclusion criteria: i. female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control ii. allergy/sensitivity to any component of the test treatment iii. iga score for acne of 2 (mild) or 4 (severe) iv. iga score for post inflammatory hyperpigmentation of 2 (mild) or 4 (severe) v. subjects who have not complied with the proper wash-out periods for prohibited medications (supplement i). vi. medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the clinical study vii. skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris viii. evidence of recent alcohol or drug abuse ix. history of poor cooperation, non-compliance with medical treatment, or unreliability x. exposure to an investigational study drug within 30 days of the baseline visit
study to evaluate the safety and effectiveness of usl255 in patients with refractory partial-onset seizures

Conditions: Epilepsy

Summary: the purpose of this study is to examine the safety and effectiveness of usl255 as adjunctive therapy in patients with refractory partial onset-seizures.


Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to visit 1. * currently on a stable dosing regimen of 1 to 3 aeds for at least 4-weeks prior to visit 1 (12 weeks for phenobarbital and primidone). * have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline. exclusion criteria: * have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to visit 1. * have a history of pseudoseizures, or status epilepticus, within 3 months prior to visit 1. * have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma. * have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of visit 1. * currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past. * have taken topiramate within the past 6 months.

Keywords: epilepsy partial onset seizure adjunctive therapy
clinical study evaluating the safety and efficacy of roflumilast in type 2 diabetic patients with diabetic neuropathy

Conditions: Type 2 Diabetes (Adult Onset); Diabetic Neuropathies

Summary: evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in type 2 diabetic patients with diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of type 2 diabetes mellitus (t2dm). * hba1c at baseline: ≥7.5 % to 8.5 %. * bmi between ≥26 and ≤35 kg/ m2. * established diabetic neuropathy diagnosed by nerve conduction study (ncs). exclusion criteria: * patients diagnosed with type 1 diabetes mellitus or diabetes secondary to pancreatitis or resection of the pancreas. * patients diagnosed with hemoglobinopathies, hemolytic anemia, or other diseases which interfere with hba1c measurement. * thyroid disease, cardiovascular disease, peripheral vascular disease, coagulopathy, moderate to severe liver disease (bilirubin\>1.5mg), or renal excretion ≤90ml/min. * patients on medications which can result in a change of weight (orlistat, metformin, clozapine, gabapentin) and patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, non-selective β-blockers, thiazides, etc.) * treatment with any diabetes medications other than glimepiride prior to intervention. * clinically significant cardiac abnormalities (diagnosed clinically, history, or by x-ray/ecg) that were not related to type 2 diabetes mellitus and that required further evaluation. * patients with morbid obesity (bmi ≥ 40 kg/ m2). * history or current diagnosis of major depressive disorders or other psychiatric disorders. * pregnant and breastfeeding women. * patients with any inflammatory diseases. * patients on cytochrome p450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, etc.). * patients with low vitamin b12 levels according to suggested normal values for t2dm patients over 60 years old (\<400 pmol/l).

Keywords: diabetes mellitus diabetic neuropathy hyperglycemia
clinical investigation using med3000 gel or tadalafil tablets in the treatment of erectile dysfunction

Conditions: Erectile Dysfunction

Summary: an open-label investigation using med3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. each patients will be expected to participate for up to 30 weeks. eligible patients will be randomised to receive either med3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.


Eligibility criteria:
inclusion criteria: * male heterosexual patients aged 22-70 years. * confirmed clinical diagnosis of mild, moderate or severe ed for more than 3 months. * involved in a continuous heterosexual relationship with their partner for at least 6 months. exclusion criteria: * any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease. * history of unstable medical or psychiatric condition or using any medication that, in the opinion of the principal investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation.
study in patients with overactive bladder treated with toviaz® after failure of previous therapy

Conditions: Overactive Bladder; Urinary Incontinence

Summary: this is a observational study in patients treated with fesoterodine (toviaz), who have failed on previous treatment for overactive bladder. it will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients with oab after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms. * required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome * due to intolerance: persistent and/or unacceptable adverse events exclusion criteria: * hypersensitivity to the active substance or to peanut or soya or any of the excipients. * history of acute urinary retention (requiring catheterisation) * gastric retention * uncontrolled narrow angle glaucoma * myasthenia gravis * severe hepatic impairment (child pugh c) * concomitant use of potent cyp3a4 inhibitors in subjects with moderate to severe hepatic or renal impairment * severe ulcerative colitis * toxic megacolon.

Keywords: observational
trans-cranial direct current stimulation on alcohol craving

Conditions: Alcohol Dependence

Summary: the goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tdcs) for alcohol craving in individuals with alcohol dependence. the main question it aims to answer is whether 10 sessions of tdcs can reduce craving for alcohol. participants will be randomized into active group and sham group. researchers will compare the severity of craving in these groups.

craving is defined as strong desire for substance use, and is one of the core symptoms of alcohol dependence which is highly correlated with relapse. transcranial direct current stimulation (tdcs) involves applying a small direct current (1-2ma) to the prefrontal cortex; its therapeutic effect for depression and cognition has been demonstrated by several randomized studies. our preliminary study has shown that tdcs has the potential to reduce craving in alcohol-dependent patients without adverse events. furthermore, our previous studies have shown that serum brain-derived neurotrophic factor (bdnf) level is elevated after alcohol withdrawal. the current study aims at examining the association between craving and serum bdnf level in alcohol-dependent patients receiving tdcs. the study recruits 40 patients with alcohol dependence. patients will receive tdcs for 2 weeks during admission, and followed for 2 weeks after tdcs. we'll compare their improvements in craving scores every week, and investigate the correlation between craving and serum bdnf level. this study will bring innovations to the treatment of alcohol dependence based on our previous studies.

Eligibility criteria:
inclusion criteria: 1. be between 20-65 years of age 2. have sufficient cognitive function to understand the study and complete the informed consent process 3. be diagnosed with alcohol dependence as defined by dsm-iv through a structured interview (mini-international neuropsychiatric interview, m.i.n.i.) exclusion criteria: 1. intellectual disabilities 2. bipolar disorder 3. psychosis (schizophrenia) 4. major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures) 5. intracorporeal electronic or metal implants (e.g., cardiac pacemaker) 6. pregnant or breastfeeding women 7. allergy to headgear and electrode materials 8. trauma or infection to the head 9. intracranial space occupied lesion (such as brain tumor, avm, etc.) or patients who have undergone brain surgery, meningitis and encephalitis 10. patients who are expected to undergo brain and major surgery during the trial period

Keywords: transcranial direct current stimulation, craving
the tobacco, alcohol, prescription medication and other substances tool

Conditions: Substance Use Disorder

Summary: the purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.


Eligibility criteria:
inclusion criteria: * primary care patients * able to provide informed consent exclusion criteria: * inability to comprehend spoken english * inability to self-administer the instrument on the tablet computer due to physical limitations * previously enrolled in the study

Keywords: substance use substance use disorder screening brief assessment
comparative study between transcoronoid and infrazygomatic anterior maneuvers

Conditions: Trigeminal Neuralgia

Summary: new technique in targeting v2 under ultrasound guidance

the classical approach of v2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained v3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure v2 stimulation without v3 which make the thermal radio frequency 80 celsius can be performed safely

Eligibility criteria:
inclusion criteria:above 40 severe pain normal neurological examination - exclusion criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry -
a phase 3 study to evaluate the safety and efficacy of ckd-843 in male patients with androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: this is a multi-centers, randomized, double-blind, parallel-group, phase 3 trial to evaluate the efficacy and safety of ckd-843 in male patients with androgenetic alopecia

the participants were randomly assigned to one of the following groups: ckd-843 dose #1, ckd-843 dose #2, placebo, or dutasteride group. they received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

Eligibility criteria:
key inclusion criteria: * male of age 18-50 years * clinical diagnosis of androgenetic alopecia * written informed consent key exclusion criteria: * other types of alopecia or other diseases that can cause hair loss * clinically significant scalp disease such as seborrheic dermatitis or psoriasis * clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the investigator * participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose
the effect of mindfulness-based stress reduction programme given to infertile women

Conditions: Depression Anxiety Disorder; Demography, Family; Awakening Early

Summary: purpose of the study this study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol. materials and method it will be conducted in a randomized controlled experimental design. this randomized controlled trial will follow the consolidated standards of reporting trials (consort) 2010 guidelines.

this study was planned as a randomized controlled experimental study to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol levels. it will be conducted in a randomized parallel controlled experimental design using consolidated standards of reporting trials (consort) guidelines. women applying to the infertility outpatient clinic of health sciences university ümraniye training and research hospital in ümraniye district of istanbul province will constitute the sample population of the study. women applying to the infertility outpatient clinic who meet the inclusion criteria and who voluntarily agree to participate in the study will be included in the study. according to the power analysis, a total of 86 infertile women, 43 in the intervention group and 43 in the control group, will constitute the sample of the study. while mindfulness-based stress reduction program will be applied to the intervention group with the zoom program, which is an online training platform, routine follow-up will be applied to the control group within the scope of outpatient follow-up of the relevant institution. the participants included in the study will be administered the informed voluntary consent form, descriptive characteristics information form, dass-21, perceived stress scale and salivary cortisol test as part of the pre-test. within the scope of post-test and follow-up test, dass-21, perceived stress scale and salivary cortisol test will be applied again. discussion and conclusions of the study will be written as a result of the findings

Eligibility criteria:
inclusion criteria: * - agree to participate in the 8-week mbsr training * having completed the informed consent form and volunteering to participate in the study * speaking and understanding turkish * idiopathic infertile women * primary infertile women * ytu treatment has not started * having attempted ytu at most three times before * be able to use zoom program exclusion criteria: * - illiteracy, * the woman has a cognitive and auditory problem, * having a chronic disease * not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.) * having participated in any awareness-based training program in the last 1 year exclusion criteria - not participating in any session of the 8-session training program, not participating in any of the pre-test, post-test-1 and post-test-2 being an infertile woman

Keywords: infertility women, mindfulness cortisol anxiety depression
pet/ct imaging in covid-19 patients

Conditions: COVID-19; SARS-CoV-2 Infection

Summary: this is a pet/ct study using the 18f-αvβ6-binding-peptide.the goal of this study is to evaluate this peptide in patients after infection with sars cov2.

the goal of the study is to to acquire 18f-αvβ6-bp pet/ct images in patients diagnosed with sars cov2 and to demonstrate the ability of 18f-αvβ6-bp to detect lung damage.

Eligibility criteria:
inclusion criteria: * men and women age ≥ 18 yrs * diagnosed with sars cov2 * must have 2 sequential covid negative tests prior to each scan * must have no previous lung disease prior to sars cov2 infection * lung image (xray or ct) taken during infectious/ diagnosis period * will sign the irb-approved consent form * able to remain motionless for up to 30-60 minutes per scan. exclusion criteria: * life expectancy \<3 mo * women who are pregnant or breast-feeding * patients who cannot undergo pet/ct scanning because of weight limits(\>350lbs) * lack of availability for follow-up assessments * re-infection with sars cov2 between scan sessions * other active infectious respiratory illness

Keywords: covid-19; sars-cov2 infection
asthma in the elderly: a study of choline supplementation

Conditions: Asthma in the Elderly

Summary: asthma in the elderly is poorly understood, as most studies have not included this patient group. in a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. the present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. the investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (asthma control test) and spirometric values (fev1, fev1/fvc, fef25-75%). the investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin e (ige) and homocysteine levels.


Eligibility criteria:
inclusion criteria: * asthma exclusion criteria: * no history of smoking more than 10 pack/years, * no gastrointestinal cancers, * no liver or kidney disease, * no bipolar disorder.
psychometric properties of sit-to-stand test in spinal cord injury

Conditions: Spinal Cord Injuries

Summary: 1. do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (stst) in ambulatory individuals with spinal cord injury (sci)? 2. what are the factors associated with ability to perform stst in ambulatory individuals with sci? 3. are the single-time sit-to-stand test (stsst) and five-time sit-to-stand test (ftsst) reliable, valid and responsive to determine functional alteration in ambulatory individuals with sci?

* to cross-sectionally compare characteristics (duration and amount of lower limb loading) of sts movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with sci. * to investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the stsst and ftsst in ambulatory patients with sci. * to investigate concurrent validity and factors associated with ability of the stsst and ftsst in ambulatory patients with sci. * to investigate the ability of the stsst and ftsst to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with sci. * to investigate internal and external responsiveness of the stsst and ftsst to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with sci. * to estimate the minimal clinically important difference or clinical significance of the ftsst in ambulatory patients with sci.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 - 29.9 kg/m2 * having an incomplete sci from traumatic or non-traumatic causes * ability of independent standing up from a chair with or without hand support * ability of independent walking with or without walking device over at least 10 meters continuously. * ability to follow commands used in the studies exclusion criteria: any ambulatory individuals with incomplete sci who present signs and symptoms that might affect ability to perform stst will be excluded from the study such as * pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (nrs) * joint deformities that affect mobility * other neurological disorders such as having brain lesions * unstable medical conditions * pregnancy

Keywords: sit-to-stand test psychometric properties