Kornimate/medical-research-clean huggingface dataset:
new score for pseudo- acanthosis nigricans

Conditions: Pseudo Acanthosis Nigricans

Summary: each side of the neck pseudo acanthosis nigricans was randomized in to either receiving glycolic acid peel or saline. evaluation was done at baseline and after 3 sessions 2 weeks apart by percentage involvement and by anasi score


Eligibility criteria:
inclusion criteria: * mild to moderate severity * age \> 18 years old exclusion criteria: * pregnant and lactating patients, * patients with systemic diseases as connective tissue disease, diabetes, * skin infection * use of immunosuppressive drugs * susceptibility for post peel hazards as hyperpigmentation * scarring and keloidal tendency
clinical performance comparison of two contact lenses

Conditions: Myopia

Summary: the purpose of this study is to compare the clinical performance of two contact lenses.


Eligibility criteria:
inclusion criteria: * existing daily soft lens wearer. * require a distance visual correction in both eyes. * have a contact lens spherical distance refraction between -1.00d and -6.00d. * have refractive astigmatism less than or equal to 1.00d in both eyes. * achieve 20/30 or better corrected distance acuity. * have normal eyes with no evidence of abnormality or disease. exclusion criteria: * requires presbyopic correction. * requires ocular medications. * grade 3 or 4 ocular abnormalities. * grade 3 corneal staining in more than one region. * has had refractive surgery. * any other injury or ocular surgery within 8 weeks prior to study enrollment. * has abnormal lacrimal secretions. * pre-existing ocular irritation that would preclude contact lens fitting. * has keratoconus or other corneal irregularity. * polymethyl methacrylate (pmma), hybrid or rigid gas permeable (rgp) wear in the previous 8 weeks. * wears habitual contact lenses that are toric, multifocal or worn extended wear. * any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear. * diabetic. * infectious or immunosuppressive disease. * history of chronic eye disease (e.g glaucoma or age related macular degeneration). * pregnancy, lactation or planning pregnancy at time of enrollment. * participation in any concurrent clinical trial or in another trial in the last 30 days.
study of safety, tolerability and pharmacokinetics of single oral jtt-251 doses in healthy and type 2 diabetic subjects

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety, tolerability, and pk (pharmacokinetics) of single oral doses of jtt-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the pk of jtt-251 in healthy subjects.


Eligibility criteria:
inclusion criteria: healthy subject cohorts: * healthy male or female subjects * body mass index (bmi) between 19.0 and 31.0 kg/m2 (inclusive) type 2 diabetic subject cohorts: * male or female type 2 diabetic subjects diagnosed for at least 3 months * bmi between 25 and 40 kg/m2 (inclusive) * have a glycosylated hemoglobin (hba1c) of \>6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents or \>6.5% to ≤10.0% (inclusive) if treated with metformin exclusion criteria: healthy subject cohorts: * known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic, and dermatological or connective tissue disease * subjects with a systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>90 mmhg type 2 diabetic subject cohorts: * subjects with a known medical history or presence of type 1 diabetes mellitus * subjects with known medical history of acute metabolic diabetic complications * subjects with uncontrolled hypertension (systolic blood pressure \>160 mmhg and/or diastolic blood pressure \>95 mmhg with documented ongoing treatment)

Keywords: safety tolerability pharmacokinetics food-effect diabetes
upper limb tremor reduction in essential tremor patients

Conditions: Essential Tremor

Summary: this study is designed to demonstrate the safety and tolerability of the encora therapeutics tremor mitigation device in subjects with upper limb tremor caused by essential tremor.

a prospective, randomized, blinded clinical trial. subjects meeting all inclusion criteria will have five days of treatment with each of the three arms, received in a randomized order. subjects will complete two rounds of assessments each day. arm 1: inactive stim arm 2: stim therapy utilizing a specific dermatome arm 3: stim therapy utilizing a tailored frequency

Eligibility criteria:
inclusion/exclusion: inclusion criteria: 1. between the ages of 22 and 80 years of age 2. a diagnosis of essential tremor (definite or probable based on trig criteria) 3. at least one hand exhibiting tremor \> 2 as assessed by the essential tremor rating 4. assessment scale (tetras) finger to nose task, duck wing task, or archimedes spiral completed during the screening visit 5. stable tremor medications for at least 30 days prior to enrollment and the ability to maintain stable medications through the duration of the study randomization inclusion criteria 1. during the baseline evaluation period, a median tremor score of \> 2 on at least one hand as assessed by the tetras finger to nose task, the duck wing task, or the archimedes spiral and 2. during the baseline evaluation period, a median score of \> 3 on any one of the subject-assessed items of the bain \& findley activities of daily living scale (bf-adl) exclusion criteria: 1. previous surgical interventions for tremor reduction on the upper limb being used for inclusion in this study (eg, thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, or focused ultrasound) 2. use of botulinum toxin for treatment to hand tremor within six months of enrollment 3. suspected or diagnosed epilepsy or other seizure disorder 4. other possible causes of tremor, including parkinson's disease, drug-induced tremor, or dystonia 5. pregnant 6. swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site 7. numbness, tingling or pain affecting the tested upper extremity (eg, suspected or confirmed peripheral neuropathy, carpal tunnel syndrome) 8. known allergy to silicone 9. subjects are unable or unwilling to comply with the protocol requirements 10. subject is part of a vulnerable population who is unable to give informed consent for reasons of incapacity, dementia, immaturity, adverse personal circumstances or lack of autonomy. this may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. 11. vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
integrative approaches to cancer survivorship: project 3

Conditions: Breast Cancer

Summary: the purpose of this study is to conduct a randomized controlled trial or rct of the following 2 supportive care interventions in recent breast cancer survivors: an integrative medicine intervention based on ayurvedic medicine and a health education intervention.

post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. in addition, cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. few effective treatment options exist for these symptoms. integrative medicine is rising in popularity in the united states; however, few integrative medicine modalities have been rigorously studied. ayurveda, a whole system of medicine that originated in the indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. in the integrative medicine intervention, ayurvedic nutrition and lifestyle guidance will be presented, along with instruction in yoga. in the health education intervention, informative content on issues relevant to breast cancer survivors will be presented including the physical, social and emotional impacts of survivorship. the investigators aim to perform a pilot rct in breast cancer survivors with impaired quality of life. specifically, the investigators aim to assess feasibility of randomization, adherence and retention to the integrative medicine and health education interventions.

Eligibility criteria:
inclusion criteria: * female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * having received chemotherapy as part of their primary therapy for breast cancer * be in complete remission * aged 18 years or older * able to read, write, and understand english * karnofsky performance status (kps) greater than or equal to 60 * have impaired quality of life * ability to give informed consent exclusion criteria: * having received ayurvedic treatment within 6 months of study enrollment * receiving chemotherapy or radiotherapy at the time of study enrollment. anti-her2 directed therapy is not exclusionary. * being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). smaller surgical procedures such as implant exchange are not exclusionary. * patients on adjuvant hormone therapy for less than 2 months * have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. smaller surgical procedures such as implant exchange are not exclusionary.
efficacy of popliteal nerve blocks with and without dexamethasone on the duration of analgesia for foot & ankle surgery

Conditions: Foot and Ankle Procedures

Summary: the purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (put the nerve to sleep with bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.


Eligibility criteria:
inclusion criteria: * 60 patients (30 per group) undergoing foot and ankle procedures * willingness and ability to sign an informed consent document * no allergies to anesthetic or analgesic medications * american society of anesthesiologists (asa)physical status class i - iii * aged 18-90 years,either sex exclusion criteria: * refusal to participate in the study * age\ 90 years - * contraindications to regional blockage including but not limited to: * patient refusal to regional blockade * infection at the site of needle insertion * systemic infection * bleeding diathesis or coagulopathy

Keywords: pain management postoperative opioid requirements perioperative outcomes dexamethasone anesthetic adjuvant analgesic adjuvant
a 12 week study of qva149 compared to fluticasone/salmeterol (advair) for treatment of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: study is to show that qva149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation


Eligibility criteria:
inclusion criteria: * age \>= 40 years, patients with airflow limitation indicated by post-bronchdilation fev1 \>=30% and \<80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mmrc grade 2 or greater exclusion criteria: * prolonged qtcf \>450 ms, paroxysmal atrial fibrillation, type i or uncontrolled type ii diabetes, history of asthma, copd diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: copd
epc performance investigation for stereoelectroencephalography

Conditions: Epilepsy

Summary: the objective of this multicentre study is to collect preoperative, intra operative, early, short, intermediate and mid-term(one years) on the related clinical complications and functional outcomes of market-approved alcis products to demonstrate safety and performance of these devices in a real-world setting.

outcome data collected from this study will provide the basis for post-market surveillance (pms) reporting, clinical study report (csr), clinical evaluation report (cer) on alcis devices and support peer-reviewed publications on products performance and safety.

Eligibility criteria:
inclusion criteria: * to be included, patients must be: * 18 months to 65 years * patient with drug-resistant and disabling focal epilepsy * informed and willing to sign an informed consent form approved by ec / for minors: if one of the parents cannot consent within the timeframe provided by the protocol, then only one parent's signature is required * affiliation to the social security or foreign regime recognized in france * for prospective inclusion: patient considered for seeg exploration as part of pre-surgical assessment of epilepsy * for ambispective inclusion: * must have undergone an seeg exploration with one alcis device before the date of the initiation visit * follow-up visits (at least 12-month) must be prospective * must have complete information available for each completed visit (demographics, preoperative information, implantation information, device details) \*. exclusion criteria: * • not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times) * any medical condition that could impact the study at investigator's discretion (e.g. allergy...) * pregnant women (contraindication to seeg exploration) * adult subject to legal protection measure * skull thickness inferior at 2 mm
transpark_long: the diagnostic value of early transcranial ultrasound in patients with extrapyramidal diseases in a swedish population

Conditions: Parkinsonism; Tremor; Dementia

Summary: popular science summary of the project the purpose of the study is to investigate in a swedish population how well the investigators' previous ultrasound findings match the final diagnosis (pd, aps or et) after a particularly long follow-up time, which greatly increases the certainty that the diagnosis does not change more and is thus correct. furthermore, the investigators want to study whether the initial ultrasound findings have changed during the control interval and whether measurement results regarding the diameter in one of the fluid-filled rooms in the brain (third ventricle) can be correlated with the development of cognitive impairment or dementia later in the course of the disease. for this, this study have got ethical permission to go into the patients' medical records and to call a subgroup back to the clinic to be able to do a new examination and a memory test.


Eligibility criteria:
inclusion criteria: * patients with parkinsonism or essential tremor who came into contact with our clinic before 2017 * satisfactory transcranial bone window * previous tu (clinical indication) exclusion criteria: * no transcranial bone window

Keywords: transcranial ultrasound substantia nigra
effects of cognitive-behavioral therapy for insomnia in nurses with post covid-19 condition

Conditions: Cognitive Behavioral Therapy

Summary: background: neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of covid-19. although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. previous research supports the usefulness of cognitive behavioral therapy for insomnia (cbt-i) as self-management strategies in adults with insomnia, anxiety, depression, and pain. however, their effects on post covid-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms. aim: to investigate the effects of cbt-i on insomnia, anxiety, depression, and pain in nurses with post covid-19 condition. methods: in this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (cbt-i and control). the intervention phase will last 6 weeks, followed by a three-month follow-up. primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. these variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention. discussion: this study will provide evidence of the effects of cbt-i on improving insomnia, anxiety, depression, and pain among nurses with post covid-19 condition. results could also enhance means by which to discontinue benzodiazepine hypnotics.


Eligibility criteria:
inclusion criteria: * nurses with post covid-19 condition exclusion criteria: * history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
ds-8201a in pre-treated her2 breast cancer that cannot be surgically removed or has spread [destiny-breast02]

Conditions: Breast Cancer

Summary: this study will compare ds 8201a to standard treatment. participants must have her2 breast cancer that has been treated before. their cancer: * cannot be removed by an operation * has spread to other parts of the body

the study is designed to compare ds 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with t-dm1.

Eligibility criteria:
inclusion criteria: * is the age of majority in their country * has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed her2-positive expression as determined according to american society of clinical oncology - college of american pathologists guidelines evaluated at a central laboratory 3. was previously treated with ado-trastuzumab emtansine (t-dm1) * has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy) * is her2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. if archived tissue is not available, agrees to provide a fresh biopsy. * male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least: 1. 7 months after the last dose of ds-8201a (females); 4.5 months after last dose of ds-8201a (males) 2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants) 3. 7 months after the last dose of trastuzumab/capecitabine * has adequate hematopoietic, renal and hepatic functions exclusion criteria: * has previously participated in an antibody drug conjugate study sponsored by daiichi sankyo. prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy * has had prior treatment with capecitabine * has uncontrolled or significant cardiovascular disease * has a history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, has current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out by imaging at screening * has active central nervous system (cns) metastases

Keywords: breast cancer metastatic breast cancer ds 8201a destiny - breast 02
a phase 1 study to evaluate the pharmacokinetics of gs-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment

Conditions: Chronic Hepatitis C

Summary: this is a phase 1 open-label, parallel-group, single-dose study to evaluate the pharmacokinetics of gs-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic (\> 6 months), hepatic impairment. * in the opinion of the investigator, be in good health. exclusion criteria: * severe hepatic encephalopathy. * prior placement of a portosystemic shunt. * hepatorenal or hepatopulmonary syndrome. * suspicion of hepatocellular carcinoma.

Keywords: hepatitis c (hcv) infection moderate hepatic impairment severe hepatic impairment
an expanded access programme with iressa for patients with non-small-cell lung cancer and cancer of the head and neck

Conditions: Non Small Cell Lung Cancer; Cancer of the Head and Neck

Summary: the purpose of this study is to provide zd1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage iii or iv) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.


Eligibility criteria:
inclusion criteria: * have received at least one course of standard systemic chemotherapy or radiation therapy * are ineligible for chemotherapy or radiotherapy * are ineligible or not candidates for enrollment in available zd1839 trials for nsclc or squamous cell h\&nc * are, in the investigators opinion, not medically suitable for chemotherapy. exclusion criteria: * current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any zd1839 protocol available to the patient, or previous enrollment in a blinded zd1839 protocol * patients from a blinded protocol may be considered for acceptance, with astrazeneca's permission, only after trial completion and unblinding of all patients. * patients eligible for or previously enrolled in an open-label or unblinded zd1839 clinical trial may be considered for acceptance with astrazeneca's permission * incomplete healing from prior oncologic or other major surgery