Kornimate/medical-research-clean huggingface dataset:
efficacy and mechanism of augmentation of cognitive behavioral therapy with transcranial alternating current stimulation(tacs) for obsessive-compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder (OCD)

Summary: this study aims to evaluate the feasibility and clinical outcome of the exposure-based cognitive-behavioral therapy (cbt) concurrent with transcranial alternating current stimulation (tacs) in treating obsessive-compulsive disorder (ocd) patients, and explores the potential neural mechanisms of treatment effect by electroencephalography (eeg).

the current study aims to evaluate feasibility and clinical outcome of exposure-based cbt (erp) combined with tacs over the prefrontal cortex (mpfc) in treatment of ocd patients. 120 ocd patients whose symptom were mainly associated with "contamination/clean" will be randomized into three groups (erp+active tacs, erp+sham tacs stimulation and waiting list). all patients except those in the waiting list will be received 10 sessions of individual cbt in a two-month period, including 8 sessions of concurrent tacs with erp (tacs+erp). based on the eeg parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency). three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using y-bocs at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tdcs+erp (session 10#). the patients will also receive eeg at each point. the current study aims to explore whether the administration of online tacs together with erp (tacs+erp) will improve the efficacy of erp and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.

Eligibility criteria:
the investigators recruited outpatient adults with ocd confirmed by the mini-international neuropsychiatric interview (mini). the following inclusion and exclusion criteria were also applied: inclusion criteria: * 18-60 years old, * with at least 9 years of education * y-bocs score ≥16 * no history of serious medical, neurological illness or other psychotic disorders other than ocd (anxiety or mild to moderate depression secondary to ocd was not exclusionary) * medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study * no previous exposure to erp or tacs exclusion criteria: * history of serious medical, neurological illness or other psychotic disorders other than ocd * ocd symptoms are severe, preventing the patient from completing the required assessment and examination * serious suicide risk * women who are pregnant or planning to become pregnant * currently taking antiepileptic medication * clinically significant physical illnesses or laboratory test abnormalities that have clinical significance

Keywords: cognitive-behavioral therapy exposure and response prevention transcranial alternating current stimulation
a continuous glucose monitor based insulin bolus calculator (cgm-ibc) study b

Conditions: Diabetes Mellitus

Summary: this study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor.

individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. this dose is often based on what they are eating and their glucose value. insulin bolus calculators may be helpful in recommending an insulin dose. this study examines the safety of an app-based insulin calculator manufactured by welldoc (columbia, md). this app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. this study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes using the dexcom g6 continuous glucose monitor exclusion criteria: * pregnancy

Keywords: continuous glucose monitor, insulin calculator
a 12 week study to assess changes in joint inflammation using ultrasonography in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: to evaluate the changes in joint inflammation produced by cimzia over 12 week treatment period measured by power/color doppler and gray scale ultrasound.

since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. only adverse event (ae) data will be summarized in a table, with frequency counts and percentages.

Eligibility criteria:
inclusion criteria: * diagnosed with adult-onset rheumatoid arthritis (ra) \>6 months and \<3 years * active ra * must have failed at least one disease modifying anti rheumatic drug (dmard) treatment * subject can have attempted no more than one previous anti tumor necrosis factor (anti-tnf) and discontinued due to drug intolerance exclusion criteria: * subject cannot have a second non-inflammatory musculoskeletal condition * subject cannot have a diagnosis of any other inflammatory arthritis * subject cannot have any previously infected prosthesis * subject cannot have arthroplasties in any of the joints assessed in the study * subject cannot have a history of chronic infections * subject cannot have known tuberculosis (tb) disease, high risk of acquiring tb, or latent tb infection * subject cannot have a history of or current lymphoproliferative disorder * subject cannot have known human immunodeficiency virus (hiv) infection * subject cannot have received a live or attenuated vaccine within 8 weeks * subject cannot have current or history of malignancy * subject cannot have a history of blood disorders * subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease * subjects must not have a history of adverse reaction to polyethylene glycol (peg), a protein medicinal product, or ultrasound gel applied to the skin

Keywords: arthritis joint pain inflammation rheumatoid arthritis
secondary prevention of depression through group-based act-therapy preceded by an experimental abm-procedure

Conditions: Major Depression

Summary: depression (major depressive disorder; mdd) is a very common mental disorder. research suggests that individuals with prior depressive episodes have a risk of the relapse or recurrence of mdd. secondary prevention has been identified as a key goal in the long-term management of the disease. the current project aims to investigate whether group based acceptance and commitment therapy (act) can reduce surrogate and clinical markers of relapse in a group highly vulnerable to depressive episodes. the group intervention will consist of eight sessions, and each group will consist of maximum 12 persons. the project also studies whether attention bias modification (abm) preceding the act intervention will enhance the effect. abm will be administered over a fourteen days period prior to the act-intervention. effect will be measured over a period of 12 months. the primary outcome is changes in depressive symptoms. act-specific secondary outcome measures are also included. subjects with a history of major depression (n=200), currently in remission, will be recruited from sørlandet hospital (100 participants). matched participants (100 participants) will be recruited at the university of oslo. in the first phase, participants from sørlandet hospital will be randomized to abm treatment or control condition. in the second phase all participants from sørlandet hospital will receive group based act treatment. group based act and abm represent interventions that are time and cost effective, and that could be made available to large number of individuals struggling with mdd.


Eligibility criteria:
inclusion criteria: * subjects with a history of major depression, currently in remission exclusion criteria: * current or past neurological illness, bipolar disorder, psychosis or drug addiction.
effectiveness and safety of generic delayed-release dimethyl fumarate (sclera® or marovarex ®, hikma) in routine medical practice in the treatment of relapsing-remitting multiple sclerosis in mena region

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of generic dmf (sclera® or marovarex ®, hikma) in patients undergoing routine clinical care for rrms in mena region

this is an observational, multi-center, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. in the study sites, patients undergoing routine clinical care for rrms and initiated treatment with generic dmf (sclera® or marovarex ®, hikma) in accordance with the approved spc will be followed up and assessed for a total of 12 months.

Eligibility criteria:
inclusion criteria: 1. patients who initiate treatment with hikma generic dmf at baseline in accordance with the approved summary of product characteristics 2. age ≥ 18 years 3. patients who had a diagnosis of rrms per 2010 or 2017 revised mcdonald criteria who are : 1. newly diagnosed who had no prior dmt, or 2. switched patients who had ≥1 prior dmts, other than dmf 4. patients who agree to participate in the study and provide a written informed consent exclusion criteria: 1. patients with previous exposure to dmf other than (sclera® or marovarex ®-hikma), fumaderm (fumaric acid esters), or compounded fumarates. 2. patients participating in other clinical studies 3. patients who meet any of the contraindications to the administration of the study drug according to the approved summary of product characteristics

Keywords: dimethyl fumarate generic dimethyl fumarate delayed-release dimethyl fumarate disease modifying treatments nervous system multiple sclerosis relapsing-remitting multiple sclerosis cohort study observational study effectiveness safety health related quality of life
mechanisms of exercise intolerance in chronic obstructive pulmonary disease

Conditions: COPD

Summary: 1: is endothelium function impaired in copd? other chronic cardiovascular diseases are associated with endothelial dysfunction, and the endothelium plays an important role in regulating vascular tone, tissue blood flow, coagulation and the inflammation process. although the specific causes of endothelial dysfunction remain unclear, physical inactivity, chronic systemic inflammation and smoking are all known to be associated with endothelial abnormality. 2. is muscular sympathetic nerve activity (msna) increased in copd? a balanced regulation of blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore contribute to the exercise intolerance and skeletal muscle depletion seen in patients with copd.skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is thus adapted to meet energy requirements. during physical activity, the sympathetic nervous system is activated ("exercise pressor reflex"), resulting in increased ventilation, heart rate and a redistribution of cardiac output from inactive to active tissues. the redistribution of cardiac output to the body organs is heterogeneous. blood flow to skeletal, respiratory and cardiac muscle increases as exercise intensity increases, whereas blood flow to gastrointestinal, renal and reproductive tissues decreases. as blood pressure during exercise remains largely unchanged, the redistribution of blood flow is caused by changes in vascular conductance. these conductance changes are caused by an overall vasoconstriction induced by the increased sympathetic outflow of noradrenaline (na), and a vasodilation of vascular beds supplying the working skeletal -, cardiac- and respiratory muscle.


Eligibility criteria:
inclusion criteria: * forced expiratory volume at on second/ forced vital capacity fixed ratio \<0.70, - forced expiratory volume at one second \<60% of predicted and medical * research council scale \> or equal to 3 * arterial oxygen saturation at rest\> 90%, * body mass index \>18, * left ventricle ejection fraction\> 45. exclusion criteria: * unstable ischemic heart disease, * severe heart valve failure, * pulmonary emboli, * severe heart failure, * severe infections, * musculoskeletal disorders, * malignant disease, * contraindicated medicine as anticoagulants.
wear and migration in the corin mini-hip/metafix and ecima polyethylene

Conditions: Hip Osteoarthritis

Summary: the primary objective of this study is to determine whether the mini hip (corin, u.k.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (metafix, corin, u.k.). the secondary objectives of this study are to determine whether the trinity (corin, u.k.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ecima highly cross-linked polyethylene.


Eligibility criteria:
inclusion criteria: * women and men between the ages of 18 and 65 years old. * scheduled to receive a hip replacement * willing and able to give informed consent for participation in the study. * diagnosed with hip osteoarthritis * able (in the investigators opinion) and willing to comply with all study requirements. * willing to allow his/her general practitioner and consultant, if appropriate, to be notified of participation in the study exclusion criteria: the participants may not enter the study if any of the following apply: * inflammatory arthropathy, osteoporosis or deformities of the proximal femur. * significant comorbidities that would make follow up difficult or uncomfortable * any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk due to participation in the study, may influence the result of the study, or the participants ability to participate in the study.
safety and effectiveness of different shangring device sizes for adult male circumcision in lusaka, zambia

Conditions: Male Circumcision

Summary: the purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of shangring sizes for adult voluntary medical male circumcision (vmmc) within routine service delivery in lusaka, zambia.

we conducted a randomized controlled trial and enrolled 500 hiv-negative men aged 18-49 years at 3 clinics. participants were randomized to 1 of 2 study arms (standard sizing arm vs modified sizing arm) in a 1:1 ratio. all 14 adult shangring sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the standard sizing arm; the modified sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (aes), pain, and healing.

Eligibility criteria:
inclusion criteria: * must be aged 18 to 49 years; * must be hiv-uninfected per same-day routine voluntary testing at the clinic; * must be uncircumcised (on examination); * must be in good general health, at the discretion of the clinician; * must be free of genital ulcerations or other visible signs of sti (on examination); * must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule; * must freely consent to participate in the study and sign a written informed consent form; * must provide full contact information including cell phone number, address, and other locator information. exclusion criteria: * has an active genital infection upon visual inspection; * has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates shangring mmc; * takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; or * has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia * has a self-reported allergy or sensitivity to lidocaine or other local * is not available to be circumcised on the same day as screening.

Keywords: hiv prevention shangring adverse events wound healing voluntary medical male circumcision (vmmc) medical device zambia
predictors of non-invasive ventilation failure in patients with acute cardiogenic pulmonary edema

Conditions: Acute Cardiogenic Pulmonary Edema

Summary: the aims of our study was to identify early predictors of non-invasive ventilation failure, so as to alert clinicians early that endotracheal intubation and mechanical ventilation might be appropriate.


Eligibility criteria:
inclusion criteria: * presence of acpe diagnosed based on spo2 below 90% with \>5 l/ min oxygen via reservoir face mask * acute respiratory distress as evidenced by severe dyspnea * breathing frequency of \>30 breaths/min, and use of accessory respiratory muscles or paradoxical abdominal motion in association with tachycardia * cardiac gallops, bilateral rales, and typical findings of congestion on chest radiography, without a history suggesting pulmonary aspiration or evidence of pneumonia. exclusion criteria: * patients were excluded from the study if they were intubated before icu admission, or required immediate intubation without prior niv, or presented a respiratory or cardiac arrest * severe hemodynamic instability (systolic arterial pressure \<70 mmhg despite adequate fluid repletion and use of vasoactive agents) or life-threatening ventricular arrhythmias. * patients were also excluded if they were unresponsive, agitated, and unable to cooperate; or if they had any condition that precluded application of a face mask including upper airway obstruction * recent oral or facial trauma or surgery * recent gastric or esophageal surgery * inability to clear respiratory secretions or high risk for aspiration. * in addition, patients were excluded if they had a "do not intubate" order or refused research authorization.
vitamin d influence on oocyte donation

Conditions: Disorder of Phosphate, Calcium and Vitamin D Metabolism; Female Infertility Due to Diminished Ovarian Reserve; Hormonal Requirement; Reproductive Disorder

Summary: objective: to investigate the correlation between total and bioavailable serum 25-oh vitamin d, ovarian reserve and ovarian response to controlled stimulation in egg donors.

design: retrospective study. setting: university affiliated private ivf center. intervention: serum analysis of vitamin d, bioavailable vitamin d, antimullerian hormone (amh), antral follicular count (afc), reproductive outcome of oocytes recipients main outcome measure: amh, afc, number of oocytes retrieved and number of mature oocytes, pregnancy and implantation rate of donated oocytes'recipients.

Eligibility criteria:
inclusion criteria: * caucasian race, * between 18 and 34 years of age, * all donors had normal menstrual cycles of 26-34 days, * normal weight range (bmi 18- 25 kg/m2), * normal uterus and ovaries on transvaginal ultrasound (no signs of polycystic ovarian syndrome), and * an antral follicle count (afc) \>10, * normal karyotype exclusion criteria: * current or past exposure to radiation or hazardous chemical substances, * history of drug use, * family history of hereditary chromosomal diseases, * sexually transmitted diseases

Keywords: egg donation vitamind ovarian reserve ovarian stimulation
early detection and intervention for women at-risk of psychosis

Conditions: Prodromal Schizophrenia

Summary: this study aims to examine the effectiveness of the cognitive behavioral therapy in preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.

eligible subjects with informed consent provided will be randomly assigned to the cognitive behavioural therapy (cbt) group or psychoeducation group. each group consists of 8 session spanning for 8 week.

Eligibility criteria:
inclusion criteria: * women of age 18-64 * at-risk mental state as defined by the comprehensive assessment of at-risk mental states (caarms) * with an informed consent * able to understand cantonese and read/write chinese exclusion criteria: * those mental conditions that requires other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders) * those medical conditions that severely limits participation, comprehension, or adherence to the treatment (e.g., epilepsy, dementia, terminal medical illness); * those who are receiving structured psychotherapy or counselling
oxaliplatin + 5-fluorouracil/leucovorin (5-fu/lv) (folfox4) versus doxorubicin as palliative chemotherapy in advanced hepatocellular carcinoma patients

Conditions: Carcinoma, Hepatocellular

Summary: primary: * overall survival (os) secondary: * time to tumor progression (ttp) * response rate (rr) * improvement of quality of life (qol) * safety * secondary resection rate


Eligibility criteria:
inclusion criteria: * histologically, cytologically or clinically diagnosed (in patient with cirrhosis, alpha-fetoprotein(afp)≥400μg/l and morphological evidence \[contrast computed tomography(ct)/magnetic resonance imaging(mri)\] of hypervascular liver tumor, elevated afp level due to other reasons \[germ cell carcinoma, progressive chronic hepatitis, pregnancy, etc\] can be excluded) unresectable hepatocellular carcinoma, ineligible or if the patient does not consent to receive local invasive treatment (chemo-embolism, ablation, etc.). * at least one measurable lesion (on ct: ≥2cm, on spiral ct or mri ≥1cm) * have not received previous palliative systemic chemotherapy for metastatic disease. if the patient received previous systemic chemotherapy as adjuvant treatment, he must have been completed at least 12 months previously. * patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (hepatic artery infusion, trans-artery embolization or trans-artery chemo-embolization) or at least 8 weeks after the last radiotherapy/ablation/ percutaneous ethanol injection to the target lesion. * karnofsky performance score≥70, barcelona of cancer liver category stage b/c * patients must have adequate organ and marrow function: * neutrophilus≥1.5x10\^9/l * platelets≥75x10\^9/l * asparagine aminotransferase,alanine aminotransferase\<2.5 upper normal limit(unl) * total bilirubin\<1.5 unl * international normalized ratio\<1.5 * child stage a or b * normal base line left ventricular ejection fraction (lvef result must be above or equal to the lower limit of normal for the institution) exclusion criteria: * documented allergy to platinum compound or to other study drugs. * any previous oxaliplatin or doxorubicin treatment, except adjuvant treatment more than 12 months before the randomization. * previous liver transplantation. * patients concomitantly receiving any other anti-cancer therapy, including interferon-α and herbal medicine which was approved by local authority to be used as "anti-cancer" medicine, except radiotherapy to non-target lesion (bone metastasis, etc) * patients who are receiving any other study treatments. * pregnant or lactating women or women of childbearing potential without proper contraceptive methods. * history of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. * central nervous system metastasis * other serious illness or medical conditions the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.