Kornimate/medical-research-clean huggingface dataset:
online, guided interventions to reduce generalized anxiety disorder among indian university students

Conditions: Anxiety Disorders

Summary: this controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (cbt)-based online guided and unguided self-help intervention to reduce generalized anxiety disorder (gad) in indian university students. the investigators aim to assess if these novel electronic health (ehealth) interventions can be integrated into indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.

students from three indian colleges will be invited to complete an online, self-report survey. based on their answers, they are categorized into clinical, subclinical, and asymptomatic for generalized anxiety disorder (gad). those who meet the diagnostic criteria for gad as detailed in the diagnostic and statistical manual of mental disorders (dsm), 4th edition are classified as clinical. those who score a 5.7 or above using dimensional scoring of the gad-q-iv but are not "clinical" are classified as subclinical. all others are asymptomatic. after ruling out those with a clinical ptsd diagnosis (scoring 38 or above on the pcl5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time.

Eligibility criteria:
inclusion criteria: * current student of one of the 3 college sites * subjects must have a clinical or subclinical diagnosis of generalized anxiety disorder (gad); clinical diagnosis is met by self-reporting dsm-iv criteria for gad; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the gad-q-iv exclusion criteria: * unable to give informed consent. * is currently receiving mental health treatment. * has clinical ptsd (a score of 38 or above on the pcl5)

Keywords: guided self-help student mental health task shifting prevention
single port access (spa) cholecystectomy versus standard laparoscopic cholecystectomy

Conditions: Symptomatic Gallbladder Stones; Cholecystitis; Biliary Pancreatitis

Summary: background: single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses. objective: demonstrate the validity of single port access (spa) cholecystectomy compared to multiple ports laparoscopic cholecystectomy. hypothesis: spa cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. spa cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. spa cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed. methods: all patients offered cholecystectomy, either spa or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally. surgical technique, either for spa cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports. randomization will be performed before surgeries after patients have given their informed consent to the study. no specific test or cost will be necessitated by the study. patients will be informed orally and will receive a short study summary, allowing them to give an informed consent. endpoints: * morbidity * body image and cosmetic results * post-operative pain (opioid sparing effect) * operative time * hospital stay


Eligibility criteria:
inclusion criteria: * age more than 18 years exclusion criteria: * contraindication to laparoscopy * liver disease * cognitive trouble

Keywords: single port access laparoscopy cholecystectomy cholangiography cosmesis
incidence of hypophosphatemia after treatment with iron isomaltoside/ferric derisomaltose or ferric carboxymaltose in subjects with iron deficiency anaemia

Conditions: Iron Deficiency Anaemia; Iron Deficiency Anemia

Summary: the trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (ida).

this trial was designed to evaluate the effect of iv iron isomaltoside/ferric derisomaltose compared with iv ferric carboxymaltose on s-phosphate in subjects with ida caused by different etiologies. the subjects received either a single intravenous (iv) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two iv doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). the study subjects were monitored for up to 35 days from baseline.

Eligibility criteria:
inclusion criteria include: * subjects having ida caused by different aetiologies * haemoglobin (hb) ≤ 11 g/dl * body weight \> 50 kg * serum ferritin (s-ferritin) \< 100 ng/ml * estimated glomerular filtration rate (egfr) ≥ 65 ml/min/1.73 m2 * serum phosphate (s-phosphate) \> 2.5 mg/dl * intolerance or unresponsiveness to oral iron * willingness to participate and signing the informed consent form (icf) exclusion criteria include: * acute bleeding \> 500 ml within 72 hours * anaemia predominantly caused by factors other than ida * hemochromatosis or other iron storage disorders * previous serious hypersensitivity reactions to any iv iron compounds * treatment with iv iron within the last 30 days prior to screening * treatment with erythropoietin or erythropoietin-stimulation agents * red blood cell transfusion, radiotherapy, and/or chemotherapy * received an investigational drug within the last 30 days prior to screening * planned surgical procedure within the trial period * hepatic enzymes \> 3 times upper limit of normal * surgery under anaesthetic within the last 30 days prior to screening * any non-viral infection within the last 30 days prior to screening * alcohol or drug abuse within the past 6 months * vitamin d deficiency * untreated hyperparathyroidism * kidney transplantation * active malignant disease, disease-free for less than 5 years * history of a psychological illness or seizures * pregnant or nursing women.

Keywords: iron deficiency anaemia iron deficiency anemia ida iron deficiency intravenous iron replacement therapy iron isomaltoside ferric derisomaltose hypophosphatemia ferric carboxymaltose monofer monoferric monover monofar monoferro
effect of platelet inhibition according to clopidogrel dose in patients with body mass index ≥ 27

Conditions: Cardiovascular Disease; Overweight

Summary: the purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (bmi) ≥ 27 kg.m-2.

the goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with bmi ≥ 27 kg.m-2 1 - biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation. 2 - clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.

Eligibility criteria:
inclusion criteria: * male or female, * old (e) of more than 20 years * bmi ≥ 27kg.m-2 * patients hospitalized for acute coronary syndrome (whatever the st segment and troponin dosage) * patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days) exclusion criteria: * patients unwilling. * patient participating in another study. * patients with cardiogenic shock * patient on anti gpiibiiia or stopped less than 72 hours before the test aggregability * patients scheduled for surgery in less than 6 months * ischemic stroke older than 6 weeks. * history of hemorrhagic stroke (any time) * patients on or candidates for avk * patients with a different anti adp (ticlopidine, prasugrel) * patients with an indication against clopidogrel (side effects, bleeding ...) * thrombocytopenia \< 100000/mm3 * anemia (ht \< 30%) * thrombocythaemia (ht \> 52%) * pregnancy

Keywords: cardiovascular disease maintenance dose clopidogrel overweight antiplatelet agents
a single-blinded, randomized, placebo controlled phase ii trial of prophylactic treatment with oral azithromycin versus placebo in cancer patients undergoing antineoplastic treatment during the corona virus disease 19 (covid-19) pandemic

Conditions: COVID

Summary: prophylactic treatment in cancer patients undergoing antineoplastic therapy during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * histologically confirmed cancer diagnosis * ongoing systemic antineoplastic treatment irrespective of application route * age ≥ 18 years * life expectancy of at least 3 months * adequate renal, cardiac and liver function * corrected qt time (qtc) ≤ 450 ms * eastern cooperative oncology group (ecog) performance status of \< 3 * capable of understanding the study and giving informed consent * negative covid-19 test at study entry as measured by routine testing exclusion criteria: * use of any investigational agent within 28 days prior to study start * patients with active opportunistic infections * pregnant or lactating women * women of childbearing potential and male subjects not willing to use adequate contraception methods during the study period * hypersensitivity to azithromycin or other macrolides * concurrent medication with ergotamine, theophylline, digitalis * inability to swallow tablets
complete: international acute ischemic stroke registry with the penumbra system aspiration including the 3d revascularization device

Conditions: Stroke, Ischemic

Summary: the purpose of this registry is to collect performance and safety data on the penumbra system including the 3d revascularization device in a real world patient population with acute ischemic stroke (ais) secondary to intracranial large vessel occlusion (lvo).

registry objective: the primary objective of this registry is to collect real-world performance and safety data on penumbra system including the 3d revascularization device in a patient population with acute ischemic stroke (ais) secondary to intracranial large vessel occlusion (lvo). registry design: this will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior lvo who are eligible for mechanical thrombectomy using the penumbra system. registry duration: subjects will be in the registry for approximately 90 days from enrollment to last follow-up.

Eligibility criteria:
inclusion criteria: * patient age ≥ 18 * pre-stroke mrs 0-1 * patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the penumbra system * planned frontline treatment with penumbra system * signed informed consent per institution review board/ethics committee exclusion criteria: * any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days. * currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Keywords: large vessel occlusion acute ischemic stroke mechanical thrombectomy penumbra system 3d revascularization
effects of breathing exercises on reaction time

Conditions: Breathing, Mouth

Summary: the aim of the study was to investigate the short and long-term effects of breathing exercises on reaction time.

a total of 40 participants who volunteered to participate in the study from the students of the department of physiotherapy and rehabilitation, faculty of health sciences, bandırma onyedi eylül university will be included in the study. participants will be randomly divided into two groups using a simple random numbers table. the study group (15 people) will be given respiratory exercises (12 sessions). the control group (15 people) will receive no intervention. in the study, after the demographic characteristics of the participants are obtained, reaction time will be evaluated with auditory and visual reaction tests and upper extremity reaction tests. all evaluations are planned to take a total of 15 minutes. the same assessments will be performed in both groups. to measure the long-term effect, after the initial evaluations are completed, the study group will be given a total of 12 sessions of breathing exercises for 4 weeks (3 days a week). after 4 weeks, both groups will be evaluated again. to measure the short-term effect, the respiratory exercise program will be started after the 1st evaluation in the study group, and the 2nd evaluation will be made after the first session. canan demir will perform breathing exercises, and the other researchers who will evaluate will not know which group the participants are in. in this way, the study will be single-blinded. translated with www.deepl.com/translator (free version)

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * to be between the ages of 18-30 * not having any problems that prevent breathing exercises exclusion criteria: * acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin * having had any injury and/or operation (trauma, surgery, fracture, etc.) in the last 6 months * regular medication use * presence of respiratory disease (asthma, copd, etc...)
patet ratio to rule out transient tachypnea of the newborn

Conditions: Transient Tachypnea of the Newborn

Summary: this study aims to find out whether diagnosis of transient tachypnea of the newborn(ttn) can be predicted via evaluating pulmonary artery doppler indices.

transient tachypnea of the newborn(ttn) is the most common diagnosed disease in state of neonatal respiratory distress. however there is not an adequate method to diagnose or rule out ttn. in several studies pulmonary artery doppler indices are investigated as the possible indicators of pulmonary function. as a result of these studies, physiological processes in fetal lung maturation were established; pulmonary tissue impedance or resistance decreases with increasing gestational age, leading to increased pulmonary blood flow. in a normal lung maturation process the peak sistolic velocity is reached in midsystole, but in case of any reason disturbing the nornal development process,the peak occurs earlier. we suggested that ttn, which is a factor increasing pulmonary tissue impedance like respiratory distress syndrome(rds) and pulmonary hypoplasia, would change pulmonary artery(pa) doppler indices, thus by the way of evaluating pulmonary artery doplerr indices, we could predict possible diagnosis of ttn

Eligibility criteria:
inclusion criteria: * singleton pregnancies who delivered beyond 34 weeks gestational age exclusion criteria: * fetal abnormality, chronicle maternal disease, pregnancy complication (preeclampsia, diabetes, intrauterine growth restriction,etc.)
active surveillance for prostate cancer with indolent features

Conditions: Prostate Cancer

Summary: in patients with prostate cancer with indolent features, disease progrssion may be very slow and in many cases will never become clinically evident during the patient's lifetime. active surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the morbidity of active therapy in patients with stabe indolent parameters, while offering early detection of disease activity in others who will need active therapy to control their disease. we hypothesize that active surveillance will permit the avoidance of therapy related morbidity in the majority of appropriate patients and will be associated with maintaining their quality of life.


Eligibility criteria:
inclusion criteria: 1. men 65 years of age or older who were diagnosed with prostate cancer in the past 3 month prior to inclusion 2. gleason's score of 6 or less. 3. clinical t1c per digital rectal exam. 4. pre biopsy psa serum level of 6.0ng/ml or less. 5. the presence of cancer in a single biopsy core of at least 8 taken. 6. the presence of cancer in no more than 10% of the length of the core involved. 7. patient's consent to engage in active surveillance after being informed of the benefits and potential risks of this approach as well as of alternative lines of therapy. 8. israeli residence with the readiness to be available for the followup schedule. exclusion criteria: patients who do not meet the above eligibility criteria

Keywords: prostate cancer active surveillance indolent features
evaluation of cytokine biomarkers in melanoma patients during immunotherapy

Conditions: Melanoma

Summary: open prospective clinical trial to develop the computer software (intelligent prognostic system) for predicting the efficacy of anti-pd-1 immunotherapy of melanoma patients in routine practice


Eligibility criteria:
inclusion criteria: 1. morphological verification of cutaneous melanoma. verification of metastases is not necessary 2. ecog 0-1 3. age of patients - 18 years and older 4. no prior chemotherapy, immunotherapy, radiation or hormonal therapy 5. adequate contraception for women of childbearing age 6. written consent of the patient to participate in the study exclusion criteria: 1. non-compliance with the previously listed criteria 2. pregnancy and breastfeeding 3. therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology 4. history of another malignancy other than the study indication under this trial within 5 years of study enrollment. does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
chronic myelogenous leukemia (cml) - follow on: study of bms-354825 in subjects with cml

Conditions: Myeloid Leukemia, Chronic, Chronic-Phase

Summary: this is a phase iii study of bms-354825 in subjects with chronic phase philadelphia chromosome or bcr-abl positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (gleevec).


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * subjects with philadelphia chromosome positive (ph+) (or bcr/abl+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate. * men and women, 18 years or older * adequate hepatic function * adequate renal function * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. exclusion criteria: * women who are pregnant or breastfeeding * subjects who are eligible and willing to undergo transplantation during the screening period * a serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy * uncontrolled or significant cardiovascular disease * medications that increase bleeding risk * medications that change heart rhythms * dementia or altered mental status that would prohibit the understanding or rendering of informed consent * history of significant bleeding disorder unrelated to cml * concurrent incurable malignancy other than cml * evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Keywords: chronic phase chronic myelogenous leukemia
dermacyd in odor reducing.

Conditions: Hygiene

Summary: primary objective: - to prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of dermacyd (different fragrances) and glycerine vegetal soap granado traditional secondary objective: - to evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.


Eligibility criteria:
inclusion criteria: * perfect mucosa in the product analysis region * volunteers with active sexual life: normal papanicolau test performed less than one year is mandatory * bacterioscopy describing the vaginal flora * negative trichomonas vaginalis test * negative whiff test * willingness in using preservative in the sexual intercourse during the study period * use the same category cosmetics products * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion exclusion criteria: * use of antiinflammatory / immunosuppression / antihistaminic drugs * atopic or allergy history to cosmetic products * active cutaneous disease (local and/or disseminated) in the evaluated area * disease which can cause immunosuppression, such as diabetes, hiv, etc. * endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs * intense solar exposure (to get a tan) during the 15 days before the evaluation * gynecologic treatment until four weeks before the evaluation * any vaginal infection detected during the inclusion * other conditions considered by the investigator as reasonable for exclude the patient in the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.