Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of ziprasidone in adolescents with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

on march 24, 2009, pfizer inc. stopped late stage geodon pediatric clinical trials in schizophrenia (a1281134 - placebo controlled; a1281135 - open label). as recommended by the dsmb, these studies were stopped due to lack of efficacy. no safety concerns were identified.

Eligibility criteria:
inclusion criteria: * participation in double-blind treatment study a1281134, meeting specific criteria of duration and safety exclusion criteria: * imminent risk of suicide or homicide, as judged by the site investigator * serious adverse event related to study medication in study a1281134 * significant prolongation of qt interval in study a1281134

Keywords: adolescent subjects
comparison of the effectiveness of three different gargates in radiotherapy-associated oral mucositis

Conditions: Head and Neck Cancers; Oral Mucositis

Summary: this study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy.

the research was conducted as a randomized controlled clinical trial between january 2020 and january 2022. the sample of the research; patients who applied to hospital radiotherapy unit, received 50-60 gy radiotherapy in the oral cavity, had a primary diagnosis of head and neck cancer, had no metastasis, had no complaints about mucositis, were older than 18 years old, spoke turkish, and agreed to participate, in the study. with the closed-envelope randomization method, 48 patients were included in the sample, 12 patients for each of the saline, sodium bicarbonate, thyme honey, and control groups. the routine protocol of the clinic was applied to the control group. patients in the intervention group (thyme honey, saline and sodium bicarbonate group) were treated 3 times a day for 6 weeks, in addition to the routine protocol of the clinic; they were asked to gargle with 20 ml of the solution in the group they were randomized to, 15 minutes before, 15 minutes and 6 hours after radiotherapy. intraoral evaluations were made every week by the responsible physician of the radiotherapy unit, who did not know which group the patients were in (single blind). study data; obtained using the sociodemographic and disease data collection form, the national cancer institute common toxicity criteria v4.03, the oral evaluation guide, and the washington university quality of life questionnaire. in the study, chi-square analysis was used for the relationship between two categorical variables, one-way anova for differences in measurements, levene test for homogeneity of variance, and bonferroni analysis to find out from which group or groups the difference originated. support was received from the health sciences university scientific research project office for the study (2020/029)

Eligibility criteria:
inclusion criteria: * primary diagnosis is head and neck cancer * to be receiving radiotherapy at a dose of 50-60 gy in the oral cavity * not be metastatic * om grade 1 (according to nci-ctcae v4.03) * be 18 years or older * volunteer to participate in the study * speak turkish exclusion criteria: * have an autoimmune disease * have dental disease * using dentures * being allergic to thyme honey * refusing to participate in the research * to have received radiotherapy treatment in the 6-month period before the start of the study criteria for terminating the study * the patient's desire to leave the study * continuing the treatment in another city * interruption or termination of radiotherapy treatment * patient's death

Keywords: nurse radiotherapy salin sodium bicarbonate thyme honey head and neck cancers oral mucositis
the effect of acupressure and foot exercise on ankle brachial index in individuals with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with type 2 diabetes.

diabetes mellitus (dm) is a health problem that affects many lifelong systems and organs throughout the world, increases the risk of premature death, affects the individual, family, society and the world, has a serious spiritual and financial care burden, and has important and vital consequences. diabetes can cause damage to nerves as well as small and large vessels. patients who have had dm for a long time will experience circulatory disorders in the upper and lower extremities. ankle-brachial index (abi) is a non-invasive examination of blood vessels that functions to detect clinical signs and symptoms of ischemia, reduced peripheral perfusion that can lead to angiopathy and diabetic neuropathy. studies indicate that foot exercise and acupressure application can be used as an alternative intervention to increase the value of the ankle-brachial index in patients with type 2 diabetes. when the literature was examined, no comprehensive study could be found comparing the effect of foot exercise and acupressure application on the ankle brachial index in diabetic patients in our country. it is thought that acupressure application and ankle exercises will accelerate peripheral circulation and may be effective on the ankle brachial index. this study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with type 2 diabetes.

Eligibility criteria:
inclusion criteria: * being diagnosed with type 2 diabetes * be 18 years or older * ability to speak turkish * ability to establish verbal communication * volunteering to participate in the research exclusion criteria: * presence of any psychiatric disease diagnosed by a physician * presence of diabetic ulcers on both feet and legs * presence of any amputation in the foot or leg * having myalgia in the foot, * foot fracture * edema in the feet

Keywords: acupressure ankle brachial index exercise
seroprevalence of covid-19 in the staff of the university hospitals of strasbourg

Conditions: COVID-19

Summary: the grand est region is one of the most affected regions in france during the first wave of the covid-19 epidemic. a significant increase in the number of patients hospitalized for sars-cov 2 infection at the university hospitals of strasbourg (hus) led to a sudden saturation of their capacities. hospital workers appear to be a population at particular risk for this new infectious agent. the percentage of hospital workers who have been in contact with the virus or have contracted covid-19 is unknown. the objective of this work is to determine the prevalence of sars-cov-2 positive serologies among hospital staff screened from june 22, 2020 to november 1, 2020 following a screening campaign offering serological testing to all volunteer hus professionals.


Eligibility criteria:
inclusion criteria: * adult subject (≥ 18 years of age) * hospital staff practicing at hus who performed sars-cov 2 serology in the period from 06/22/2020 to 11/1/2020 exclusion criteria: - subject not meeting inclusion criteria

Keywords: covid-19 sars-cov-2 prevalence of sars-cov-2
the effects of exercise on some biochemical parameters in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: background: ra may progress with articular and non-articular involvement.depression prevelance is found to increase for ra patients according to healthy population and to be correlated with pain, decreased quality of life, fatigue and physical disability.bdnf level was found significantly lower in ra patients with depression. aim of this study is to investigate the variation of bdnf, vegf, tnf- α, il-6, il-1β, irisin and α- klotho levels following acute exercise. methods: this study included 45 ra patients and 45 age and sex matched healthy controls. blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.


Eligibility criteria:
inclusion criteria: * patients who were aged between 18-65 years, * patients who got diagnosed according to american college of rheumatology criteria * patients who were being followed at firat university department of rheumatology exclusion criteria: * patients who had regular exercise habits, malignancy, pregnancy, incorporation, * patients who took anti-tnf treatment * patients who had changes of medical treatment in last 3 months * patients who diagnosed with fibromyalgia syndrome and osteoarthritis for lower extremity * patients who had cardiac symptoms according to new york heart association * patients who had dysfunction that can prevent physical activity

Keywords: rheumatoid arthritis biochemical parameters exercise
assessment of tartrate-resistant acid phosphatase (trap) as a bone resorption marker in stage iv breast cancer patients with bone metastasis

Conditions: Breast Cancer

Summary: the purpose of this research study is to evaluate the usefulness of the trap protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of zometa® in treating symptoms of bone metastases due to breast cancer. tartrate-resistant acid phosphatase (trap) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. bone destruction causes pain and bone fractures. this study will measure trap levels in serum taken from breast cancer patients to see if trap levels will be able to predict the effect of zometa® treatment on bone destruction, pain and bone fractures.


Eligibility criteria:
inclusion criteria: 1. histologic or cytologic documentation of breast cancer. 2. stage iv breast cancer patients with bone metastasis for whom zometa treatment will be initiated. 3. age \> 18 4. written informed consent prior to study entry 5. patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor. 6. life expectancy of at least 6 months. 7. we will include patients who have had previous or current radiation therapy to breast exclusion criteria: 1. concurrent malignancy with a second primary 2. stage i, stage ii and stage iii 3. ecog performance status 3 or 4. 4. renal failure - serum creatinine \>2.o mg/dl at screening 5. ast or alt \> uln x 3. at screening 6. bilirubin \> 3.0 mg/dl at screening 7. pregnant women 8. prior or current bisphosphonate therapy 9. any skeletal related event due to malignancy prior to study enrollment. 10. patients with osteoporotic fractures prior to study enrollment. 11. allergy to bisphosphonates 12. any radiation therapy for the treatment of bone metastases \<4 weeks prior to study start. 13. any chronic medical condition which would preclude performance or adherence to protocol requirements 14. inability to provide informed consent -
laparoscopic versus hand assisted laparoscopic trans-peritoneal laparoscopic nephrectomy as one day surgery (i.e.: are there differences in postoperative outcome / convalescence)

Conditions: Renal Cancer

Summary: the purpose of this study is to describe the postoperative outcomes after laparoscopic transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of our experiences from the previous study to optimize the postoperative outcomes.


Eligibility criteria:
inclusion criteria: 1. patient between 25-80 years old. 2. diagnosed as cancer renis 3. can read and understand danish 4. no cardiac disease lead to close cardiologic observations 5. any t, any n any m stadia. exclusion criteria: 1. mentally sick patient 2. dement 3. living alone 4. cardiac problem 5. per operative bleeding with the need to blood transfusion 6. operation time at afternoon

Keywords: laparoscopic nephrectomy one day surgery
ranibizumab versus dexamethasone implant in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: between december 2016 and june 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the ophthalmologic clinic of university "g. d'annunzio", chieti-pescara, italy.


Eligibility criteria:
inclusion criteria: * age \>18 years old * bcva greater than 0.5 logmar in the study eye at baseline examination * presence of recent dme * cmt \> 300µm as measured using the sd-oct at the baseline examination exclusion criteria: * any previous ocular surgery in the last 6 months * laser treatments * prior ocular trauma * retinal vascular diseases * vitreo-retinal interface diseases * medium lens opacities (according to lens opacities classification system)
bisphosphonate-associated jaw osteonecrosis and pet imaging

Conditions: Bisphosphonate-associated ONJ; Osteomyelitis of the Jaw; Osteolytic Lesions of the Jaw; Osteoradionecrosis of the Jaw

Summary: 1. bisphosphonate-associated osteonecrosis of the jaw(onj)is detectable by positron emission tomography(pet). 2. bisphosphonate-associated onj can be diagnosed and characteristically differentiated from other bony pathologies of the jaw(osteomyelitis, osteolytic lesions, and osteoradionecrosis)by pet imaging.

is to review medical records of approximately 1000 patients with bisphosphonate-associated onj who have had pet imaging at the time of diagnosis. also to review medical records of patients who have been diagnosed with jaw osteomyelitis, osteoradionecrosis, and cancerous lytic lesions who received pet imaging at the time of diagnosis. if sufficient information regarding presentation and treatment cannot be obtained form the medical record, approximately 300 patients will contacted by mail (and phone if necessary) by the pi or sub-investigators to question them regarding the onset of symptoms, treatment interventions, and outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of bisphosphonate-associated onj, osteomyelitis, osteoradionecrosis,and osteolytic lesions who received pet imaging at presentation exclusion criteria: * anyone who has not been diagnosed with bisphosphonate-associated onj, osteomyelitis, osteoradionecrosis,or osteolytic lesions who received pet imaging at presentation
augmenting clozapine with sertindole - sercloz

Conditions: Schizophrenia

Summary: the purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.

around 20 % of patients with schizophrenia are treatment-resistant. clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. in the study clozapine treatment is augmented with sertindole. patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. the purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.

Eligibility criteria:
inclusion criteria: * icd10 diagnosis of schizophrenia (f20.0-3) * clozapine treatment minimum 6 months * total panss \>65 * no antipsychotic other than clozapine drug 1 month prior inclusion exclusion criteria: * qtc \>500 ms * violence to spc of clozapine or serdolect * major depression * significant substance misuse interfering with participating in the study * cardiovascular disease

Keywords: schizophrenia treatment-resistant sertindole clozapine
comparison between dead sea solar and water treatment to sulfur pool and medicinal mud treatment in patients with ra

Conditions: Rheumatoid Arthritis

Summary: prospective open label crossover self controlled study. the study population will randomly be divided into two groups. the study will take place in lot spa hotel at the dead sea in two cycles (one of 16 participants and one of 14 participants) and will be comprised of 3 main stages: 1. initial exposure to treatment for 14 days excluding friday and saturday (each of the two groups will have its own treatment protocol) 2. 12-month washout period 3. crossover of the two groups and second exposure to treatment for 14 days excluding friday and saturday (each of the two groups will have its own treatment protocol). the population in the study will be composed of patients diagnosed and treated for rheumatoid arthritis at the soroka university medical center who are 18 and above of age. the patients will be selected by the pi and his team and addressed regarding their willingness to participate in the study.


Eligibility criteria:
inclusion criteria: 1. male and female ≥ 18 2. patients with diagnosed rheumatoid arthritis 3. patients with moderate disease activity (das28 \> 3.2) exclusion criteria: 1. patients who suffer from photosensitivity 2. patients with suspected lupus erythematoides 3. patients with tendency to sudden loss of consciousness and/or dizziness 4. patients under chemotherapeutic treatment 5. patients with active malignancy 6. patients with lowest level of physical functioning (class 4) 7. patients with serious uncontrolled concomitant chronic disease 8. drug abuser 9. patients with severe peripheral venous insufficiency 10. pregnant women
near-infrared spectroscopy (nirs) for intracranial hematoma detection in children

Conditions: Intracranial Hematoma

Summary: this is a study to determine whether the near infrared spectroscopy (nirs) optical density (od) measurement with an infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (ct) scans as the gold standard.

a key decision point in the management of patients with an acute traumatic brain injury is determining the presence of an intracranial hematoma that may require neurosurgical intervention. an expanding hematoma can lead to significant neurological morbidity or death due to brainstem compression or further ischemic injury. unfortunately, no single physical sign, symptom, or score reliably indicates the presence of an intracranial hematoma. a computerized tomography (ct) scan of the head is the gold standard for emergent identification and localization of acute intracranial hematomas. however, the ionizing radiation from ct scans is associated with an increased risk of developing malignancies. near infrared spectroscopy (nirs) is a non-invasive technology that may be useful as an adjunctive modality to ct scanning for early identification of intracranial hematomas. a hand-held nirs device called the infrascanner has shown about 90% sensitivity and specificity for detecting intracranial hematomas in adults and a few small studies have shown similar results in children. the present study will aim to validate this device in a wide age range of pediatric subjects and in multiple hospital settings where this device may serve as a valuable screening tool.

Eligibility criteria:
inclusion criteria: * males or females ≤18 years admitted to the children's hospital of philadelphia (chop) ed or picu with a known or suspected traumatic head injury undergoing a head ct scan to evaluate for the presence of an intracranial hematoma. * head injury occurred \<12 hours prior to presentation for the initial ct scan, or the subject had a clinical change prompting repeat ct scanning. exclusion criteria: * evidence of extensive scalp injury including lacerations, avulsions, or abrasions that will impair proper coupling of the infrascanner device to the subject's head or prevent placement of the device in the specified locations. * history of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.

Keywords: intracranial hematoma traumatic brain injury near infrared spectroscopy nirs
evaluation of ave5026 in the prevention of venous thromboembolism in cancer patients undergoing chemotherapy

Conditions: Venous Thromboembolism; Cancer

Summary: the primary objective was to compare the efficacy of once daily subcutaneous injections of semuloparin sodium (ave5026) with placebo in the prevention of venous thromboembolism \[vte\] in cancer patients at high risk for vte and who were undergoing chemotherapy. the secondary objectives were to evaluate the safety of semuloparin sodium (ave5026), to document semuloparin sodium (ave5026) exposures, to try identifying a metagene predictor of vte and to assess the survival status at one year in this population.

randomization had to take place just prior to the first study drug injection (randomization ratio 1:1). the study period per participant was variable depending on the duration of chemotherapy. it included: * a screening period up to 3 weeks, * a double-blind treatment period, * a follow-up period of 1 month. study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).

Eligibility criteria:
inclusion criteria: cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy exclusion criteria: * required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic; * high risk of bleeding; * severe renal impairment (estimated creatinine clearance \<30 ml/min); * ecog (eastern cooperative oncology group) performance status 3 \& 4; * major surgery within 4 weeks before randomization; * known hypersensitivity to unfractionated heparin \[ufh\] or low molecular weight heparin \[lmwh\]. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Keywords: chemotherapy