Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, pharmacokinetics and pharmacodynamics of oral doses of pth134 in post-menopausal women

Conditions: Post-menopausal Osteoporosis

Summary: this study is designed to provide information about the bone-anabolic response of pth134 when administered orally, in comparison to forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in pth134.


Eligibility criteria:
inclusion criteria: * post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old exclusion criteria: * use of estrogen or hormone replacement therapy * use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose. * use of bisphosphonates and strontium ranelate * cancer or history of malignancy of any organ system * any radiation therapy to the skeleton. * any known clinically significant disease affecting calcium metabolism. any history of metabolic disorders including paget's disease, osteogenesis imperfecta, or osteomalacia. * history or clinical evidence of any impairment of thyroid function * other protocol-defined inclusion/exclusion criteria apply.

Keywords: osteoporosis
clinical benefit of cbt for insomnia in primary care

Conditions: Insomnia

Summary: the purpose of this study is to evaluate using an rct the potential benefits of cbt for insomnia in the community


Eligibility criteria:
inclusion criteria: * adult years (18+), living at home * meets clinical/rdc criteria for chronic insomnia exclusion criteria: * deteriorating health * untreated major mental disorder
investigation of lumbo-sacral instability using custom made table - a pilot study

Conditions: Low Back Pain

Summary: the aim of the study is to evaluate the feasibility and validity of conventional radiographs of the lumbo-sacral spine when the patient is lying on a special table which facilitates maximal lumbo-sacral flexion. the results gained from the radiographs with the patient on the table will be compared with those gained from standard flexion-extension radiographs of the lumbo-sacral spine.

after enrollment in the study patients will complete a set of questionnaire concerning degree, extent and quality of their low back problem. afterwards a lateral conventional radiograph of the lumbar spine with the patient on a custom made positioning table will be taken. the table facilitates optimal flexion of the lumbar spine. afterwards sagittal translation and rotation are measured on the flexion-extension radiographs and the radiograph taken on the custom made table. differences between the measurements will be determined.

Eligibility criteria:
inclusion criteria: * chronic low back pain (≥ 3 months) * clinical suspicion of lumbo-sacral instability * functional conventional radiographs of lumbar spine * pain intensity \> 4 / 10 on visual analogue scale * age 20-60 years exclusion criteria: * radicular pain * pain at more than two locations * lumbar spine surgery * scoliosis * lumbar spondylolysis * lumbar spondylodiscitis * anatomic aberrations of lumbar spine * unconsolidated spine fractures * neurologic deficits * spine tumor * neuromuscular disease * rheumatic disease * severe osteoporosis * radiotherapy within the last 5 years * pregnancy * insufficient german language skills * no informed consent

Keywords: low back pain spine lumbar spine lumbar instability radiology functional radiology
rehabilitation of patients after subarachnoid hemorrhage

Conditions: SAH

Summary: the study's main objective will be to assess which effect early initiated rehabilitation has on the frequency of complications and the level of physical and cognitive functioning after aneurysmal subarachnoid hemorrhage (sah). to this end the following aspects will be investigated: the frequency of complications (with special emphasis on pulmonary complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains and lines) * length of stay in hospitals and socio-economic impact * physical and cognitive function in the early and chronic phase after sah * health-related quality of life and participation in society in the chronic phase

oslo university hospital (ous) is the primary hospital for health region south-east regarding treatment of patients with sah. approximately 120 patients are referred annually. ous,rikshospitalet, dept of neurosurgery offers 24/7 service of surgical and vascular aneurysm repair performed by a dedicated vascular team. patients admitted in 2012 are treated in accordance to the standard institutional protocol plus an early rehabilitation model adapted to sah, while patients admitted in 2011 who did not receive any early rehabilitation, but apart from that were treated identically, serve as a control group. all patients admitted to the intermediate unit at ous in 2011 and 2012 with aneurysmal sah and repaired aneurysm will be invited to participate in this study. examination of the patients from both 2011 and 2012 will be performed as part of routine, neurosurgical follow- up which is in the early phase at 3-6 months and in the chronic phase at least 12 months post sah. exclusion criteria for participation in the study: unsecured ruptured aneurysm, symptomatic aneurysm without rupture, previous sah or brain injury, diagnosis of a neurodegenerative disorder, patients from other health regions or tourists, patients that were treated at the intensive care unit (icu )only.

Eligibility criteria:
inclusion criteria: * all patients admitted to the intermediate unit at ous in 2011 and 2012 with aneurysmal sah and repaired aneurysm will be invited to participate in this study. exclusion criteria: * unsecured ruptured aneurysm, * symptomatic aneurysm without rupture * previous sah or brain injury, diagnosis of a neurodegenerative disorder * patients from other health regions or tourists * patients that were treated at the intensive care unit (icu )only.

Keywords: sah early rehabilitation mobilisation
live-streaming vs face-to-face teaching method effectiveness in training surgical clerkship

Conditions: Teaching Method

Summary: the goal of this observational study is to assess objectively whether teaching for simple wound sutures via live-streaming (ls) using go-pro® has the same effectiveness as the traditional face-to-face (ftf) teaching. the main question it aims to answer is whether training simple wound suturing skills to surgical clerkships via ls has the same effectiveness as the ftf training. after initially doing pre-test, participants will be randomized into two groups: ls and ftf. after teaching exposure, the participants will be given 1 week period of self-training to master the skill (as such procedural skills require a period of self training before we examine the effect of teaching exposure). afterwards, they underwent post-test again with the previously same examiner, using the same osce rubric to avoid bias. researchers will compare if the ls and ftf groups to see if training simple wound suturing skills to surgical clerkships via ls has the same effectiveness as the ftf training.


Eligibility criteria:
inclusion criteria: * surgery clerkships * willing to participate voluntarily and give consent to the study exclusion criteria: * participants who drop out between 1 week period of pre-test and post-test * participants not willing to be involved in the teaching exposure

Keywords: teaching method live-streaming face-to-face simple wound suturing
comparison of antisecretory effect of a single dose of rabeprazole 20 mg and omeprazole 20 mg in obese subjects

Conditions: Gastroesophageal Reflux

Summary: this study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric ph monitoring, in a prospective, monocentre, randomized manner. monitorings are separated between 6 and10 days. the main outcome criteria of analysis is the percentage of time with gastric ph above 3 during 24hours.


Eligibility criteria:
inclusion criteria: * helicobacter negative obese subject (bmi 30 to 40), * 18 to 55 years old, * normal hepatic biology and morphology (echography) * contraceptive methods in women. exclusion criteria: * subjects with previous abdominal surgery, with diabetic or immunosuppressive treatment.
efficacy of tocilizumab in modifying the inflammatory parameters of patients with covid-19 (covitoz-01)

Conditions: Covid19

Summary: unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with covid-19.

national, unicenter, randomized, open-label, controlled phase ii clinical trial with a drug marketed and administered under conditions of use other than those approved. the study is designed to evaluate the effect of adding tocilizumab to standard or standard of care for patients infected with covid-19 and diagnosed with mild-moderate pneumonia. 78 patients are expected to be included in the study in a single center in spain. the study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). once the patients complete the study, they will continue with their usual follow-up.

Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age who have given their informed consent. this will be collected verbally and will be recorded in the medical record by the investigating doctor. 2. the patient is diagnosed with mild-moderate sars-cov-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents: to. basal oxygen saturation\> 90% b. curb-65 ≤1 c. pao2 / fio2≥300 or sato2 / fio2≥315 3. the patient is hospitalized or meets hospital admission criteria. 4. the patient is not expected to enter the icu or die in the next 24 hours. exclusion criteria: 1. participants in another simultaneous clinical trial. 2. use of other immunomodulators. 3. coinfection with the hepatitis b virus (detectable agsup-hbv). 4. pregnancy (or planning to become pregnant during the course of the study), or lactation period. 5. presence of laboratory abnormalities of grade ≥ 4.
a study of elecsys® troponin t hs gen 6 in participants with symptoms of acute coronary syndrome

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Summary: this prospective, non-interventional, single arm, longitudinal cohort multicenter study will recruit approximately 5600 consecutive all-comers, consisting of patients with signs and symptoms of acute coronary syndromes (acs) who present in the emergency department (ed). the main objective of the study is to determine the clinical performance of elecsys troponin t hs gen 6 versus the centrally adjudicated clinical diagnosis at various time points after ed presentation using the previously determined clinical cut-off of a universal 99th percentile upper reference limit.


Eligibility criteria:
inclusion criteria: * age ≥20 years * signed informed consent form * troponin or other cardiac marker determination planned as part of suspected acute coronary syndromes routine care * demonstrating symptoms suggestive of acute coronary syndrome and/or myocardial ischemia, such as any of the following: 1. chest pain, pressure, or a burning sensation across the precordium and epigastrium; 2. pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm; 3. acute onset or worsening dyspnea; 4. nausea, vomiting or indigestion; 5. lightheadedness or syncope; 6. diaphoresis; 7. generalized weakness or fatigue; or, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected. exclusion criteria: * none
eosinophilic cationic protein as a biomarker in diagnosis of acute exacerbation of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. it is changed to acute exacerbation of chronic obstructive pulmonary disease when respiratory symptoms worsen, beyond normal day-to-day variations, severely enough that changes in medication are required. inflammation is a core feature of acute exacerbation of chronic obstructive pulmonary disease since it gives insight into the pathological changes causing an exacerbation. eosinophils may play a significant role in airway inflammation in some patients with chronic obstructive pulmonary disease. previous studies have indicated that eosinophilic airway inflammation is also associated with the development of severe acute exacerbation of chronic obstructive pulmonary disease. eosinophilic cationic protein has various biological activities, including antibacterial, antiviral, antiparasitic and neurotoxic functions, and it contributes to the regulation of fibroblast activity. eosinophilic cationic protein also induces airway mucus secretion and interacts with the coagulation and complement systems. eosinophilic cationic protein has been developed as a marker for eosinophilic disease and quantified in biological fluids including serum, bronchoalveolar lavage and nasal secretions. it is found in diseases such as allergic asthma and allergic rhinitis but also occasionally in other diseases. only activated eosinophil granulocytes release the granule content and therefore the determination of eosinophilic cationic protein concentration is a considerably more specific indicator of eosinophil inflammation than eosinophil granulocyte count in peripheral blood as serum eosinophilic cationic protein levels increase during acute exacerbation of chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: * clinical features of chronic obstructive pulmonary disease * spirometry compatible with the gold criteria (forced expiratory volume 1/ forced vital capacity \<70%) post bronchodilator. exclusion criteria: * patients with bronchial asthma * asthma -chronic obstructive pulmonary disease overlap syndrome * atopic patients * pneumothorax * congestive heart failure * cancer of any kind * a history of major surgery in the preceding 4 weeks. * patients undergoing mechanical ventilation or presenting with azotaemia (serum creatinine \>1.5 mg/dl).
time efficient exercise to reverse sarcopenia and improve cardio-metabolic health

Conditions: Exercise Training and Sarcopenia

Summary: participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical function will be carefully measured.

in a society that is growing in the number of older adults who are also becoming more sedentary, it is critical to identify the types of exercise that harness significant health benefits. first, we hypothesize that older adults (60-80 y) need a certain background level of physical activity, judged by number of steps per day. this is important, especially to fat metabolism. secondly, because older adults claim they don't have time to exercise, we have developed a time efficient program (10 min/day) that has shown promise for offsetting sarcopenia and significantly improving cardiovascular function. our aim 1 is to determine the range of daily step counts in older adults (60-80 y; n=24) that is needed to prevent acute impairment of post-prandial fat metabolism, measured the morning after exercise. we have recently shown in young adults that when their level of background physical activity drops below the range of 5,000 - 8,500±500 steps/d, that they don't adapt positively to an acute 1 h bout of exercise (i.e.; 'exercise resistance') that normally improves fat metabolism. our aim 2 is to determine the ability of a time-efficient 24-week program of exercise training for both maximal neuromuscular power and aerobic power to counteract sarcopenia and declines in aerobic power and functional tests in men and women 60-80 y. we have recently found in a preliminary study of older men and women (50-70 y) that performing multiple maximal 4 s sprints of rapid acceleration cycling bouts for only 8 weeks, eliciting maximal power, displayed significant (p\<0.05) increases in muscle thigh volume (mri), whole body muscle mass, maximal neuromuscular power and peak oxygen consumption. we now propose to train older men and women (i.e.; 60-80 y; n=60) for longer durations (i.e.; 24 weeks) and describe the time course of adaptations. we will additionally monitor their background levels of daily physical activity and determine if it correlates with improvements in neuromuscular and cardiovascular function.

Eligibility criteria:
inclusion criteria: * relatively healthy exclusion criteria: * relatively unhealthy
evaluation of balance and ankle proprioception in calcaneal spur patients

Conditions: Calcaneal Spur

Summary: this study will be conducted to investigate the difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects

a calcaneal spur, also known as enthesophyte, is an abnormal bone outgrowth at the inferior part of the calcaneus, which is the most common site of bony spur occurrence. although there is consensus that a calcaneal spur is a common cause of heel pain, approximately 20% of calcaneal spurs are asymptomatic and its pathology remains not fully understood.ankle joint position sense (jps) refers to the ability to accurately perceive and reproduce the position of the ankle joint in space. balance, on the other hand, encompasses the ankle joint's positional stability during both static and dynamic activities.several investigations have demonstrated a significant association between ankle jps and balance, indicating that individuals with better proprioceptive acuity in the ankle joint tend to exhibit superior postural stability, ). it was found that higher plantar fascia and heel fat pad stiffness and thickness are related to higher postural sway in anterior-posterior and medial-lateral directions based on the single-leg balance tests. these results suggest that the morphological and mechanical properties of plantar fascia and heel fat pad play an important role in balance performance.

Eligibility criteria:
inclusion criteria: * age will range from 40-60 * both sex male and female * unilateral calcaneal spur * patients with pain and inflammation at the bottom of heel, or the location where the spur is present. * all subjects have body mass index less than 29 kg/cm2 * sharp pain like a knife in the heel when standing up in the morning * pain may also appear at the end of the day or after spending long periods of time on the feet * sharp pain with the first steps in the morning or after a long period of rest and dissipating when weight bearing is initiated. * all diagnosed patients, were evaluated and confirmed radiologically by specialist doctor, by performing a standard x-ray foot profile image exclusion criteria: * surgery within the last 6 months * sensory or motor paralysis -received steroid injections within the last 3 months- * discrepancy in length of the lower extremities greater than or equal to 1 cm. * systemic disease in the last six months that may predispose to heel pain(e.g., rheumatoid arthritis and lupus). (dudoniene v et al.,2023). * calcaneal spurs are associated with various medical conditions, including obesity, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, reiter's disease, and spondylarthritis.

Keywords: calcaneal spur balance ankle proprioception
twenty years' experience in retroperitoneal lymph node dissection for testicular cancer in a tertiary referral center

Conditions: Testicular Cancer

Summary: the aim of this study is to evaluate the oncologic and functional outcomes of rplnd as primary treatment (stage i and iia-iib with negative markers) or of residual masses after chemotherapy (pc-rplnd) in the treatment of patients with seminomatous and non-seminomatous. in order to evaluate the role and the͛clinical impact of different surgical techniques of rplnd will be included patients treated with open, laparoscopic, and robot-assisted techniques

the purpose of this study is to evaluate the oncologic and functional outcomes of rplnd as primary treatment or residual masses after chemotherapy in the treatment of patients with seminomatous and nonseminomatous tumors. in order to evaluate the role and clinical impact of different surgical techniques of rplnd will be included patients treated with open, laparoscopic, and robot-assisted techniques. the study will be divided into two phases (a prospective and a retrospective phase): * phase 1 prospective is characterized by a multicenter prospective observational study international in which patients, competitively enrolled, undergo rplnd with open, laparoscopic or robot-assisted performed according to standard clinical practice from september 1, 2021 to october 31, 2026 and with 5-year follow-up. * retrospective phase 2 is characterized by a multicenter retrospective international study involving the selection of patients who have already undergone rplnd, from january 2000 to december 2020 with a minimum follow-up of 12 months and data available from medical records, institutional databases, outpatient referrals or follow-up phone calls

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * rplnd of residual mass after chemotherapy in patient with testicular neoplasm seminomatous or nonseminomatous performed by open, laparoscopic, or robotic technique * primary rplnd for seminomatous or nonseminomatous testicular neoplasm of stage i or iia-iib with negative markers performed with open, laparoscopic or robotic technique * rplnd performed by open, laparoscopic, or robotic technique for the treatment of tumors seminomatous or nonseminomatous chemiorefractory testicular tumors progressing after i and ii line of chemotherapy * acquisition of informed consent exclusion criteria: * patient with comorbidities with contraindication to surgery * hemorrhagic diathesis retrospective phase. patients with the same inclusion and exclusion criteria as in the prospective phase and already undergoing rplnd surgery with open, laparoscopic, or robotic technique from january 2000 to december 2020 in the͛framework of the normal course of care with a minimum follow-up of 12 months. (estimated to include approximately 120 patients).
a study of single doses of ro4998452 in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: this randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of ro4998452 in patients with diabetes mellitus type 2. on 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of ro4998452 or placebo. anticipated time of study treatment is 3 weeks. target sample size is \<50.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age * type 2 diabetes mellitus, diagnosed for at least 3 months at screening * treatment with diet and exercise * bmi between 27 and 40 kg/m2 exclusion criteria: * type 1 diabetes * history of ketoacidosis, hyperosmolar coma, or lactic acidosis * renal disease or renal dysfunction * evidence of significant diabetic complication * currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation) * history of anti-diabetic triple therapy