Kornimate/medical-research-clean huggingface dataset:
study to evaluate weight gain as assessed by change in bmi z-score in pediatric subjects with schizophrenia or bipolar i disorder

Conditions: Schizophrenia; Bipolar I Disorder

Summary: to compare changes in body mass index (bmi) z-score following treatment with olz/sam vs olanzapine


Eligibility criteria:
inclusion criteria: * subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar i disorder, diagnosed according to diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria * subject is an outpatient or will be able to be treated on an outpatient basis (per investigator judgement) by study week 2 * subject has reliable family/legal guardian support available for outpatient management * subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, aes, or nonadherence to current medication) based on investigator judgment * subject must not be a danger to self or others (per investigator judgement) exclusion criteria: * subject presents with a major depressive episode(bipolar i disorder) or other neuropsychiatric diagnosis (according to dsm-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study * subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to screening, or other clinically significant neurological condition within the 12 months prior to screening * subject poses a current suicide risk as assessed by the investigator or as confirmed by the baseline columbia-suicide severity rating scale (c-ssrs) * subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine * subject has taken opioid agonists within 14 days prior to screening, or within 30 days prior to screening (for long-acting opioid agonists) * subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery) * subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to screening * subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to screening * subject has a bmi percentile \>98th or \<5th * subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at screening (hemoglobin a1c \[hba1c\] \>= 6%) * subject has started a smoking cessation program within the 6 months prior to screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to screening * subject has participated in a clinical study of an investigational product within the last 30 days prior to screening

Keywords: lybalvi schizophrenia bipolar i disorder pediatric olanzapine samidorphan
long-term safety and efficacy study of fitusiran in patients with hemophilia a or b, with or without inhibitory antibodies to factor viii or ix

Conditions: Hemophilia

Summary: primary objective: to characterize the long-term safety and tolerability of fitusiran secondary objectives: * to characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: * bleeding episodes * spontaneous bleeding episodes * joint bleeding episodes * to characterize the effects of fitusiran on health-related quality of life (hrqol) measures in participants ≥17 years of age

the estimated total time on the study for a participant is up to 90 months (including screening, treatment period and safety follow up period).

Eligibility criteria:
inclusion criteria : * participant must be at least 12 years of age inclusive, at the time of signing the informed consent * participants with severe hemophilia a or b who have completed a phase 3 fitusiran clinical trial * male * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in the protocol. in countries where legal age of majority is above 18 years, a specific icf must also be signed by the participant's legally authorized representative exclusion criteria: * completion of a surgical procedure within 14 days prior to screening, or currently receiving additional factor concentrate or bpa infusion for postoperative hemostasis * current participation in immune tolerance induction treatment (iti) * current use of factor concentrates or bypassing agents (bpas) as regularly administered prophylaxis designed to prevent spontaneous bleeding episodes except for participants requiring factor concentrates or bpas prophylaxis during the study dosing pause period * use of compounds other than factor concentrates or bpas for hemophilia treatment * current or prior participation in a gene therapy trial * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \>1.5 × upper limit of normal reference range (uln) for patients who are naïve to fitusiran at study start; alt and/or ast \> 5 x uln for patients who were in the fitusiran arm in the parent study * additional exclusions for participants not currently participating in a fitusiran trial at the time of enrollment in the lower dose cohort: * clinically significant liver disease * history of arterial or venous thromboembolism the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparing everolimus and sirolimus in renal transplant recipients

Conditions: Renal Failure

Summary: this study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, zortress (the study drug) and rapamune (which is used in the current standard immunosuppression regimen).

zortress is fda approved, is used as standard of care at some other institutions, and may also be given as standard of care if it is believed to be the best immunosuppression regimen for a particular kidney transplant recipient. the rationale for testing zortress vs. rapamune is to determine which of these drugs is more effective in preventing chronic rejection of the transplanted kidney. because these two drugs are related to each other there is no current literature addressing the replacement of rapamune with zortress in an immunosuppression regimen, therefore the goal of this study is to compare these two immunosuppression drugs.

Eligibility criteria:
inclusion criteria: 1. patients must give written informed consent before any assessment is performed. 2. primary renal transplant recipients between ages 18 and 75 years of age. 3. females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable. exclusion criteria: 1. total cholesterol \> 300 mg/dl or triglycerides \> 400 mg/dl despite lipid lowering therapy 2. pre-existing bone marrow suppression (white blood cell count of \< 3000, platelets \< 100,000) 3. active infection (hepatitis b virus, hiv) 4. malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an oncologist or if patient has had no malignancy for at least 2 years prior to the transplant 5. allergy or intolerance to zortress, rapamune, cyclosporine, or anti-thymocyte globulin

Keywords: kidney kidney transplant renal failure end stage renal disease kidney transplant recipient
the effect of exercise therapy in painful shoulder disorders

Conditions: Shoulder Pain; Shoulder Disease; Balance; Distorted; Exercise

Summary: 20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.

20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. exercises will be applied 3 days a week for 4 weeks, 45-55 minutes by a physiotherapist within the framework of shoulder rehabilitation. in addition, balance exercises will not be given. balance measurements will be made by the biodex balance system, which provides objective data.

Eligibility criteria:
inclusion criteria: * having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon, * pain severity felt by the patient above-8 according to the visual analogue scale divided into 10 equal intervals, * patients who were recommended conservative treatment exclusion criteria: * any previous surgical operation, * skeletal system fractures or dislocations, * other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy
five year follow-up of internet-based cognitive behaviour therapy (cbt) for social anxiety disorder (sad)

Conditions: Social Anxiety Disorder

Summary: social anxiety disorder (sad) is one of the most prevalent anxiety disorders in the western world. cognitive behavioural therapy (cbt) is the psychological treatment that has the largest empirical support. however, the availability to cbt is very limited in sweden due to lack of therapists with proper training. therefore it is important to evaluate alternative forms of treatment that are more time efficient. one of these methods is internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder. in this study, the investigators aim to conduct a follow-up assessment five years after completed internet-based cbt. participants received treatment within the context of a randomised controlled trial conducted in 2005. thus, in the present study there will be no treatment interventions, only assessment.


Eligibility criteria:
inclusion criteria: * must have a primary diagnosis of social phobia exclusion criteria: * substance abuse during the last 6 months * other dominating diagnosis (not phobic personality disorder) * a history of bipolar disorder or psychosis * major depression according to dsm-iv and \>20 on madrs-s * risk of suicide * start of medication or change of dosis during the last 2 months * other parallel psychological treatment * previous cbt (last 3 years) for social phobia

Keywords: cognitive behaviour therapy
reliability of functional measures in hemodialysis patient.

Conditions: End Stage Renal Disease

Summary: the investigators pretend to calculate values absolute and relative reliability that have not been yet reported (short physical performance battery, one-leg balance and timed up and go).

patients suffering from end stage renal disease are commonly involved in haemodialysis treatment, which is the most common treatment at this stage. haemodialysis substitutes the renal function but is associated with several alterations that lead to decrease in functional capacity and health related quality of life (hrqol). many studies show that functional capacity, physical activity level and hrqol is significantly worse than their healthy sedentary age - matched counterparts. it is unknown if low physical activity, uraemia or anaemia are responsible for the decreased functional capacity of this cohort. physical performance tests are frequently used to assess haemodialysis patients since is a feasible and low-cost evaluation. the purpose of the present study is quantified how the functional capacity changes over a -6 months period in a group of haemodialysis patients. additionally the investigators pretend to calculate values absolute and relative reliability that have not been yet reported (short physical performance battery, one-leg balance and timed up and go).

Eligibility criteria:
inclusion criteria: * people under hemodialysis treatment at least 3 months * be medicable stable * complete all the physical tests exclusion criteria: * heart stroke in the previous 6 weeks of the study * inferior limb amputation without artificial aids * cerebral vascular disease (ictus, ischemic) * disability to complete functional tests
stop-ca (statins to prevent the cardiotoxicity from anthracyclines)

Conditions: Heart Failure

Summary: this research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. atorvastatin is from a family of medications that are commonly called "statins"

this research study is a phase ii clinical trial. phase ii clinical trials test the effectiveness of a drug and determine whether the investigational drug works in treating a specific disease. "investigational" means that the drug is being studied. the chemotherapy drug that the participant have been scheduled to be treated with, doxorubicin, has been associated with the development of heart failure in some patients. this research study is testing whether atorvastatin can protect the hearts of patients being treated with doxorubicin and can reduce cardiac injury and the risk of heart failure. atorvastatin is not approved by the fda (the u.s. food and drug administration) for use to reduce the cardiac injury after doxorubicin. atorvastatin is approved by the fda for lowering cholesterol and for reducing the risk of heart attack and stroke. the heart is a muscle that pumps blood and atorvastatin may protect the heart by preserving cardiac muscle function. the investigators will test whether atorvastatin protects the heart using a combination of imaging tests on the participants heart, blood tests, and stress testing. the imaging tests will involve an echocardiogram (an echo) and cardiac magnetic resonance (cmr), a type of magnetic resonance imaging (mri) scan.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * all patients with newly diagnosed nhl and hl * scheduled to receive anthracycline-based therapy exclusion criteria: * statin use or statin use is indicated based on guidelines * pregnancy or breastfeeding * unable to provide informed consent * unexplained persistent elevation of transaminases (\>3 times upper limits of normal) * concomitant use of cyclosporine * renal failure: estimated glomerular filtration \<45 ml/min/1.73 m2 * contraindication to a cmr (metallic object, severe claustrophobia, pacemaker, vascular clip * lvef of \<50% at baseline

Keywords: cancer treatment related to heart failure
ibd cancer and serious infections in france (i-care 2)

Conditions: IBD; Ulcerative Colitis; Crohn Disease

Summary: this is a french prospective longitudinal observational multicentre cohort study. primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with cd and uc and treated with jaki, anti-il23p19, and s1p modulators.

number of patients : 6 000 at least participating investigators : 250 at least recruitment period : 3 years 6 months primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with cd and uc and treated with jaki, anti-il23p19, and s1p modulators. secondary objectives : * to assess the presence and the extent of safety concerns in patients treated with jaki, anti-il23p19, and s1p modulators for each outcome of interest separately (cancer, serious infections, arterial thrombotic events, venous thrombotic events) * to investigate prospectively the impact of jaki, anti-il23p19 and s1p modulators strategies on the natural history of ibd and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations * to assess the evolution of epros on a trimester basis and the impact of jaki, anti-il23p19, and s1p modulators on epros in ibd * to evaluate the benefit-risk ratio of strategies based on a wider use of jaki, anti-il23p19, and s1p modulators therapy for ibd * to assess the healthcare costs and cost-efficacy of current therapeutic strategies in ibd.

Eligibility criteria:
inclusion criteria: * patient with an established diagnosis of crohn's disease, ulcerative colitis or ibd unclassified based on usual radiological, endoscopic or histological criteria. * patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-pro as required and to be contacted by a study coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required. exclusion criteria: * patient unable to sign the informed consent form * patient with no regular access to internet * patient refusing to sign the informed consent form * patient enrolled in a randomized clinical trial (if the investigational product received was blinded, and if the treatment is unknown at time of enrolment in i-care 2)

Keywords: uc cd
a multi-center post-market data collection protocol to evaluate the performance of orthofix spine devices

Conditions: Spinal Disorders/Injuries

Summary: this protocol is designed to study orthofix regulatory approved and commercially available spine devices to generate real world evidence (rwe) of device safety and performance in the treatment of patients with spine injuries and/or disorders following the local medical standard of care. the clinical data generated from this study will support compliance to global regulatory requirements including but not limited to the european medical device regulation (eu mdr) for the applicable devices.


Eligibility criteria:
inclusion criteria: 1. patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing orthofix spine devices. 2. patient is 18 years or older at the time of surgery. 3. patient is capable of understanding the content of the patient information / informed consent form (icf) for the prospective segment of the study. 4. patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection. note: for retrospective segment of the study: a waiver of consent for retrospective data collection is in place or an informed consent is obtained from the participating patient prior to data collection as required by local regulations. exclusion criteria: 1. patient may be excluded from study participation if there are other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.
irbesartan versus placebo in combination with ramipril for treatment of albuminuria

Conditions: Albuminuria

Summary: albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. the purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.


Eligibility criteria:
inclusion criteria: * subjects must be willing and able to provide written informed consent. * males and females 55 years of age and over * subjects must have a history of high blood pressure and elevated cardiovascular risk defined as one of the following: 1. diabetes 2. advanced coronary disease defined as previous myocardial infarction. active angina, or significant changes in tests indicating ischemia 3. artery disease in the legs, limiting walking capacity and/or blood flow in the legs 4. stroke occurring more than 3 months prior to the screening visit * all subjects must also have albuminuria (protein in the urine) that is confirmed by a urine test at the first study visit. * all subjects must currently be treated with a class of drugs called ace inhibitors (e.g., benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) for at least 2 months prior to the study. * women of childbearing potential (wocbp) must be using adequate methods of contraception to avoid pregnancy throughout the study and four weeks after the study ends. exclusion criteria: * women who are pregnant or breastfeeding. * acute systemic febrile/infectious disease or infectious or inflammatory disease of the kidneys * narrowing of the kidney arteries * hypotension (low blood pressure) or very high blood pressure * moderate or severe heart failure * chronic autoimmune disease * cancer unless cured or no further treatment needed * severe kidney failure * allergy to drugs used in the study: arbs (candesartan, irbesartan, losartan, telmisartan, valsartan, and/or any other arb currently or previously in development) and ace-inhibitors (benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) * administration of any other investigational drug within 30 days of planned enrollment into the study. * any circumstances that would prevent coming for study visits or taking study drugs

Keywords: albuminuria hypertension elevated cardiovascular risk albuminuria in hypertensive subjects at elevated cardiovascular risk
comparison of hydroxyethyl starch and crystalloid coload combined with norepinephrine infusion for hypotension

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the ed50 and ed90 for an effective 6% hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. in addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. however, the ed50 and ed90 for an effective 6% hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. the purpose of this study is to investigate the ed50 and ed90 for an effective 6% hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * 18-40 years * primipara or multipara * singleton pregnancy ≥ 37 weeks * american society of anesthesiologists physical status classification i to ii * scheduled for elective cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmhg * hemoglobin \< 7g/dl * coagulation or renal function disorders * known allergy to hydroxyethyl starch * fetal distress, or known fetal developmental anomaly

Keywords: crystalloid hydroxyethyl starch 130/0.4 postspinal anesthesia hypotension cesarean section norepinephrine coload