Kornimate/medical-research-clean huggingface dataset:
behavioral interventions for improvement of adherence at exercise-based cardiac rehabilitation (ecra)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to investigate the effects of an extended behavioral intervention in exercise-based cr for improvement of physical capacity, adherence, psychological and physiological parameters, compared with usual care.

consecutive patients will be included at the coronary care unit (ccu), linköping university hospital, sweden. physiotherapists ask patients for informed consent at the ccu and book an appointment at the exercise-based cr 2-3 weeks after discharge for baseline tests. after baseline testing patients will be randomized to either extended intervention or routine care. randomization will be stratified by submaximal exercise capacity. patients randomized to the extended intervention group receive an additional appointment to a physiotherapist within a week. thereafter patients in both groups start the exercise-based cr program, including aerobic exercise and resistance exercise, 3 times/week for 16 weeks, according to international guidelines for exercise-based cr. the extended intervention is based on components from behavioral medicine including: specific goal-setting, self-monitoring and feed-back. changes in the endpoint variables will be measured from baseline to first (16 weeks at end of intervention) and second (12 months after index event) follow-up visits. sample size calculations are based on previous clinical data from a similar exercise-based cr setting (n=50) on differences in aerobic exercise capacity measured by submaximal exercise test (watts) before vs after finished exercise-based cr. with a power of 80% and a two-sided significance level of p\<0.05 and least mean difference at 10 watts (sd 20 watts) and a calculated loss of follow-up of 20%, the estimated sample size is 160 patients.

Eligibility criteria:
inclusion criteria: * primary care event due to coronary artery disease and/or percutaneous coronary intervention (pci) at the coronary care unit, linköping university hospital * age \<75 years exclusion criteria: * serious physical or psychological disease interfering with participation in exercise-based cr * inability to understand the swedish language

Keywords: exercise-based cardiac rehabilitation physical capacity adherence behavioral medicine
optimization of nutritional therapy in mechanically ventilated, critically ill patients.

Conditions: Critically Ill

Summary: the aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.


Eligibility criteria:
inclusion criteria: * age over 18 years * mechanical ventilation * an hospital stay of at least three days at the intensive care unit of the university hospital of tübingen * possibility to perform indirect calorimetry measurements (fio2 ≤70, pco2 ≤ 0,5) * possibility to perform bioelectrical impedance analysis (bia) * underlying indication for enteral or/and parenteral nutritional support * written informed consent from the patient or a legal authorized person exclusion criteria: * cardiac pacemaker
family asl: longitudinal study of deaf children and hearing parents who receive services to support the learning of asl

Conditions: Deafness; Hearing Loss

Summary: this study examines the development of american sign language by deaf and hard of hearing (dhh) children and their parents.

after being informed about the study and potential risks, adult participants who give written informed consent and children whose parents who give written permission will be enrolled in the study. they will participate in preliminary language tasks to assess baseline performance on american sign language (asl) measures. subsequently they will have weekly sessions with an asl specialist to support their development of asl, following a 6-week on/6-week off abababab sequence.

Eligibility criteria:
inclusion criteria: children: * children ages 2;00 - 2;11 at the start of the longitudinal project * child is deaf/ hard-of-hearing * participating in a program utilizing a bimodal bilingual philosophy adults: - one adult caregiver for each child exclusion criteria: * children with previously-diagnosed conditions other than deafness known to affect language and cognitive development * families without access to internet (at home or other locations)

Keywords: language sign language language development child language child, preschool parents caregivers
assessment of lower extremity isokinetic muscle strength and balance in individuals with chronic low back pain

Conditions: Back Pain

Summary: low back pain is one of the common problems that 80% of people experience at least once in their lifetime. between 60% and 90% of the adult population are at risk for low back pain at some point in their lives. while most resolve within six weeks, relapses are common. pain that lasts longer than 12 weeks is defined as chronic pain, and causes significant limitation in daily life and a high psychosocial burden due to pain. chronic low back pain significantly limits occupational activities due to a decrease in functional status.

although chronic low back pain is a problem locally related to the lumbar and sacroiliac joints, it is also affected by changes in the joint and muscle structure of the lower extremity or affects these structures biomechanically. it has been shown that the endurance of the gluteus maximus muscle and the flexibility of the knee and hip flexors are decreased in individuals with chronic low back pain. studies investigating knee extensor muscle strength in individuals with low back pain in the literature have shown that the maximum voluntary contraction of the knee extensors and the isokinetic strength of the knee extensors are decreased.

Eligibility criteria:
inclusion criteria; * being between the ages of 18 - 65, * volunteer. exclusion criteria; * having a musculoskeletal or neuromuscular disease that limits mobility, * presence of lower extremity sequelae, * having undergone surgery on the lumbar region, having a history of systemic, inflammatory or cancer * participants of both genders will be included in the study.

Keywords: balance
high-dose dual therapy with different administration frequencies

Conditions: Helicobacter Pylori Infection

Summary: this study is a single center, randomized controlled clinical study. the enrolled patients are hp positive. they are diagnosed as hp positive by rapid urease test and/or 13c urea breath test. according to the declaration of helsinki, 327 patients will be included in this study. after obtaining the written informed consent of the patients, hp culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of hp and its impact on hp eradication.

according to relevant literature research, amoxicillin tid groups (including before meal group and after meal group) were given vonorasen (takeda china) 20mg bid and amoxicillin 1.0 tid (zhejiang jinhua kangenbei biopharmaceutical co., ltd.). amoxicillin qid group was given vonorasen (takeda china) 20mg bid and amoxicillin 0.75 qid (zhejiang jinhua kangenbei biopharmaceutical co., ltd.), all the drugs were purchased by the patients from the hospital. the three groups were treated for 14 days respectively, and 13c urea breath test was performed 6 weeks after drug withdrawal. the negative ones were judged as hp eradication.

Eligibility criteria:
inclusion criteria: * ability and willingness to participate in the study and to sign and give informed consent * confirmed h. pylori infection exclusion criteria: * pregnant and lactating women; * history of gastrointestinal malignancies; * history of previous subtotal gastrectomy; * serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; such as grade iv cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, wilson disease, etc; * history of hematological diseases * people who are allergic to drugs; * the guardian or patient refused to join the group; * alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors; * no legal capacity or poor self-knowledge * administration of antibiotics, bismuth, antisecretory drugs, or chinese herb medicine in the preceding 8 weeks

Keywords: helicobacter pylori dual therapy
relative bioavailability study of enzalutamide in prostate cancer patients

Conditions: Prostate Cancer; Pharmacokinetics of Enzalutamide

Summary: a multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (gnrh) analogue or orchiectomy (i.e., medical or surgical castration) at study entry. * progressive disease by prostate-specific antigen (psa) or imaging. disease progression for study entry is defined as one or more of the following 3 criteria: * psa progression defined by a minimum of 2 rising psa levels with an interval of ≥1 week between each determination. the psa value during the pre-investigational period should be ≥2 μg/l (2 ng/ml); * soft tissue disease progression defined by the response evaluation criteria in solid tumors, version 1.1 (recist 1.1) for soft tissue disease * bone disease progression defined by two or more new lesions on bone scan exclusion criteria: * treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study. * history of seizure or any condition that may predispose to seizure. also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (day 1 visit). * patients who previously received treatment with enzalutamide. * concomitant use of drugs that are potent inducers and/or inhibitors of cyp3a4 and cyp2c8. * confirmed cyp2c8 poor metabolizer status based on genotyping analysis.

Keywords: phase 1 prostate cancer bioavailability food effect pharmacokinetics xtandi enzalutamide mdv3100
arterial elasticity: a substudy of strategic timing of antiretroviral treatment (start)

Conditions: Cardiovascular Diseases; HIV

Summary: the purpose of this study is to find out if starting anti-retroviral therapy (art) above 500 cluster-of-differentiation-4 (cd4)+ cells/milliliter (ml) ('early art group') is better at reducing the stiffness of arteries than waiting to start art until the cd4+ drops below 350 cells/ml ('deferred art group'). artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. in this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.


Eligibility criteria:
inclusion criteria: * simultaneous co-enrollment in the start study * signed informed consent exclusion criteria: * inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation

Keywords: hiv cardiovascular diseases vascular stiffness
safety study of ophthalmic solution in healthy, normal volunteers

Conditions: Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the safety of r89674 0.25% ophthalmic solution in healthy normal volunteers


Eligibility criteria:
inclusion criteria: healthy normal volunteers age \>=3 years with normal ocular health and a best-corrected logmar score of 0.3 or better - exclusion criteria: intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \< 18 years of age -

Keywords: healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic
influence of the implant-prosthetic connection in the marginal bone loss and bacterial leakage

Conditions: Dental Implant; Bone Loss; Bacterial Infections

Summary: this study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.

location: this study is going to take place in the dentistry hospital of the university of barcelona (campus of bellvitge). study subjects: the sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. all of them are being properly informed about the study according to the comité ético (ceic) del hospital odontològic universitat de barcelona guidelines, and informed consent must be signed prior to the interventions. material: registration papers for the study, dental implants, surgery material, prosthetic components, florida probe software®, periapical x-rays, computer, software stata 14 and software imagej®. determinations: clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.

Eligibility criteria:
inclusion criteria: * subjects who accept signing voluntarily the informed consent before doing any action related to the study. * ≥18-years-old patients. * edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns. * single implants successfully osseointegrated placed at least 16 weeks post-extraction. * o'leary plaque index and or bleeding on probing ≤25%. * dental implants with screwed-retained prosthesis. exclusion criteria: * systemic diseases that can interfere dental implant placement. * any contraindication for surgery procedures. * heavy smokers (\> 20cig/day). * background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study. * patients who have had participated with another clinical trial the last 30 days. * pregnant women or in lactation. * patients with bad oral hygiene or not motivated. * probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space. * guided bone regeneration required in the same time of the implant placement.

Keywords: dental implant internal connection external connection conical connection marginal bone loss implant prosthetic connection bacterial leakage
retrospective registry study of patients with cancer treated with high-dose methotrexate

Conditions: Acute Kidney Injury; Drug Toxicity

Summary: this retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of methotrexate, acute kidney injury and any associated impact of delayed elimination of methotrexate on future courses of chemotherapy and disease outcomes in adults and children with cancer. the study will compare current practice with existing guidelines and best practices to identify potential gaps in the management of high-dose methotrexate administration and delayed elimination of methotrexate. the study will identify variations in practice and outcomes in different study centers, countries, cancer types, patient age groups, by different methotrexate doses and infusion times and different supportive care measures used. the study will also document the proportion of high-dose methotrexate courses in which glucarpidase has been used and any toxicities attributable to the use of glucarpidase.


Eligibility criteria:
inclusion criteria: * a diagnosis of any cancer from january 1, 2001 to june 30, 2021. * receipt of high-dose methotrexate chemotherapy, defined as a dose of 500 mg/m2 of body surface area or higher. * medical records available for review. * any age; any cancer type. exclusion criteria: * none.

Keywords: carboxypeptidases delayed methotrexate clearance hematologic neoplasms hyperhydration leucovorin osteosarcoma
a 3-week study investigating patient use and functionality of formoterol in a novel inhalation device in patients with asthma

Conditions: Asthma

Summary: this study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (mddpi) device in a real-life situation.


Eligibility criteria:
inclusion criteria: * patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary * patients who have a current diagnosis of asthma * patients who have a documented forced expiratory volume at 1 second (fev1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a \>12% increase in fev1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at visit 1. the administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry. exclusion criteria: * patients who were enrolled in study cfor258f2304 or cfor258f2306, or who have any experience using the certihaler® device. * qtc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ecg) that in the opinion of the investigator would present a safety hazard for continuation in the study * patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies * other protocol-defined inclusion and exclusion criteria apply

Keywords: asthma, formoterol multi-dose dry powder inhaler (mddpi)
efficacy of rapamycin therapy with chronic immune thrombocytopenia

Conditions: Immune Thrombocytopenic Purpura

Summary: the aim of our study is to evaluate the efficacy of rapamycin with refractory immune thrombocytopenic purpura (ritp) and explore the further mechanism.

rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. many studies have shown that the drug contributes to the expansion of regulatory t cells and preserves the highly suppressive function of autoreactive t cells. patients with ritp often display a decreased proportion of regulatory t cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in ritp patients.

Eligibility criteria:
inclusion criteria: * clinical diagnoses of idiopathic thrombocytopenic purpura * hormone and immune suppression, splenectomy is invalid exclusion criteria: * patients had a bad tolerance to rapamycin * platelet counts \< 10\*10e9/l during the treatment of rapamycin

Keywords: refractory immune thrombocytopenic purpura rapamycin regulatory t cells
a phase iii confirmatory study of k-877 extended release tablet

Conditions: Dyslipidemias

Summary: to investigate the efficacy and safety of k-877 extended release (er) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using k-877 immediate release (ir) 0.2 mg/day (twice daily) as a control.


Eligibility criteria:
inclusion criteria: 1. patients with dyslipidemia had to be age 20 years or older at written informed consent 2. patients who have received dietary or exercise guidance from 12 weeks or more prior to screening 3. patients with the fasting serum tg \>= 200 mg/dl twice consecutively at screening exclusion criteria: 1. patients with a fasting serum tg \> 1000 mg/dl at screening 2. patients who require administration of prohibited drugs during the clinical trial period after written informed consent 3. patients with uncontrolled thyroid disease 4. patients with type 1 diabetes and uncontrolled diabetes \[hba1c(ngsp) \>= 8.0 % at screening\] 5. patients with uncontrolled hypertension (sbp \>= 160 mmhg or dbp \>= 100 mmhg) 6. patients with an ast or alt three times the upper limit at screening 7. patients with an ck five times the upper limit at screening 8. patients with cirrhosis or those with biliary obstruction 9. patients with acute myocardial infarction within 3 months before obtaining informed consent 10. patients with heart failure class iii or higher according to nyha cardiac function classification 11. patients with malignant tumor or those who are judged to have a high risk of recurrence 12. patients with a history of serious drug allergies (anaphylactic shock, etc.) 13. pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods 14. patients who have collected 400 ml or more of whole blood within 16 weeks, or 200 ml or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before screening 15. patients who have received k-877 (pemafibrate) 16. patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks 17. patients who have been determined inappropriate by the investigator, etc
safety and tolerability study of the monoclonal antibody ct-011 in patients with hepatocellular carcinoma

Conditions: Primary Hepatocellular Carcinoma

Summary: the objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody ct-011 administered intravenously to patients with primary hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years and above, both genders. 2. histologically or cytologically confirmed primary hepatocellular carcinoma (hcc) 3. no fibrolamellar subtype hcc 4. not eligible for any other systemic anti-neoplastic treatment approved for hcc 5. not eligible for transarterial chemoembolization (tace ). 6. no more than 1 prior systemic therapy. previous tace or radiofrequency ablation (rfa) that were used for hcc, are permitted. 7. not a candidate for curative surgical resection or liver transplantation 8. measurable disease defined by the identification at least 1 measurable lesion by mri using recist criteria. tumor in area of tace or rfa must be enlarging post-procedure to be considered measurable disease. 9. alpha-fetoprotein (afp) greater than the upper limit of normal (uln) 10. child's pugh classification a 11. ecog performance status 0-1 exclusion criteria: 1. patients progressing to liver failure. 2. no core biopsy within the past 7 days 3. patients who are eligible for transarterial chemoembolization (tace) 4. patients on concurrent anti-neoplastic therapy (including interferon) 5. patients who have received any systemic anti-neoplastic therapy not approved for the treatment of hcc. 6. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids 7. presence of metastasis.

Keywords: primary hepatocellular carcinoma