Kornimate/medical-research-clean huggingface dataset:
palbociclib in estrogen receptor positive (er+) human epidermal growth factor receptor 2 positive (her2+) metastatic breast cancer

Conditions: HER2-positive Breast Cancer; Breast Cancer Metastatic

Summary: this study will determine the recommend dose of palbociclib in combination with letrozole and another medication, ado-trastuzumab emtansine (t-dm1). additionally, researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer. the study will include a safety lead-in with escalating dosing of palbociclib to determine the recommended phase ii dose (rp2d) of palbociclib in this combination and an expanded phase ii of palbociclib at the rp2d in combination with letrozole and ado- trastuzumab emtansine (t-dm1). the starting dose of palbociclib will be 75 milligrams (mg) by mouth (po) daily for each 21 day cycle. if 0 of 3 patients at the 75mg dose level experience a dose limiting toxicity (dlt), the next 3 patients will be enrolled at the next higher dosing cohort of 100mg po daily for each 21 day cycle. if 0 of 3 patients at the 100mg dose level experience a dlt, the next 3 patients will be enrolled at the next higher dosing cohort of 125mg po daily for each 21 day cycle. if 0 of 3 patients at the 125mg dose level experience a dlt, 125mg po daily of palbociclib will be the phase ii recommended dose used in the phase ii expanded cohort. patients receiving the phase ii recommended dose in phase i will be enrolled in phase ii of the study. during safety lead-in and expanded phase ii, letrozole 2.5mg po will be administered daily for each 21 day cycle and t-dm1 3.6 milligrams per kilograms intravenously (iv) will be administered on day 1 of each 21 day cycle.


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of estrogen receptor (er) positive and her2 (human epidermal growth factor receptor 2) positive metastatic breast cancer based on local laboratory results. * prior treatment with a taxane (including paclitaxel, docetaxel and/or nanoparticle protein-bound paclitaxel). * prior treatment with trastuzumab with or without pertuzumab. * measurable or non-measurable disease per response evaluation criteria in solid tumors (recist) criteria version 1.1. * eastern cooperative oncology group performance status of 0-2 * adequate organ and marrow function * women must be post-menopausal * must be able to swallow pills exclusion criteria: * current or anticipated use of other investigational agents * prior therapy with a cyclin-dependent kinase 4/6 inhibitor * subject has received chemotherapy or radiotherapy within 14 days prior to cycle 1, day 1 of the study or has not recovered from adverse events due to agents administered more than 14 days earlier * subject has leptomeningeal disease * history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in study * subject has other illness or disease that the investigator believes will interfere with study requirements.

Keywords: palbociclib
tacrolimus and sirolimus as prophylaxis after allogenic non-myeloablative peripheral blood stem cell transplantation

Conditions: Graft Versus Host Disease; GVHD

Summary: the purpose of this study is to extend the use of tacrolimus and sirolimus to determine how effective it is in preventing graft versus host disease (gvhd)in patients that have received non-myeloablative peripheral blood stem cell transplantation.

* after the screening procedures confirm that the patient is eligible to participate in the research study, they will be admitted to the hospital to receive chemotherapy and stem cell transplantation (sct). the duration of the hospitalization for the procedure is approximately 8 days. * patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days. * just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent graft versus host disease (gvhd). both medications are taken orally. * patients will also take medications to help prevent possible infections (e.g. acyclovir). filgrastim, a white blood cell growth factor, will be given daily in an injection under the skin, starting the day after the stem cell transplant and until the patients blood counts have recovered. * after the stem cell infusion, the patient will be examined and have blood tests weekly for 1 month. at about the 1-month visit, a bone marrow biopsy and/or blood tests will be performed to determine the percentage of donor's cells in the blood or bone marrow. these tests will be repeated at 3-4 months after transplant. * at 3-4 months after the transplant, patients will also have tests to reassess the response of your disease to transplant. this may involve a bone marrow biopsy, blood tests, and/or radiology studies depending upon the type of cancer. * follow-up will continue for the remainder of the patients life.

Eligibility criteria:
inclusion criteria: * patients with hematologic malignancies who are at a high risk of complications after conventional transplantation * availability of a related donor who is identical at 6 hla loci * greater than 18 years of age * performance status 0-2 * life expectancy of \> 100 days exclusion criteria: * pregnancy * evidence of hiv infection * heart failure uncontrolled medication * total bilirubin \> 2.0mg/dl that is due to hepatocellular dysfunction * ast \>90 * serum creatinine \>2.0 * cholesterol \> 300mg/dl while adequately treated

Keywords: non-myeloablative peripheral blood stem cell pbsct tacrolimus sirolimus
evaluation of the changes of pleth variability index during preoxygenation for predicting hypotension

Conditions: Hypotension on Induction

Summary: the aim of this study is to investigate whether the change in pleth variation index (pvi) according to preoxygenation can predict hypotension during anesthesia induction.

in patients with hypovolemia or dehydration, pulse pressure variation can be increased by spontaneous forced inspiratory breathing. pvi is a noninvasive method of indicator of fluid responsiveness like purse pressure variation. we expected that the amount of change in pvi between at the time of entering operating room and after preoxygenation with forced inspiration method could be different depending on the patient's volume status. after entering operating room, monitoring devices, anesthesia depth sensor, and radical-7® pulse co-oximeter® are attached. patients rest for 5 minutes, and then baseline systolic blood pressure, diastolic blood pressure, mean blood pressure, and heart rate are collected every 1-minute. pleth variability index (pvi), perfusion index (pi) are also measured continuously. for pre-oxygenation of anesthesia, take 8 deep breaths at flow 10 l/min of 100% oxygen for 1 minute with maximally forced inspiration. after that, for 2 minutes, patients breathe as usual while maintaining oxygen supply. until tracheal intubation or laryngeal mask insertion. anesthesia is induced with target concentration infusion of 4.0 ng/ml of remifentanil and 4.0 ug/ml of propofol. when the patient loses consciousness, rocuronium 1.0 mg/kg is administrated and endotracheal tube or laryngeal mask is inserted 2 minutes after. pvi, pi, blood pressure, and heart rate are measured until tracheal intubation or laryngeal mask insertion. anesthesia induction-related hypotension is defined as a decrease in mean arterial pressure below 60 mmhg at any timepoint from baseline parameter collection to until airway device insertion. the parameters are analyzed by comparing between groups with and without anesthesia induction-related hypotension.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective surgery under general anesthesia exclusion criteria: * (1) american society of anesthesiologists (asa) physical status classification iii or higher (2) patients with cognitive impairment who are unable to follow instructions (3) patients with pulmonary dysfunction (4) other patients who are judged inappropriate to the experiment by the researcher

Keywords: hypovolemia pulse wave analysis hypotension anesthesia, general
impact on hypoglycaemia awareness of real time cgm and intermittent continuous glucose data

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia; Impaired Awareness of Hypoglycemia; Type1diabetes

Summary: this clinical study proposes to assess the impact of libre on frequency, duration and severity of hypoglycaemia, compared with the dexcom g5 realtime cgm and will focus on people with impaired awareness of hypoglycaemia.

good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. continuous glucose monitoring (cgm) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. this reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function. the abbott libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. in contrast to realtime cgm the libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).

Eligibility criteria:
inclusion criteria: * adults over 18 years of age * type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide \<200 pmol/l * severe hypoglycaemic event in the last 12 months requiring third party assistance or a gold score ≥ 4 * type 1 diabetes for greater than 3 years * on an intensified multiple dose insulin injection regimen for \> 6 months (mdi) * previous type 1 diabetes structured education (either group or 1:1) exclusion criteria: * use of cgm or libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision) * use of regular paracetamol * pregnant or planning pregnancy * breastfeeding * enrolled in other clinical trials, except at the discretion of the chief investigator * have active malignancy or under investigation for malignancy * severe visual impairment * reduced manual dexterity * unable to participate due to other factors, as assessed by the chief investigators

Keywords: type 1 diabetes hypoglycemia
study to assess the metabolic impact of irta© and patients satisfaction in type 1 diabetic patients, treated by either insulin pump or multiple daily insulin injections, and using freestyle libre®, a real-time continuous glucose monitoring

Conditions: Type 1 Diabetes

Summary: a prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with irta support

freestyle libre® continuous glucose monitoring (cgm) system may improve glycemic control. however, this system contributes to the complexity of insulin adjustment by the diversity of the data delivered by cgm system. insulin real-time advisor (irta©), a decision support software, has been developed in order to guide patients in the adaptation of their treatment according to cgm data. irta© provides advice applicable to thousand situations according to six parameters: glucose level, trend arrows, meals, physical activity, before bedtime, time since the previous bolus. type of advice : * insulin injection (carb and correction) * to continue treatment without modification * to lower the insulin dose (temporary basal rate) * sugar intake advice * glucose level control with cgm, self-monitor blood glucose, blood ketones monitor * to change catheter for patients treated by insulin pump.

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * patients with type 1 diabetes mellitus for more than 2 years * treated by either insulin pump for more than 6 months or multiple daily insulin injections. * using freestyle libre® for more than 3 months * accepting irta use * patient able to provide free and informed consent * patient able to provide written non-disclosure agreement exclusion criteria: * pregnancy, breastfeeding or pregnancy project in the future 6 months * patients with no smart phone or internet access * patients legally protected (under judicial protection, guardianship or supervision) * patients with acute illness (psychiatric, infection, cancer,...) * patients using another cgm system (enlite® or dexcom g4®)

Keywords: real time continuous glucose monitoring decision support software
safety and efficacy study of palbociclib plus cetuximab versus cetuximab to treat head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Summary: the purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in hpv-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy. * measurable disease as defined per recist v. 1.1. tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented. * hpv- negative scchn tumor as determined per institutional standard (eg, p16 ihc; multiplex nucleic acid sequence based amplification \[nasba\] or other polymerase chain reaction \[pcr\]-based assays). * documented progressive disease according to recist v1.1 (appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for r/m disease (min. 50 mg/m2 for cisplatin, minimum area under the curve \[auc\] \> 4 for carboplatin). * availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue \[block preferred, or 15 unstained slides\]), which will be used for centralized, retrospective biomarker analysis. if archived tumor tissue is not available, then a de novo biopsy will be required for patient participation. key exclusion criteria: * prior nasopharyngeal cancer, salivary gland or sinus tumors. * more than one chemotherapeutic regimen given for r/m disease. prior treatment with immunotherapy is allowed. * known active uncontrolled or symptomatic central nervous system (cns) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. patients with a history of cns metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. * progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced scchn. * difficulty swallowing capsules. * prior use of cetuximab in the r/m disease treatment setting (except cetuximab during curative radiotherapy)

Keywords: palbociclib, cetuximab, human papillomavirus, squamous cell carcinoma, head and neck cancer
meditoxin® treatment in patients with cervical dystonia

Conditions: Dystonia; Dystonic Disorder

Summary: to determine the efficacy and safety of meditoxin in subjects with cervical dystonia compared with placebo (normal saline)


Eligibility criteria:
inclusion criteria: * male or female aged 20 to less than 75 years * subjects requiring treatment for a clinical diagnosis of cervical dystonia with toronto western spasmodic torticollis rating scale(twstrs)-total score \>=20 and twstrs-severity score \>=10 exclusion criteria: * subjects with pure anterocollis * subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, lambert-eaton syndrome) * a history of an anaphylactic response to botulinum toxin type a and other involved ingredients of investigational product * subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study
sgm-101 in colorectal brain metastases.

Conditions: Rectal Neoplasms; Rectum Cancer; Colorectal Neoplasms; Brain Metastases; Brain Neoplasms; Brain Diseases; Brain Cancer; Brain Tumor; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Cancer; Gastrointestinal Disease; Intestinal Disease

Summary: this study assesses the feasibility of sgm-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting sgm-101 intravenously 3 - 5 days prior to surgery.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to any study-mandated procedure; 2. patients aged over 18 years old; 3. all women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment. 4. has the ability to communicate well with the investigator in the dutch language and willing to comply with the study restrictions. 5. diagnosed with brain metastasis of colorectal origin and scheduled for a resection. exclusion criteria: 1. history of any anaphylactic reaction; 2. previous use of sgm-101; 3. other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma; 4. laboratory abnormalities defined as: 1. aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase) or alkaline phosphatase levels above 5 times the or; 2. total bilirubin above 2 times the uln or; 3. serum creatinine above 1.5 times the uln or; 4. platelet count below 100 x 109/l or; 5. hemoglobin below 4 mmol/l (females) or below 5 mmol/l (males); 6. known positive test for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibody or patients with untreated serious infections; 5. patients pregnant or breastfeeding; 6. any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
using affective differences to predict response to behavioral treatment for major depressive disorder

Conditions: Depression

Summary: this study will determine how people with depression differ from healthy people in brain activity and interpreting emotions, both before and after receiving a psychotherapy treatment.

major depressive disorder is a serious form of depression that may be treated with psychotherapy. however, up to 40% of adults with depression do not show reduced symptoms when treated with cognitive therapy or behavioral activation (ba), two common forms of psychotherapy. certain indicators are generally linked with a successful outcome of psychotherapy-demographic and clinical characteristics, comorbidity, and treatment adherence-but no factors reliably predict outcomes of psychotherapy in individuals. this study will test whether two characteristics related to the way people process emotions, affective asymmetry and affective reactivity, can predict whether people with depression will improve with ba therapy. both depressed and healthy participants will be recruited for this study. participation in this study will last 31 weeks. all participants will complete baseline assessments at weeks 1 and 2. depressed participants will then begin receiving 16 weekly sessions of ba therapy. all participants will be assessed again after 8, 16, 17, and 28 weeks. assessments will include the following: a urine toxicology screening; interviews on mental and physical health, family and childhood experiences, and current mood and functioning; computer tasks; recordings of electroencephalography (eeg) activity; recordings of reaction to a startle probe; recordings of electromyography (emg) activity; recordings of electrodermal activity (eda); and measurement of blood pressure.

Eligibility criteria:
inclusion criteria: * healthy participants should have no lifetime history of psychiatric disorder * depressed participants should have a current diagnosis of major depressive disorder, as defined by the dsm-iv exclusion criteria: * history of bipolar affective disorder * history of psychosis * current non-psychotic axis i disorder, if it constitutes the predominant aspect of the clinical presentation and immediately requires treatment other than that offered in the study * history of substance dependence within the past 6 months * antisocial, borderline, schizotypal, or schizoid personality disorders * evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments * current treatment with catecholaminergic antihypertensive medication, such as reserpine, beta-blockers, clonidine, and alphamethyldopa * current use of antidepressant medication * clear indication of secondary gain * current suicide risk sufficient to preclude treatment on an outpatient basis * severe, unstable concurrent psychiatric conditions likely to require hospitalization within 6 months of study entry * already receiving a targeted psychotherapy aimed at depression

Keywords: major depressive disorder, eeg, negativity bias
phase ii clinical trial prospective, open, nonrandomized treatment of osteonecrosis of the femoral head by the administration of autologous mesenchymal stem cells

Conditions: Osteonecrosis of the Femoral Head

Summary: the purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (mscs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * clinical diagnosis and imaging (rx and nmr) of idiopathic osteonecrosis of the femoral head * stadiums \<iiic arco ranking exclusion criteria: * those on investigator judgment not in a good position to tolerate the procedure. * clinical criteria and anesthetics that contraindicate surgery (eg asa iv-v) * serious illness uncontrolled * pregnant women * patients with hiv infection + * acute infection (in the previous 15 days) or chronic (other than hiv) * previous treatments of osteonecrosis * active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation. * lack of informed consent or revocation thereof.

Keywords: osteonecrosis of the femoral head stem cell mesenchymal stem cells femoral head