Kornimate/medical-research-clean huggingface dataset:
emotion regulation group skills training for eating disorders

Conditions: Eating Disorders; Emotions; Skill, Coping

Summary: emotion regulation difficulties appear to play a role in the development and maintenance of several eating disorders. this pilot study aims at examining whether a short add-on group skills training in emotion regulation for young adults with different eating disorders is feasible in a psychiatric clinical setting. we also investigate if the treatment increases knowledge of emotions, and decreases self-reported difficulties with emotion regulation, alexithymia, symptoms of eating disorder, anxiety and depression, as well as clinical impairment. six skills training groups were piloted with a total of 29 participants (m = 21.41 years, sd = 1.92). the treatment consists of five sessions dealing with psychoeducation about emotions and emotion regulation skills training. paired samples t-test was used to compare differences between before-and-after measures.


Eligibility criteria:
inclusion criteria: * being enrolled as a patient at the eating disorder unit at eh child- and adolescent psychiatric clinic in linköping, sweden * having an eating disorder diagnosis as primary diagnosis. * being between the ages of 18-25 years * having sufficient knowledge of the swedish language exclusion criteria: * clinical diagnosis of schizophrenia * clinical diagnosis of psychosis * clinical diagnosis of severe autism spectrum disorder * having a cognitive disability * having ongoing drug or alcohol abuse * clinical diagnosis of bipolar disorder * insufficient knowledge of the swedish language

Keywords: eating disorders young adults emotion regulation skills
pharmacoeconomics in the application of 5-azacitidine in the treatment of myelodysplastic syndromes and acute myeloid leukemia

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia

Summary: the investigators want to compare the global response rate of patients with myelodysplastic syndrome (mds) and acute myeloid leukemia (aml) after six months of treatment with 5-azacitidine on two different doses. first group of 50 mg/m2 for 10 days each 28 days versus 75 mg/m2 for 7 days on 28 days cycles.

5-azacitidine it's the standard treatment for patients with mds and it is widely used for aml in patients that aren't fit for intensive treatment. the standard dose of azacitidine is 75 mg/m2 for 7 días on 28 days cycles. nevertheless there are studies of pharmacokinetics that have showed there is no difference on plasmatic distribution between 25, 50, 75 or 100 mg/m2 with similar concentration curves. the actual presentation of azacitidine is 100 mg per bottle with less of 24 hours of utility after opened. looking for optimizations on the use of 5-azacitidine, we have changed the dosing to 50 mg/m2 for 10 days on 28 days cycles with a total dose application of 95% of the traditional regimen with the saving of 5 bottles of the drug.

Eligibility criteria:
inclusion criteria: * age ≥18 years * confirmed diagnosis of mds that require treatment with 5-aza characterized by: i) raeb-1 defined as the presence of 5%-9% of myeloblasts in bone marrow; ii) raeb-2 defined as the presence of 10%-19% of myeloblasts in bone marrow or 5%-19% blasts in peripheral blood; iii) ipss-r very high, high or intermediate * confirmed aml with blasts ≥ 20% in bone marrow or peripheral blood and that its not candidate to receive intense chemotherapy at consideration of the physician. * performance status of 0, 1 o 2 by the eastern cooperative oncology group (ecog). * availability to sign an informed consent exclusion criteria: * previous treatment for mds or aml with chemotherapy or another antineoplastics including hypomethylating agents. * acute promyelocytic leukemia
imaging pituitary activation by exendin

Conditions: Diabetes Mellitus, Type 2

Summary: the main goal is the comparison of pituitary uptake of ga-68-nodaga-exendin-4 in patients with and without adequate response (based on hba1c or weight loss) to glp-1r agonist treatment.

the prevalence of type 2 diabetes (t2d) is increasing and a better understanding of the mechanisms of t2d becomes increasingly important. the glucagon-like peptide 1 receptor agonists (glp-1ra), such as exendin, can be used as potent antidiabetic drugs for treatment of t2d. not all patients with t2d respond to treatment with glp-1ra and some even respond with contradictory effects, but the underlying mechanism for this observation remains unclear. interestingly, uptake of an exendin-based radiotracer was observed in the pituitary gland in diabetes patients. in this study, the effect of glp-1ra on the hpa axis will be further studied for an improved understanding of the mechanisms and contradictory treatment responses. patient data will be obtained and will consist of metabolic characterization (laboratory parameters and oral glucose tolerance test), an acth assay and determination of cortisol excretion. in addition, ga-68-nodaga-exendin-4 pet/ct imaging will be performed in 10 patients with treatment response (decrease in hba1c or weight loss) and 10 patients without response after glp-1ra therapy. in 5 patients with high radiotracer uptake, an additional brain mri scan will be performed for improved anatomical referencing.

Eligibility criteria:
inclusion criteria: patients with treatment response: * age ≥18 years * subject is diagnosed with type 2 diabetes * subject showed response to glp-1ra treatment * ability to sign informed consent patients without treatment response: * age ≥18 years * subject is diagnosed with type 2 diabetes * subject showed no response to glp-1ra treatment * ability to sign informed consent exclusion criteria: * liver disease * renal disease * pregnancy or the wish to become pregnant within 6 months after the study * breastfeeding * age \<18 years * pituitary disorder * inability to sign informed consent * exclusion criteria for mr: * fragments, clips or devices in brain, eyes, spinal canal * implantable defibrillator or pacemaker (wires) * mandibular magnetic implants * neurostimulator, bladder stimulator, non-removable insulin pump * metal tissue-expander in chest * cochlear implant * ossicular replacement prosthesis

Keywords: exendin glp-1 receptor agonist hpa-axis imaging
a single arm phase 2 study to evaluate efficacy and safety of trastuzumab deruxtecan for patients with her2 mutant nsclc

Conditions: HER2-mutant Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of t-dxd in participants with her2 mutant metastatic non-squamous nsclc.


Eligibility criteria:
inclusion criteria: * pathologically documented metastatic non-squamous nsclc. * has relapsed from or is refractory to at least one-line of anticancer treatment. * documented her2 exon 19 or 20 mutation from central ffpe tumour tissue testing. * who or ecog performance status of 0 or 1. * presence of at least one measurable lesion assessed by the investigator based on recist 1.1. * lvef ≥ 50% within 28 days before enrolment. exclusion criteria: * mixed small cell lung cancer, squamous histology nsclc, and sarcomatoid histology variant nsclc. * corrected qt interval (qtcf) prolongation to \> 470 ms (females) or \> 450 ms (males), based on average of the screening triplicate 12-lead ecg. * history of (non-infectious) ild/pneumonitis that required steroids, has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out by imaging at screening. * has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to grade ≤1 or baseline. participants with clinically stable chronic grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the astrazeneca study physician or designee. * has been previously treated with her2-targeted therapies, except for pan-her class tkis or has received prior treatment with an adc which consists of an exatecan derivative that is a topoisomerase i inhibitor.

Keywords: dl05 t-dxd her2-mutant non-small cell lung cancer nsclc trastuzumab deruxtecan erbb2
serum kisspeptin levels in infertile women

Conditions: Infertility, Female; Unexplained Infertility; Anovulation

Summary: the study population is comprise of 90 women those age varies between 18-38 year-old. the first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility and the third group will comprise of 30 women those partners with male subfertility. a 2 cc blood sample for kisspeptin analysis will be drawn from the antecubital vein from each participants. the patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

the study population is comprise of 90 women those age varies between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes confirmed in hysterosalpingography , follicle stimulating hormone levels \<12 iu. the first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility and the third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /ml, type a + type b motility \<%32 and kruger morphology \<4%. a 2 cc blood sample for kisspeptin analysis will be drawn from the antecubital vein from each participants and centrifuged and sera will be kept in -80 c till recruitment has been completed. kisspeptin, e2, progesterone, anti-mullerian hormone levels will be measured with elisa method. the patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

Eligibility criteria:
inclusion criteria: * ages varying between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse * patent tubes confirmed in hysterosalpingography * follicle stimulating hormone levels \<12 iu * no other relevant medical history exclusion criteria: * ages other than 18-38 year-old with wish of baby for least than one year despite of unprotected sexual intercourse * obstructed tubes confirmed in hysterosalpingography * follicle stimulating hormone levels \>12 iu * history thyroid disease * increased prolactin levels * history of chemo/radiation therapy
a randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of ninerafaxstat in patients with symptomatic non-obstructive hypertrophic cardiomyopathy

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Summary: fortitude-hcm is a global, multicenter, double-blind, parallel-group, placebo-controlled phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of standard of care in patients with symptomatic nhcm


Eligibility criteria:
select inclusion criteria: * has a clinical diagnosis of hcm consistent with current american college of cardiology/american heart association and european society of cardiology guideline definitions * has had confirmation of nhcm by the echocardiography core laboratory based on screening rest and exercise stress echocardiography * new york heart association (nyha) functional class ii or iii at screening * functional limitation as defined by a screening cpet select exclusion criteria: * has a known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nhcm * has any other condition judged by the investigator to be the primary cause of dyspnea, exercise intolerance, and/or angina * has an inability to exercise on a treadmill or bicycle (eg, orthopedic limitations) * has any medical condition that precludes upright exercise stress testing other protocol-defined inclusion and exclusion criteria apply.

Keywords: nhcm non-obstructive hcm non-obstructive hypertrophic cardiomyopathy hcm hypertrophic cardiomyopathy
study of the chk1 inhibitor bbi-355, an ecdna-directed therapy (ecdtx), in subjects with tumors with oncogene amplifications

Conditions: Non-small Cell Lung Cancer; Non-Small Cell Lung Adenocarcinoma; Non-Small Cell Squamous Lung Cancer; Head and Neck Squamous Cell Carcinoma; Esophageal Cancer; Gastric Cancer; Breast Cancer; Bladder Cancer; Ovarian Cancer; Endometrial Cancer; Liposarcoma

Summary: bbi-355 is an oral, potent, selective checkpoint kinase 1 (or chk1) small molecule inhibitor in development as an ecdna (extrachromosomal dna) directed therapy (ecdtx). this is a first-in-human, open-label, 3-part, phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended phase 2 dose of bbi-355 administered as a single agent or in combination with select therapies.

bbi-355 is administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

Eligibility criteria:
key inclusion criteria: * locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists, * single agent arm: evidence of oncogene amplification, * bbi-355 combination with erlotinib arm: evidence of amplification of wildtype egfr, * bbi-355 combination with futibatinib arm: evidence of amplification of wildtype fgfr1, fgfr2, fgfr3, or fgfr4, * availability of ffpe tumor tissue, archival or newly obtained, * measurable disease as defined by recist version 1.1, * adequate hematologic function, * adequate hepatic and renal function, * eastern cooperative oncology group performance status (ecog ps) 0 or 1, * other inclusion criteria per study protocol. key exclusion criteria: * well-known tumor activating oncogene mutations or fusions, * prior exposure to chk1 inhibitors, * bbi-355 combination with erlotinib arm: prior exposure to egfr inhibitors, * bbi-355 combination with futibatinib arm: prior exposure to fgfr inhibitors, * hematologic malignancies, * primary cns malignancy, leptomeningeal disease, or symptomatic active cns metastases, with exceptions per study protocol, * prior or concurrent malignancies, with exceptions per study protocol, * history of hbv, hcv, or hiv infection, * clinically significant cardiac condition, * active or history of interstitial lung disease (ild) or pneumonitis, or history of ild or pneumonitis requiring steroids or other immunosuppressive medications, * qtcf \> 470 msec, * prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation, * other exclusion criteria per study protocol.

Keywords: ecdna extrachromosomal dna amplification oncogene amplification checkpoint kinase 1 chk1 egfr amplification fgfr1 amplification fgfr2 amplification fgfr3 amplification
anamorelin hcl in the treatment of non-small cell lung cancer-cachexia (nsclc-c): an extension study (romana 3)

Conditions: Cachexia; Non-Small Cell Lung Cancer

Summary: the administration of anamorelin hcl in patients with non-small cell lung cancer-cachexia (nsclc-c) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

this is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of anamorelin hcl in nsclc-c patients.

Eligibility criteria:
inclusion criteria: * has completed the day 85 visit in the original trial (study ht-anam-301 or ht-anam-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial * ecog performance status ≤2 * life expectancy of \>4 months at time of screening * if woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method) * must be willing and able to give signed informed consent and, in the opinion of the investigator, to comply with the protocol tests and procedures exclusion criteria: * women who are pregnant or breast-feeding * had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period * currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol * inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded * has an active, uncontrolled infection * has known or symptomatic brain metastases * receiving strong cyp3a4 inhibitors * receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to day 1, and throughout the study duration * other clinical diagnosis, ongoing or intercurrent illness that in the investigator's opinion would prevent the patient's participation * patients actively receiving a concurrent investigational agent, other than anamorelin hcl
a study to evaluate the efficacy and safety of ct-p27 in an influenza challenge model

Conditions: Influenza A

Summary: this study is to evaluate the efficacy of ct-p27 measured by quantitative pcr viral load from nasopharyngeal mucosa, compared to placebo.

this study is a randomised, double-blind, placebo-controlled, single-centre, phase iia study. all enrolled subjects will be given a single dose of 10 mg/kg ct-p27, 20 mg/kg ct-p27, or placebo intravenously and then followed by day 36.

Eligibility criteria:
inclusion criteria: * healthy male \& female volunteers exclusion criteria: * current clinically significant disease * pregnant or nursing mother * abnormal pulmonary function, nose or nasopharynx

Keywords: efficacy safety
lithium for parkinson's: an extension trial

Conditions: Parkinson Disease

Summary: this study will examine the effects of 24 weeks of lithium therapy achieving serum lithium levels of 0.25-0.50mmol/l on mri and blood-based biomarkers in parkinson's disease patients who have completed one of our current 24-week lithium clinical trials.

in observational studies, small daily doses of lithium from smoking cigarettes have been associated with a 77% reduced risk of developing parkinson's disease (pd). in addition, lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several pd animal models. recently, our group has shown 24-weeks of low-dose lithium therapy in pd to be associated with improvements in both mri and blood-based biomarkers implying that lithium may be slowing the progression of the disease. however, these findings stemmed from only three of four patients receiving mris. our group is now conducting two larger studies enrolling a total of 35 pd patients who are being treated with either 45mg/day or 20mg/day of lithium or placebo therapy for 24 weeks. because our earlier study showed maximum improvements in pd biomarkers in patients with serum lithium levels of 0.25-0.50mmol/l and there are large interpatient variations in serum lithium levels achieved from the same lithium dosage, this present study will adjust lithium dosing in each patient to achieve this target serum lithium level for an additional 24 weeks. mri and blood-based biomarker changes from baseline will be compared in patients with serum lithium levels ≥ 0.25mmol/l and \<0.25mmol/l from one of the 24-week studies and within individual patients. results from this study may identify a target serum lithium level range associated with maximum improvements in pd biomarkers that can be used in the design of future, larger lithium pd lithium trials, which may eventually support lithium as a disease-modifying therapy for pd that could improve patients' long-term prognoses.

Eligibility criteria:
1. all pd patients completing study00007253 or study00008239 at the university at buffalo will be eligible. 2. no unstable cardiac, medical, neurologic or psychiatric condition in the opinion of the pi. 3. no current use of illicit drugs or current alcohol abuse in the opinion of the pi. 4. no history of brain surgery or possible need for brain surgery including deep brain stimulation (dbs) for at least 24 weeks in the opinion of the pi. 5. women with child bearing potential will need a negative pregnancy test and not be nursing an infant at screening. women with child bearing potential will need to report using barrier method or hormonal contraception. 6. willing and able to sign informed consent and follow study procedures.

Keywords: lithium biomarker free water neurofilament light chain
robotic flexible ureteroscopy versus standard flexible ureteroscopy for renal stones

Conditions: Renal Stone

Summary: this is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.

this is a prospective randomized controlled trial comparing robotic flexible ureteroscopy and standard flexible ureteroscopy for patients with treatment of renal stones. all consecutive patients who are scheduled for flexible ureteroscopy for treatment of renal stones would be screened for study eligibility. patients are randomised to receive either robotic or standard flexible ureteroscopy with an allocation ratio of 1:1. by computer generated random block. the urologist performing the surgery could not be blinded due to the nature of the intervention. patients receiving the treatment and investigators assessing for any disease recurrence are blinded from the allocated treatment arm.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old with informed consent * being willing and able to provide written informed consent exclusion criteria: * patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture) * american society of anesthesiologists (asa) physical status classification system \>3 * untreated urinary tract infection * renal stones \> 3cm in diameter
different amoxicillin treatment regimens in erythema migrans patients

Conditions: Erythema Migrans

Summary: the purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.


Eligibility criteria:
inclusion criteria: * erythema migrans exclusion criteria: * pregnancy * extracutaneous manifestations of lyme borreliosis * immunocompromising state * serious adverse event to beta lactam antibiotic * receiving antibiotic with antiborrelial activity within 10 days
study of aripiprazole in the treatment of patients with psychosis associated with dementia of the alzheimer's type

Conditions: Alzheimer Disease

Summary: the purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the alzheimer's type.


Eligibility criteria:
inclusion criteria: * institutionalized patients with alzheimer's

Keywords: psychosis associated with dementia of the alzheimer's type