Kornimate/medical-research-clean huggingface dataset:
effects of a hydroxyapatite-based mouth gel on calcium content of plaque

Conditions: Dental Caries

Summary: the aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.

\>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. a dentist applies the gel on all teeth. at baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). a "split-mouth" concept will be used: subjects in group a: baseline plaque collection: quadrant 1 and 4 plaque collection after 3 days: quadrant 2 and 3 subjects in group b: baseline plaque collection: quadrant 2 and 3 plaque collection after 3 days: quadrant 1 and 4 (the time between last application of the gel and plaque collection will be 1 h) the plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (aas). for all subjects: calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.

Eligibility criteria:
inclusion criteria: * girls and boys (7-11 years) * visible plaque * \>= 4 teeth * good overall health exclusion criteria: * allergic to one or more ingredients of the mouth gel * medication intake (e.g. antibiotics) * any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
cbt enhanced with social cognitive training

Conditions: Depression

Summary: depression in youth is a serious public health concern for which more personalized treatments are needed. this study will test the effect of an intervention aimed at enhancing depressed children's social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. participants in both the r61 (n=42) and r33 (n=82) will be youth between 12 and 17 years old currently experiencing a depressive disorder. youth will be randomized to either an enhanced cbt intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind as compared to cbt only. the primary target is improvement in the social cognitive skills at post treatment in the first trial (r61) and improvements in both social cognitive skills and depressive symptoms at post-treatment and at a 4-month follow-up (r33).

depression in youth is a recurrent and impairing disorder. although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy -- cbt), there remains a critical need to build upon these therapies in order to reach even more youths with depression. one variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and cbt (e.g., social perspective taking; theory of mind). the first rct (r61) will test the efficacy of an intervention aimed at increasing children's social cognitive (sc) abilities.youth (ages 12-17; n=42) with depression diagnoses or clinical levels of depressive symptoms (cesd \> 20) will be randomized to either the social cognitive training enhanced cbt (sct-cbt) or cbt only. pre- and post-treatment evaluations will assess the social cognitions. in the second rct (r33), we will conduct a replication trial with a new sample of 82 youth (ages 12-17) again randomized to sct-cbt or cbt only. youth will be evaluated with regard to the sc abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 4-month follow-up (r33). finally, in the r33 we will test if increases in sc abilities partially account for the relation between treatment condition and decreases in depression. if the sct-cbt intervention significantly improves children's sc abilities and social functioning and decreases depression, then this will provide therapists with a more efficient and personalized treatment of depression in youth,

Eligibility criteria:
inclusion criteria: * 12- to 17-years-old * diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the children's depression rating scale (cdrs) \>= 40 exclusion criteria: * ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder * current alcohol or substance use disorder with significant impairment * imminent risk of suicide * reading level \< 4th grade * estimated iq\<80

Keywords: depression adolescents treatment
a study of nilotinib in adult patients with imatinib resistant or - intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase

Conditions: Chronic Myeloid Leukemia

Summary: a multicenter, open label study of nilotinib in cml patients ph + with imatininb resistant in blast crisis, accelerated phase or chronic phase. the main purpose is evaluate the safety and efficacy of nilotinib.


Eligibility criteria:
inclusion criteria: stratum 1: 1. currently participating in novartis study camn107a2109 2. written signed and dated informed consent prior to any study procedures being performed stratum 2: 1. male or female 2. \> 18 years 3. ecog 0,1,2 4. asl/alt \<= 2.5 uln or \<= 5.0 uln 5. alcaline phosfatase \<= 2.5 uln 6. serum bilirrubin \<= 1.5 uln 7. serum creatinine \ =50 ml/min / 24 hours 8. serum lipase \<= 1.5 uln exclusion criteria: stratum 1 and stratum 2: 1. reduction of the cardiac function 2. use of coumadin 3. other severe medical concurrent conditions 4. treatment with medications that prolonged the qt interval. 5. mayor surgery 15 days before the inclusion in the protocol 6. pregnant women or lactation other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced disease, resistance, intolerance
effects of sensory training and electrical stimulation on sole of the foot sensations in patients with acute hemiplegia

Conditions: Hemiplegia; Stroke, Acute; Sensory Disorders

Summary: the aim of this study is to investigate the effects of the sole of foot sensory education and electrical stimulation on proprioceptive and cortical senses in patients with acute hemiplegia.

hemiplegia is a syndrome characterized by disorders of motor and sensory functions, speech and mental abilities. hemiplegia is a common neurological problem in the world and is the third most common cause of death. in addition to motor loss in patients after stroke, sensory problems are accompanied and close to 60% of stroke patients experience sensory problems. in a limited number of studies in the literature, it is stated that sensory impairment in the lower extremity negatively affects standing, walking speed, balance during ambulation and symmetrical gait. at the same time, it has been proven that the sole of the foot sense plays an important role in the balance of sitting, standing up and performing independent daily living activities. after a stroke, sensory training increases functionality, patients with sensory training recover faster, mobility, balance and daily life activities become better, and daily life improvement is expressed. the purpose of sensory training is to maximize the patient's learning through the connection between environment and repetitive activities. the aim of this study is to compare the effects of neurodevelopmental physiotherapy program combined with sensory training or electrical stimulation on the sole of the foot proprioceptive and cortical senses in individuals diagnosed with hemiplegia. there is no study on how proprioceptive and cortical sensations will be affected in acute hemiplegic patients if sensory training and electrical stimulation are added to the classical treatment program. by finding and comparing the effects of active (sensory training) and passive treatment (electric stimulation) with this study, it was planned to propose an effective treatment protocol for developing the sole of the foot senses to the experts working in this field. as a result, purpose of the study is to prevent inadequate sensory input in hemiplegic patients from adversely affecting quality of life.

Eligibility criteria:
inclusion criteria: * participating to the study in a voluntary basis * patients with 50-80 years old * a stroke diagnosis by a neurologist * a stroke attack within 6 months * minimum 18 points from mini mental test * medically stable exclusion criteria: * unstable condition * other neurological or orthopaedic problems that will affect function other than stroke * uncontrolled hypertension * diabetic foot ulcers * part/total foot amputation

Keywords: electrical stimulation sensory education sensory evaluation stroke proprioception
use of [18]f-fdg on pet/ct as an alternative non-invasive method for staging of lung cancer

Conditions: Non-small Cell Lung Carcinoma

Summary: to evaluate the diagnostic accuracy of the 18fluor-fluorodeoxyglucose (\[18f\]fdg) in the positron emission tomography/computed tomography (pet/ct) as compared to mediastinoscopy for staging of non-small cel lung carcinoma.

the main aim of this study is to validate the \[18f\]fdg on pet/ct for the diagnosis of metastatic ganglions at the mediastinum in sus patients with non-small cell lung carcinoma considering sensitivity, specificity, positive predictive value, negative predictive value, accuracy. other specific aims are: * analyze the diagnosis performance of the \[18f\]fdg on pet/ct in two timepoints (1 and 2 hours after exam), in relation to the staging of the non-small cell lung carcinoma * evaluate the addition of the iodinated contrast in the \[18f\]fdg to improve the images obtained from the pet/ct in the staging of the non-small cell lung carcinoma

Eligibility criteria:
inclusion criteria: 1. individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma 2. patients who previously underwent staging of the disease with ct 3. clinical stages i-iii ajcc 7th edition. 4. patients with indication for mediastinoscopy and linfonodal biopsy 5. patients without treatment for lung cancer 6. patients with biochemical and haematological exams 7. women of childbearing potential using contraceptive methods and negative pregnancy test 8. adults with more than 18 years old. 9. both genders exclusion criteria: * pregnant women * patients with other types of patients

Keywords: non-small cell lung carcinoma pet/ct 18f-fdg
safely delivered targeted high-dose irradiation followed by adoptive immunotherapy with regulatory and conventional t cells to increase potency of hematopoietic stem cell transplantation in high-risk acute leukemia

Conditions: Acute Myeloid Leukaemia (AML); Acute Lymphoblastic Leukemia ALL; High Risk Leukaemia; Leukaemia Relapse

Summary: the study is a monocentric, interventional study that evaluates the efficacy of allogeneic hla-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor treg/tcon adoptive immunotherapy for high-risk acute leukemia patients.


Eligibility criteria:
inclusion criteria: * aml patients * diagnosis of aml with indication to allogeneic hematopoietic cell transplantation. * diagnosis of adverse genetic risk leukemia or presence of mrd or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure. * availability of a hematopoietic stem cell donor (family or unrelated hla-matched or hla-haploidentical with the patient) suitable to be treated with g-csf (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses. * age ≥ 18 and ≤ 65 years * ecog ≤ 2 * hct-ci ≤ 4 (51,52) * absence of relevant psychiatric diseases * signature of the informed consent all patients * diagnosis of all, either t or b (philadelphia negative) or mixed phenotype with indication to allogeneic transplant * presence of mrd or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure. * availability of a hematopoietic stem cell family donor (family or unrelated hla-matched or hla-haploidentical with the patient) suitable to be treated with g-csf (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses. * age ≥ 18 and ≤ 65 years * ecog ≤ 2 * hct-ci ≤ 4 * absence of relevant psychiatric diseases * signature of the informed consent exclusion criteria: * aml patients * aml in cr mrd- * aml with \> 5% peripheral blasts or bone marrow infiltration ≥ 30% * age \ 65 years * ecog \> 2 * unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment * pregnancy * no signature of the informed consent * all patients * all with \> 5% peripheral blasts or bone marrow infiltration ≥30% * philadelphia positive all * age \ 65 years * ecog \> 2 * unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment * pregnancy * no signature of the informed consent

Keywords: aml all sharp total marrow/lymphoid irradiation treg tcon relapse
skills to enhance positivity in young adults

Conditions: Positive Affect; Mindfulness; Gratitude; Savoring; Depression

Summary: the goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. skills to enhance positivity (step) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. the current study aims to test feasibility and acceptability in a group setting of young adults. the specific aims of step also seek to establish whether participants who received step report a significant increase in attention towards positive affect compared to those receiving treatment as usual (tau). they also seek to explore whether participants who received step will report a significant decrease in suicidal ideation and depression compared to those receiving tau. the final aim is to explore whether an increase in attention to positive affect regardless of condition is a potential mechanism of change for reductions in suicidal ideation and depression. participants will be randomized into step or tau groups, they will complete baseline and follow-up assessments after a period of 3-months. participants enrolled in step will receive in-person group sessions focusing on psychoeducation of positive affect as well as skills in mindfulness, gratitude and savoring designed to promote positive affect. after completing the group sessions they will also receive text messages for one month, where they will receive prompts to practice skills they learned in the group setting.


Eligibility criteria:
inclusion criteria: * participants must have a recent history of depression and are english-speaking * participants also must have a cell phone with text-messaging capabilities exclusion criteria: * participants who have acute psychotic disorders or cognitive deficits that would preclude full understanding of the protocol, intervention and assessment materials
clinical and molecular characterization of familial microsatellite stable colorectal cancer

Conditions: Colorectal Neoplasms

Summary: two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. the purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.

patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. the histopathology of the tumors will be reviewed. tumor specimens will be analysed on molecular defects.

Eligibility criteria:
inclusion criteria: - colorectal cancer before the age of 51 years microsatellite stable tumor exclusion criteria: -

Keywords: hereditary colorectal cancer microsatellite instability chromosomal instability
helicobacter pylori sample collection protocol pre therapy subjects

Conditions: Helicobacter Pylori Infection; Gastric Ulcer; Nausea; Abdominal Pain; Weight Loss; Stomach Ulcer; Loss of Appetite; Bloating

Summary: the primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an h. pylori infection by upper esophagogastroduodenoscopy (egd) and gastric biopsy.

stools will be collected and tested, at a later date, in a clinical performance study with an investigational h. pylori antigen assay. this study will be coordinated by the sponsor.

Eligibility criteria:
inclusion criteria: * adult ≥ 22 years, either gender * subject is symptomatic showing signs and symptoms of gastritis * subject is not under evaluation for post-therapy follow up diagnosis * subject is already undergoing upper egd and obtaining a gastric biopsy as part of routine care for h. pylori diagnosing * biopsy is obtained from antrum and/or corpus and is tested by crm * at least two of the three crm tests are performed * subject whose egd with biopsy procedure occurred ≤ 7 days prior to stool collection * willing and able to sign the irb approved informed consent form for this project, or able to provide informed consent in accordance with 21 cfr 50 subpart b exclusion criteria: * any subject that does not meet the inclusion criteria * subject with current severe h. pylori infection * subject ingested compounds that may interfere with detection of h. pylori e.g. 4 weeks for all antibiotics, 2 weeks for bismuth preparations or proton pump inhibitors prior to egd/collection * subject recently tested, less than 3 months and knowledge of h. pylori absence * subject tested, less than one year and knowledge of h. pylori presence but not undergone prescribed treatment * pregnant or lactating * inability or unwilling to perform required study procedures * subject is unable or unwilling to provide informed consent
investigating the role of motivational interviewing in swedish patients undergoing knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: knee arthroplasty is a successful surgical treatment for end-stage osteoarthritis. most patients are satisfied with the result, however, 10% of the patients have remained dissatisfied over the last decades despite the advantages of the surgical procedure. previous studies suggest that rehabilitation needs to be individualized and that some patients request additional support. patient empowerment is a patient-centered strategy to increase, amongst other, patient engagement, participation, and motivation. patient empowerment can be defined as a "process that helps people gain control over their own lives and increases their capacity to act on issues that they themselves define as important". one way of increasing patient empowerment is through motivational interviewing. motivational interviewing is an evidence-based approach in which patients are supported to identify behavior changes toward their own individual goals. the aim of this study is to investigate if motivational interviewing could increase satisfaction in patients undergoing knee arthroplasty. furthermore, we want to examine role mi in this patient group with interviews of both mi-practitioners and patients as well as detailed investigations about the mi sessions.


Eligibility criteria:
inclusion criteria: scheduled for primary knee arthroplasty exclusion criteria:

Keywords: knee arthroplasty patient empowerment motivational interviewing
randomized, double-blind phase 1 safety and tolerability study of pafuramidine maleate (db289) in healthy subjects

Conditions: Healthy

Summary: this is a phase 1 study to establish the safety and tolerability profile of pafuramidine maleate 100 mg bid administered orally for 14 days to healthy subjects

this is a phase 1, randomized, double-blind, placebo-controlled, parallel treatment single center safety and tolerability study. subjects who meet all inclusion criteria and none of the exclusion criteria will be randomized in a 4:1 fashion to receive either pafuramidine maleate 100 mg tablets or matching placebo tablets administered twice daily for 14 days.

Eligibility criteria:
inclusion criteria: 1. healthy male and female volunteers a minimum of 18 years to 75 years of age 2. female must be non-lactating and either be of non-child-bearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation) or if of child-bearing potential, must have a negative human chorionic gonadotropin (hcg) pregnancy test and be practicing effective dual barrier contraceptive method from consent to 42 days after initiation of study drug administration. 3. negative test for hepatitis b surface antigen, hepatitis c antibody and hiv 1 and 2 antibody within 14 days prior to admission to this study 4. the subject has provided written informed consent prior to admission into this study. exclusion criteria: 1. history of clinically relevant medical illnesses that in the investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, cns trauma or active seizure disorders, allergic or immunologically-mediated disorders 2. history of drug or alcohol abuse, (\* 10 drinks weekly) 3. blood donation within 30 days prior to dosing 4. history of drug allergies, anaphylaxis or laryngeal edema 5. use of any medication within 7 days before dosing with study medication or anticipated need for any medication during the study conduct 6. use of any investigational medication within 6 weeks prior to dosing with study medication or scheduled to receive an investigational drug other than pafuramidine maleate during the course of this study 7. clinically significant abnormal laboratory value at screening including cbc, blood chemistry or urinalysis 8. clinically significant anomalies noted on physical examination or ecg 9. resting pulse rate of \> 100 beats per minute or \< 45 beats per minute during the screening period, either supine or standing. 10. any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study 11. the subject has been previously enrolled in this study. -

Keywords: safety tolerability assessment of potential adverse events and/or laboratory abnormalities