Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of tenalisib (rp6530) in patients with relapsed/refractory chronic lymphocytic leukemia (cll)

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: the trial is a phase ii, open label, simon's two stage study design to evaluate the efficacy and safety of tenalisib in patients with cll who have relapsed or are refractory after at least one prior therapy.

tenalisib is a highly specific and orally available dual pi3k δ/γ inhibitor. pre-clinical experiments demonstrated that tenalisib is highly effective in killing primary cll cells in vitro. a phase ii study is planned to evaluate the efficacy and safety of tenalisib in patients with relapsed/refractory cll.

Eligibility criteria:
inclusion criteria: 1. patients with diagnosis of b-cell cll 2. disease status defined as refractory to or relapsed after at least one prior therapy. 3. presence of measurable lymphadenopathy presence of \> 1 nodal lesion 4. ecog performance status ≤ 2. 5. adequate bone marrow, liver, and renal function exclusion criteria: 1. richter's (large cell) transformation, or pll transformation. 2. cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter). 3. prior exposure to drug that inhibits pi3k 4. patient with asct/allo-sct receiving treatment for active gvhd. 5. ongoing severe systemic bacterial, fungal or viral infection. 6. central nervous system (cns) involvement of leukemia or lymphoma. 7. ongoing immunosuppressive therapy including systemic corticosteroids. 8. known history of severe liver injury as judge by investigator. 9. any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation 10. women who are pregnant or lactating. 11. known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (hiv) infection. ii. hepatitis b virus (hbv) infection iii. hepatitis c virus (hcv) infection iv. active cmv infection -

Keywords: phosphoinositide 3-kinase pi3k delta and gamma inhibitor tenalisib leukemia, lymphocytic, chronic, b-cell
a study to learn about the study medicine called pf-07328948 in adults with heart failure (branch-hf)

Conditions: Heart Failure

Summary: the purpose of this study is to learn about the safety and effects of the study medicine (pf-07328948) for the possible treatment of heart failure (hf).

all participants in this study will take either the study medicine (pf-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. the study determines if the study medicine (pf-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard-of-care medications for heart failure that include sodium-glucose cotransporter 2 (sglt2) inhibitors. participants will be involved in this study for about 48 weeks. during this time, participants will visit the study clinic 15 times. in general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.

Eligibility criteria:
this study is seeking participants who are: key inclusion criteria include: * aged 18 years or older. * - clinically confirmed to have a diagnosis of heart failure for at least 3 months * new york heart association class ii-iv symptoms * left ventricular ejection fraction greater than 40% * body mass index of 27 kg/m2 or higher * kansas city cardiomyopathy questionnaire-23 total symptom score \< 85 * six-minute walking distance greater than 75 meters key exclusion criteria include: * type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body. * major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor. * history of heart transplantation, or currently listed for a heart transplant, or current planned use of iv vasodilators and/ or inotropes * prior intolerance/known hypersensitivity to an sglt2 inhibitor or contraindication to an sglt2 inhibitor

Keywords: heart failure with mildly reduced ejection heart failure with preserved ejection fraction
exploratory study of upper and lower endoscopic fuse system

Conditions: Gastrointestinal Diseases

Summary: single-center, exploratory study of endochoice's upper and lower gastrointestinal endoscopic systems utilizing endochoice's full spectrum optical technology

the investigational devices are endochoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the endochoice's proprietary optical system that enhances their field of view.

Eligibility criteria:
inclusion criteria: * male and female patients ages of 18-75 * the patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance. * signed informed consent form exclusion criteria: * patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study. * patients who are unable to consent * pregnant female patients of any age.
sphenopalatine ganglion block to treat shoulder pain during and/or after cesarean

Conditions: Ipsilateral Shoulder Pain

Summary: the purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (spg) block to manage ipsilateral shoulder pain (isp) during and/or after cesarean.

shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. investigators will consent 100 patients, and will enroll 10 patients who develop isp and have a score of is \>5/10 on the verbal analog pain scale (vas). patients will be their own controls. transnasal spg block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the vas a number of times.

Eligibility criteria:
inclusion criteria: * cesarean * presence of post-operative isp, vas \>5/10 * american society of anesthesiologists class 1 - 3. * no allergy to lidocaine exclusion criteria: * american society of anesthesiologists class 4 or 5. * allergy to lidocaine * nasal pathology (e.g., deviated septum) * patients who receive sedatives during cesarean * bleeding diathesis * any patient who the pi feels will be unable to comply with all protocol related procedures * shoulder pain prior to cesarean
a first-in-human, proof of concept study of cpk850 in patients with rlbp1 retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this first-in-human study is to explore the maximum tolerated dose (mtd) of cpk850 as determined by the single ascending dose ranging portion of the study. this study will also evaluate the safety and potential efficacy of cpk850 on improving visual function in patients with decreased visual function from rlbp1 retinitis pigmentosa due to biallelic mutations in the rlbp1 gene.

this study will potentially include 4 cohorts with a minimum of 3 patients per cohort. this trial design used a staggered patient enrollment with continuous data reviews to limit as much unforeseen risk as possible prior to enrolling each patient in each cohort or initiating another cohort. only one eye (designated as the study or treated eye) will be dosed per patient. each patient will be followed for 5 years after the subretinal injection of cpk850.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 to 70 years inclusive. * the visual acuity in the study eye at the screening 1 visit should be no better than 60 etdrs letters. * clinical diagnosis of bothnia dystrophy, newfoundland rod-cone dystrophy or other progressive retinitis pigmentosa phenotype with mutations in the rlbp1 gene verified by genetic testing. * visible photoreceptor (outer nuclear) and retinal pigment epithelium (rpe) layers on standard oct scan in the study eye at the screening 1 visit. exclusion criteria: * history of hypersensitivity to the study drug or to drugs of similar classes or to any of the medications required in the perioperative period. * pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints * any contraindication to the planned surgery or anesthesia as determined by the treating physician (surgeon, anesthesiologist, internist, or designee). * women who are pregnant, or lactating or women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for two months after treatment

Keywords: clinical trials, dark adaptation, gene therapy, rlbp1 mutation, retinitis pigmentosa.
a study of a lifestyle program on recurrent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on atrial fibrillation (af)-related symptoms.


Eligibility criteria:
inclusion criteria: * paroxysmal or persistent atrial fibrillation. * planned elective catheter ablation of af. exclusion criteria: * prior catheter ablation. * presence of pacemaker/icd. * longstanding persistent af. * uncontrolled af (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).
routine outcome monitoring in mental health outpatient

Conditions: Affective Disorders; Anxiety Disorders; Psychotic Disorders; Personality Disorders

Summary: scientific background: inherent gaps exist between the worlds of research and clinical therapy, especially in mental-health systems. developed as an important strategy aimed to bridge them, widening efforts worldwide have implemented routine outcome monitoring (rom), a method devised for systematic ongoing quantitative measurements used in diverse clinical practices, from psychotherapies to psychiatric management. the efficacy of this approach has been repeatedly demonstrated in various measures, such as satisfaction with treatment by patients and therapists, lower drop-out rates, symptomatic benefits, and more. objectives: the aim of the current study is to test the feasibility and the clinical benefits of implementation of a routine outcome monitoring system in a public clinical center, as a pioneering project in israel, at the "shalvata" mental health center. working hypotheses: incorporation of a rom system in routine clinical practice is hypothesized to improve patients' and therapists' overall satisfaction, allow for early detection and intervention in therapeutic raptures, decrease drop-out rates, and improve various clinical outcome measures. methods: the suggested study is a two-stage (implementation and intervention) open trial. 900 new outpatients in 'shalvata' clinics will be recruited and randomized to intervention (rom) and control groups. assessment questionnaires will be filled periodically using 'core-net', a computerized system enabling repeated measurements and feedback in a user-friendly and efficient manner. data analysis: the evaluation of the differential influence of monitoring processes on overall efficiency as compared to control group will be tested using multiple analysis of variance (manova). the predictive value of possible variables on process and outcome of therapy will be assessed using stratified regression analyses. the possible causal effects between specific lagged variables will be assessed using hierarchical linear modeling and time series analysis. contribution: this pioneering study is the first in israel to offer a routine systematic evaluation of therapeutic processes, as well as assessing its clinical effects. consequently, a large and meaningful data-set will emerge, enabling significant enrichment of our evidence-based understanding of therapeutic processes.


Eligibility criteria:
inclusion criteria: * patients undergoing intake to the clinic and beginning therapy exclusion criteria: * mental retardation or dementia * hebrew illiteracy * adults who are not under their own legal custody * not being able to fulfill the questionnaires with minor help

Keywords: routine outcome monitoring psychotherapy alliance feedback informed treatment mental health outpatients
outpatient antibiotics following previable rupture of membranes (ppprom) between 18 0/7 and 22 6/7 weeks gestational age

Conditions: Pregnancy Preterm; Pregnancy Prom; PROM, Preterm (Pregnancy); PROM (Pregnancy); Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor; Premature Birth

Summary: a randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.


Eligibility criteria:
inclusion criteria: * english-speaking * pregnant * live, singleton gestation * patient able to provide informed consent * gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture * diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic ph (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (afi) of less than 4cm exclusion criteria: * gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age * patient desires pregnancy interruption or induction of labor * known major fetal anomaly or aneuploidy * amniocentesis ≤ 7 days of diagnosis of rupture of membranes * cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes * known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics * current antibiotic use at the time of membrane rupture diagnosis * vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis * febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees celsius) and/or within first 24 hours of diagnosis * active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis * cervical dilation of ≥ 4 cm * prolapse of fetal parts beyond the level of the internal cervical os * declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation
care-hf long term follow-up

Conditions: Heart Failure

Summary: the care-hf long-term follow-up trial evaluates the effects of cardiac resynchronization (cr) therapy on the mortality of patients from the care-hf program for an additional 4 year follow-up. investigators are free to choose whatever available treatment they believe is in the patient's best interest.

the care-hf study enrolled 813 patients from 82 centers in 12 european countries (austria, belgium, denmark, finland, france, germany, italy, netherlands, spain, sweden, switzerland, and uk). all patients that were reported to be alive in may 2005 will be asked to participate. in the care-hf ltfu program patients from the care-hf trial were asked to be enrolled for an additional 4 year follow-up. investigators were free to choose whatever available treatment they believe is in the patient's best interest, however the outcome of the care-hf trial suggested that all patients should receive crt therapy on top of optimal medical treatment.

Eligibility criteria:
inclusion criteria: * patients who have participated in the care-hf program and were reported to be alive in may 2005 * patients who signed a patient data release consent form exclusion criteria: * patients who have not participated in the care-hf program * patients with exclusion criteria required by local legislation

Keywords: cardiac resynchronization therapy (crt) all-cause mortality long-term follow-up
evaluation of non-invasive continuous vs intermittent bloodpressure monitors in maintenance dialysis (bp dialysis)

Conditions: End Stage Renal Disease; End Stage Renal Disease on Dialysis; Dialysis Hypotension; Dialysis Induced Hypertension

Summary: prospective, single center, open label, non-randomized, post-market study of the tablo hemodialysis system and vitalstream monitor in participants with end-stage kidneydisease undergoing in-center hemodialysis.


Eligibility criteria:
inclusion criteria: * participant is at least 18 years of age and has provided informed consent and has signed a health insurance portability and accountability act of 1996 (hipaa) compliant authorization statement. * participant weighs ≥ 34kg. * participant has end stage kidney disease (eskd) adequately treated by maintenance dialysis. exclusion criteria: * participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand. * the non-invasive blood pressure (nipb) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.

Keywords: tablo outset medical, inc. caretaker medical, llc vitalstream eskd
longitudinal ultrasonographic study of patients with spondylarthritis starting biological therapy

Conditions: Spondyloarthritis; Ultrasonography

Summary: patients with spondylarthritis (spa) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). patients with high disease activity of spa may need biological treatment (anti-tnf alpha), which are very expensive medications. thus it is necessary to have a sensitive method for assessing the response to treatment. ultrasonography (us) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response. the present study will include patients with spa starting on anti-tnf alpha treatment (as first biologic medication or when switching to a new biologic treatment). the study is an extension of the ongoing nordmard study (norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). the patients will be examined by use of us of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months. the objectives are to explore us as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the us pathology with clinical and laboratory findings.


Eligibility criteria:
inclusion criteria: * spa * planning to start anti-tnf alpha treatment exclusion criteria: * patients not being able to communicate in norwegian or not being able to fill in questionnaires * surgery in more than 5 of the joints/entheses to be examined by us

Keywords: spa anti-tnf alpha treatment ultrasonography synovitis enthesitis
proton radiation therapy for pituitary adenoma

Conditions: Pituitary Adenoma

Summary: the purpose of this study is to collect information from medical records to see what effects proton beam radiation has on pituitary tumors and analyze possible side effects.

data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility criteria:
inclusion criteria: * histologically proven pituitary adenoma. * age 18 years or older. * status post biopsy, gross total resection (from initial surgery for recurrent disease) or subtotal resection. * good to moderate neurological function status exclusion criteria: \*previous radiation that would compromise the ability to deliver the prescribed treatment.

Keywords: pituitary tumor outcomes proton radiation
comparison of simple and continuous suture techniques in oral surgery

Conditions: Wound Heal

Summary: the study aims to compare two different suture techniques regarding wound healing. in this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. for this purpose, selçuk university faculty of dentistry, department of oral and maxillofacial surgery, being treated at the full arch flap opened (for alveoplasty). half of the arch will be closed by a simple suture. the other half will be closed by continuous suture technique. it is planned to evaluate wound healing with the landry healing index and early wound healing score. it is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. on the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the vas scale. data collected from these assessments will be statistically compared for simple and continuous sutures.


Eligibility criteria:
inclusion criteria: * needing full arch alveoplasty * no smoking exclusion criteria: * uncontrolled systemic condition * not participating in control appointments * complications about wound healing
the opioid-sparing effect and reduced ponv using propacetamol in pca among patients with high risk of ponv

Conditions: PONV; Propacetamol

Summary: while patient-controlled analgesia (pca) has the advantage of effectively reducing the degree of postoperative pain, it can also affect the patient's outcome by several adverse effects such as postoperative nausea and vomiting (ponv). especially for high risk group of patients for ponv, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be sought. propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and is used widely for post operative pain management. this study aims to see the opioid-sparing effect and the degree of ponv when propacetamol is added to pca for high risk ponv patients.


Eligibility criteria:
inclusion criteria: 1. patients scheduled for either 1-2 level spine fusion or laminectomy 2. asa (american society of anesthesiology) physical status 1 or 2 3. non-smoking female patients, between the age 20 and 65 exclusion criteria: 1. administration of any anti-emetic agents within 24 hours prior to surgery 2. administration of any opioid agents within 7 days prior to surgery 3. regular administration of any steroid agents 4. drug or alcohol-abuser 5. patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. patients who are pregnant, illiterate, or foreign. 6. patients administered to intensive care unit after surgery

Keywords: nausea vomiting