Kornimate/medical-research-clean huggingface dataset:
cll11: a study of rituximab with chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (stage 1b)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (ro5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (cll). patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either ro5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. in the us, this trial is sponsored/managed by genentech.

protocol bo21004 is divided into 3 separate unique protocol ids for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points. * bo21004 (stage 1a) \[nct01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (glb) compared to chlorambucil (clb) reported separately. * bo21004 (stage 1b) \[nct01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (rclb) compared to chlorambucil (clb) reported here. * bo21004 (stage 2) \[nct02053610\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (glb) compared to rituximab plus chlorambucil (rclb) reported separately.

Eligibility criteria:
inclusion criteria: * adults \>/=18 years * documented cluster of differentiation antigen 20 (cd20) + b-cell chronic lymphocytic lymphoma (b-cll) * previously untreated chronic lymphocytic leukemia (cll) requiring treatment according to the national cancer institute (nci) criteria * total cumulative illness rating scale (cirs) \> 6 and/or creatinine clearance \< 70 ml/min exclusion criteria: * prior cll therapy * transformation of cll to aggressive non-hodgkin's lymphoma (nhl) (richter's transformation) * history of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (dcis) of the breast treated with lymphectomy alone * positive hepatitis serology (hbv, hcv) or positive hiv or human t cell leukemia virus (htlv) testing * patients with active infection requiring systemic treatment
effectiveness of "no more" anti-lice medical device to kill lice and lice eggs

Conditions: Lice

Summary: the purpose of this study is to determine effectiveness of an anti-lice treatment using the medical device "no more" which is designed to kill lice and lice eggs on the head.

the clinical trial protocol include 2 visits first visit: explanation and signing of consent forms. diagnosis: prof. shemer will check if the patients have sufficient living lice or lice eggs and if so they will be scheduled to receive treatment. second visit: -spread the "no more" on the head of the boy or girl on dry hair. * after five minutes comb with an adequately thick comb and the eggs will fall out easily with the pulling of the comb. * wash the hair. * combing the hair again with a thick comb for five minutes and/or 20 combings; checking if the head is free of eggs and lice via a visual inspection by the head researcher. outcome 1. if there are no live eggs and/or lice then the patient has completed treatment - and the research. (this outcome is defined as successful treatment.) 2. if there are eggs only then the patient is scheduled for a third visit after seven days (+/- one day). 3. if live lice are found this outcome is defined as failure and the patient will not be scheduled for an additional visit third visit: after seven days (+/- one day) professor shemer will conduct a visual inspection for lice and lice eggs. combing with a thick comb for five minutes and/or 20 combings and if there are live lice or lice eggs treatment success: no eggs and no lice immediately with the end of the treatment (second visit). no lice or live lice eggs after seven days (+/- one day). number of participants: up to 80 participants when at least 50 participants complete the treatment. age range: 3-18 years

Eligibility criteria:
inclusion criteria: patients that are suffering from lice and lice eggs that agree to refrain from any other treatment or salve designed for the treatment of lice and/or lice eggs throughout the course of the research study. patients that orally and in writing express their agreement to participate in the study - consent in writing will be provided by two parents; oral consent will be provided by the participants themselves. exclusion criteria: pregnant or nursing women. patients lacking the faculties for proper judgment.

Keywords: anti-lice treatment
pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma including fgfr2 rearrangement

Conditions: Cholangiocarcinoma

Summary: this is a phase 2 study to investigate the efficacy and safety of pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with fgfr2 rearrangement who have failed at least 1 previous therapy


Eligibility criteria:
inclusion criteria: 1. men and women, aged 18 or older. 2. histologically or cytologically confirmed cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination. 3. radiographically measurable disease per recist v 1.1 4. documentation of fgfr2 rearrangement. 5. documented disease progression after at least 1 line of prior systemic therapy. 6. ecog performance status of 0\~1. 7. life expectancy ≥12 weeks. exclusion criteria: 1. prior receipt of a selective fgfr inhibitor. 2. history of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance). 3. currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination. 4. use of any potent cyp3a4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. topical ketoconazole will be allowed.

Keywords: cca fgfr2 pemigatinib
"geriatric assessment adapted" therapy for ph- all elderly patients

Conditions: Leukemia, Lymphoblastic, Acute

Summary: this study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. this will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.

treatment: 1. frail patients: * pretreatment with pdn * induction with vinblastine and pdn * maintenance with mtx, 6-mp, vbl and pdn 2. fit patients: * pretreatment with pdn * induction with vcr, dnr and pdn * consolidation with mtx, ara-c and g-csf * autologous transplantation * maintenance with mtx, 6-mp, vcr, and pdn 3. intermediate patients: * pretreatment with pdn * induction with vcr, dnr and pdn * consolidation with mtx, ara-c and g-csf * a second cycle of consolidation therapy * maintenance with mtx, 6-mp, vcr, and pdn

Eligibility criteria:
inclusion criteria: * age \> 60 years old * cytomorphologic and immunophenotypic diagnosis of all (all fab groups except l3 and all immunophenotypes except smig+ b-all) * signed informed consent exclusion criteria: * age \<= 60 years old * ph+ all * refuse to sign informed consent

Keywords: geriatric assessment adapted therapy leukemia, lymphoblastic, acute older patients > 60 years old ph negative
a phase 3 study to evaluate the efficacy and safety of intravitreal ksi-101 in participants with macular edema secondary to inflammation (mesi) - pinnacle

Conditions: Macular Edema Secondary to Inflammation

Summary: a phase 3 study to evaluate the efficacy and safety of intravitreal ksi-101 in participants with macular edema secondary to inflammation (mesi)


Eligibility criteria:
inclusion criteria: * patients with mesi, with a cst of ≥320 and \<400 microns on sd-oct and a bcva score of ≥25 and ≤78 etdrs letters (between \~20/25 and 20/320 snellen equivalent) in the study eye at day 1; * diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the study eye. exclusion criteria: * me in the study eye secondary to diabetes, rvo, or wamd * active or suspected ocular or periocular infection in either eye

Keywords: mesi macular edema inflammatory macular edema macular edema associated with inflammation
prospective post-market study examining the effectiveness of the ecofit®

Conditions: Degenerative Joint Disease; Femoral Fracture; Osteoarthritis, Hip; Traumatic Arthritis

Summary: the purpose of this study is to evaluate the safety and effectiveness of the ecofit hip with implacross e polyethylene for total hip replacement surgery.

this study will assess the performance and success rate of the ecofit total hip system. survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.

Eligibility criteria:
inclusion criteria: * subject must be a candidate for a total primary hip replacement. * subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, or a femoral fracture which can be treated by a primary hip replacement and no other hardware * subject has a bmi of 40.00 kg/m2 or less at the time of enrollment * subject is likely to be available for evaluation for the duration of the study * subject is able and willing to sign the informed consent and follow study procedures * subject is not pregnant exclusion criteria: * subject has had a prior hip replacement in the subject hip * subject has an active cancer or is a survivor for \<5 years except for squamous cell or basal cell skin cancer * subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol * subject is currently a documented substance abuser (alcohol or other addictions) * subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic * subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity * subject has a bmi \> 40.00 kg/m2 * subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and alzheimer's disease) * subject is a prisoner * subject is pregnant * subject has known materials sensitivity (to metals)
olanzapine versus active comparator in the treatment of bipolar i disorder

Conditions: Bipolar Disorder

Summary: this is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar i disorder.


Eligibility criteria:
inclusion criteria: * male or female subject, 18-70 years of age * female subjects of childbearing potential must be using a medically accepted means of contraception * each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol * subjects must be considered reliable exclusion: * female subjects who are either pregnant or nursing * uncorrected hypothyroidism or hyperthyroidism * narrow-angle glaucoma * subjects who present a serious and immediate risk of endangering him or herself

Keywords: bipolar i disorder
trial of vitamin d in hiv progression

Conditions: HIV Infection

Summary: the purpose of this study is to determine the efficacy and safety of vitamin d3 (cholecalciferol) supplementation on hiv progression and incidence of pulmonary tuberculosis among hiv-positive tanzanian adult men and women initiating highly active antiretroviral therapy (haart).

hiv-infected adults initiating antiretroviral therapy in resource-limited settings experience high mortality, pulmonary tuberculosis, and other comorbidity rates during the first year of hiv treatment. observational studies have shown low vitamin d is a risk factor for hiv progression and incidence of pulmonary tuberculosis among adults initiating haart; however, whether this relationship is causal and if vitamin d supplementation starting at haart initiation can improve health outcomes has not been determined. this study is a randomized, double-blind, placebo-controlled trial conducted to examine the effect of vitamin d3 supplementation on morality and pulmonary tuberculosis for adults initiating haart. participants are hiv-positive tanzanian men and women aged 18 years and older, who are initiating haart at the time of randomization whose baseline 25-hydroxyvitamin d (25(oh)d) concentration is \<30ng/ml. eligible individuals are randomized to receive a) a vitamin d3 regimen consisting 50,000 iu of vitamin d3 taken orally once per week for 4 weeks (weeks 0, 1, 2, 3) followed by 2,000 iu of vitamin d3 supplements taken orally once per day starting at 4 weeks until study discharge at 12 months or b) placebo pills taken once weekly for 4 weeks (weeks 0, 1, 2, 3) followed by placebo pills taken daily starting at 4 weeks until study discharge. participants will be followed for 12 months after art initiation.

Eligibility criteria:
inclusion criteria: * hiv-positive * men or women * 18 years of age or older * initiating haart at time of randomization * 25(oh)d concentration \<30 ng/ml at haart initiation exclusion criteria: * pregnant women * enrolled in another micronutrient trial
studies of psychiatric predisposing factors, treatment-related cardiovascular effects, and prognostic factors associated with antimuscarinic drug (tolterodine) for female overactive bladder syndrome

Conditions: Antimuscarinic Drug

Summary: overactive bladder syndrome (oab) affects around 17 % of female population. however, the etiology of oab was complicated and unclear in many aspects. in particular, the research about psychiatric aspect of etiology in oab was paucity. besides, research about prognostic factors and impact of cardiovascular system of oab treatment was also paucity. therefore the aims of the investigators study were (1) to analyze the etiology of oab in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-oab and oab female patients, and before and after tolterodine treatment.


Eligibility criteria:
inclusion criteria: * all cases are female patients with lower urinary tract symptoms
identification of biomarkers for patients with vascular anomalies

Conditions: Vascular Anomaly; Generalized Lymphatic Anomaly; Kaposiform Hemangioendothelioma; Kaposiform Lymphangiomatosis; Gorham-Stout Disease; Klippel Trenaunay Syndrome; Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi

Summary: the study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. the study will also use blood (serum and plasma) and tissue collected and stored in a tissue bank maintained by the department of hematology/oncology.

while vascular anomalies are rare diseases, they can be life-threatening and devastating to affected children and their families. advances in diagnosis, monitoring and therapies will be significantly improved if non-invasive biomarkers that are sensitive and specific can be identified. obtaining a tissue biopsy to help in diagnosis can actually worsen the disease and so identification of specific blood biomarkers is highly desirable. studies will measure angiogenic factors in serum and plasma samples at baseline and on therapy. tissue removed during surgical resection or blood removed prior to sclerotherapy will be used to obtain cells and tissue for the assessment of where biomarkers are coming from and to identify disease-causing pathways for new therapeutic targeting.

Eligibility criteria:
inclusion criteria: * any patient having labs drawn as standard of care will have blood drawn for the study if consented/ assented. * all patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank. exclusion criteria: * n/a

Keywords: generalized lymphatic anomaly vascular anomaly kaposiform hemangioendothelioma kaposiform lymphangiomatosis vascular endothelial growth factor biomarkers gla kla khe gsd
a trial of a single delivery of sb-061 in osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: this study evaluates a novel agent, sb-061, for the treatment of osteoarthritis of the knee. half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

the treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. sb-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. subjects will receive 1 intra-articular injection of either sb-061 or placebo and be followed for 3 months to evaluate pain amelioration. subjects and investigators are blinded to treatment allocation.

Eligibility criteria:
inclusion criteria: * femorotibial osteoarthritis of the knee * radiological oa kellgren-lawrence grade 2 or 3 * womac pain 1 score of the target knee of ≥4 and ≤ 9 exclusion criteria: * hypersensitivity to medications or to intra-articular injections * intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study * high dose systemic corticosteroid treatment of longer (\>14 days) duration w/in 6 months of study * major surgery or arthroscopy of the target knee within year prior to study * planned surgery in the target knee within the next 3 months * concomitant inflammatory disease affecting either knee

Keywords: knee
cerebral desaturation and postoperative dysfunction after thoracic surgery

Conditions: Thoracic Surgery; Cognitive Dysfunction

Summary: the purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. we also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (pocd) in patients undergoing lung resection.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective lobectomy or wedge resection via thoracotomy * one lung ventilation (olv duration) ≥ 45 min exclusion criteria: * previous cerebral disease, * dementia, * severe cognitive dysfunction * emergency surgery * pregnancy * patient refusal to give consent * inability to give consent * age ≤18 years * asa ≥ iv.
combination of chemotherapy and gefitinib as first-line treatment

Conditions: Non-Small-Cell Lung Cancer

Summary: the results of fastact2 show that chemotherapy plus erlotinib significantly prolonged pfs and os of patients with nsclc. however, outcome of the combination therapy are similar to those reported in several trials of single-agent egfr tkis. so which is the optimal first-line treatment for patients who harbored a sensitive egfr mutation? the investigators need a head-to-head study to reply.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age \>=18 years 3. histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage iv non-small cell lung cancer (nsclc) 4. a cytologic diagnosis is acceptable (i.e., fna or pleural fluid cytology) 5. measurable or non-measurable disease 6. able to comply with study and follow-up procedures exclusion criteria: * evidence of small cell, carcinoid, or mixed small cell/non-small cell histology * malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer * symptomatic or untreated brain metastases * prior systemic chemotherapy for nsclc * unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) * history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications * gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (iv) alimentation, or prior surgical procedures affecting absorption * pregnancy or lactation

Keywords: lung adenocarcinoma,egfr mutation, chemotherapy, gefitinib
fractional micro-needle radiofrequency and i botulinum toxin a for primary axillary hyperhidrosis

Conditions: Primary Axillary Hyperhidrosis

Summary: because of the limiting data about an efficacy and safety of fractional radiofrequency for the treatment of hyperhidrosis, this study aim to compare clinical efficacy by hyperhidrosis disease severity score (hdss) between fractional microneedle radiofrequency device and intradermal botulinum toxin type a injection for the treatment of primary axillary hyperhidrosis. the secondary objectives to determine the improvement change of iodine starch test, total amount of sweat production by trans-epidermal water loss (tewl), patient's satisfaction and their quality of life by dermatology life quality index and side effect between the groups.


Eligibility criteria:
inclusion criteria: male or female subjects, age between 18-60 years * healthy volunteers * subjects who have experienced with excessive sweating on both sides of axillary areas and have a positive result for iodine starch test on the screening day * willing to participant into the study and voluntary to sign in the informed consent form exclusion criteria: active bacterial or fungal infection over tested area / axillae * pregnancy and breast feeding * previously underwent the surgical treatment such as radical resection of sweat glands for primary axillary hyperhidrosis * currently being treated with intradermal botulinum toxin type a injection at axillary area for less than 12 months * currently being inserted the cardiac pace maker or any other internal electronic devices * secondary hyperhidrosis caused by hyperthyroidism, drug induced, abnormal autonomic or neurological disorder that affect sweat gland * allergy to botulinum toxin type a * known contact allergy to iodine * unable to follow and comply to the study protocol

Keywords: fractional micro-needle radiofrequency intradermal botulinum toxin a