Kornimate/medical-research-clean huggingface dataset:
sickle cell anemia screening and prevention in northern israel

Conditions: Thalassemia; Sickle Cell Anemia

Summary: since 1987, a screening for β thalassemia in pregnant women is carried on in northern israel, and from 1999 all the samples were tested also for hgb s, hgb c, hgb d, hgb o arab and others. in this study, the investigators intend to summarize the results of this preventive program aiming to detect couples at risk for having offspring with thalassemia or sca, the compliance regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies born.


Eligibility criteria:
inclusion criteria: all pregnant women tested and their husband in those cases that the woman test revealed abnormal hemoglobin. exclusion criteria: no exclusion criteria.

Keywords: thalassemia sickle cell anemia carrier detection prenatal diagnosis genetic counseling
efficacy of ipsilateral high thoracic ultrasound-guided erector spinae plane block in thoracic cancer surgeries

Conditions: Thoracotomy; Erector Spinae Plane Block; Thoracic Cancer; Shoulder Pain

Summary: to evaluate the effectiveness of ultrasound guided erector spinae plane block (espb) in controlling post thoracotomy ipsilateral shoulder pain.

the aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. it can be performed posterolaterally, anterolaterally or even anteriorly. post-thoracotomy ipsilateral shoulder pain could undermine pain management in the post-thoracotomy patient. erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. it is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. it has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of c3 when it was performed at t2. ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status class i and ii. 2. age ≥ 18 and ≤ 60 years. 3. patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy. exclusion criteria: 1. patient refusal. 2. local infection at the puncture site. 3. coagulopathy with the international normalized ratio (inr) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor ii) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin k deficiency \& therapeutic anticoagulants drugs). 4. unstable cardiovascular disease. 5. history of psychiatric and cognitive disorders. 6. patients allergic to medication used.
longitudinal study of dental implant therapy in hiv positive patients

Conditions: Dental Implant

Summary: the purpose is to place implants in hiv positive and hiv negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in hiv positive patients versus hiv negative patients.

this study will review the osseointegration of implant supported restorations in hiv positive and hiv negative patients, then follow patients over a 3 year period of time. the treatment outcome as measured according to mish criteria for implant success. patients will be examined at each interval for the presence of pain, infection, mobility, and radiographic bone height of each implant.

Eligibility criteria:
inclusion criteria: * healthy enough to undergo the proposed therapy without compromise to existing health status * at least 19 years old * able to read and understand written english without the aid of ad hoc interpretation * able to cognitively understand the proposed study and therapy and possible prognoses * able to consent for their own inclusion in the study. * implant supported restorations are limited to the following edentulous areas: mandibular arch (excluding 2nd and 3rd molar areas), maxillary anterior and premolar areas exclusion criteria: * smoker * uncontrolled diabetes * uncontrolled hypertension * bisphosphonate user * bruxer * extraction site healed less than 6 months * women pregnant or lactating at the time of enrollment * previous malignant neoplasm * a known hypersensitivity to titanium metal * any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing * any indication of an inability to make autonomous decisions

Keywords: hiv implant crown
prone positioning vs. prone positioning and no inhalation in covid-19 ards.

Conditions: Respiratory Distress Syndrome

Summary: the investigators aim to investigate the effects of prone positioning and prone positioning with no inhalation for covid-19 patients with ards.

the investigators aim to investigate the effects of prone positioning and prone positioning with no inhalation for covid-19 patients with ards. patients with covid-19-associated ards were ventilated in prone position with or without no inhalation, the arterial blood gas (abg) tests were performed at 16 hours after prone positioning.

Eligibility criteria:
inclusion criteria: * adult patients with covid-19 associated ards exclusion criteria: * patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure
the role of multi-modality therapy for the treatment of high-grade soft tissue sarcomas of the extremities

Conditions: Sarcoma

Summary: patients with grade ii and iii soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. all patients in this protocol will receive adjuvant chemotherapy.

patients with grade ii and iii soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. all patients in this protocol will receive adjuvant chemotherapy.

Eligibility criteria:
patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses: liposarcoma (round cell or pleomorphic). fibrosarcoma. malignant fibrous histiocytoma. inflammatory malignant fibrous histiocytoma. myxoid malignant fibrous histiocytoma. malignant giant cell tumor. angiomatoid malignant fibrous histiocytoma. leiomyosarcoma. malignant hemangiopericytoma. rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined). soft tissue sarcoma resembling ewing's sarcoma. synovial cell sarcoma. epithelioid sarcoma. clear cell sarcoma. neurofibrosarcoma. epithelioid schwannoma. malignant triton tumor. angiosarcoma. mixed malignant mesenchymoma. alvelar soft part sarcoma. malignant granular cell tumor. all lesions must be grade ii or iii. no patients with grade i lesions will be acceptable. patients must have undergone a limb-sparing procedure in which all gross tumor has been removed. clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites. the soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint. the definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization. patients must not have received any prior chemotherapy or radiotherapy for their sarcoma. patients without a history of any other malignant disease except basal cell carcinoma. patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function. patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.

Keywords: chemotherapy radiation therapy sarcoma surgery
senolytics treatment of interstitial lung disease in common variable immunodeficiency

Conditions: Common Variable Immunodeficiency; Interstitial Lung Disease Due to Systemic Disease

Summary: the purpose of this study is to determine if the supplement, fisetin, can be used as a treatment option for common variable immunodeficiency (cvid) by comparing its efficacy to placebo.


Eligibility criteria:
inclusion criteria: * patient must have received a diagnosis of cvid according to the international consensus document (icon) at least 30 days before enrollment. * physician diagnosis of possible glild associated with cvid. * iga results. * female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile. (a negative pregnancy test for women whose menopausal status is determined by self-reported absence of menstrual periods in the past 12 months will be required within 72 hours prior to randomization). * patient must be able and willing to comply with the requirements of this study protocol. exclusion criteria: * unable or unwilling to give informed consent. * presence of any condition that the investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial. * pregnant and/or lactating. women of childbearing potential (wcbp) must have a negative pregnancy test within 72 hours prior to randomization. wcbp who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first ip administration through 48 hours after the last ip administration. * men who are unwilling to abstain from sex with wcbp or use an adequate method of contraception from the time of the first ip administration through 48 hours after the last ip administration. * prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia. * patient currently hospitalized or under immediate consideration for hospitalization. * current use of tobacco products or as per clinical judgement. * current excessive caffeine intake (400 mg or more per day).
continuous glucose monitoring profile description under alpelisib treatment in patients with advanced breast cancer

Conditions: Breast Cancer; Diabetes

Summary: the purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (freestyle libre pro) over 14 days

aaren is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. patients will wear a noninvasive glucose monitoring sensor, the freestyle libre pro for a 14 day period. forty patients will be enrolled.

Eligibility criteria:
inclusion criteria: 1. women suffering breast cancer and eligible to treatment with alpelisib 2. age ≥18 years 3. menopausal women (for at least 24 months) 4. informed consent form signed exclusion criteria: 1. men 2. pregnant ou child-bearing potential women

Keywords: breast cancer, alpelisib, hyperglycemia
study to evaluate clinical real world outcomes of lorlatinib after alectinib in alk-positive nsclc japanese patients

Conditions: ALK-positive Non-small-cell Lung Cancer

Summary: to evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (alk) tyrosine kinase inhibitor (tki) to tki sequence sequence treatment after failure of alectinib as a first-line treatment in japanese alk positive non-small cell lung cancer (nsclc).

this study is a post-approval, company-sponsored, observational study. this study is a multicenter, non-interventional, retrospective, chart review of patients with alk+ nsclc patients treated using lorlatinib as the second/later line therapy in japan after failure of alectinib treatment as the first line therapy from 20 november 2018. all decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. data will be collected if available per study site. patients in this study are those who started treatment with lorlatinib from 1 may 2019 to 31 december, 2020 in clinical practice.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc, with any tumor, node and metastasis (tnm) stage. * confirmed alk gene rearrangement by any validated test. * confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record. * confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st may 2019 to 31st december 2020. exclusion criteria: -participating on any clinical trials of which final results has not yet been reported during the study period.

Keywords: alk lorlatinib alectinib real world retrospective
dexmedetomidine in the treatment of agitation associated with dementia (tranquility iii)

Conditions: Agitation; Dementia

Summary: a study to determine the safety and efficacy of bxcl501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[prn\]), for a maximum of 168 doses within a 12-week treatment period.

a randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of bxcl501 in male and female subjects (65 years and older) with acute psychomotor agitation associated with dementia. approximately 150 subjects will participate in this study. subjects will receive a single film consisting of bxcl501 40 µg dose or bxcl501 60 µg dose or placebo. subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.

Eligibility criteria:
inclusion criteria: 1. all subjects must have a diagnosis of probable alzheimer's disease based on nia-aa criteria (2018). if subject biomarker data are unavailable, per the 2018 nia-aa diagnostic criteria, the clinical diagnosis of probable ad will be based on the 2011 nia-aa criteria 2. episodes of psychomotor agitation (e.g., kick, bite, flailing) 3. subjects exhibit behaviors that are congruent with the international psychogeriatric association criterion for agitation representing a change from the subject's usual behavior 4. a score of 0 to 20 on the mini-mental state exam (mmse) and require moderate to full assistance with activities of daily living 5. subjects who read, understand, and provide written informed consent, or who have a lar to provide consent on their behalf 6. subjects who are deemed to be medically appropriate for study participation by the principal investigator 7. participants who agree to use a medically acceptable and effective birth control method exclusion criteria: 1. subjects with dementia or other memory impairment not due to probable ad. 2. clinical diagnosis of probable ad should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function. 3. subjects with agitation caused by acute intoxication. 4. subjects with significant risk of suicide or homicide per the investigator's assessment. 5. subjects who are medically unstable or in recovery. note: subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location. 6. history of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia. 7. subjects with laboratory or ecg abnormalities. 8. subjects who have received an investigational drug within 30 days prior to screening. 9. subjects who are currently suffering from substance abuse. 10. subjects with a potential cause for delirium (relatively recent onset agitation and dementia)
steroid and anticoagulant therapy in covid19

Conditions: Pneumonia, Viral

Summary: as covid-19 has neither standard treatment protocol nor guidelines, there are many treatment protocols foranti-inflammatory corticosteroids and anti-coagulations for severe covid-19 pneumonia patients. this study aimed to assess the most suitable modality in this high-risk group. methods: a prospective, experimental study design was adopted, that included 123 severe covid-19 pneumonia patientsadmitted at assiut universityhospital from april 10th, 2020, to september10th, 2020. patients were divided into 3 groups according to a combined corticosteroid and anticoagulants therapy protocols. group a included 32 patients, group b included 45 patients, and group c included 46 patients. assessment of cases was conducted according to the treatment type and duration, weaning duration from oxygen therapy, length of hospital and icu stay, and complications during treatment.three months follow up after discharge was performed.


Eligibility criteria:
inclusion criteria: * respiratory distress \[respiratory rate (rr) \>30 breaths/min at rest\], mean oxygen saturation ≤93%,ratio of arterial oxygen partial pressure to fractional inspired oxygen (pao2/fio2) ≤300 mmhg,\>50% lung involvement on imaging within 24 to 48 hours of admission exclusion criteria: * pnumonia not caused by covid19
evaluation of the safety and effectiveness of a probiotic bacterium to boost the immune response to influenza vaccines

Conditions: Influenza

Summary: this project aims to test the hypothesis that oral consumption of a specific strain of the probiotic bacterium lactobacillus fermentum (trademarked pcc®) is able to significantly enhance the immune response to a vaccine for influenza.


Eligibility criteria:
inclusion criteria: * persons must be adult men and women aged 18-49 years (have not reached 50th birthday). * persons must be able and willing to provide informed consent. * persons must be willing to receive the influenza vaccine (fluvax®) given as an intramuscular injection. * persons must be willing to consume one gelatin capsule per day containing either probiotic bacteria or placebo (inactive substance) for the duration (42 days) of the study. * persons must be willing to provide blood specimens, each of 10 ml, collected by venepuncture. * persons must be willing to notify study personnel of a range of health effects by questionnaire. exclusion criteria: * any health condition for which the influenza vaccine is not recommended including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency diseases (including hiv infection) or on-going immunosuppressive therapy. * currently pregnant; nursing mothers; or planning a pregnancy within one month of vaccination. * allergy to latex, egg, or egg protein, or the antibiotics neomycin or polymyxin. * a prior serious reaction to a vaccine, or have had guillain-barre syndrome. * received an influenza vaccine in the past. * received any other vaccine within one month prior to enrolment * are participating in another research study involving any study medication

Keywords: influenza bioadjuvant probiotic hai immunity vaccine immune response to influenza vaccine
airway alkalinization and nasal colonization

Conditions: Healthy Subjects; Cystic Fibrosis

Summary: the study will be a randomized, cross-over study of tham followed by saline or saline followed by tham in human non-cf and cf subjects to assess nasal colonization

16 subjects per group will be randomized to receive study drug or saline followed by a wash out period and cross-over to the other treatment, three times daily for 4 days. nasal swab will be done at baseline and after both study treatment and saline treatment for assessment of airway colonization.

Eligibility criteria:
healthy subjects: inclusion criteria: * 16 subjects, aged 16-80, clinically stable with no significant changes in health status for 14 days prior to day 1, written informed consent obtained fom subject. exclusion criteria: * pregnant or lactating * use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to screening, smoked in the last 6 months. cf subjects: inclusion criteria: * fev1% \>35%, o2 saturation \>90% on room air, clinically stable with no significant changes in health status for 14 days prior to day 1, written informed consent obtained from subject. exclusion criteria: * same as for healthy subjects.
adagrasib in combination with palbociclib in patients with advanced solid tumors (krystal-16)

Conditions: Advanced Solid Tumor

Summary: this study will evaluate the safety and clinical activity of mrtx849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with kras g12c mutation.

this study will evaluate the pharmacokinetics and preliminary clinical activity of mrtx849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with kras g12c mutation. mrtx849 is an orally available small molecule inhibitor of kras g12c and palbociclib is a small molecule inhibitor of cdk 4 and 6.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of a solid tumor malignancy with kras g12c mutation * unresectable or metastatic disease. * no available treatment with curative intent * adequate organ function exclusion criteria: * history of significant toxicity on prior kras g12c or cdk4/6 inhibitor therapies * history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow * other active cancer * cardiac abnormalities
study of qls31905 and/or ql1706 combination with chemotherapy in the advanced malignant solid tumors

Conditions: Advanced Solid Tumor

Summary: this study aims to evaluate the efficacy and safety of qls31905 and/or ql1706 plus chemotherapy in patients with claudin18.2-positive advanced solid tumors.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in the study and sign the informed consent form; * eastern cooperative oncology group (ecog) performance status score of 0-1; * expected survival time ≥ 3 months; * histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors; * no prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease; * tumor tissue samples determined to be positive for claudin18.2 by immunohistochemistry (ihc); * at least one measurable lesion per recist v1.1; * patients with adequate cardiac, liver, renal function, etc. exclusion criteria: * history of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ; * underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study; * known central nervous system metastases; * patients with hepatitis b; patients with hepatitis c; patients who test positive for syphilis, or patients with a known history of hiv or positive hiv screening test; patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; * patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.