Kornimate/medical-research-clean huggingface dataset:
repeated administration of cannabis varying in thc and cbd

Conditions: Cannabis

Summary: the majority of the \>3 million medical cannabis patients in the u.s. use cannabis products to manage pain but many questions remain. this project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated with increased pain sensitivity; 2) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of thc and cbd, and is this tolerance reversible following a period of abstinence; 3) how does repeated cannabis use affect levels of endocannabinoids, and are these changes associated with changes in pain sensitivity and abuse liability? in this study, the investigators will enroll participants (n=100 healthy, cannabis-using men and non-pregnant women, ages 21-65) inpatient for 15 days. they will be randomized to one of four cannabis conditions (n=25/group). following a day of standardization on which participants will receive their assigned cannabis condition (day 1), cannabis will be administered repeatedly for 14 days (day 2-15). the investigators will measure abuse-related effects ("good drug effect"), endocannabinoid levels and two distinct types of experimental pain: the cold pressor test and quantitative sensory testing thermal temporal summation. given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with thc:cbd ratios that are representative of most medical cannabis products on pain, abuse liability, and endocannabinoids is imperative.


Eligibility criteria:
inclusion criteria: 1. males or females, 21-65 years old 2. for females: not pregnant or breast-feeding, and uses an acceptable form of birth control (e.g., condoms, iud) 3. uses cannabis on a near-daily basis 4. not seeking treatment for cannabis use 5. able to provide informed consent 6. able to perform study procedures exclusion criteria: 1. meets dsm-v criteria for any substance use disorder other than cannabis, nicotine or caffeine 2. uses other illicit drugs ≥1 day/week in the prior 4 weeks 3. medical history, physical, psychiatric examination, or significant illness at the clinical discretion of the study physician; for example, history of heart disease, diabetes, hypertension (bp \> 140/90) or uncontrolled asthma 5. use of any prescription or daily use of over-the-counter medications 6. recurrent, ongoing pain 7. insensitivity to the thermal stimuli of the cold pressor test or quantitative sensory testing 8. history of physical violence or paranoia during cannabis withdrawal
effect of capacitive and resistive radiofrequency on postpartum diastasis recti

Conditions: Diastasis Recti Abdominis (DRA); Radiofrequency

Summary: to evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis.

eighty females postpartum with rectus diastasis will be included in this study; they will be recruited the outpatient clinic at el mahalla al kobra (the first author's pervious workplace) and will be referred by obstetric and genecology physicians. patients will be assigned into two groups. group a: it will include 40 patients participating in abdominal belt. group b: it will include 40 patients participating in abdominal belt plus tecar therapy.

Eligibility criteria:
inclusion criteria: * 1. postpartum women (7 days after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus). 2. multiparous women (2-3) times delivered vaginally with or without episiotomy. 3. their age will be ranged from 20 -35 years old. 4. their bmi will be less than 30 kg/cm2. exclusion criteria: * any participant will be excluded if she meets one or more of the following criteria: postpartum women will be excluded from the study if they have: 1. abdominal or back surgery. 2. abdominal hernia. 3. history of abnormal pregnancy, uterine fibroid or polyhydramnios during pregnancy. 4. neurological disorders as multiple sclerosis, stroke and spinal lesion. 5. musculoskeletal diseases such as fractures muscle strains, severe knee osteoarthritis which may affect their physical activity.

Keywords: diastasis recti, radiofrequency therapy, physical exercises, postpartum
impact of exercise training on ischemia with non-obstructive coronary arteries (inoca): the exinoca study

Conditions: Coronary Microvascular Disease; CMD

Summary: the purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function. hypotheses: the first hypothesis is that in inoca, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body. the second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.

a significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (cmd), a condition known as ischemia with no obstructive coronary artery disease (inoca). despite a considerable patient population affected by inoca, the specific mechanisms underlying cmd are not fully understood, often resulting in a lack of targeted treatment. there is evidence to suggest that exercise capacity is linked to coronary microvascular function, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored. this study aims to identify mechanisms underlying cmd in angina and to assess whether exercise training can improve the condition. the current study is a randomized controlled trial testing the effect of exercise training in patients with cmd. 100 patients will be randomized 1:1 to exercise training or control. the primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.

Eligibility criteria:
inclusion criteria: * coronary microvascular dysfunction, defined as myocardial bloodflow reserve (mbfr) \< 2.5 or hyperemic myocar-dial blood flow (hmbf)\<2.3 ml/g/min using \[15o\]h2o-pet * no obstructive coronary artery disease exclusion criteria: * females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). the female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile * heart failure, defined as left ventricular ejection fraction of less than 40% * uncontrolled hypertension defined as blood pressure above target 140/90 for all * co-morbidity resulting in \<1 year expected survival * considered by the investigator, for any reason, to be an un-suitable candidate for the study. * unable or unwilling to exercise, e.g. due to arthritis or in-jury\* * already are regularly physically active and/or have a maxi-mal oxygen uptake \>45 ml/kg/min
efficacy study of methenamine + methylthioninium chloride vs phenazopyridine for the symptomatic control of dysuria

Conditions: Dysuria

Summary: the purpose of this study is to evaluate the efficacy of the combination of methenamine + methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic relief of dysuria.

* single blind, randomized, prospective study. * length of experience: 03 days to 07 days. * 03 visits (days 1, 4 and 7). * evaluation of the efficacy and safety of the medication. * shall be assessed for adverse events.

Eligibility criteria:
inclusion criteria: * patients who agree to participate by agreeing to the terms proposed in the clinical trial; * patients aged over 18 years of any ethnicity; * presence of dysuria with marking greater than or equal to 5 measured points on the categorical scale pre-treatment for pain symptom; exclusion criteria: * patients who are febrile (axillary t º: ≥ 38 ° c), with back pain or lumbar; * patients with complicated clinical presentation of urinary tract infection; * patients with a history of allergy or intolerance to any known or suspected one of the ingredients of the product under investigation; * patients who are pregnant or during lactation, or childbearing potential and are not making use of effective contraception; * patients presenting with renal disease or severe liver disease, according to medical history and / or laboratory; * patients presenting with severe systemic disease according to the known medical history; * patients who received antibiotic treatment, anthelmintic within 7 days prior to study entry; * patients unable to understand the guidelines specified in this protocol or can not attend all study visits or unable to complete the log; * pregnancy or risk of pregnancy and lactating patients; * any finding of clinical observation (history and physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.

Keywords: symptom of dysuria
peripheral vascular function in obstructive sleep apnoea

Conditions: Obstructive Sleep Apnoea; Obesity

Summary: peripheral vascular function is impaired in people with obstructive sleep apnoea who are untreated compared with age-, weight- and sex-matched healthy controls.

obstructive sleep apnoea (osa) is a chronic respiratory disorder associated with endothelial dysfunction, increased sympathetic activation and increased cardiovascular risk. the standard treatment paradigm is continuous positive airway pressure (cpap), however, patient adherence to cpap is variable. it is unclear to what extent that poor adherence to cpap therapy augments vascular endothelial function and reduces cardiovascular risk compared to excellent adherence. the main aim of this research is to investigate vascular endothelial function in osa patients who are poorly-adherent to cpap therapy. nitric oxide (no)-mediated, endothelium-dependent macrovascular and microvascular function (by brachial artery flow-mediated dilatation and forearm cutaneous thermal hyperaemia, respectively) and generalised microvascular function (by post-occlusion reactive hyperaemia) will be assessed in three obese osa patient populations (high-adherence (n=20); low adherence (n=20); and, untreated (n=20)) and age-/bmi-matched osa-free controls. we will also assess body composition, cardiovascular risk, lipid status and functional capacity. this research will evaluate treatment efficacy in patients who are poorly-adherent to cpap treatment and could identify whether an alternative approach to their care should be explored.

Eligibility criteria:
inclusion criteria: * obstructive sleep apnoea diagnosed using overnight polysomnography * age 18-90 years exclusion criteria: * unable to perform the tests involved in the study * unable to provide written informed consent
awake vs. asleep craniotomy for non-eloquent gliomas

Conditions: Intracranial Glioma

Summary: this study protocol examines a comparison between local and general anesthesia (awake vs. asleep craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).

this is a single-center, prospective randomized open or non-blinded end-point (probe) clinical trial. patients will be selected by the neurosurgeon according to the inclusion and exclusion criteria. patients who consent to randomization will have confirmed non-eloquent status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups utilizing a dynamic minimization approach. the experimental group with randomization of patients who will undergo awake craniotomy for both high and low grade gliomas in non-eloquent areas or a control group of patients who will have asleep craniotomy for both high and low grade gliomas in non-eloquent regions.

Eligibility criteria:
inclusion criteria 1. patients with age ≥18 years old. 2. who grade i, ii, iii, and iv glioma in non-eloquent brain cortex based on magnetic resonance imaging (mri) 3. an elective procedure. 4. a single lesion. 5. no major comorbidities that would necessitate an extended hospital stay. 6. newly diagnosed tumors. exclusion criteria 1. patients with age \< 18 years old. 2. non-gliomas 3. eloquent location (motor, sensory, language) 4. non-elective procedure. 5. multiple lesions. 6. major comorbidities. 7. recurrent tumors. 8. patients lacking capacity to consent.

Keywords: craniotomy awake craniotomy
telerehabilitation for patients with parkinson's disease at any moment

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with parkinson's disease at any stage. the main questions it aims to answer are: will patients with parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • will this training be safe and impact the patient's well-being perception? participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.they will be requested to perform the motor tasks per a predetermined protocol over 3 months. their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch.

in this cohort study, the feasibility and safety of a telerehabilitation and telemonitoring approach will be tested in people with parkinson's disease at any stage. enrolled subjects will be given a tablet through which they will log in with their own credentials to a telerehabilitation platform where a library of videoclips displaying as many different motor activities, grouped by difficulty (very easy - easy- advanced) and function domain (trunk alignment, balance, hand dexterity, speech articulation, ventilation...), will be available. patients will perform the exercises according to a pre-determined training protocol, observing and imitating the tasks presented in the videoclips by experienced physiotherapists or speech therapists. a training duration of 45 minutes/day, 3 times/week for no less than 27 sessions (equal to 1200 minutes of total training) will be recommended. moreover, subjects will be given a smartwatch to be worn 24 hours/ day, for at least 5 days/week. every 15 +/- 3 days, one physiotherapist will call the patients to check the correct use of the devices, the level of adherence to the exercise program and the need for shaping the training difficulty to the user's skills.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease (according to movement disorder society criteria) * ability to provide written informed consent. exclusion criteria: * moderate-severe cognitive impairment (moca≤18) * any other factor known to interfere with the ability to interact with the telerehabilitation platform (e.g. poor visual acuity, lack of family support); * comorbidities with adverse impact on functioning or survival or affecting the performance of physical exercise (e.g. serious neoplastic diseases, cardiovascular diseases not controlled pharmacologically including arterial hypertension or hypotension, cardiac arrhythmias, heart failure, musculoskeletal diseases, dizziness or vertigo); * severe depression or other neuropsychiatric disorders; * expected need for adapting antiparkinsonian drug regimen over a 6 month period.

Keywords: telerehabilitation telemonitoring empowerment functioning
zanubrutinib, lenalidomide and rituximab (zr2) in elderly treatment-naive patients with diffuse large b-cell lymphoma (dlbcl)

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of the zanubrutinib, lenalidomide and rituximab (zr2) regimen in elderly treatment-naive patient with diffuse large b-cell lymphomas.


Eligibility criteria:
inclusion criteria: * treatment-naive pathologically confirmed patients with diffuse large b-cell lymphoma (dlbcl) * refuse to undergo systemic chemotherapy or not suitable for chemotherapy * radiography detects measurable lesions defined as at least 1 clearly defined lesion/nodule with both long and short diameters longer than or equal to 1.5cm * life expectancy of at least 3 months determined by researchers * the patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research * research drugs have not been used before exclusion criteria: * the patient has received systemic or local anti-tumor treatment, including chemotherapy, within three weeks before enrollment * the patient has complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * laboratory measures meet the following criteria at screening (unless caused by lymphoma): 1. neutrophils\<1.5 x 10\^9/l 2. platelets\<80 x 10\^9/l 3. alt or ast is 2 times higher than the normal upper limit, akp and bilirubin are 1.5 times higher than normal upper limit 4. creatinine is 1.5 times higher than the normal upper limit * other concurrent and uncontrolled medical conditions that the researchers believe that they will affect the patient's participation in the study, including patients with psychosis or other known or suspected patients who cannot fully comply with the research protocol * hiv-infected patients * patients with hbsag positive are required to have negative hbv dna before entering the group. in addition, if the patient is hbsag negative but hbcab positive (regardless of hbsab status), hbv dna test is also required, and if the result is positive, anti-viral treatment is also required, and negative hbv dna is required before entering the group * other medical conditions determined by the researchers that may affect the study
efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis

Conditions: Pancreatectomy

Summary: the purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

the purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Eligibility criteria:
inclusion criteria: \*all patients planned to undergo pancreatectomy. exclusion criteria: * asthma * allergic reactions to nsaids * ckd * internal hemorrhoids * anti-platelet medications
pre-operative physiotherapy to prevent post-operative complications

Conditions: Abdominal Surgery

Summary: the purpose of this study is to assess the roll of pre-operative chest physiotherapy, in addition to the usual care given after major abdominal surgery, in the prevention of post-operative respiratory complications.


Eligibility criteria:
inclusion criteria: * major abdominal surgery exclusion criteria: * respiratory disease * pregnancy * mental disease * dementia * alzheimer's disease

Keywords: adult
efficacy of narrative exposure therapy (net) in treating women after human trafficking or forced prostitution

Conditions: Posttraumatic Stress Disorder; Depression; Dissociation

Summary: the purpose of this study is to perform an evaluation of a trauma-focused short-term intervention (narrative exposure therapy; schauer, m., neuner, f. \& elbert, t.) on a variety of clinical outcome measures (ptsd, depression, somatic complaints, dissociation) in women after sexual exploitation and women trafficking.


Eligibility criteria:
inclusion criteria: * sexual exploitation or women trafficked or forced prostitution * symptoms of post traumatic stress disorder exclusion criteria: * current psychotic symptoms

Keywords: somatic complaints
arx788 in her2-positive metastatic breast cancer patients

Conditions: HER2-positive, Metastatic Breast Cancer

Summary: a phase 2 study of arx788 given every 6 weeks in her2-positive, metastatic breast cancer patients.

a single arm, phase 2 study of arx788 in her2-positive, metastatic breast cancer patients. the arx788 will be administered every 6 weeks (q6w) intravenous (iv) infusion.

Eligibility criteria:
inclusion criteria: * 18 to 75 years old (including upper and lower limits), male or female; * unresectable locally advanced, recurrent or metastatic bc; * has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic bc; * tissue samples determined to be her2 positive (defined as ihc3+ or fish+); * has at least one measurable target lesion as per recist1.1 criteria; * has recovered from any ae (≤ grade 1) related to prior surgery and prior cancer treatment; * adequate bone marrow, liver, kidney and coagulation function; * ecog performance status score of 0-1; * voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit. exclusion criteria: * has known history to be allergic to any active ingredient or excipient of arx788; * with meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy; * has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment; * has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease; * has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection; * has cardiac insufficiency; * uncontrolled hypertension; * has evidence of severe or uncontrollable systemic diseases; * received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial; * breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial; * is unwilling or unable to stop wearing corneal contact lens during the trial; * has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product; * has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form; * other conditions that the investigator considers inappropriate for participation in this trial, such as poor compliance.

Keywords: arx788 her2-positive breast cancer q6w
safety and tolerability of omalizumab in adults and adolescents with severe allergic asthma

Conditions: Asthma

Summary: this study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study cige25011e2.


Eligibility criteria:
inclusion criteria: * patients with a history of severe allergic asthma who completed the treatment period of cige250011e3 protocol, without experiencing any significant drug-related adverse events * male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee exclusion criteria: * patients who had not received study medication for greater than 84 days since visit 38 of study cige240011e3 * pregnant females or nursing mothers * patients with know hypersensitivity to any ingredients of omalizumab or related drugs other protocol-defined inclusion/exclusion criteria may apply

Keywords: asthma anti-immunoglobulin e omalizumab allergic asthma