Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, pharmacokinetics and efficacy of img-007 in adult alopecia areata participants

Conditions: Alopecia Areata (AA)

Summary: the primary objective of the study is to evaluate the safety of img-007 in adults with alopecia areata.

this is a phase 1b/2a, open label study to assess the safety, pk, and efficacy of img-007 in adult aa participants with 50% or greater scalp hair loss. the study will consist of two cohorts with three periods: a screening period of up to 5 -weeks, a 16-week treatment period and a 20-week follow- up period. approximately 6 and 24 participants will be sequentially enrolled into cohort 1 and cohort 2, respectively, to receive three intravenous infusions of img-007 over 4 weeks.

Eligibility criteria:
key inclusion criteria: * male or female aged ≥ 18 and ≤ 65 years * aa with current episode of hair loss of \> 6 months but \< 8 years * aa with ≥ 50% scalp involvement as defined as salt score ≥ 50 key exclusion criteria: * known hepatitis b, hepatitis c, or human immunodeficiency virus infection * evidence of active or latent tuberculosis (tb) * history of untreated or inadequately treated tb infection. * active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the screening visit * concurrent hair loss due to other etiologies * primary "diffuse" type of aa * active inflammatory diseases on the scalp that would interfere with the assessment of aa * history or presence of hair transplants or micropigmentation of the scalp * active systemic diseases that may cause hair loss * other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.

Keywords: img-007 alopecia areata alopecia hair loss skin disease immune system disorder dermatologic agents
a phase i study of ljm716 in squamous cell carcinoma of head and neck, or her2+ breast cancer or gastric cancer

Conditions: HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma; HER2 + Breast Cancer; HER2 + Gastric Cancer; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma

Summary: this primary purpose of this study is to estimate the maximum tolerated dose (mtd) and/or recommended dose for expansion (rde) and preferred dosing schedule of ljm716 given by iv infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or her2 overexpressing metastatic breast cancer or gastric cancer


Eligibility criteria:
inclusion criteria: * patients with her2+ breast cancer, or her2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma * site of disease that can be safely biopsied exclusion criteria: * patients received prior anti-her3 antibody treatment * patients with impaired cardiac function * brain metastases that have not been adequately treated * malignant disease other than that being treated in this study * pregnant or nursing (lactating) women * laboratory abnormalities as specified in the protocol other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma breast cancer gastric cancer squamous cell carcinoma of head and neck esophageal squamous cell carcinoma
head-to-head comparison of [68ga]ga-psma-d5 with [68ga]ga-psma-11 pet/ct in pca diagnosis, recurrence, and metastasis

Conditions: Prostate Cancer; PET/CT

Summary: to prospectively evaluate the radiodrug biodistribution of a novel pet imaging agent \[68ga\]ga-psma-d5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68ga\]ga-psma-11.

\[68ga\]ga-psma-d5 pet/ct was used for initial assessment of prostate cancer or detection of recurrence. the maximum standardized uptake value (suvmax) was used to evaluate tumor uptake. the sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[68ga\]ga-psma-11 pet/ct.

Eligibility criteria:
inclusion criteria: * aged from 18 to 90 years old; * complete mri images and clinical data (such as psa level, gleason grade, etc.); * prostate cancer detected by psa or imaging examination, or clinically suspected recurrence after standardized treatment; * simultaneous \[68ga\]ga-psma-d5 and \[68ga\]ga-psma-11 examinations within two weeks; * willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment; * sign informed consent. exclusion criteria: * patients who cannot cooperate with the examination; * concurrent malignant tumors; * previous alcohol allergy; * patients with liver and kidney dysfunction; * other circumstances deemed by the investigator to be inappropriate for trial participation.
cardioneuroablation for recurrent vasovagal syncope and bradyarrhythmias: the cna-fwrd registry

Conditions: Vasovagal Syncope; AV Block-2Nd Degree-Type 1; Sinus Pause

Summary: the cna-fwrd registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.

the cna-fwrd registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation. major inclusion criteria for enrollment are history of vvs or symptomatic bradyarrhythmia, age \< 60 years, and evaluation by a physician and discussion about potential candidacy for radiofrequency cardioneuroablation or permanent pacemaker implantation for medically refractory symptoms. for analysis purposes, patients awaiting the intervention will remain in the "control group" and will cross-over to the "procedural group" after successful completion of radiofrequency cardioneuroablation procedure. the follow-up for the procedure group will start at completion of cna procedure, but patients who eventually do not get the procedure will stay in the control group until the end of the study, with similar follow-up performed as for the patients undergoing rfca procedure. if a patient in the control group undergoes permanent pacemaker placement, then the day after the procedure the patient will be removed from the control group for follow up.

Eligibility criteria:
inclusion criteria: * symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures * age \< 60 years exclusion criteria: * age \> 60 years * intra-/infra-hisian av block * intrinsic sinus node disease * history of supraventricular tachycardia * history of ventricular tachycardia * presence of structural heart disease related * prior history of catheter ablation * presence of inheritable arrhythmic conditions * orthostatic hypotension on hutt test * abnormal thyroid function levels * proven indication for permanent pacemaker implantation

Keywords: vasovagal syncope av block sinus pause pacemaker cardioneuroablation radiofrequency ablation
dysfunctional breathing in difficult asthma.

Conditions: Asthma

Summary: we plan to use the life shirt to record tidal volume, respiratory rate and breathing pattern over a 6 hour period in patients admitted with difficult asthma. the life shirt will also be used to collect the same data over the same time period in a group of healthy controls. this data will then be correlated with the assessment of the supervising consultant as to whether the patient has any element of dysfunctional breathing contributing to their symptoms. it is hoped that the data obtained may in future be used to offer treatment to those patients with dysfunctional breathing.

hypothesis dysfunctional breathing patterns are more prevalent in patients with a diagnosis of difficult to treat asthma than healthy volunteers. design this will be an open, prospective study, recruiting sequential patients admitted electively to undergo the difficult asthma protocol (dap). these patients are generally admitted during a period of stability, but still have significant symptoms despite asthma therapy. healthy volunteers will be recruited from hospital staff and their family and friends. we will recruit patients over a 12 to 18 month period and hope to enrol 60 patients. on the final day of their 4 day admission, patients will be asked to wear the life vest from 0800hrs. during the morning they will undergo a 6 minute walk to test to assess their responses during exercise. they will also be reviewed by the supervising consultant to discuss the results of their investigations. while wearing the shirt, the patient will be asked to keep a diary of their activities and symptoms. the life shirt can be removed by the patient at the time of discharge. 20 healthy volunteers will be recruited from the hospital staff. they will be asked to wear the life vest while undertaking their normal daily activities. they will also undertake a 6 minute walk test. tidal volume, minute volume and respiratory rate will be recorded at rest and during exertion, aided by the patient diary. breathing pattern and features of dysfunctional breathing, such as frequent sighs, will also be noted. this will subsequently be correlated with the assessment of the supervising consultant with regard to the presence of dysfunctional breathing. data will also be analysed with regard to whether there are any differences between healthy volunteers, patients felt to have asthma, and those felt not to have asthma by their admitting consultant.

Eligibility criteria:
inclusion criteria: * physician diagnosis of difficult asthma exclusion criteria: * current breastfeeding

Keywords: difficult asthma respiratory inductance plethysmography
pilot usability and feasibility testing on kinect-enhanced training system for lymphatic exercises

Conditions: Breast Cancer; Lymphedema

Summary: correct performance of therapeutic lymphatic exercises has the potential to relieve lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast cancer survivors' quality of life and reduce the risk of lymphedema. kinect-tolf (kinect-enhanced the-optimal-lymph-flow training system) is an innovative intelligent kinect-enhanced training system to teach patients to perform the lymphatic exercises correctly. the kinect-tolf training system is not a medical device but a computer/mobile and motion-sensor program that helps patients to perform the lymphatic exercises correctly. the kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. the goal of the proposed project is to evaluate the usability and feasibility of kinect-tolf.


Eligibility criteria:
inclusion criteria: * women who have received surgical treatment for breast cancer (stage i-iii), including mastectomy, lumpectomy, sentinel lymph node biopsy (slnb), slnb plus lymph node dissection or axillary lymph nodes dissection * report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing * may or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation * have history or no history of lymphedema or have or not been treated for lymphedema; * able to speak and understand english since the proposed usability testing is designed to only test the english version of the intervention. * women willing to come to the nyu perlmutter cancer center for the research visit. exclusion criteria: * women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema; * known metastatic disease (stage iv), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions; * women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (bmi) may not be possible with an impedance device according to the manufactures.
safety and efficacy of intralesional hilow hyaluronic acid in the treatment of peyronie's disease (pd)

Conditions: Peyronie Disease

Summary: prospective, open-label, single-arm, multicentric, pilot clinical study to confirm the safety of hilow hyaluronic acid sodium salt for intralesional penile injection in patients affected by pd.

prospective, open-label, single-arm, multicentric, pilot clinical study to confirm the safety of hilow hyaluronic acid sodium salt for intralesional penile injection in patients affected by pd. fourty patients aged 18-75 and affected by pd in the acute phase will be enrolled in the study. the primary endpoint is the incidence of adverse events with causal relationship during the 2.5 months of active treatment and during follow-up. the scondary endpoint is the overall improvement of the clinical condition by evaluation of the patient's global improvement (pgi-i scale), the amelioration in the degree of the curvature of the penis and the amelioration in the length of the penis after the induction of penile erection.

Eligibility criteria:
inclusion criteria: * basal degree of penile curvature not less than 30° * preserved erection * documented absence of coagulation defects (at least one examination of coagulation factors within the 3 months prior to the start of the study) * written informed consent exclusion criteria: * presence of hourglass deformity * presence of calcified plaques * congenital curvature of the penis * previous penile surgery * concomitant oral treatment for ipp * ongoing intralesional therapy or in the 3 months prior to the start of the study * use of any traction device * clinically stable disease * history of symptomatic disease \> 12 months * known hypersensitivity or allergies to the components of the product * any other clinical condition judged by the investigator not to be compatible with the participation in this study
effect of resistance training on metabolic control and outcome in prediabetes (nmr-based metabonomics)

Conditions: Prediabetic State

Summary: this study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.

most of exercise interventions involved aerobic exercises, investigators were not able to find a single long term study focusing on type 2 diabetes prevention with resistance training and aerobic exercise. it has been known that for those who have already had diabetes, resistance training can reduce insulin resistance and hba1c level, improve lipid profile, and decrease blood pressure. based on previous findings, investigators will evaluate how the different exercising interventions impact on insulin resistance, metabolic control, and the incidence and prevalence of diabetes in prediabetes population who receive 12 months of either resistant training or aerobic exercise. further more, metabolomics approach will be introduced to detect biological markers,and therefore,to analyze the predictive values of metabolomics on long term outcomes of prediabetes population.

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of prediabetes according to the american diabetes association (ada) guidelines * level 4 of muscle strength * willingness to accept exercise intervention * provision of written informed consent. exclusion criteria: * type 2 or other types of diabetes * women who are pregnant * hepatic dysfunction, as evidenced by alanine aminotransferase (alt) or alkaline phosphatase (alp) levels greater than 2.5-fold the upper limits of normal * crucial organ failure or other severe diseases, including myocardial infarction * malignancy

Keywords: resistance training prediabetic state metabolomics
using of sglt2 inhibitors in patients with type 2 dm

Conditions: Type 2 Diabetes

Summary: to detect the efficacy of sglt2i in improving the metabolic parameters in patients with type 2 diabetes. - to detect the side-effects of sglt2i

type 2 diabetes mellitus (t2dm) is a worldwide health problem, with a continuously increasing prevalence . good management of blood glucose level is critical to delay progression of the underlying metabolic dysfunction and to reduce the risk of diabetic complications . sodium-glucose cotransporter-2 inhibitors (sglt2i) are a new class of antidiabetic drug acting by increasing urinary glucose excretion. first approved in 2014, sglt2i have been widely used to treat patients with type 2 diabetes they are effective in reducing blood glucose, and surprisingly have shown benefits beyond glycaemic control . physicians have reported improved hypertension, heart failure, chronic kidney disease, fatty liver disease and obesity however, sglt inhibitors are not magical drugs, and their use is not free of side effects ( reported side effects include urinary tract infections, genital infection, dehydration, and hypotension, plus the usual side effects of antidiabetic medications as hypoglycemia . the optimum practical guideline for adding sglt2 inhibitors to treatment regimens of patients with diabetes is controversial .many local guidelines and treatment policies exist, yet we need to develop our own local policy at assiut university hospitals to suit our patients needs and expectations, balancing between efficacy and side effects.

Eligibility criteria:
inclusion criteria: 1. adults (≥18 years) 2. both genders ( male and female) 3. type 2 diabetic patients exclusion criteria: 1. history of svere hypoglycemia 2. patients with history of weight loss 3. patients with history of recurrent uti
distress and quality of life during the diagnostic phase of a suspected serious lung disease

Conditions: Suspected Lung Cancer

Summary: the purpose of this study is to gain insight in the distress experience and quality of life of patients suspected of having a serious lung disease during the diagnostic phase and the period between diagnosis and start of treatment

a life-threatening disease often leads to distress, an emotional experience that can interfere with coping. studies in lung cancer patients show high prevalence of distress during the course of the disease. however until now, very few research was done during the diagnostic workup. this prospective study will describe and explore distress, quality of life and illness perception in lung cancer patients during the diagnostic period until first follow-up visit 4 weeks after start of therapy. patient reported questionnaires will be used.

Eligibility criteria:
inclusion criteria: * ambulatory patient * imaging suggestive of lung cancer * written informed consent * able to complete questionnaires exclusion criteria: * solitary pulmonary nodule * previous diagnosis of cancer

Keywords: suspected lung cancer diagnostic work-up
treatment of varicose veins with the elves® radial® 2ring slim fiber. are there limitations?

Conditions: Varicose Veins

Summary: this study aims to prove that the elves® radial® 2ring slim fiber is safe and effective in endovenous laser ablation (evla) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.


Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years old. 2. patient must sign and date the informed consent form prior to treatment. 3. presence of unilateral or bilateral primary symptomatic varicose veins (ceap grade ≥ c2). 4. patient has an insufficient great saphenous vein (gsv), with or without laser ablation of anterior accessory saphenous vein (aasv), posterior accessory saphenous vein (pasv), and/or small saphenous vein (ssv), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (evla). 5. maximum diameter of the to be treated veins is ≤ 14mm. exclusion criteria: 1. current deep vein thrombosis. 2. acute superficial thrombosis. 3. mean diameter of the to be treated veins \> 14mm. 4. tortuous or very superficial veins considered unsuitable for laser treatment. 5. recurrent varicose veins. 6. pregnancy. 7. coagulopathy or bleeding disorders. 8. contraindications to the use of general or regional anesthesia.
the effects of cranial electrotherapy stimulation (ces) on brain function, brain chemistry and mood

Conditions: Mood

Summary: document whether the fischer wallace cranial stimulator produces any measurable changes in brain activity.

the advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. the present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; ces) using an fda-approved device can alter brain function, mood and responses to cognitive tasks.

Eligibility criteria:
inclusion criteria: * 21 to 55 years old * otherwise physically healthy (normal physical exam, ecg, blood and urine chemistries) * female participants must use medically approved method of contraception. if barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom). * if on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks. exclusion criteria: * opiate maintenance (e.g., methadone or buprenorphine) * drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses. * meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). past abuse/dependence (greater than 3 years) is acceptable. * meets criteria for alcohol dependence. past abuse/dependence (greater than 3 years) is acceptable. they may meet criteria for alcohol abuse. * physical health problems * history of significant cardiac problems * history of seizures * pregnancy * persons with a demand-type cardiac pacemaker * persons receiving vagus nerve simulation * persons receiving deep brain stimulation * participants cannot have any conditions that are contraindicated for mri

Keywords: cranial stimulation bold (blood oxygenation level dependent) fmri (functional magnetic resonance imaging) spectroscopy