Kornimate/medical-research-clean huggingface dataset:
nivolumab (bms-936558; mdx-1106) in combination with sunitinib, pazopanib, or ipilimumab in subjects with metastatic renal cell carcinoma (rcc) (checkmate 016)

Conditions: Renal Cell Carcinoma; Clear-cell Metastatic Renal Cell Carcinoma

Summary: the purpose is to determine the safety, effectiveness and best dose to use when giving nivolumab in combination with sunitinib, pazopanib, or ipilimumab for the treatment of metastatic renal cell carcinoma.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects with histological confirmation of rcc * advanced or metastatic disease * measurable disease as defined by recist 1.1 criteria * karnofsky performance status (kps) ≥80% * available tumor tissue (archival or recent acquisition) * subjects enrolled in the i-1, i-3 expansion arms and in-3 addition arms must not have received any prior systemic therapy for rcc with the following exceptions: 1. one prior adjuvant or neoadjuvant therapy for localized or locally advanced rcc is allowed provided recurrence occurred ≥ 6 months after the last dose of the adjuvant or neoadjuvant therapy 2. only prior cytokine based treatment for metastatic rcc \[eg, interferon-alpha (ifn-alpha) or interleukin 2 (il-2)\] as prior therapy is allowed exclusion criteria: * active central nervous system (cns) metastases * active or history of autoimmune disease * ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation * history of cerebrovascular accident including transient ischemic attack within the past 12 months * history of pulmonary embolism or deep vein thrombosis (dvt) within the past 6 months * chronic systemic steroids (\>10 mg/day prednisone equivalents) or any other immunosuppressive agents * white blood cell (wbc) \<2,000/mm3 * neutrophiles \<1,500/mm3 * platelets \<100,000/mm3 * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>3x upper limit of normal (uln) * total bilirubin \>1.5x uln (except subjects with gilbert syndrome, total bilirubin \<3.0 mg/dl) * cardiac ejection fraction \<lln (lower limit of normal) * serum creatinine \>1.5x uln or creatinine clearance \<40 ml/min (cockroft-gault formula) exclusion criteria for arm s and arm p only: * for dose escalation cohorts - subjects who received prior sunitinib or pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior sunitinib and pazopanib * poorly controlled hypertension * active bleeding or bleeding susceptibility
active surveillance versus surgery in thyroid papillary microcarcinoma

Conditions: Papillary Microcarcinoma of the Thyroid

Summary: the primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mptc) .

the primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mptc) . a further objective is to identify events associated with high risk of local recurrence and distant metastases. patients will be randomized to surgery or active surveillance. patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Eligibility criteria:
inclusion criteria: * age \>or =18 * suspicious nodule \< or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit) * cytology consistent with the tir4 or tir 5 class * sieric tsh in th standard range (with or without levo-tyroxin therapy) * normal string motility to fibrolaringoscopy * written informed consent exclusion criteria: * ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures * calcitonin increase above normal levels * clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote * any contraindications to surgery

Keywords: papillary microcarcinoma of the thyroid surgery outcome follow up
assessment of pd-1 and pd-l1tissue expression levels in lichen planus patients: a case-control study

Conditions: Lichen Planus

Summary: assessment of programmed cell death protein 1 (pd-1) and programmed cell death ligand 1 (pd-l1) tissue expression levels in lichen planus patients: a case-control study

this prospective case control study will be conducted at kasr al-aini dermatology outpatient clinics and will include 30 lp patients and 30 normal healthy controls which will be recruited and assessed for eligibility for inclusion according to the above criteria. all participants (patients \& controls) will be subjected to the following: * written informed consent. * detailed history including onset, course, duration of the disease and history of drug intake within 1 month before the eruption. * clinical assessment of the severity by using lp severity index (lpsi) (kaur et al., 2020). * skin biopsy will be taken under local anesthesia : * from each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in pbs and kept frozen at -80 degrees celsius for elisa study. * from each lp patient; two punch skin biopsies will be taken and preserved in pbs and kept frozen at -80 degrees celsius for elisa study: i. the first biopsy will be a 3 mm punch biopsy from the center of lp lesional skin of sun protected area ii. the second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing lp lesion of sun protected area * the level of pd1 and pd-l1 will be detected using elisa technique. * the lesional biopsy will be assessed by routine hematoxylin and eosin (h\&e) to confirm the diagnosis of lp * patients' serial numbers only will be used on data collection sheets and elisa specimens' labels. data will be entered on a computer with access limited to the researchers in order to ensure confidentiality of patients' information and lab results.

Eligibility criteria:
inclusion criteria: * age group above 18 years old * patients of both genders * classic type of cutaneous lp. exclusion criteria: * topical treatment for lp 2 weeks before enrollment in the study or systemic treatment for lp 4 weeks before enrollment in the study and 3 years for systemic retenoids. * actinic lp , lp pigmentosus and mucosal only lp * drug induced lichenoid eruption * conditions precluding taking skin biopsy : bleeding tendency , lidocaine allergy * pd-1 associated-diseases e.g.: sle, cancers including melanoma and non-melanoma skin cancers, and bullous pemphigoid

Keywords: lp pd-1 pd-l1
animal bite victims seeking medical services at concerned hospitals

Conditions: Vaccine-Preventable Diseases

Summary: the goal of this observational study is to study the magnitude of the animal bite problem during one year ,to determine the percentage of compliance for full pep doses and factors affecting the health seeking behavior among these victims. to assess the management of the wound (first aid management done by the patient and in the hospital). participants will be asked to answer a questionnaire consisting of five parts and followed for completing their anti-rabies vaccination schedule.

animal bites pose a major public health problem in children and adults worldwide. numerous animal species have the potential to bite humans leading to rabies which is a disease of mammals , including dogs, wolves, foxes, cats, lions, mongooses, bats, monkeys and humans, however, the use of dogs as pets or companions, and for security, hunting, and breeding has contributed to their growing population. surveillance data revealed that people in egypt experience a large number of animal bites annually with more than 200,000 animal bites recorded each year mostly from dogs. on average 60 people die annually from rabies in egypt. rabies is 100% fatal disease but can be prevented with successful rabies control program which comprise of three pillars:1. community participation; education, public awareness. 2. access to mass vaccination of dogs. 3. access to post bite treatment. pep is the administration of wound care and immunization after potential exposure to the rabies virus. as a part of zero by 30 strategy set by who to control dog-mediated human rabies by 2030, the strategic advisory group of experts of the who needed the current scenario of health-seeking behavior of exposed individuals and the use of rabies vaccines and immunoglobulin in rabies endemic countries. in this regard, perception of victims and their attitude towards treatment forms an important role for prevention against rabies. it is also necessary to detect trends to evaluate the effect of preventive efforts implemented by the ministry of health.

Eligibility criteria:
inclusion criteria: * victims recently exposed to bite by any animal causing rabies exclusion criteria: * other types of animal bites

Keywords: animal bite, vaccine compliance
comparison of graded motor imagery and mirror therapy in chronic stroke rehabilitation

Conditions: Stroke

Summary: the study is conducted to assess whether the gmi or mt reduce the level of spasticity. also to compare the level of independence in gmi and mt in the chronic stroke patients.

a stroke is a medical condition that occurs when inadequate blood flow to a part of the brain leads to cell death. there are two primary types of strokes: ischemic, caused by reduced blood flow, and hemorrhagic, caused by bleeding. both types result in impaired brain function in the affected areas. a systemic review was conducted on the effectiveness of mirror therapy on lower extremities, stal and walk in early stage and long term stroke. results shown better results with using mirror the than control group. non-randomized controlled trial study was conducted on stroke patients treated by graded n imagery. it consisted of 28 subjects and the experimental group included 14 and other 14 included in the control group. graded motor imagery showed better results than the convent therapy as 10 patients showed better outcomes in the intervention group and only 4 patients sho improvement in the control group.

Eligibility criteria:
inclusion criteria: * age:45 to 65 years * first ever unilateral stroke and over 3 months since onset. * both ischemic and hemorrhagic stroke individuals were included. exclusion criteria * patients suffering from psychological problems. * visual impairments. * fractures. * any other neurological disorder * inflammatory joint diseases * medical instability e.g uncontrolled htn * any systemic disease

Keywords: stroke speech disorder stroke rehabilitation hypertension
a study of pet/ct scans with the radioactive tracer 89zr-dfo-daratumumab in people with myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to see if using the radioactive tracer 89zr-dfo-daratumumab with pet/ct scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. we also want to see if 89zr-dfo-daratumumab pet/ct scans can predict a participant's response to therapy, and if they can better locate any leftover disease following treatment compared to the standard imaging methods.


Eligibility criteria:
inclusion criteria: * age ≥ 21 years * histologically/immunohistochemistry-confirmed cd38-positive multiple myeloma * at least one tumor lesion on ct, mri, or fdg pet/ct within 90 days of protocol enrollment * ecog performance status 0 to 2 * participant is capable of having an informed consent discussion (legally authorized representatives are not permitted to sign on a participant's behalf). exclusion criteria: * life expectancy \< 12 months * pregnancy or lactation * patients who cannot undergo pet/ct scanning because of weight limits. pet/ct scanners may not be able to function with patients over 450 pounds. * history of anaphylactic reaction to humanized or human antibodies. * previous treatment with daratumumab. previous treatment with other myeloma therapies will be allowed.

Keywords: cd38-targeted immunopet 20-098
follow-up on the high: low study - the longterm effects of growth hormone

Conditions: HIV Infections; HIV-Associated Lipodystrophy Syndrome

Summary: a follow-up study on the randomized, controlled, double-blind high: low study. we will examine the participants from the high: low study min. 6 months after finishing the high: low study. we will look at the parameters: quality of life, sugar-metabolism, fat-metabolism, fat-redistribution and cytokines. the study will use the participants control visit, and the only additional examination will be the danish mos-hiv questionnaire.


Eligibility criteria:
inclusion criteria: * over 18 years of age * participated in and completed the high: low study * informed consent signed exclusion criteria: * patient stopped at hvidovre hospital, or didn't finish the high: low study

Keywords: growth hormone quality of life fat redistribution sugar metabolism fat metabolism cytokines
the acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake

Conditions: Obesity; Diabetes

Summary: sucrose is the most used sweetener in beverage and foods in denmark. other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. malt extract has a sweet flavor but contains a different composition and amount of carbohydrates together with a small amount of protein compared to sucrose. malt extract may therefore be a better alternative than sucrose as a sweetener due to a lower increase and more sustained blood glucose level. this could be of interest in relation to diabetes and appetite regulation but this is yet to be investigated. thus the objective is to investigate the effect of malt extract vs. sucrose on: 1. 3-hour change in the concentration of glucose and insulin 2. 3-hour change in subjective appetite sensations (visual analogue scales, vas scores) 3. ad libitum energy intake design: 20 men will participate in the 2-way, randomized, double-blind crossover study. the test drinks is isocaloric with 75 g carbohydrates test drinks: malt extract solution and sucrose solution (10%) three-hour subjective appetite ratings and blood samples will be assessed every half-hour. subsequently, the subjects will served an ad libitum lunch


Eligibility criteria:
inclusion criteria: * healthy, * bmi: 18.5-24.9 kg/m2, * weight stable (within +/- 3 kg) two months prior to study inclusion, * non-smoking, * nonathletic (\< 10 h hard physical activity), exclusion criteria: * bmi \> 25 kg/m2, * change in smoking status, * daily or frequent use of medication, * suffering from metabolic diseases, * suffering from psychiatric diseases, * suffering from any other clinical condition, which would make the subject unfit to participate in the study, * hemoglobin \< 7.5 mmol/l. * alcohol and drug abuse * blood donation, 3mo prior to the present study and during study participation

Keywords: malt extract carbohydrate glucose response insulin response appetite appetite regulating hormones
measurement of cerebral blood flow using transcranial doppler ultrasound in children with sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) affects haemoglobin - the molecule in blood cells which carries oxygen. it causes red blood cells to become abnormal crescent (or sickle)- shaped. sickled red blood cells cannot travel through small blood vessels as easily as normal red blood cells which can lead to blockages. this means that oxygen may be prevented from getting to where it is needed. individuals with sickle cell disease also suffer form abnormality in the lining of their blood vessels, which contributes to the damage. damage and blockage can occur in the blood vessels in the brain and means that children with sickle cell disease have a significant risk of suffering from strokes. research has shown that transcranial doppler ultrasonography can be used in this setting to identify children at most risk of getting strokes. ultrasound is therefore used in children with sickle cell disease to measure the blood flow in the vessels in the brain. this research has formed the basis of the national health service (nhs) standard of care for sickle cell disease in the united kingdom (uk) which uses transcranial doppler ultrasonography at once a year to screen children with sickle cell disease aged 2 to 16. ultrasound is used because it is portable, does not uses ionising radiation such as x-rays, is non-invasive and gives good results. however, the results are dependent on the operator. this means that the screening service is provided by centres of excellence with experienced scanning staff visiting clinics in smaller hospitals with portable machines. there is a lack of research comparing the use of portable machines to laboratory-based machines. this is important because screening can identify children at high risk of stroke and may be used by clinical staff to make a decision about the care of the child.

please see above

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sickle cell disease * under surveillance as part of the nhs sickle cell \& thalassaemia screening programme * children between the ages of 2 - 16 years old. those under 16 years of age must be accompanied by a responsible adult. exclusion criteria: * participants older than 16 years of age as this is outside the scope of the sickle cell screening programme. * individuals unable to give fully informed and voluntary consent. * individuals with inadequate temporal windows as it will not be possible to record measurements of velocity.
feasibility and safety of autologous unconditioned peripheral nerve tissue delivery to the substantia nigra (guide)

Conditions: Parkinson's Disease

Summary: this is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. ten participants will be enrolled to receive bilateral delivery of peripheral nerve tissue (pnt) to the substantia nigra at the time of deep brain stimulation (dbs) surgery. after 12 months, participants will be followed long term through annual visits for the rest of their lives. participants will serve as their own donor for the tissue.

we recently designed open-label safety studies to investigate the use of an autologous source of cellular tissue from the peripheral nervous system (van horne et al., 2017, 2018; quintero et al. 2022), reparative peripheral (sural) nerve tissue containing a variety of cells and neuroprotective factors (chau et al. 2022). while our previous studies have used injury-activated peripheral nerve tissue (pnt), where the sural nerve is transected and allowed to regenerate in situ for up to about 2 weeks before implantation, here we propose to use naïve, previously uninjured, nerve tissue delivered bilaterally to the substantia nigra at the time participants are undergoing deep brain stimulation (dbs) surgery. participants will be assessed preoperatively, then undergo dbs surgery and delivery of autologous pnt, and then assessed postoperatively at two weeks after surgery, 6 months, 12 months and annually thereafter for adverse events and clinical outcomes.

Eligibility criteria:
inclusion criteria: * undergoing dbs * diagnosis of clinically established or clinically probably pd (parkinson's disease) as defined by mds criteria * age 40-75, inclusive * able and willing to undergo ioflupane/spect * able to tolerate the surgical procedure * able to undergo all planned assessments * available access to the sural nerve exclusion criteria: * any condition that would not make the subject a candidate for dbs * previous pd surgery or intracranial surgery * typical, nonparkinsonian syndrome ioflupane/spect signal * female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study * unable to undergo an mri * an obstructed trajectory path to the substantia nigra

Keywords: peripheral nerve tissue
multicentre randomised study comparing a taurolidine lock and a standard saline lock in paediatric oncology

Conditions: Children; Medical Device; Primary Prevention; Oncology

Summary: interest of a taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. multicentric, controlled, randomized and double-blind label study.

the patient will be followed according to the type of pathology and the respective treatment protocol either taurolock or physiological serum at each time cathter will be used.

Eligibility criteria:
inclusion criteria: 1. patient less than or equal to 21 years of age at inclusion. 2. patient for whom a central catheter is planned to be inserted\*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as picc line). \*1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal). 3. patient treated for a cancer. 4. patient with regular follow-up in the inclusion center. 5. informed consent signed by the patient if adult or by legal representatives if minor. 6. patient benefiting from a social security coverage. 7. time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks. exclusion criteria: 1. patient with retinoblastoma. 2. allografted patient. 3. patient with a life expectancy of less than 6 months. 4. patient refusing to participate in the protocol. 5. patient already receiving a central venous catheter-related infection prevention lock (ilcvc). 6. patient with known allergy to citrate or (cyclo)-taurolidine. 7. patient taking other drugs with a known contraindication with citrate or (cyclo)-taurolidine. 8. patient with an external femoral catheter. 9. patient with a piccline-type peripheral venous inserted central catheter. 10. patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons. 11. patient under guardianship and curatorship.