Kornimate/medical-research-clean huggingface dataset:
bevacizumab, dacarbazine and interferon-alfa to treat metastatic melanoma

Conditions: Metastatic Melanoma

Summary: the purpose of this study is to determine whether combination therapy with bevacizumab (avastin), dacarbazine and interferon-alfa-2a (roferon-a) is effective in patients with locally advancing or metastatic melanoma.

dacarbazine (dtic) has been approved for treating metastatic melanoma in the 1970s, and after that numerous schedules and dacarbazine-based combinations have been studied in this disease. dtic as a single agent gives a response rate of only 20%, but there have been efforts to improve this poor result by using dtic in different combinations.treatment of melanoma with combination chemotherapy and interferon-α (ifn-α) has given 50-60% response rates,but increase in the overall survival time has not been reached in controlled phase iii studies. thus, standard reference therapy in treatment of metastatic melanoma still is single dacarbazine or its combination with s.c. ifn-α. in addition, new studies with melanoma cells in vitro show that dacarbazine causes transcriptional up-regulation of vascular endothelial growth factor (vegf), suggesting a potential clinical benefit of combination of dtic and anti-vegf therapy. ifn-α has been used in adjuvant therapy and in treatment of metastatic melanoma. ifn-α exerts its effects through antiproliferative, apoptosis-inducing and particularly antiangiogenic effects in addition to immunologic modulation. the purpose of this study is to determine whether combination therapy with bevacizumab (avastin), dacarbazine and interferon-alfa-2a (roferon-a) can increase progression-free survival and overall survival in patients with locally advancing or metastatic melanoma.

Eligibility criteria:
inclusion criteria: * histologically confirmed malignant melanoma either locally progressing inoperable or metastatic * measurable/evaluable disease in accordance with recist criteria * who performance status 0-2 * normal organ function * signed written informed consent exclusion criteria: * unevaluable disease * major surgery within 28 days prior to day 0 * uncompleted radiotherapy * cns metastases * serious non-healing wound or ulcer * bleeding diathesis or coagulopathy * uncontrolled hypertension * clinically significant cardiovascular disease * depression or psychosis, which needs medication * ongoing treatment with aspirin (\>325 mg/day) * pregnancy * any other serious or uncontrolled illness * previous chemotherapy for metastatic melanoma

Keywords: melanoma metastatic bevacizumab
the intestinal microbiome in triple negative breast cancer treated with immunotherapy

Conditions: Breast Neoplasms

Summary: this study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-pd-1 immunotherapy (pembrolizumab) versus patients who do not.


Eligibility criteria:
inclusion criteria: * age ≥18 years * female biological sex * newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer * plan to initiate preoperative anti-pd-1 immunotherapy using pembrolizumab * overweight or obesity, defined as a body mass index \>=25 kg/m2 * ability to provide written informed consent * allow the collection and storage of biospecimens and data for future use exclusion criteria: * active autoimmune disease * concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis) * digestive disease disorders (e.g., irritable bowel syndrome, crohn's disease) * currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks * recent (within 90 days) use of glucocorticoids for more than 10 consecutive days * any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol * any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
the effects of mulligan mobilization technique in older adults with neck pain

Conditions: Neck Pain

Summary: when the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. this study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of life in older adults with neck pain.

neck pain is common in older adults. there are a lot of approaches for treatment of neck pain such as soft tıssue mobilizations, electirical stimulations etc. mulligan proposes mobilization with movement (mwm) technique for various musculoskeletal disorders. but there is no study related mwm for older adults with neck pain. the purpose of this study is to examine the effect of mulligan mobilization technique on pain, range of motion (rom), functional level, kinesiophobia, depression and quality of life (qol) in older adults with neck pain. the hypothesis of our study is mwm can be effective on rom, kinesiophobia, depression and qol in older adults with neck pain.

Eligibility criteria:
inclusion criteria: * ongoing neck pain for at least 3 months, * having no neurological, rheumatological or musculoskeletal problems * having not taken any analgesic medication for neck pain for the last 3 months. exclusion criteria: * neck pain originating from various pathologies * presence of cord compression, * vertebrobasilar artery insufficiency, * severe radiculopathy, * osteoporosis or osteopenia (t score\>-1), * long-term use of anticoagulant or corticosteroid drugs, * patients who had received any treatment for their neck pain.

Keywords: neck pain older adults mobilization
impact of closure of patent foramen ovale on apnoea-hypopnoea-index, nocturnal hypoxemia and systemic vascular function in patients with obstructive sleep apnoea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study in patients with obstructive sleep apnoea (osa) and concomitant patent foramen ovale (pfo) is to assess the impact of percutaneous pfo closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed moderate to severe osa * age \> 17 years * written informed consent for study participation. exclusion criteria: * patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction) * patients with central sleep apnea syndrome * patients with other causes of pulmonary hypertension * intracardiac shunt other than via pfo * severe valvular heart disease * abnormal left ventricular (lv) systolic function (ejection fraction \<50%) * obesity with bmi \> 40 * contraindication to toe * severe pulmonary arterial hypertension (mean pulmonary artery pressure \> 45 mmhg)
improving academic and social functioning in middle-schoolers with autism

Conditions: Autism; Autism Spectrum Disorder

Summary: the goal of this study is to test how well two group interventions work for middle-school children with autism spectrum disorder (asd). one of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions.


Eligibility criteria:
inclusion criteria: * diagnosis of autism * no intellectual disability * problems with organization, materials management, and planning and prioritization * problems with social skills * fully included in middle school * stable medication and behavioral treatment regime exclusion criteria: * home schooled * severe co-occurring psychopathology (e.g., aggression, suicidal) * non english-speaking

Keywords: social skills executive functions academic achievement middle school
clinical trial to evaluate the efficacy and safety of nexpowder™ for diverticular bleeding in the lower gastrointestinal tract

Conditions: Lower Gastrointestinal Bleeding; Diverticular Bleeding

Summary: clinical trial to evaluate the efficacy and safety of nexpowder™ for diverticular bleeding in the lower gastrointestinal tract


Eligibility criteria:
inclusion criteria: * adults aged 19 years or older at the time of screening * patients diagnosed with diverticular bleeding exclusion criteria: * patients diagnosed with upper gastrointestinal bleeding
phenotypic and transcriptomic description of megakaryocytes in sickle cell patient

Conditions: Sickle Cell Disease (SCD)

Summary: sickle cell disease is the most common inherited blood disorder in the world. chronic hemolysis induces platelet activation and chronic inflammation. platelets and megakaryocyte, as medullar platelets precursors, are known to play a role in innate immunity. little is known about the role of megakaryocytes at basal state and during acute complication in sickle cell disease patients. the aim of this study is to evaluate the role of megakaryocytes in sickle cell disease.

sickle cell disease is the most common inherited blood disorder worldwide. it is a hemoglobinopathy characterized by a chronic hemolysis, vaso-occlusion, endotheliopathy, coagulation activation and chronic inflammation. it is a multisystemic disease leading to acute (vaso-occlusive crisis, acute chest syndrome) and chronic complications with multiorgan damage. platelets are activated and release pro-inflammatory mediators in sickle cell disease patients. less is known about megakaryocytes, precursors of platelets, in sickle cell disease. nevertheless, it recently has been shown that megakaryocytes, are also produced in the lung and can displayed a pro-inflammatory transcriptomic signature depending on local conditions. an increase in pulmonary megakaryocytes has been described in vascular diseases associated with excessive coagulation, in acute respiratory distress syndrome, and infections demonstrated that during severe sars-cov2 pneumonia, there was an increase in circulating megakaryocytes characterized by a pro-inflammatory transcriptomic signature. acute chest syndrome represents the first cause of mortality in patients with sickle cell disease, characterized by an acute respiratory failure whose pathophysiology includes vaso-occlusive phenomena, infection and inflammation. given a pro-inflammatory and pro-thrombotic state in sickle cell disease, particularly in acute chest syndrome, we suggest that the megakaryocyte may be involved in the pathophysiology of sickle cell disease. the aim of this study is to evaluate the role of megakaryocytes by peripheral blood sampling from 10 sickle cell disease patients at rest since at least 1 year, 10 sickle cell disease patients at rest and 20 patients during acute complications (10 sickle cell disease patients during vaso-occlusive crises, 10 sickle cell disease patients during acute chest syndrome).

Eligibility criteria:
inclusion criteria: * sickle cell disease ss or s-béta° thalassemia * patient at steady state since at least 1 year or at steady state (without crisis), or during vaso-occlusive crisis or during acute chest syndrome * age \> 18 years old exclusion criteria: * patient objects to take part in the study hematologic disorder (leukemia, myeloma, myelodysplasic syndrome, myeloproliferative syndrome) * immune thrombocytopenia, immunosuppressive or anti-inflammatory (biotherapies, corticosteroids, non steroidal anti-inflammatories drugs) page 12 sur 23 * anti-platelets agents * red blood cell exchange or transfusion \< 3 months

Keywords: megakaryocyte sickle cell disease
peng-block versus fib-block in emergency room

Conditions: Pain Relief in Proximal Femoral Fracture

Summary: the trial aims to verify a possible greater analgesic efficacy of peng (pericapsular nerve group) block compared to iliac fascia block (fib block) in elderly patients (age \> 65 years) suffering from traumatic fracture of proximal femur in emergency room.

prospective randomized double-blind single-center preliminary study aimed to demonstrate a possible greater analgesic efficacy of the peng block compared to the iliac fascia block (fib block) in elderly patients (age \> 65 years) suffering from traumatic fracture of the proximal femur in emergency room. the study will cover patients aged \> 65 years suffering from a proximal traumatic fracture of the femur who access the emergency room of santo spirito hospital in rome (asl roma 1).

Eligibility criteria:
inclusion criteria: * all patients \> 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of santo spirito hospital in rome (asl rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of regional health system (regione lazio). exclusion criteria: * failure to acquire written and valid informed consent * asa \> 3 * obesity (bmi\> 35 kg / m2) * contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics) * patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, nsaids, acetaminophen for chronic painful conditions; * history of alcohol or drug abuse; * severe kidney or liver failure; * cognitive alterations, dementia, psychiatric pathologies
opt-in: online parent training intervention for young children diagnosed with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. the main question\[s\] it aims to answer are: 1. does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group? 2. does an online intervention for autistic children result in reduced autism symptoms in children, and decreased stress and increased self-efficacy in parents, compared to a psychoeducational control group? 3. what are the predictors of response to intervention (i.e., child sex and age; initial autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education). parents will be given six compulsory and eight optional online modules that will teach them skills to use while interacting with their autistic children to improve social and communication behaviours and minimize behaviours that interfere with learning. the comparison group will receive six compulsory and eight optional online modules that will teach them about autism more broadly including diagnostic criteria, symptom profiles across development, etc.


Eligibility criteria:
inclusion criteria: * child diagnosed with autism or autism spectrum disorder within the last six months at baseline exclusion criteria: * parent does not speak english well enough to complete questionnaires * parent or child has complete vision or hearing loss. * parent or child is medically unstable.
active versus expectant management of the third stage of labor

Conditions: Postpartum Hemorrhage

Summary: the purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.

postpartum hemorrhage is the leading cause of maternal mortality worldwide. during the third stage of labor, the period following the delivery of the baby until the delivery of the placenta, the patient is at increased risk for blood loss. controversy remains as to the optimal method of delivering the placenta. two predominant, yet very different, strategies have emerged. expectant management is most commonly used in the united states. this includes waiting for signs of placental separation, followed by maternal pushing to expel the placenta. then uterotonic agents are administered,usually oxytocin. this is in contrast to active management, which consists of uterotonic administration immediately following delivery of the fetus, in association with gentle umbilical cord traction and fundal massage. this is the predominant practice in the united kingdom, where the uterotonic agents of choice are either oxytocin alone, or a combination of oxytocin and ergometrine. comparison: active management with oxytocin to expectant management of the third stage of labor on the effect of postpartum hemorrhage.

Eligibility criteria:
inclusion criteria: * singleton gestation * cephalic presentation * \>37 weeks gestation * \>16 years of age exclusion criteria: * multiple gestation * breech presentation * blood dyscrasias * multiparous females para \>5 * placenta previa * patients on anticoagulants * previous history of postpartum hemorrhage * iufd * non-reassuring fetal heart rate pattern

Keywords: third stage of labor
a study to evaluate preemptive therapy in hepatitis c (hcv) organ transplant recipients

Conditions: Hepatitis C; Kidney Transplant; Complications; Heart Transplant Infection

Summary: this study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of hcv from a hcv positive donor to a hcv negative solid organ recipient.


Eligibility criteria:
inclusion criteria: * listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis c infection * willing to accept and consent for accepting hepatitis c positive graft exclusion criteria: * existing chronic liver disease (liver cirrhosis) * concomitant infection with hiv or chronic hepatitis b * patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired hcv infection * pregnancy (pregnant patients do not undergo solid organ transplants)
covid-19 vaccine responses in pidd subjects

Conditions: X-linked Agammaglobulinemia; XLA; Primary Immune Deficiency; CVID; Common Variable Immunodeficiency; Primary Antibody Deficiencies; Secondary Hypogammaglobulinemia

Summary: the goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with sars-cov-2 mrna vaccines.

individuals with primary and secondary antibody immunodeficiency are at higher risk for severe covid-19 disease. humoral immunity is thought to be the predominant protection against covid-19, however mrna vaccines have been shown to elicit both antibody and cellular responses. the goal of our study is to assess the cellular immune responses of participants with antibody deficiency diseases, including x-linked agammaglobulinemia (xla), common variable immunodeficiency (cvid), and secondary hypogammaglobulinemia, before and after immunization with sars-cov-2 mrna vaccines. our aim is to examine sars-cov-2 spike-specific t cell immune responses before and after immunization with mrna vaccines in a cohort of individuals with antibody deficiencies compared to healthy volunteers. our secondary objectives include (1) detecting cellular immune response differences between immunized and infected participants, (2) observing cellular immune responses over time, and (3) comparing clinical outcomes between vaccination, infection, and underlying antibody deficiency. the results will show whether antibody deficiency individuals can mount t cell responses to sars-cov-2 vaccination or infection, data that are expected to inform health policy of sars-cov-2 implementation in immunocompromised individuals. findings will further provide foundation for larger cohort studies of sars-cov-2 vaccination in other immunocompromised populations.

Eligibility criteria:
inclusion criteria: 1. diagnosis of antibody deficiency with confirmatory lab or genetic testing 2. stable on immunoglobulin replacement therapy 3. age \>6 months and able to provide consent, or assent with parental consent if \<18 years 4. willing and able to receive the pfizer biontech bnt162b2 mrna or the moderna mrna-1273 vaccines exclusion criteria: (1) history of other chronic disease with depressed immune function or immune suppressive medication

Keywords: x-linked agammaglobulinemia primary immune deficiency common variable immunodeficiency sars cov 2 infection primary antibody deficiencies covid-19 secondary hypogammaglobulinemia
evaluation of the haemostatic agent purabond in ent tors

Conditions: Hemorrhage

Summary: to evaluate the use of purabond in ent tors for diagnostic and therapeutic procedures. consecutive patients enrolled retrospectively via case note review. outcome measures - primary and secondary haemorrhage, swallowing outcomes, need for nasogastric tube or tracheostomy, readmission.

transoral robotic surgery (tors) has been increasingly utilised in ear, nose and throat (ent) surgery over the past 20 years offering unprecedented 3-dimensional (3-d) views and enabling access to traditionally 'difficult-to-reach' tumours. it is now becoming a viable first line treatment option for oropharyngeal squamous cell carcinoma (opscc) compared to chemoradiotherapy. one of the main concerns is serious haemorrhage that can lead to death. purabond® (also known as purastat ®; 3d matrix ltd, tokyo, japan), which consists of the rada16 family of synthetic peptides. purabond® is a self-assembling viscous solution that once applied on the surgical bed, it forms a transparent hydrogel 3-d matrix to achieve local haemostasis. its transparent nature allows visualisation of the surgical field, permitting real-time assessment of intraoperative haemostasis. there are some studies demonstrating that it can promote healing. we aimed to assess the effect of purabond in ent tors for diagnostic and therapeutic procedures such as oropharyngectomy and tongue base mucosectomy. patients were enrolled from a single tertiary university hospital trust in the united kingdom (university hospitals birmingham national health service foundation trust). case notes for all patients were analysed retrospectively. data extracted included patient demographics (age, sex, smoking history), procedure details (date, indication for surgery and type of tors procedure) and tumour details (histopathology including p16 status and stage). the primary outcome measure was post-operative haemorrhage rate (primary; within 24 hours of surgery, and secondary; between 1-30 days post-surgery). secondary outcome measures included, length of hospital stay (los), post-operative swallowing complications, in particular whether feeding tube insertion or tracheostomy was performed either prior to or within 30 days of surgery, hospital re- readmission rate within 30 days of surgery, and surgeon-reported ease of purabond® application. descriptive statistical analysis was undertaken where applicable (mean, median, standard deviation) using microsoft excel® version 16.31.

Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing ent transoral robotic surgery (tors) with purabond application between august 2021 - may 2022 at a single centre teaching university hospital nhs trust exclusion criteria: * purabond not applied * incomplete case notes