Kornimate/medical-research-clean huggingface dataset:
physiological mechanisms of therapeutic horseback riding intervention effects in a psychiatric population of asd youth

Conditions: Autism Spectrum Disorder; Mental Disorders

Summary: this randomized control trial (rct) seeks to assess the mechanisms underlying therapeutic horseback riding's (thr) previously observed significant positive effects on asd youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durability, dose and sub-population effects of the intervention.

this randomized control trial (rct) will test the hypothesis that physiological response patterns of salivary cortisol, cardiovascular, and electrodermal activity account for our previously observed significant outcomes (i.e., reduced irritability and hyperactivity, and improved social and communication), and additional outcomes (emotion regulation caregiver quality of life and crisis mental health care usage), in youth ages 6-16 yrs. with asd and co-occurring psychiatric diagnoses randomized to a 10-week manualized thr intervention compared to a no-horse barn activity (ba) control (aim 1). we will evaluate the durability of aim 1 outcomes in the thr group compared to the ba control group six-months after the intervention period (aim 2). finally, we will explore dose and sub-population effects of thr and ba interventions by comparing effect size differences in thr and ba groups to (a) a 10-week wait-list control group; (b) a hybrid intervention group (five weeks ba followed by five weeks thr); and (c) a subsample of the thr study population randomized following psychiatric hospitalization (aim 3).

Eligibility criteria:
inclusion criteria: * documented asd diagnosis and a co-occurring psychiatric disorder * abc irritability subscale score ≥8 * leiter-iii nonverbal iq ≥ 40 * meet symptom criterion score (minimum number of symptoms necessary for a dsm-v (mood, anxiety, or adhd diagnosis) on casi-5) * meet asd cut-offs on the scq (≥ 11) and on ados-2 * only one child with asd per family to maintain independent observations * a consistent caregiver (i.e., parent or legal guardian) to complete study outcome measures exclusion criteria: * medical or behavioral issues that prevent participation * ward of the state * judged during riding center screen to have significant riding experience * smoking or regular use of oral, inhaled, or topical steroids on a regular basis, factors known to affect cortisol levels * participants weighing 200 pounds or greater will be excluded due to the riding center's safety policies * participants will not be allowed to begin baseline assessments until at least six months have passed from the time they last engaged in mounted eaat, given pilot evidence for the six-month maintenance of thr effects.

Keywords: human-animal intervention physiology mechanisms of action children adolescents emotion regulation cortisol heart rate electrodermal activity
prognostic factors for acute pulmonary embolism in critically ill patients

Conditions: Acute Pulmonary Embolism (PE)

Summary: acute pulmonary embolism (pe) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. previous several reports have described the variable outcome of patients with pe with reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock) and 65% (post cardiopulmonary resuscitation). nevertheless, there are no published studies from korean hospitals that assessed the outcome of acute pe treated in the hospital with iv unfractionated heparin. we conducted this study to determine the outcome, risk factors, clinical characteristics and demographics of patients with acute pe and to identify possible demographic and clinical factors associated with prognosis.


Eligibility criteria:
inclusion criteria: patients admitted to the severance hospital, yonsei university health system with primary diagnosis of pe between january 2008 and december 2012. (diagnosed by ct and treated in the hospital with iv unfractionated heparin) exclusion criteria: 1. diagnosis was prior to arrivalor 2. anticoagulation was contraindicated 3. diagnosis was not confirmed by ct

Keywords: acute pte, prognostic factors
erector spinae plane block versus local wound infiltration after modified radical mastectomy

Conditions: Post Operative Pain; Erector Spinae Plane Block; Local Infiltration

Summary: this randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided erector spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. modified radical mastectomy (mrm) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. poor postoperative pain management can lead to increased chances of the development of chronic pain. therefore, adequate postoperative pain management after breast cancer surgery is essential. regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea \& vomiting and postoperative pulmonary complications. it also facilitates early ambulation. thoracic epidural (te), paravertebral block (pvb), pectoral nerve i \& pectoral nerve ii blocks, serratus anterior plane block and erector spinae plan block have been used with good results. in particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. further, in meta-analysis, the esp block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. in esp block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. the la diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) physical status i-ii * scheduled for unilateral modified radical mastectomy exclusion criteria: * patient refusal. * patient with neurological deficit. * patient with bleeding disorders. * uncooperative patient. * infection at the block injection site. * patients with history of allergy to local anesthetics. * advanced hepatic, cardiac or renal failure. * chronic opioid consumption. * body mass index (bmi)≥ 30 kg m-2 * chronic use of gabapentin or pregabalin
long acting paliperidone in dually diagnosed people with schizophrenia: an open-label pilot study

Conditions: Schizophrenia

Summary: comorbid substance abuse leads to many deleterious effects such as medical comorbidities and nonadherence, which is one of the most problematic issues. people with schizophrenia and substance use disorders (suds) are at an increased risk nonadherence compared to those who do not use alcohol and illicit drugs. the investigators propose that this new marketed injectable antipsychotic with many benefits over other available long acting injectable agents would be beneficial in the dually diagnosed population and may represent a specific schizophrenia subpopulation where long acting agents may be considered an important therapeutic option.


Eligibility criteria:
inclusion criteria: * be between ages 18 and 64 * either gender * any race * meet dsm-iv-tr criteria for schizophrenia or schizoaffective disorder. * alcohol and/or cannabis use defined as a dsm-iv diagnosis abuse, dependence or regular use defined as 3 times per week during the past year * agree to take or use birth control during the study. exclusion criteria: * previous lack of response or serious adverse event to risperidone or paliperidone. * currently on a long acting injectable antipsychotic. * a score of less than 10 on the evaluation to sign consent (esc). * medical illnesses, which may compromise safe study participation. * pregnant and lactating females. * qtc interval \> 450 milliseconds males or \> 470 milliseconds in females * currently on acamprosate, naltrexone and disulfiram.

Keywords: schizophrenia substance abuse
attenuating cancer treatment-related toxicity in oncology patients with a tailored physical exercise program

Conditions: Breast Neoplasms

Summary: the aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.

the positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. to date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits. in this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival. this study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program atope performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.

Eligibility criteria:
inclusion criteria: * 18 years or older * breast cancer diagnosis i-iii stage * on the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy. * if they meet other criteria which predisposes to higher toxicity. * have signed informed consent. * have medical clearance for participation. exclusion criteria: * patient underwent previous cancer treatments. * patients were previously diagnosed with cancer. * pregnant patients. * patients performing other type of therapeutic exercise at diagnosis time with an intake \>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day. * therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \>70%, metastasis etc.).

Keywords: breast neoplasm breast cancer therapeutic exercise cardiotoxicity muscle toxicity
a study of the safety and efficacy of infliximab (remicade) in subjects with fistulizing crohn's disease

Conditions: Crohn Disease

Summary: a study of infliximab in patients with fistulizing crohn's disease

this is a medical research study for patients with crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). fistulas are a common complication of crohn's disease. fistulas rarely close spontaneously but they may get better with treatment of the underlying crohn's disease. this study will investigate the safety and efficacy of maintenance dosing of an anti-tnf (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas. subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.

Eligibility criteria:
inclusion criteria: * single or multiple draining fistulas * crohn's disease of at least 3 months' duration, exclusion criteria: * crohn's disease complications for which surgery might be indicated * positive stool culture

Keywords: crohn's disease infusions
study of the treatment of algerian patients with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the algerian population. current drug therapy as well as disease status and patient function will be assessed.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis progressing for \< 2 years. exclusion criteria: * rheumatoid arthritis progressing for \< 3 months. * rheumatoid arthritis onset at \< 18 years of age. * participation in another clinical study. * rheumatoid arthritis related connective tissue disorder. * any neuropsychological disorders.
peg-rhg-csf in patients with malignant solid tumors receiving chemotherapy

Conditions: Malignant Solid Tumors

Summary: the purpose of this study is to estimate the safety and efficacy of peg-rhg-csf in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with age ≥ 18 years * diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer * karnofsky performance status ≥ 70 * life expectancy of at least 3 months * written informed consent are acquired exclusion criteria: * uncontrolled infection,temperature is 38.0 ℃ or higher * pregnancy * other situations that investigators consider as contra-indication for this study

Keywords: peg-rhg-csf
creative arts therapy on body image, self-esteem, anxiety and depression in post-treatment prostate cancer patients

Conditions: Prostate Cancer; Creative Arts Therapy

Summary: the goal of this clinical study is to assess the feasibility of implementing a creative arts therapy intervention of drawing and painting in hong kong prostate cancer patients and preliminarily examine the effects of this intervention on prostate cancer patients' health outcomes via a two-armed randomized controlled trial. the two arms will be (i) the creative arts therapy intervention group and (ii) a active control group. participants will join five sessions. sessions will start with a 10-15-minute rapport-building discussion and continue with a 60-minute intervention. session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. each session will follow a three-step process of psychodynamic model to ensure the optimal effect of the intervention. the interventions will be held at private room at hospital.


Eligibility criteria:
inclusion criteria: * adult participants diagnosed with localised prostate cancer, regardless of the stage and age 18 years or older; * are not currently receiving active therapy, including chemotherapy, radiotherapy or surgical treatment, by the time of the study or completed treatment more than one year ago and are not on any active treatment; * were being followed up by the urology team or department of surgery at the chinese university of hong kong; * are willing to participate in the study; * are able to read chinese and communicate in cantonese; * are physically able to attend and complete art therapy sessions; * do not have significant comorbidities, including cerebrovascular accident, severe depression, or dementia that could affect their ability to participate in the study; * signed an informed consent form. exclusion criteria: * adult participants diagnosed with a mixed type of terminal cancer; * are undergoing active therapy; * have participated in other art therapy interventions; * have physical issues preventing them from holding a pen; * have a mental status and/or communication problem that might compromise their capacity to give informed consent; * have significant comorbidities such as cerebrovascular accident, severe depression, or dementia, as determined by standardized screening tools a score of 20-27 on the patient health questionnaire and score 25 or less on the mini-mental state examination.

Keywords: creative arts therapy prostate cancer body image slef-esteem anxiety depression active treatment
the establishment and analysis of the clinical prediction model of acupuncture and moxibustion for stroke recovery

Conditions: Stroke

Summary: electronic health records of stroke convalescent patients will be selected from the third affiliated hospital of zhejiang chinese medical university from january 2012 to december 2019. relevant clinical data will be extracted according to case data, and model-based decision tree analysis will be conducted to establish and evaluate the clinical prediction model.

cases will be screened according to inclusion and exclusion criteria.patients' basic information, risk factors, types of stroke, tcm diagnosis, all treatment during hospitalization, neurological impairment evaluation, imaging examination results and other contents will be recorded.finally, statistical processing will be carried out to establish the prediction model, draw roc curve and evaluate the model.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke * the incidence is between 30 days and 180 days * age ≥ 18 years old * the first onset exclusion criteria: * subarachnoid hemorrhage * transient ischemic attack * other intracranial lesions * non-atherosclerotic thrombotic cerebral infarction * surgery, trauma, congenital disability leading to limb dysfunction
expanded access to bezuclastinib for patients with nonadvanced systemic mastocytosis or advanced systemic mastocytosis

Conditions: Systemic Mastocytoses, Indolent; Systemic Mastocytoses, Aggressive

Summary: the purpose of this expanded access program (eap) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (nonadvsm) or advanced systemic mastocytosis (advsm) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.


Eligibility criteria:
key inclusion criteria: * able to provide written informed consent and commit to eap assessments. * ≥18 years of age. * able to swallow tablets. * diagnosed with asm, sm-ahn, mcl, bmm, ism, or ssm according to the 2022 who classification for sm * not receiving adequate disease control on current therapy(ies). * have clinically acceptable laboratory screening results. exclusion criteria: * patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial. * patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent. * pregnant or currently breastfeeding. * prior or ongoing clinically significant illness or medical or physical condition other protocol-defined criteria apply.

Keywords: systemic mastocytosis nonadvanced systemic mastocytosis advanced systemic mastocytosis systemic mastocytosis with an associated hematologic neoplasm (sm-ahn) aggressive systemic mastocytosis (asm) mast cell leukemia (mcl) bone marrow mastocytosis (bmm)
gv1001 and gemcitabine in sequential combination to gemcitabine monotherapy in pancreatic cancer

Conditions: Advanced Unresectable Pancreatic Cancer

Summary: to investigate the efficacy of gv1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

the trial is a phase iii, multinational, multicentre, controlled, randomised open-label trial. it will involve 520 advanced pancreatic cancer patients. patients will be randomly assigned to receive gemcitabine alone or gv1001 plus gm-csf followed by addition of gemcitabine at the time of 1st progression of disease. the experimental treatment is given prior to the current standard treatment in 50% of the patients.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas. 2. adequate hematological parameters: hemoglobin \>/= 9.5 g/dl \[si units, 5.9 mmol/l\] wbc \>/= 3000/mm3 \[si units, \>/= 3 x 109/l\] platelets \>/= 100,000/mm3 \[si units, \>/= 100 x 109/l\] 3. adequate baseline liver function: total bilirubin \< 3x uln and without liver metastases: ast (sgot) \</= 2.5 x uln alt (sgpt) \</= 2.5 x uln with liver metastases: ast (sgot) \</= 5 x uln alt (sgpt) \</= 5 x uln 4. serum creatinine \</= 1.5 mg/dl \[si units, 132 µmol/l\]. 5. performance status ecog 0-1. 6. male or female 18 - 75 years inclusive. 7. minimum life expectancy of 3 months. 8. written informed consent. exclusion criteria: 1. treatment with chemotherapy for pancreatic cancer. 2. treatment with other investigational drugs within the last 4 weeks prior to inclusion 3. immune-suppressive therapy \<4 weeks prior to inclusion 4. chronic corticosteroid use except for asthma inhalers / topical use 5. radiotherapy within 8 weeks of randomisation. 6. other prior malignancies except for adequately treated non-melanoma skin cancers (bcc, scc) and carcinoma in situ of the cervix. 7. known diagnosis of hiv (aids), hepatitis b, c. 8. known history of or co-existing autoimmune disease. 9. known cns metastases. 10. clinically significant serious disease or organ system disease not currently controlled on present therapy. 11. pregnancy or lactation. 12. women of childbearing potential not using reliable and adequate contraceptive methods\* 13. known sensitivity to any components of vaccine, gemcitabine or gm-csf. 14. unable for any other reason to comply with the protocol (treatment or assessments). * adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.

Keywords: advanced unresesctable adenocarcinoma pancreatic cancer