Kornimate/medical-research-clean huggingface dataset:
an observational study on atypical antipsychotics long-term treatment patients with schizophrenia

Conditions: Schizophrenia

Summary: this multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in chinese patients with schizophrenia. the atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. this is an open, cohort, multi-center observational clinical study. the main purpose is to evaluate the safety. and the second purpose is to evaluate the efficacy of atypical antipsychotics. the efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. this study belongs to iv period post-marketing drugs research. planned sample size is 3000 cases. visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. the main indexes include physical examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/ blood biochemical tests / prolactin (prl) / thyroxine, etc.), adverse events, 12-lead electrocardiogram( ecg), extrapyramidal syndrome(eps )assessment, sexual function evaluation, medication and other subjective feelings. the second indexes include scales of positive and negative syndrome scale(panss)，clinical global impression-severity of illness scale(cgi-s), calgary depression scale for schizophrenia(cdss),personal and social performance scale(psp), the mos 36一item short form health survey(sf-36), relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.


Eligibility criteria:
inclusion criteria: 1. an in-patient or out-patient (male or female) and aged ≥18 years 2. a diagnosis of schizophrenia,dsm-iv(diagnostic and statistical manual diploma in social medicine-iv) 3. subjects must have the ability to effectively communicate with investigator,complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures. 4. patients are taking or will take atypical antipsychotics which include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine exclusion criteria: 1. participation in other clinical studies. 2. other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
coeliac plexus neurolysis versus splanchnic nerve neurolysis

Conditions: Cancer Pain

Summary: pain is prevalent among patients with gastrointestinal cancers. standard procedures such as coeliac plexus neurolysis (cpn) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases. meanwhile, splanchnic nerve neurolysis (snn) as an alternative to cpn is more effective for cancer pain relief. although previous studies investigating the role of cpn/snn mainly focus on pancreatic cancer cases, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.

pain is prevalent among patients with gastrointestinal cancers. there is abundant evidence that coeliac plexus neurolysis (cpn) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases while the evidence for other upper abdominal cancer pain is less robust but emerging. meanwhile, there is an increasing interest in utilising splanchnic nerve neurolysis (snn) as an alternative to cpn for cancer pain relief. although previous studies investigating the role of cpn/snn involved heterogenous types of intra-abdominal malignancies, majority of cases were pancreatic cancer. therefore, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.

Eligibility criteria:
inclusion criteria: * age\>=18 * diagnosis of unresectable intra-abdominal cancer * visceral pain attributable to the cancer with nrs \>= 4 * able to understand instructions, give consent, complete questionnaires exclusion criteria: * primary pancreatic cancer or metastatic disease involving pancreas * gross celiac axis distortion identified on imaging * acute abdomen condition eg. intraabdominal sepsis, tumor rupture * other non-cancer causes attributable to the pain * gross ascites * previous coeliac plexus or splanchnic nerve neurolysis * contraindications to neurolytic procedures eg. bleeding tendency; local or systemic infections; allergic to local anesthetics, contrast or alcohol; intestinal obstruction; anatomical distortion along needle trajectory * patients believed to be inappropriate for study by investigators
cannabinoids for the reduction of inflammation and sickle cell related pain

Conditions: Sickle Cell Disease

Summary: a randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (scd).

a randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (scd). primary objective: to determine whether dronabinol will improve pain and qol in adults with scd and chronic pain. secondary objectives: to assess dronabinol's effect on markers of inflammation in patients with scd compared to placebo. to determine the safety and tolerability of dronabinol use in adults with scd compared to placebo.

Eligibility criteria:
* age \>18 years * clinical diagnosis of scd (hbss, hbsc, hbsβ+; thal, hbsβ0thal, hbs variants) * baseline score of 60 or lower on the ascq-me 7-day pain interference domain * if on a scd modifying therapy (hydroxyurea, regular blood transfusions, l-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months * if using opioids for pain at home, on stable dose for at least 3 months * one urine toxicology negative for cannabinoids within 30 days of randomization * no known intolerance to dronabinol, or marijuana * no history of psychotic episode, psychosis, or active suicidality * no contraindication to dronabinol with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician * willing to abstain from cannabis, medical and illicit, during study weeks 1 through 8 * not pregnant or nursing * if a woman capable of becoming pregnant, willing to use a medically accepted form of birth control for the duration of study participation. accepted forms include oral contraception, medroxyprogesterone, contraceptive implants or patch, surgical sterilization, total abstinence. * able to consent for research * no daily cannabis use * no diagnosis of active substance use disorder
macitentan to prevent prvo

Conditions: Pulmonary Embolism

Summary: about half of patients who suffer of a pulmonary embolism (blood clots in the lungs), do not clear completely the clots overtime, increasing the risk of having a new blood clot in the lungs and elevated blood pressure in the pulmonary artery; therefore, developing fatigue, shortness of breath, and heart failure. the objective of this clinical trial is to compare 3 months of daily macitentan (a medicine to increase the diameter of the pulmonary artery) in addition to blood thinners vs. blood thinners alone in patients with acute blood clots in the pulmonary artery: question 1: whether the use of macitentan in addition to blood thinners enhances the process of cleaning the blood clot in the pulmonary artery compared to blood thinners alone. question 2: whether the use of macitentan in addition to blood thinners is associated to improve the fatigue and shortness of breath in patients after a pulmonary embolism compared to blood thinners alone. participants will be asked to take a capsule for 3 months in addition to blood thinners. the capsule could contain either macitentan (medicine) or a placebo (not medicine). in 3 months, participants will have a new image of the pulmonary artery to document the cleaning of the clots. also, blood and urine samples will be collected, as well as a questionnaire will be filled out. in 6 months, patients will have repeated images of the heart as well as repeated questionnaires.


Eligibility criteria:
inclusion criteria: * age 18-75 years old. * acute high-risk or intermediate-risk pe diagnosed by ctpa within 28 days prior to enrollment exclusion criteria: * contraindication for anticoagulation * allergy or contraindications to macitentan or any other endothelin receptor antagonist. * surgical interventions to treat pe including catheter-directed thrombolysis, catheter-based thrombectomy, or surgical pulmonary embolectomy. * known inherited or acquired hypercoagulable states * history of pulmonary embolism prior to index pe * history of pulmonary hypertension including group 1 (primary pulmonary hypertension), group 2 (secondary to left heart disease), group 3 (secondary to lung disease), group 4 (chronic thromboembolic pulmonary hypertension) * severe chronic obstructive pulmonary disease * severe uncontrolled asthma * pregnancy or fertility treatment * breastfeeding * life expectancy is less than 6 months * history of radiation therapy to the chest * current or previous use within 90 days of an endothelin-receptor antagonist, prostacyclin analogue, phosphodiesterase type 5 inhibitor, or nitric oxide donor. * severe allergic reaction to iodine contrast * subjects receiving cyp3a4 and cyp2c9 inhibitors or inducers such as rifampin, ritonavir, fluconazole, amiodarone * not able to read or understand the english language

Keywords: macitentan pulmonary embolism pulmonary hypertension post-pe syndrome
study of effects of oral creon capsules in adult participants with exocrine pancreatic insufficiency not due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or pancreatic cancer

Conditions: Exocrine Pancreatic Insufficiency (EPI)

Summary: exocrine pancreatic insufficiency (epi) is a condition where the pancreas does not have enough pancreatic enzymes to break down food. some symptoms of epi are frequent gas/bloating, unexplained stomach pains, frequent diarrhea, and foul-smelling, greasy stools. the purpose of this study is to see how effective creon is for treating symptoms of epi due to causes other than cystic fibrosis (cf), chronic pancreatitis (cp), pancreatectomy (py), or pancreatic cancer (pc). creon (pancrelipase) is an approved drug used to treat people who cannot digest food normally due to their pancreas not making enough enzymes. adult participants with a diagnosis of epi due to causes other than cf, cp, py, or pc will be enrolled. around 50 participants will be enrolled in approximately 20 sites in the united states. participants will receive oral creon capsules with each meal and snack beginning at day 1 for 27 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the course of the study at a hospital or a clinic. participants will need to be confined for 2 separate periods of 6 to 8 days each to measure co-efficient of fat absorption (during screening and after enrollment). the effect of the treatment will be checked by medical assessments, blood and stool tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of exocrine pancreatic insufficiency (epi). * participants who are on pancreatic enzyme replacement therapy (pert) at the time of consent must have a clinical diagnosis of epi by their physician. exclusion criteria: * history of cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, or fibrosing colonopathy.

Keywords: epi exocrine pancreatic insufficiency abt-slv245 creon pancrelipase
efficacy of intra-lesional injections of glucantime once a week or twice a week in the treatment of anthroponotic cutaneous leishmaniasis (acl)

Conditions: Cutaneous Leishmaniasis

Summary: anthroponotic cutaneous leishmaniasis (acl) is a parasitic disease caused by leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. many different modalities are used to treat the disease with a limited success. intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. in this study the efficacy of intra-lesional injections of glucantime weekly is compared with intra-lesional injections of glucantime twice weekly.


Eligibility criteria:
inclusion criteria: * parasitologically proven cases of cl based on positive smear and/or culture * otherwise healthy subjects on the basis of medical history. * age 9-70 years * willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years). exclusion criteria: * pregnant or lactating women * duration of lesion more than 6 months * number of lesions more than 4 * history of allergy to glucantime * serious systemic illnesses (as judged by the physician) * participation in any drug trials in the last 60 days * no indication for systemic treatment

Keywords: anthroponotic cutaneous leishmaniasis l. tropica meglumine antimoniate (glucantime)
hyposalivation response to transcutaneous electrical nerve stimulation in diabetic type 2 patients

Conditions: Diabetes type2; Hyposalivation

Summary: this study evaluates response of abnormal low salivary flow rate to transcutaneous electrical nerve stimulation (tens) in diabetic type 2 patients. response of saliva monitored for all participants receiving only one session of 5-minute extraoral tens on bilateral parotid glands.

diabetes mellitus is the most significant disorder associated with varied oral manifestation ranging from xerostomia (subjective sensation od dry mouth) to serious bacterial and fungal infections due to alterations in flow rate of saliva. systemic agents increase rate of stimulated salivary flow but often have unfavourable side effects such as profuse sweating, rhinitis, dyspepsia. use of tens in stimulation of saliva has been studied in the past which showed moderate promising results. however, it never became a part of the mainstream therapy of hyposalivation. it has been postulated that transcutaneous electric nerve stimulation (tens) could directly stimulate the auriculotemporal nerve, which supplies the parotid gland, whereas it remains unclear whether there is also an indirect action (via afferent pathways) onto the salivary reflex arch. starting a prevention program as early as possible considering the most practical, cost effective and efficient treatments with the best risk-benefit ratio will help to diminish dry mouth symptoms and sequelae (intraoral and extraoral complications).

Eligibility criteria:
inclusion criteria: 1. non-smoker diabetic patients type ii 2. patients with unstimulated resting saliva ≤ 0.16 ml/min considered to be abnormally low flow rate and included in the study (navazesh et al., 1992) exclusion criteria: * cancer patients (patients on chemotherapy/immunotherapy and history of head and neck radiotherapy). * cardiac patients (cardiac pacemakers and defibrillators). * patients wearing hearing aids. * chronic inflammatory autoimmune diseases * acute oral inflammatory disorders * patients with neurological disorders. * habits (mouth breathing, smoking, alcohol and drug abuse). * salivary gland diseases and disorders. * psychogenic diseases. * endocrine diseases. * patients undergoing pharmacological management for xerostomia.

Keywords: tens
a study of valsartan used to treat hypertension for up to 56 weeks in children ages 1 - 5 years who have hypertension

Conditions: Hypertension

Summary: drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. this study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.


Eligibility criteria:
inclusion criteria: * children have blood pressure level =\>95th percentile for age,gender \& height * parental consent must be granted exclusion criteria: * blood pessure is =\>25% higher than 95th percentile for age, gender \& height * serious, clinically significant findings upon examination and laboratory or other assessments other protocol-defined exclusion criteria will apply.

Keywords: pediatric hypertension pediatric valsartan
continuing evaluation of the lungpoint atv system

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the safety and performance of the lungpoint atv system in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer.

the lungpoint atv system is an image-guided navigation system used to access tissue samples in the lungs. this feasibility study is being conducted to assess the safety and yield of the lungpoint atv system in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer. navigation to and sampling of the patient's lung cancer tumor is conducted.

Eligibility criteria:
inclusion criteria: 1. surgical candidates age 21-75 years at screening 2. highly suspicious spn, defined as distinct nodule with a diameter of 10-30 mm in its largest dimension 3. no known endobronchial tumor 4. tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a poe. 5. willing to participate in all aspects of study protocol for duration of study 6. able to understand study requirements 7. signs study-related informed consent document exclusion criteria: 1. any contraindication to bronchoscopy, for example: (a.) untreatable life-threatening arrhythmias, (b.) inability to adequately oxygenate the patient during the procedure, (c.) acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated), (d.) recent myocardial infarction, (e.) previously diagnosed high-grade tracheal obstruction, (f.) uncorrectable coagulopathy. 2. known coagulopathy 3. platelet dysfunction or platelet count \< 100 x 103 cells/mm3 4. history of major bleeding with bronchoscopy 5. pulmonary hypertension with mean pap \>25 mm 6. moderate-to-severe pulmonary fibrosis 7. moderate to severe emphysema or copd with fev1 \ 200% predicted 8. bullae \>5 cm located in vicinity of target spn or atv tunnel 9. any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or atv tunneling, for example: (a.) asa class \> 3, (b.) \> stage 3 heart failure, (c.) severe cachexia, (d.) severe respiratory insufficiency or hypoxia 10. ongoing systemic infection 11. contraindication to general anesthesia 12. chronic use of anticoagulants (e.g., heparin, warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) 13. participation in any other study in last 30 days 14. prior thoracic surgery on the same side of the lung as the spn 15. breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study. 16. life expectancy of less than one year. 17. patients with known intrapulmonary metastases of extrapulmonary cancer/tumors 18. scheduled for lung surgery within 7 days post-scheduled diagnostic bronchoscopy
postoperative sore throat in children: comparison between two supraglottic devices, ambu® auraonce™ laryngeal mask airway (lma) and i-gel®.

Conditions: Laryngeal Masks; Pharyngitis; Minors; Anesthesia

Summary: sore throat is minor but well recognized complaint after receiving general anaesthesia. it is rated as 8th most undesirable outcome in postoperative period.it not only affects the patient's satisfaction but also can affect patient activities after leaving hospital. many factors can contribute to postoperative sore throat and the incidence has been found to vary with the method by which airway is managed. the study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery following the use of ambuauraonce lma and i-gel. the study will be done in children who are able to self-report the severity of sore throat. this study will help us to determine which supraglottic device (i-gel vs. ambuauraonce lma) is better in terms of causing less complication spells of sore throat. the use of such device will not only reduce the severity and frequency of postoperative sore throat that may affect the activities of patient after leaving hospital but also will improve satisfaction level of patient and parents.

objective: the objective of our study is to assess the frequency and severity of postoperative sore throat by comparison between two supraglottic devices, auraonce laryngeal mask airway (lma) and i-gel in children undergoing elective lower abdominal or orthopedic surgery. hypothesis: use of i-gel in children undergoing elective lower abdominal or orthopedic surgery is associated with decrease frequency and severity of postoperative sore throat as compared to use of auraonce laryngeal mask airway.

Eligibility criteria:
inclusion criteria: * 6 to 16 year old patients of both gender * asa (american society of anesthesiologists) i and asa ii patients * scheduled for elective lower abdominal surgery (inguinal hernia repair or circumcision) or orthopedic surgery (upper and lower limb) under general anesthesia. exclusion criteria: * patients with risk of aspiration (incomplete npo (nil per oral), gastroesophageal reflux disease, congenital anatomic abnormalities of aero digestive tract, delayed gastric emptying, altered mental status) * difficult airway(difficult mask ventilation or difficult laryngoscopy, cormack-lehane grade more than 2 in patient history, trismus, limited mouth opening, trauma or mass) * children who are unable to self-report pain using a four-point categorical pain scale * refusal of the parent * refusal of the child to give assent * patients having pre-existing sore throat or symptoms of upper respiratory tract infection. * obese children i.e. bmi for age percentile equal to or greater than the 95th percentile on bmi-for-age percentile growth charts.
informing the patient on the type of management, surgical or functional, after rupture of the anterior cruciate ligament

Conditions: Ligament Rupture

Summary: the purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (acl) of the knee, who will have functional or surgical management (pec) in 1st intention, after having received appropriate information.

as part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical pec, will also be followed.

Eligibility criteria:
inclusion criteria: * rupture, partial or complete, of the anterior cruciate ligament less than 3 months old (confirmed by magnetic resonance imaging); * patient with no contraindication to surgery or functional management, according to the medical team; * patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study * patient benefiting from a social security scheme; exclusion criteria: * grade 3 associated ligament injury on the fibular collateral ligament and/or the tibial collateral ligament; * symptomatic meniscal lesion; * practice of sport in national or international competition ; * recurrence of rupture of the same anterior cruciate ligament; * patient with a neurological (motor and/or sensory), vestibular or rheumatic pathology; * pregnant woman ; * protected adult patient (under guardianship, or under a regime of deprivation of liberty).