Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of speech function through patient- and parent-response outcome measurements in velopharyngeal insufficiency

Conditions: Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate

Summary: cleft lip and/or palate (cl/p) is the most common congenital malformation, with about one in 500 children born with cl/p in sweden, corresponding to approximately 175 births annually. depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected. patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (vpi), which means difficulties in closing the passage between the oral and nasal cavities during speech. velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization. the most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. however, surgical management of vpi is challenging, with variable success rates reported in the literature. in a retrospectively based questionnaire study on patients who underwent surgical treatment of vpi, 30% experienced only a small speech improvement or no improvement at all. in addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance. the aim with the current study is evaluation of speech function through patient- and parent-response outcome measurements following surgical treatment of velopharyngeal insufficiency in children with isolated or combined cleft palate.


Eligibility criteria:
inclusion criteria: * all children \< 18 years of age with isolated or combined cleft palate that will undergo pharyngeal flap surgery due to velopharyngeal insufficiency, as well as their parents, in any of the 6 specialized cleft center in sweden. exclusion criteria: * cognitive impairment making it difficult to understand the study.

Keywords: velopharyngeal insufficiency pharyngeal flap patient- and parent-reported outcome measurements cleft palate
clinical study of capecitabine, oxaliplatin and bevacizumab in colorectal cancer

Conditions: Colorectal Cancer

Summary: this study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

this study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), oxaliplatin (130 mg/m2 iv, day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Eligibility criteria:
inclusion criteria: * adult patients 20-74 years of age * histologically confirmed colorectal cancer * metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease * at least one measurable lesion according to recist exclusion criteria: * evidence of clinically detectable ascites at study treatment start * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start. * evidence of bleeding diathesis or coagulopathy * serious, non-healing wound, ulcer, or bone fracture * chronic, daily aspirin (\> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration

Keywords: advanced and/or metastatic colorectal cancer
effect of cannabinoid (thc / cbd 50%) on hyperalgesia in patients with deep endometriosis

Conditions: Endometriosis

Summary: this study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.


Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 40. * diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test. * pain with a score of 4 or more on a numerical visual scale of 11 levels (evn 0-10) in the last 3 months (includes any type of pain associated with endometriosis: dysmenorrhea, dyspareunia, dyschezia, dysuria and / or pelvic pain). * women of childbearing age \* should have a negative pregnancy test before inclusion in the study and should commit to using highly effective contraceptive methods (hormonal contraceptives, intrauterine device, intrauterine hormonal release systems, bilateral tubal occlusion, vasectomy the couple, barrier methods and sexual abstinence) during the entire duration of the study and up to 3 months after the end of it. * acceptance of participation in the study by signing the informed consent. exclusion criteria: * patients previously submitted to open abdominal surgery. * history of cancer. * suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant. * pregnancy or anticipation of pregnancy up to 3 months after the end of the study. * current breastfeeding. * use of hormonal treatment (combined oral contraception, progestin in the 3 months prior to the study, gnrh analogs in the 6 months prior to the start of the study). * use of other analgesics different from those allowed in the study. * recreational or pharmacological use of cannabinoids. * hypersensitivity to cannabinoids or any of the exceptions. * known or suspected personal history, or family history of schizophrenia or other psychotic illnesses, severe personality disorder or other major psychiatric disorders. * patients with liver or kidney failure, severe cardiovascular disease and a history of epilepsy or recurrent seizures. * patients who use concomitant potent enzyme inducers of cyp3a4, such as rifampicin, carbamazepine, phenytoin, phenobarbital, and st. john's wort.
a study of ov101 in individuals with fragile x syndrome

Conditions: Fragile X Syndrome (FXS)

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of oral ov101 (gaboxadol) in subjects with fragile x syndrome.


Eligibility criteria:
inclusion criteria: * is male and 13 to 22 years old (inclusive) at the time of informed consent. * has a diagnosis of fxs with a confirmed fmr1 full mutation (≥200 cgg repeats). exclusion criteria: * concomitant disease or condition that are clinically significant and would limit study participation * clinically significant lab abnormalities or vital signs at the time of screening * history of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months. * unable or does not have a caregiver able to comply with study requirements. * enrolled in any clinical trial within the 30 days before screening.
pbbt and wbv effect on balance and gait in stroke

Conditions: Stroke

Summary: the goal of this clinical trial is to compare the effects of perturbation based balance exercises with whole body vibration training in sub-acute stroke patients and to evaluate their effects on balance, and gait. the main aim to : * to evaluate their effects on balance, and gait. * comparison of these rehabilitation protocols and identify the more efficacious treatment. participants will perform perturbation based balance training and whole body vibration therapy to improve balance and gait. if there is a comparison group: researchers will compare both groups to see both interventions effects.

stroke usually causes impairments in a variety of areas, such as cognition, emotion, mobility limitation, sensory loss, and there after results in imbalance and gait disability as well as impairment of the activities of daily living (adls). poor balance control have a negative influence on the recovery of gait and motor function. many therapeutic interventions, such as visual feedback training, robotic devices, mirror therapy, and motor imagery training have been performed to improve balance control. reactive balance training (rbt) has emerged as a potential strategy for improving balance and participants withstood greater-magnitude perturbations before requiring multiple steps, relative to those who completed weight-shifting/gait training in sub-acute and chronic stroke patients. whole-body vibration (wbv) therapy used in clinical practice for improving neuro-motor performance in various patient populations and this training reduce disability by improving balance, gait performance, and mobility in stroke patients. according to previous literature there was a lack of comparison of these two studies. in previous literature, both of these therapeutic options i.e., perturbation based balance training (pbbt) and whole body vibration (wbv) training were used separately to see the effects in stroke population but not in combination. in this study the comparison will be done between these two exercise protocols. consequences will be manipulated for balance, and gait by using validated tools.

Eligibility criteria:
inclusion criteria: * diagnosed patient of ischemic stroke (12 week to 20 weeks). * male and female, (40-60 year). * able to maintain standing posture, 4-5 score on level of independence scale. * patients able to perform 2-meter walk test. * score less than 20-24/56 on berg balance scale. exclusion criteria: * patients with other neurological disorders (alzheimer's, parkinson's vestibular impairments etc.) * any significant balance impairment on berg balance scale. * orthopaedic problems. * patients who can't perform 30 sec sit to stand. * patients with any trauma, and blindness. * lower extremity weight bearing pain.

Keywords: perturbation exercises whole body vibration stroke balance gait
s-pantoprazole 10mg phase iii clinical study

Conditions: Non Erosive Reflux Disease

Summary: this clinical study hypothesized that s-pantoprazole 10mg would be effective to treat non erosive reflux disease than placebo.


Eligibility criteria:
inclusion criteria: * adults between the ages of 19 and 75 inclusive * patient with a history of heartburn or acid regurgitation for at least 3 months. * those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline * patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(egd) performed within 7 days of screening * capable of providing written informed consent, willing and able to a comply with all procedures of the study exclusion criteria: * history of endoscopic erosive esophagitis(ee) at screening egd. * historical evidence of the following disease/conditions : symptom of irritable bowel syndrome * more tha 3cm endoscopic barrett's esophagus or significant dysplastic changes in the esophagus * proton pump inhibitor(ppi) within 4 weeks prior to the baseline visit * h2-receptor antagonist, sucralfate, prokinetics, non steroidal antiinflammatory drugs(nsaids) (except low dose aspirin) during the 2 weeks prior to the screening * historical evidence of the following disease/conditions during 3 months: zollinger-ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper g.i. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease, * known hypersensitivity to any component of drug * pregnancy or lactation (f only)
uterotonics for severe preeclampsia

Conditions: Preeclampsia Severe

Summary: the study compares the effect of intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia


Eligibility criteria:
inclusion criteria: * pregnant women which diagnosed with severe pre-eclampsia. * singleton pregnancy. * termination of pregnancy by cesarean section after 28 weeks of gestation. exclusion criteria: * suspected or proven placental abruption. * known placenta previa or acreata. * multiple pregnancies. * obesity (bmi \>35). * anemia (\<9 g/dl). * retained placental tissues. * big baby (\> 4 kg). * presence of coagulopathy. * polyhydramnios. * presence of uterine fibroids. * medical diseases as; cardiac, liver, renal or endocrine diseases. * general anesthesia.
local recurrence prediction of by texture analysis derived from positron emission tomography (pet / ct) imaging of non-small cell lung cancer (nsclc) treated with stereotactic radiotherapy (sbrt) (retros mumofrat)

Conditions: Identify FDG PET/CT Parameters Predictive of Local Control

Summary: the aim of this retrospective multicentric study was to develop and evaluate a prognostic fdg pet/ct radiomics signature in early-stage non-small cell lung cancer (nsclc) patients treated with stereotactic radiotherapy (sbrt).


Eligibility criteria:
inclusion criteria: * nsclc stage i-ii treated by sbrt * pet/ct imaging performed within 60 days of sbrt exclusion criteria: * lack of follow-up * refusal of consent

Keywords: pet/ct radiomics early-stage nsclc stereotactic radiotherapy
lung sonography in patients with acute respiratory distress syndrome in intensive care unit

Conditions: ARDS

Summary: the purpose of this study is to evaluate the role of lung sonography during different peep settings in icu patients with ards.

acute respiratory distress syndrome (ards) is a clinical syndrome that often occurs in critically ill patients. patients with ards invariably require mechanical ventilation to improve oxygen transport. an improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (peep). in critically ill patients with ards, lung imaging is been held by the use of chest radiography and the "gold standard" technique, computed tomography (ct). we designed an observational study in which we included patients under mechanical ventilation admitted in our icu. in all patients peep changes were applied and lung sonography was performed.

Eligibility criteria:
inclusion criteria: * critically ill patients with ards admitted in icu of evangelismos hospital * length of stay \> 48 hours exclusion criteria: * age \< 18 years * emphysema fractures or skin lesions that do not allow the implementation of lung sonography * bmi \> 35 kg/m2 * length of stay \< 48 hours

Keywords: sonography icu peep
metabolic syndrome of occupational drivers

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to discover the health status of occupational drivers. the health status includes data collection of body mass index, blood pressure, central obesity, anxiety scale scores, smoking habit and related cessation therapy, etc.

occupational drivers' health is essential for passengers' safety. however, occupational drivers' health is damaged by long-term sitting and driving, lack of exercise, stress from traffic, and irregular diet. the objectives of this study were to assess the health status of occupational drivers in taiwan. the measures included blood pressure, central obesity, fasting blood sugar, triglyceride, body mass index (bmi), anxiety scale scores, and metabolic syndrome, etc.

Eligibility criteria:
inclusion criteria: * metabolic syndrome * hypertension * anxiety scale scores exclusion criteria: * hyperuricemia

Keywords: occupational drivers health status
fourth-generation immucillin derivative di4g associated therapy in cutaneous leishmaniasis

Conditions: Leishmaniasis; Leishmaniasis, Cutaneous; Leishmaniasis; American

Summary: a clinical trial to asses efficacy and safety of transition-state analog inhibitor of human purine nucleoside phosphorylase for topical use associated standard antimonial in the treatment of cutaneous leishmaniasis in bahia, brazil.

the treatment of cutaneous leishmaniasis caused by l. braziliensis in brazil with pentavalent antimony is associated with a high rate of failure, reaching up to 45% of cases. additionally, pentavalent antimony is only administered by parenteral route with important toxicity and ulcer lesion healing takes a long time, from 2 to 3 months. so, this randomized and controlled clinical trial was designed to compare the efficacy and safety of standard antimonial (20mg/day /kg for 20 days) associated with transition-state analog inhibitor of human purine nucleoside phosphorylase for topical use versus standard antimonial (20mg/kg/day for 20 days) associated with placebo for topical use in the treatment of cutaneous leishmaniasis and early cutaneous leishmaniasis caused by l. braziliensis in the endemic area of corte de pedra, bahia, brazil.

Eligibility criteria:
inclusion criteria: * newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (pcr) methods or by intradermal skin testing (montenegro test). * number of lesions: 1 to 3 ulcerative lesions. * lesion´s diameter: 1 to 5 cm. * disease duration: up to three months. exclusion criteria: * aspartate aminotransferase, alanine aminotransferase \>3 times upper limit of normal range * serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range * evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) * immunodeficiency or antibody to hiv * any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, hiv, or other major infectious diseases * lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months * negative parasitology (aspirate/biopsy/pcr) or negative montenegro test * any history of prior anti-leishmania therapy * any condition which compromises ability to comply with the study procedures * lack of ability or willingness to give informed consent (patient and/or parent / legal representative) * anticipated non-availability for study visits/procedure

Keywords: meglumine antimoniate l.braziliensis immunotherapy immucillin
establishment of the national epidermolysis bullosa registry

Conditions: Epidermolysis Bullosa

Summary: objectives: i. develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (eb). ii. generate a large data bank of clinical, historical, and genetic information concerning these patients. iii. accumulate donated tissue specimens, including selected cells and dna, from selected patient subsets for the establishment of permanent tissue cell banks. iv. promote and facilitate research in eb.

protocol outline: patients are enrolled by mail or clinic visit at 1 of 4 clinical centers. clinical, epidemiological, and laboratory data are collected. medical and family histories are obtained in a detailed interview in person, by phone, or by mail. diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated. a pedigree chart is completed on the first affected family member entered. selected patients are followed at least biannually. a study duration of approximately 10 years is anticipated.

Eligibility criteria:
* clinical diagnosis of epidermolysis bullosa

Keywords: dermatologic disorders epidermolysis bullosa genetic diseases and dysmorphic syndromes rare disease
determine the pharmacokinetics and safety of brivanib in chinese subjects with advanced primary liver cancer (hepatocellular carcinoma: hcc)

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk), safety, and tolerability of brivanib in chinese subjects with advanced hepatocellular carcinoma (hcc).


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: subjects with: * confirmed advanced primary liver cancer (hepatocellular carcinoma: hcc) * not having received prior systemic treatment for advanced hcc * normal or moderately impaired liver function (child-pugh class a or b (cp total score of ≤ 7)) * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: subjects with: * brain metastasis or evidence of leptomeningeal disease * history of impaired brain function (encephalopathy) or active heart disease * unmanageable fluid in the abdomen (ascites) * bleeding esophageal or gastric varices within 2 months prior to inclusion

Keywords: hcc
leg function and adl after alt reconstruction for head and neck cancer

Conditions: Free Tissue Flaps; Head and Neck Neoplasms

Summary: anterolateral thigh (alt) free flap tissue transfer is a commonly used method of head and neck reconstruction after head and neck cancer removal. the procedure involves removing some muscle, skin, and tissue from the thigh, and this may affect leg function. the purpose of this study is to determine the impact of alt on ambulation and activities of daily living (adls)

the alt flap may be harvested as a subcutaneous, fasciocutaneous, musculocutaneous, or adipofascial flap. at our institution, three surgeons commonly use this method of free tissue transfer to reconstruct such defects. in our experience, patients following harvest of alt flap have impairments in lower extremity function that result in decreased independence with transfers, gait and ability to independently perform adls. consequently, these patients receive physical and occupational therapy following surgery and a number of patients go on to receive therapy in a rehabilitation facility and/or as an outpatient. a number of studies have examined donor site morbidity and lower extremity function following alt flap harvest. these studies, however, are heterogeneous and primarily use patient reported and non-standardized scales as outcome measures. additionally, there is a paucity of literature related to physical therapy and occupational therapy outcomes and intervention with this patient population, despite frequent referral of these patients for post-surgical therapy. this investigation will utilize the lower extremity functional scale, the functional independence measure, dynamometry, video analysis of a single leg squat and walking speed in an effort to better assess the affect of alt harvesting on patients' functional capacity post operatively. these tests are valid and reliable measures commonly utilized in physical rehabilitation.

Eligibility criteria:
inclusion criteria: 1. over age 18; 2. head and neck cancer; 3. to undergo anterolateral thigh free tissue transfer for head and neck reconstruction exclusion criteria: 1. inability to ambulate independently prior to surgery; 2. inability to negotiate stairs prior to surgery; 3. inability to follow simple commands; 4. inability to negotiate stairs prior to surgery; 5. previous free flap harvest from either lower extremity