Kornimate/medical-research-clean huggingface dataset:
a study of abt-072 in healthy and hepatitis c virus genotype 1-infected adults

Conditions: Hepatitis C

Summary: to evaluate the safety, tolerability and pharmacokinetics of abt-072 in healthy volunteers and its anti-viral activity in hcv infected subjects.

a blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of abt-072 in healthy and hcv genotype-1 infected adults.

Eligibility criteria:
inclusion criteria: criteria for healthy adults: * informed consent has been obtained * subject is in general good health * if female, then postmenopausal * if female, then not pregnant * if male, must be surgically sterile or both he and the partner must use birth control * body mass index is 18 to 29, inclusive criteria for hcv-infected adults: * infected with hcv for at least 6 months as shown by either detectable hcv rna or reactive antibody, or liver biopsy with pathology indicative of hcv infection, or disclosure of a risk factor * subject is infected with hcv genotype 1 with detectable hcv rna of \> 50,000 iu/ml exclusion criteria: criteria for healthy adults: * if female, then pregnant or breast feeding * positive hav-igm, hbs-ag, hcv ab or hiv ab * within 6 months of start of study, drug or alcohol abuse and use of nicotine products * alcohol intake within 48 hours prior to study drug administration criteria for hcv-infected adults: * need for prescription or over-the-counter medication * child pugh score \> 5 or clinical evidence of cirrhosis * no other cause for liver disease other than hcv infection * alt or ast \> 4 x uln * creatinine \> uln * clinically significant abnormal ecg * hcv rna levels above the level of assay quantification * tsh values outside normal range

Keywords: phase 1
a trial of radiofrequency ablation for anal intraepithelial neoplasia using the halo ablation system

Conditions: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions

Summary: this is a single-center prospective pilot trial involving up to 22 subjects. this study will assess the feasibility, safety, and efficacy of radiofrequency ablation (rfa) to the anal canal using the fda cleared halo ablation system to eradicate anal hsil lesions in hiv-negative subjects with intra-anal intraepithelial neoplasia (ain). the study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal hsil within the etz in a tolerable and relatively safe manner


Eligibility criteria:
inclusion criteria: * age 18-75 years * hra 2 to 12 weeks prior to the 0 month rfa visit yielding one or more flat, non-condylomatous biopsy-proven hsils that are 1. located entirely within in the eligible treatment zone 2. contiguous with the squamocolumnar junction eligible treatment zone (etz) is defined as 1. 3 cm above the dentate line to the anocutaneous line 2. half of the anorectal circumference (meaning no more than two contiguous quadrants) * if female of child-bearing age, negative pregnancy test within 8 weeks of the 0 month rfa visit and declared intent to remain on birth control throughout the trial, or, declaration of infertility defined as subject report of status as post-menopausal or surgically sterile (status post hysterectomy or tubal ligation). * hiv negative, elisa/western blot test obtained within 12 weeks of the 0 month rfa visit exclusion criteria: 1. any biopsy-proven hsil entirely outside of the etz 2. any biopsy-proven hsil partially within the etz (for example, an hsil lesion with extension to the perianal skin) 3. any condylomas in the eligible treatment zone \> 1/2 cm diameter • note: condylomas in the eligible treatment zone \< 1/2 cm in diameter must be excised or cauterized (not treated topically or with irc) before or during visit 1 (0 month rfa visit) 4. any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis 5. history of or present anal or rectal cancer 6. history of pelvic radiation therapy 7. history of hpv vaccination or plans to initiate hpv vaccination during the trial 8. history of ablation or resection therapy within the etz other than cauterization or excision of condyloma(s) 9. history of topical therapy (imiquimod, 5-fu) within 6 months prior to the 0 month rfa visit within the etz 10. hemorrhoids \> grade ii 11. fecal incontinence (that the investigator feels may impair healing) 12. concurrent disease requiring systemic immunosuppression therapy 13. concurrent malignancy requiring systemic therapy 14. life expectancy \< 2 years
a study of shr-a1811 monotherapy or combined with pyrotinib maleate as neoadjuvant treatment in her2-positive breast cancer patients

Conditions: HER2-positive Breast Cancer

Summary: this is a phase ii trial evaluating the efficacy and safety of shr-a1811 monotherapy or combined with pyrotinib maleate in stage ii-iii her2-positive breast cancer. subjects will receive the neoadjuvant therapy of shr-a1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. efficacy will be assessed every 2 cycles.


Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18 but ≤ 75 years * histologically confirmed to be her2-positive invasive breast cancer * treatment-naive patients with stage ii-iii * eastern cooperative oncology group (ecog) score 0-1 * good level of organ function exclusion criteria: * previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) * received any other anti-tumor therapy at the same time * bilateral breast cancer, inflammatory breast cancer or occult breast cancer * stage iv breast cancer * with a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer * inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption * participated in other drug clinical trials within 4 weeks before enrollment * history of allergies to the drug components of this protocol * clinically significant pulmonary diseases * clinically significant cardiovascular diseases * history of immunodeficiency * active hepatitis and liver cirrhosis

Keywords: shr-a1811 pyrotinib her2-positive breast cancer neoadjuvant
impact of paramedical consultations in oncological supportive care in outpatients with multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma is the second most frequent hematologic malignancy, which incidence augmented between 1995 and 2018, with an annual mean variation of +0.6% to 1.1%. although treatment improved in the last years, the patients' prognostic is associated with cytogenetic abnormalities. oncological supportive care provides patients with a global perspective, in addition to specific medical treatment adapted to pathology and patient profile. it contributes to the improvement of quality of life of patients, throughout their care pathway regarding physical, psychological and social aspects, according to their specific needs as well as their caregivers'. the aim of this study is to evaluate the quality of life at 6 months after multiple myeloma diagnosis in outpatients receiving paramedical consultations in oncological supportive care from the diagnosis versus outpatients receiving paramedical consultations in oncological supportive care after 6 months after diagnosis.


Eligibility criteria:
inclusion criteria: * age superior to 18 years old * patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital * patient coming regularly to centre henri becquerel for treatment and follow up for multiple myeloma * informed consent form signed exclusion criteria: * inclusion criteria: * age superior to 18 years old * patient recently diagnosed with multiple myeloma not eligible to autologous blood stem-cell transplantation, before starting therapy in day hospital * patient coming regularly to centre henri becquerel for treatment and follow up for multiple myeloma * informed consent form signed exclusion criteria: * patient with urgent need of treatment after multiple myeloma diagnosis with urgent and absolute need of oncological supportive care immediately after diagnosis * patient deprived of liberty, under judicial supervision, under guardianship or trusteeship * history of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation

Keywords: supportive care multiple myeloma
sorafenib alone versus sorafenib combined with haic for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (haic) compared with sorafenib alone in patients with hepatocellular carcinoma (hcc) with major portal venous tumor thrombus (pvtt).

the results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (haic) may improve the survivals for advanced stage hcc. thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * portal vein tumor thrumbus confirmed in two image techniques * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/µl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic arterial infusion chemotherapy sorafenib
effect of cold immersion on patients with varicose vein

Conditions: Varicose Veins of Lower Limb

Summary: in the literature, it is stated that cold water immersion to lower extremities is effective on the symptoms of the disease. studies have shown that cold water immersion, which is one of the cold application methods, has effects on increasing joint mobility, reducing pain, reducing stress, anxiety, depression, and increasing quality of life etc. for this reason, the study is planned as a randomized controlled interventional study to determine the effect of cold water immersion directly to the lower extremity in the preoperative period of patients with varicose veins on quality of life, anxiety and symptoms experienced.

the experimental group will be informed about the lower extremity cold immersion bath during the outpatient clinic controls and will be given a liquid meter digital thermometer that will allow them to check the cold water temperature at home. patients will then be asked to do the lower extremity cold water immersion bath every day in their own home, for a total of four weeks, lasting 20 minutes in the evening before going to sleep. it is recommended that the cold water immersion for 20 minutes and the temperature of the water should be 15 0c for it to be effective on the symptoms. at the end of four weeks, patients will be informed that they should come to the outpatient clinic again. when the patients come to the outpatient clinic, information about the application will be repeated and data collection forms will be applied by face-to-face interview method. to the patients in the control group; during the research process, routine outpatient controls will be made and no attempt will be made during the research.

Eligibility criteria:
inclusion criteria: * those between the ages of 18-65 * those who have been diagnosed with lower extremity varicose disease for at least 1 year * those who have not had previous surgery due to varicose veins * no visual, hearing and sensory impairment/neurosensor disorder problem * no mental status disorder * with intact skin integrity and no open wounds * no circulatory disorder exclusion criteria: * the patient has a known cold allergy or hypersensitivity to cold * patient having surgery during the study * the patient's desire to withdraw from the study
neoadjuvant carilizumab and apatinib for recurrent high-grade glioma

Conditions: Neoadjuvant Therapy; Carilizumab; Apatinib; Recurrent High-Grade Glioma

Summary: gbm is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. the study aim to evaluate the safety and efficiency of using the neoadjuvant therapy with carilizumab and apatinib in patients with recurrent high-grade glioma.


Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. age 18-70 years old, both male and female. 3. after biopsy or surgery, the postoperative pathological diagnosis was who iii-iv glioma. 4. patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator. 5. kps score ≥60； 6. life expectancy \>12 weeks. 7. adequate organ function defined by: 1. hgb≥110g/l； 2. wbc≥3.0×109/l；neut≥1.5×109/l； 3. plt ≥75×109/l； 1. bil≤1.5uln； 2. alt and ast≤2.0×uln； 3. creatinine \< 1.5 x uln or estimated creatinine clearance≥50ml/min（using the cockcroft-gault formula） exclusion criteria: 1. presence of extracranial disease. 2. previous treatment with a pd-1, pdl-1 or ctla-4，vegfr targeted therapy. 3. pregnant or breastfeeding patients. 4. known history of testing positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids). routine testing is not required. 5. positive tests for hepatitis b virus surface antigen (hbv sag) or hepatitis c virus ribonucleic acid (hcv rna) indicating active or chronic infection. 6. history of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies. 7. known drug or alcohol abuse.
walking with fes or afo in people with ms with foot drop

Conditions: Multiple Sclerosis; Foot Drop

Summary: this investigation consists of two parallel groups of participants who will follow the same protocol. the aim of the study is to investigate the effects of using functional electrical stimulation/ankle foot orthosis (afo) or splint as an assistive mobility device over a 12 week period in people with ms who experience foot drop. patients who are clinically prescribed fes will be invited to participate in the fes arm of the study. patients who are clinically prescribed an afo will be invited to participate in the afo arm. participants will be asked to make four visits to the gait laboratory at queen margaret university. four weeks before the start of device use (baseline - 4 weeks), start of device use (baseline), after 6 weeks and 12 weeks of device use. participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. participants will also be asked to carry out a 10 metre walk and a two minute walk. both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device. participants will be asked to wear an activity monitor for 7 days after each assessment. in addition participants will be asked to complete four short standardised questionnaires (ms walking scale, ms impact scale (msis-29), fatigue severity score and the leeds ms quality of life score) at each assessment.


Eligibility criteria:
inclusion criteria: * people diagnosed with multiple sclerosis * prescribed either afo or fes to treat drop foot by their physiotherapist * aged 18-75 exclusion criteria: * unable to walk 10 meters * bilateral device use * breastfeeding or pregnant

Keywords: multiple sclerosis functional electrical stimulation ankle foot orthosis walking performance gait analysis fatigue activity monitoring
"effects of facilitated positional release technique( fprt) vs. manual myofascial release technique in female patients with piriformis syndrome

Conditions: Piriformis Syndrome

Summary: this study is a randomised control trial and the purpose of this study is to determine the "effects of facilitated postional release technique( fprt) vs manual myofascial release technique in female patients with piriformis syndrome.

the purpose of this study is to determine the "effects of facilitated positional release technique vs manual myofascial release technique in female patietns with piriformis syndrome. we make 2 groups control and treatment group . we give fprt technique to treatment group and manual release technique to control group in patients with piriformis syndrome. first we take base line readings of hip roms( abduction, adduction, internal rotation, external rotation),nprs and lefs(lower extremity functional scale).. after 2 weeks of treatment again we take same readings and compare both readings.

Eligibility criteria:
inclusion criteria: * patients with piriformis syndrome * 25-50 years * only females * diagnosed piriformis syndromr * pain from 2 months exclusion criteria: * lumbar radiculopathy * fracture * trauma to lumbar spine * surgery/ total hip relpacement * hip oa
determining the frequency of occurrence and defining the most appropriate screening test for anal intraepithelial neoplasia (ain) in patients with human papillomavirus (hpv) related gynecological diseases.

Conditions: HPV-Related Carcinoma; HPV Infection

Summary: the primary aim of the study is to determine the total risk of ain in group of hpv-rgd survivors and additionally to establish an exact risk for each of hpv-related gynecological precancers/cancers. moreover, the most appropriate screening test for hsil(ain) in this group of patients will be determined. it will be effectuated by performing two kinds of tests: hrhpv test for the 14 most common oncogenic hpv types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (hra) with potential biopsy/excision of suspected lesions and histopathological examination.


Eligibility criteria:
inclusion criteria: * hpv related gynecological disease confirmed in histo-pathological examination * the posibility to obtain material from gynecological organ and from anal canal

Keywords: anal cancer hpv anal intraepithelial neoplasia
open to laparoscopic reverse conversion of perforated appendicitis

Conditions: Laparoscopic Surgery; Acute Appendicitis With Rupture; Sepsis; Abdominal Abscess

Summary: a prospective randomized controlled trial of reverse conversion (open to laparoscopic) in management of acute perforated appendicitis

introduction: acute appendicitis (aa), a frequent intra-abdominal surgical pathology, necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical management. the surgical approach to aa is appendectomy; nevertheless, the medical literature continues to argue the merits of open vs laparoscopic surgery. as with other laparoscopic surgical techniques, the literature reports lower discomfort, earlier resumption of oral feeding and shorter hospital stay following laparoscopic appendectomy (la) as compared to open appendectomy (oa). additionally, laparoscopy has some drawbacks such as greater cost and lengthier operating durations as compared to open surgery. the goal of this clinical study: was to compare open appendectomy versus laparoscopic conversion from open (reverse conversion) for the treatment of acute perforated appendicitis in our setting. patients and procedures: 426 patients had perforated appendectomy and divided between two groups: group a (interventional) 213 patients who were subjected to the reverse conversion technique and group b (control)213 patients who were operated by the open technique. the key end goals for comparing both groups were the rates of intraabdominal abscess, rates of wound infection, rates of ileus and rates of reoperation. the hospital length of stay and the operative time were used as secondary end goals for comparison.

Eligibility criteria:
inclusion criteria: * symptoms consistent with acute perforated appendicitis, * had ultrasound or computed tomography (ct) evidence of acute perforated appendicitis, * ages ranging from 16 to 65 years. exclusion criteria: * radiological evidence of appendicular mass, * septic shock or multi-organ failure (mof) at presentation, * diabetes mellitus (dm), renal failure, morbid obesity * recent (6-month) history of thromboembolic disease * immunomodulators, * a history of inflammatory bowel disease (ibd), * postoperative pathological report of the removed appendix revealed carcinoid or crohn's disease, * american society of anesthesiology (asa) classification more than ii.

Keywords: laparoscopic appendectomy reverse conversion reoperation intraabdominal abscesses
monitoring of non-invasive ventilation

Conditions: Hypoventilation

Summary: the purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.

patient with chronic hypoventilation with stable on long term treatment (ltmv) with non-invasive ventilation for at least 3 month taking part of our ltmv program will be included. in addition to clinical examination,report from ventilator software, nocturnal sp02 and daytime arterial blood gas all patients will be investigated with sleep polygraphy and transcutaneous co2.

Eligibility criteria:
* admitted to our unit for optimal treatment of long term non invasive ventilation * readmitted for control after 6-8 weeks * then treated for at least 3 month with long term non invasive ventilation outside of hospital. * informed written consent exclusion criteria: * under 18 years old * lack of cooperation * pregnant * acute exacerbation last 3 month leading to hospital admission. * change of treatment last 3 month