Kornimate/medical-research-clean huggingface dataset:
rituximab in the treatment of hiv associated multicentric castleman disease dependent on chemotherapy

Conditions: HIV Infections; Giant Lymph Node Hyperplasia

Summary: this trial is aimed to study the efficacy of 4 weekly cycles of rituximab in hiv-infected patients with multicentric castleman disease (giant lymph node hyperplasia) dependent on chemotherapy. efficacy is assessed by the complete response rate at day 60. the patients are followed until day 365.

hiv-related multicentric castleman disease (mcd) is a lymphoproliferative disorder characterized by lymphadenopathy with angiofollicular hyperplasia and plasma cell infiltration, associated with kshv/hhv-8. patients typically have systemic manifestations such as fever associated with lymphadenopathy, hepatosplenomegaly, respiratory symptoms, peripheral edema, cytopenia, hypergammaglobulinemia, hypoalbuminemia, and high levels of serum c reactive protein (crp). symptoms correlate with an important increase of kshv/hhv-8 dna in peripheral blood mononuclear cells. hiv-mcd is characterized by a rapidly progressive and often fatal course. hiv-mcd is often refractory to treatment. vinca alkaloids produce frequent but short-lived responses, and most patients remain dependant upon chemotherapy. lymph nodes of patients with hiv-mcd specifically harbor the virus in b cells located in the mantle zone, which stain positively for the cd20 surface antigen. rituximab, a humanized monoclonal anti-cd20 antibody, has been reported to be effective in some cases, with conflicting data in other cases. the optimal schedule of infusions remains unclear. kaposi's sarcoma is often associated with hiv-mcd, and the development of aggressive non-hodgkin's lymphoma is not a rare outcome.

Eligibility criteria:
inclusion criteria: * confirmed multicentric castleman disease, with dependence on vinblastine or vp16 for at least 3 months, whenever they have been splenectomized * at least one castleman crisis since onset of chemotherapy * ongoing highly active antiretroviral therapy (haart) for at least 3 months * no threshold of cd4 cell count and hiv-rna * signed written informed consent exclusion criteria: * prior treatment with rituximab * evolutive lymphoma or kaposi's sarcoma needing treatment * absence of effective contraception * pregnancy

Keywords: hiv infections giant lymph node hyperplasia herpesvirus 8, human rituximab (mabthera) antibodies, monoclonal
pain and functional recovery after mastectomy and ibr by implant: prepectoral versus subpectoral technique

Conditions: Breast Cancer Female

Summary: this is a prospective, single-center, non-randomized study of immediate breast reconstruction (ibr) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy. the technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. the aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each. the main objective will be to evaluate the postoperative pain by bpi questionnaire. the investigators also wish to observe the functional results of the homolateral upper limb by dash questionnaire, the quality of life by breast q questionnaire and the occurrence of complications.

describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy. evaluate the postoperative pain by brief pain inventory (bpi) self assesment observe the functional results of the homolateral upper limb by disabilities of the arm, shoulder and hand (dash) self assesment observe quality of life by breast q questionary

Eligibility criteria:
inclusion criteria: 1. major patients 2. with breast cancer and indication for total mastectomy 3. with a desire for immediate breast reconstruction 4. total mastectomy procedure and immediate breast reconstruction by pre-pectoral or retro-pectoral prosthesis 5. information of the patient and collection of his/her non-opposition 6. affiliation with a social securitý scheme, or beneficiary of such a scheme exclusion criteria: 1. prophylactic mastectomies 2. metastatic patients 3. patients requiring another surgical technique 4. person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent, 5. impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons 6. pregnant or likely to be pregnant
clinical trial of lithium carbonate combined with neo-adjuvant chemotherapy to treat osteosarcoma

Conditions: Osteosarcoma

Summary: the purpose of this study is to determine whether lithium carbonate combined with neo-adjuvant chemotherapy improve the prognosis of osteosarcoma

osteosarcoma is the most common primary malignant bone tumor in childhood and adolescence, the prognosis for the disease is poor. what's more, chemotherapy resistance and serious myelosuppression occur frequently in clinical further hindered canonical adjuvant chemotherapy. in our previous researches, we observed that gsk-3b positively regulates the nf-kb pathway to promote proliferation and tumorigenicity in osteosarcoma cell. targeted inhibition of gsk3beta showed an obvious antitumor effect. it is a promising therapeutic target in osteosarcoma, especially if gsk-3b inhibition is combined with chemotherapeutic drugs. lithium carbonate, commonly use in clinical application because of its fine quality and cheap price, was proven to be effected as a kind of gsk3beta inhibitor and stimulating factor of peripheral blood leukocyte. therefore, lithium carbonate theoretically possesses effects of both anti-tumor as well as improvement of myelosuppression. we look forward to the results of clinical trials to test the effect of combinations of chemical drugs with lithium carbonate on myelosuppression, disease-free survival rate and lung metastasis rate in patients with osteosarcoma who treated with conventional chemotherapeutic regimens and wide resection. this study is a multi-centre, double-blind, randomized clinical trial phase 4. the inclusion criterion is patients with primary osteosarcoma in femur, tibia and humerus（iib）. with the help of statistic method, 400 patients were randomly divided into two groups according to sequence of entering the group: lithium carbonate group and control group (1:1). patients were suggesting continuing this trial until the end of the chemotherapy regimen or being confirmed as disease progression by recist guiding principles. according to their histological types, patients are analyzed using subgroup analysis. disease evaluation will be conducted every 8 weeks. a follow-up to count the overall survival rate after grouping was performed within at least 24 months or at most 120 months. our study may represent a novel and feasible approach by combination of conventional chemotherapy drugs and targeted drugs. more importantly, it may hopefully be a promising strategy to improve overall survival of osteosarcoma.

Eligibility criteria:
inclusion criteria: * histologically diagnosed primary classical osteosarcoma in extremities * staging iib * mri showing no skip lesion * receive standard neo-adjuvant chemotherapy, adjuvant chemotherapy,and standard surgical treatment exclusion criteria: * a history of non-standard treatment(chemotherapy or surgery) * secondary osteosarcoma or well-differentiated parosteal osteosarcoma * evident dysfunction of cardia,liver and kidney, or pregnant women or women during lactation

Keywords: lithium carbonate chemotherapy prognosis
patient perceptions and quality of life associated with the use of olapatadine 0.2% for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.


Eligibility criteria:
inclusion criteria: * 12 years of age or older. * history (within the past 24 months) of allergic conjunctivitis. * active signs and symptoms of ocular allergies. * ocular health within normal limits, as determined by the investigator or subinvestigator. * willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug. * other protocol-defined inclusion criteria may apply. exclusion criteria: * contraindications or hypersensitivity to study medication or its components. * one sighted eye or not correctable to 0.6 logmar or better in both eyes at the screening visit. * known history of recurrent corneal erosion syndrome. * ocular trauma or surgical intervention within 6 months prior to visit 1. * participation in any other investigational study within 30 days before visit 1. * pregnant or nursing. * other protocol-defined exclusion criteria may apply.

Keywords: allergic conjunctivitis
laparoscopic or abdominal radical hysterectomy for cervical cancer(stage ib1,ib2,iia1)

Conditions: Cervical Cancer

Summary: the purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (lrh) and abdominal radical hysterectomy (arh) in patient survival for cervical cancer (stage ib1, ib2, iia1).

the purpose of this study is to compare lrh (or robotic-assisted) and arh in patients with cervical cancer (stage ib1, ib2, iia1), by a multicenter stratified randomized controlled study, mainly including the following aspects: 1. to compare the differences in pfs and os between patients receiving lrh and arh. 2. to investigate whether pfs and os in lrh can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. to assess postoperative complications and quality of survival.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (stage ib1,ib2,iia1). 2. age ≥ 21 years and ≤ 70 years. 3. surgery type b and c (refer to q-m surgical staging) 4. normal range of liver and kidney function and blood count (specific details below) hemoglobin \> 60g/l platelets \> 70\*109/l leukocytes \> 3\*109/l creatinine \< 50mg/dl transaminase abnormal indicators ≤ 3 maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. no history of other malignancies. 6. non-pregnancy. 7. physical strength classification: karnofsky score ≥ 60; 8. subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. no psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, hiv infection, etc.) (note: maximum diameter measurement of cervical lesions is based on pet-ct, or ct, or mri) exclusion criteria: 1. those who are contraindicated for various surgeries and cannot undergo surgery. 2. patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. patients with recurrent cervical cancer 4. patients with ct, mri or pet-ct suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.

Keywords: cervical cancer abdominal radical hysterectomy laparoscopic radical hysterectomy
the adjunctive use of lavender and peppermint essential oils

Conditions: Joint Diseases

Summary: this study will use passive inhalation of lavender for discomfort, anxiety and peppermint for nausea following joint replacement and spine surgery

following review of records for eligibility and consent obtained during pre op visit subjects will be enrolled in study post op they will validate desire to participate and chose to inhale (2 drops of essential oil on cotton ball in a plastic bag) lavender for discomfort or anxiety or peppermint for gi distress visual analogue scales will be used to rate discomfort , anxiety and nausea

Eligibility criteria:
inclusion criteria: - elective joint replacement able to read and speak english and describe study procedures exclusion criteria: pregnancy * unable to smell, sensitivity to fragrances asthma or breathing problems have smoke or vaped in last 2 weeks if atrial fibrillation history no peppermint uncontrolled hypertension above 160/100 non employees of uh or students of cwru
mechanism(s)of airflow limitation in moderate-severe persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. treatment will include inhaled corticosteroids and long acting beta2agonists and long acting muscarinic antagonists. we are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. we are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased airway conductance in peripheral airways. we are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. for comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma. high resolution thin section ct of the lung will also be obtained. analysis will evaluate integrity of the lung parenchyma as to absence and or presence of emphysema and extent of emphysema using voxel quantification. we will also investigate optical coherence tomography to detect clinically unsuspected emphysema. we will also obtain autopsy material when available in asthmatics who expire. will also measure serum periostin as a marker of inflammation by collaborating with genetech in san francisco.

results will be evaluated during exacerbation and when stable following treatment.

Eligibility criteria:
inclusion criteria: * current non-smoking (\<10 pack yr smoking history) * stable, treated asthmatics * age 12-95 yr * post 180ug albuterol by mdi: fev 1/fvc \< 70% and fev 1 \<80% predicted exclusion criteria: * pregnancy

Keywords: asthma lung function inflammation
retrospective survey of safety of fourth dose pentacel® in children

Conditions: Diphtheria; Pertussis; Haemophilus Infection; Tetanus; Polio

Summary: the purpose of this survey is to collect selected safety data. primary objective: to collect selected safety data at 6 months following the 4th dose of the pentacel® series.

this is a retrospective survey to collect selected safety data at 6 months following the 4th dose of pentacel® in children residing in the canadian province of british columbia who have received the 4th dose of the pentacel® series before their 2nd birthday.

Eligibility criteria:
inclusion criteria: * children residing in the canadian province of british columbia who have received the 4th dose of the pentacel® series before their 2nd birthday. * written informed consent and telephone consent from the parent(s) or guardian(s). * able to comply with the survey procedures. exclusion criteria: * fourth dose of the pentacel® series received on or after the child's 2nd birthday.

Keywords: pertussis whooping cough diphtheria tetanus haemophilus influenzae poliovirus types 1, 2, and 3.
feasibility study of ablathermy focused ultrasound (usf) of breast tumors before mastectomy

Conditions: Breast Tumor

Summary: the treatment consists of tumor ablation by ablathermy focused ultrasound (usf), guided by mri, performed under local anesthesia and sedation.

the treatment consists of tumor ablation by usf, guided by mri, performed under local anesthesia and sedation. patients will be operated (mastectomy) from 48 hours after ablation.

Eligibility criteria:
inclusion criteria: * invasive breast carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of her-2. * lesion classified t1-t2-t3 unifocal or multifocal with or without associated microcalcifications * lesion recognizable and identifiable in mri * indication of mastectomy with or without axillary * lesion located more than 10 mm from the skin, the nipple and pectoralis major * no cons-indication to mri (pacemaker) * women whose age is ≥ 18 years * if premenopausal patient: patient contraceptives * patient has signed informed consent * affiliation to a social security scheme exclusion criteria: * tumor-td t4b classified or non-palpable lesion * if age \<70 years: no indication of adjuvant chemotherapy and neoadjuvant * mri lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter * inability to hold still in the prone position, arms extended, for 30 minutes * contraindication to mri * patient deprived of liberty and major subject of a measure of legal protection or unable to consent * patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.

Keywords: women breast tumor planned mastectomy
investigating the effect of ryzodeg® in adult patients with type 2 diabetes in lebanon

Conditions: Diabetes Mellitus, Type 2

Summary: the study is investigating ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.the study is being carried out to investigate the effect of ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. participants participation will not affect their medical care. in this retrospective study, the study doctor will collect data from the participants patient files available at the study site. participants will need to sign the informed consent form during a single visit. participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after ryzodeg® treatment initiation (total of 52 weeks). chart review for all patients is expected to take approximately 12 weeks.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * male or female, age above or equal to 18 years at the time of signing the informed consent. * patients diagnosed with type 2 diabetes mellitus (t2dm). * patients who were not achieving optimal glycaemic control and who required intensification of antidiabetic treatment and ryzodeg was the treatment of choice. * available and documented hba1c value at less or equal to 12 weeks prior to initiation of ryzodeg® treatment and end of study within the study windows. * available and documented follow up time of at least 52 weeks with 26 weeks follow-up prior to and after initiation of ryzodeg®. * the decision to initiate treatment with commercially available ryzodeg® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study. exclusion criteria: * previous participation in this study. participation is defined as signed informed consent. * participation in any clinical study of an approved or non-approved investigational medicinal product within 26 weeks before and after initiation of treatment with ryzodeg®. * having been previously treated with ryzodeg® prior to study start. * female who were pregnant or breast-feeding during the study. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
effect of oral probiotic supplementation on the rate of hospital acquired infection and necrotizing enterocolitis in preterm very low birth weight infants

Conditions: Nosocomial Infection; Necrotizing Enterocolitis

Summary: the purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.

there are growing numbers of evidence indicating the beneficial effects of normal enteric flora (probiotics) with regard to the host defense against infection. in vitro and in vivo studies have shown that probiotics such as lactobacilli and bifidobacteria have inhibitory effects on other pathogenic bacteria.this evidence, along with the results of recent clinical studies, has demonstrated the beneficial effects of probiotics in the prevention of nec in vlbw infants.however, most of the studies reported nosocomial infection as a secondary outcome and the findings were controversial regarding probiotics efficacy in preventing nosocomial infections. there is only one study that was aimed to investigate effects of probiotic on the incidence of nosocomial infection. given the potential benefit of probiotics against infection and the lack of clinical studies in this regard, we conducted a randomized clinical trial to determine whether probiotic supplementation (in the form of lactobacillus acidophilus and bifidobacterium infantis) could reduce nosocomial infection rate among preterm vlbw infants in a intensive care nursery setting.

Eligibility criteria:
inclusion criteria: * very low birth weight (vlbw) preterm infants (gestational age \< 35 weeks , bw \< 1500 g ) admitted to the nicu who survived the first 3 days of life exclusion criteria: * infants with chromosome abnormality or severe congenital defects, especially gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction) and infants with unstable hemodynamic status

Keywords: nosocomial infections necrotizing enterocolitis preterm infants ver low birth weight probiotics
tumor cells, tumor dna and immunological response in colonic stent placement

Conditions: Cancer of Colon

Summary: this study aims to investigate levels of circulating cell free dna (cfdna), circulating tumor dna (ctdna), circulating tumor cells (ctc) and immunological changes after self-expanding metal stent (sems) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival. furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the sems placement by monitoring cfdna and ctdna-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.

study design this prospective study will include 20 patients undergoing sems placement as a bridge to elective surgery at koege- and slagelse hospital. baseline blood samples will be collected before the procedure. after the procedure blood samples will be collected 1, 4, 12 and 24 hours after sems placement. after elective surgery a tumor sample will be collected. prior to sems placement: when potential candidates are admitted to the hospital they will be presented to the study by the relevant surgeon. the investigators will be contacted, when the patient is admitted to hospital.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 to 95 years * patients with acute malignant obstruction in the colon. * asa class i-iii (classification of the american society of anesthesiology) * signed informed consent exclusion criteria: * known immune-defects * withdrawal of informed consent * bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement. * surgery within 24 hours after stent-placement * known inflammatory bowel disease