Kornimate/medical-research-clean huggingface dataset:
reduced intensity transplant conditioning regimen for severe thalassemia

Conditions: Severe Thalassemia

Summary: this study is being done to determine if blood cell transplants, with either bone marrow or cord blood from unrelated donors, are effective in children with severe thalassemia and if this treatment approach has acceptable risks and side effects. this study includes a preparative regimen with hydroxyurea, alemtuzumab, fludarabine, thiotepa and melphalan that provides intense host immunosuppression without myeloablation. the primary hypothesis is that this regimen will promote stable engraftment of unrelated donor hematopoietic cells, support normal erythropoiesis, and result in an event free survival of \> 75% of children with thalassemia major.


Eligibility criteria:
inclusion criteria: * 1-16.00 years old * have transfusion dependent thalassemia major * shall not have an hla-matched family donor * must have a suitably matched unrelated marrow donor or ucb product * lansky score \>/= 70 * adequate pulmonary, renal, liver, and other organ function as defined in protocol * negative pregnancy test * adequate total nucleated cell or cd34+ dose of product as defined in protocol * iron chelation must be discontinued \>/= 48 hours prior to conditioning regimen exclusion criteria: * pregnant or breastfeeding * hiv positive * prior allogeneic marrow or stem cell transplantation

Keywords: thalassemia alemtuzumab hematopoietic cell transplant non-myeloablative
postoperative incidence of orthostatic intolerance and hypotension in primary unicompartmental knee arthroplasty (uka)

Conditions: Orthostatic Hypotension; Orthostatic Intolerance; Postoperative Complications

Summary: incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing uka

in today's multimodal fast-track perioperative care program (eras) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (oh), defined as a drop in systolic arterial pressure (sap) \> 20 mmhg or a drop \>10 mmhg in diastolic arterial pressure (dap) and orthostatic intolerance (oi), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation. former studies have been accessing the postoperative incidence in tha-patients (22%-40%), tka-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). one study have been accessing the postoperative incidence of oi in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative oi is not an issue in minor surgery. this study is the first, to our acknowledgement, which accesses the postoperative incidence of oi/oh in uka-patients.

Eligibility criteria:
inclusion criteria: * age \>18 years and * patients undergoing uka in spinal anesthesia at hvidovre hospital in a standardized fast-track setting. * patients that speak and understand danish * written informed consent exclusion criteria: * pre-existing orthostatic hypotension or intolerance * alcohol or substance abuse * everyday treatment with either anxiolytic or antipsychotic medicine * cognitive dysfunction * if surgery was converted to general anesthesia or total knee arthroplasty.
organized self-management support services for chronic depression

Conditions: Depression

Summary: the purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (uc); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. all intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.


Eligibility criteria:
inclusion criteria: * all patients will meet criteria for recurrent major depression or dysthymia exclusion criteria: * bipolar disorder or psychotic disorder

Keywords: chronic or recurrent depression
baclofen effects in cigarette smokers

Conditions: Nicotine Dependence

Summary: the proposed project will utilize perfusion functional magnetic resonance imaging (fmri), a functional candidate gene association approach (of dopaminergic addictions-targeted polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (gaba) b receptor agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive smoking reminders (cues that motivate continued smoking and relapse). these studies will provide a means to identify an appetitive cue-sensitive pharmacologic-responsive endophenotype. once brain/behavioral/genetic endophenotypes can be determined prior to treatment, smoking cessation treatments can be structured to meet individual needs, which will significantly improve treatment outcome.


Eligibility criteria:
inclusion criteria: * physically healthy, as determined by a comprehensive physical examination and approval of the study physician males or females who smoke cigarettes, ages 18-60. * smoke ≥ 6 cigarettes per day for at least 6 months prior to study start date. * females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential but practicing a medically acceptable method of birth control. examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (iud), the nuvaring, oral contraceptives, levonorgestrel implant, hormonal injection or complete abstinence. * provide voluntary informed consent. * must be able to read. \[subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.\] * intelligence quotient of ≥ 80. exclusion criteria: * history of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal mri. * current diagnostic and statistical manual-iv (dsm-iv) axis i diagnoses other than nicotine dependence. * presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (unless a radiologist confirms that it's presence is unproblematic). an x-ray may be obtained to determine eligibility given the possibility of a foreign body. * history of psychosis. * claustrophobia or other medical condition preventing subject from lying in the mri for approximately one (1) hour. * current diagnosis of or treatment within the last 3 months for alcohol dependence. * current use of any smoking cessation treatments such as zyban, chantix, wellbutrin, patch, gum, inhaler, electronic cigarettes, herbal preparations. * vision problems that cannot be corrected with glasses. * weight exceeding 300 pounds \[imaging data acquisition is impaired with high weight individuals\]. * history of stroke.

Keywords: nicotine addiction fmri baclofen
effects of acupuncture and intradermal acupuncture on insomnia

Conditions: Insomnia

Summary: the aim of this clinical study is to observe the therapeutic effect of acupuncture and intradermal acupuncture in the treatment of insomnia participants were randomized into the acupuncture group and control group. both groups were treated 3 times in a week and assessed before and after the treatment. hypothesis : 1. acupuncture group will produce superior effect in the treatment of insomnia compared with control group. 2. acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.

the acupuncture group is received acupuncture and intradermal acupuncture therapy at 5 acupoints on wrist and ankle. the control group is received same treatment at 5 sham points approximately 1cm lateral to the acupoints. except for the location of acupuncture points, all details of treatment are same between acupuncture group and control group. a certified practitioner treat both groups 3 times in a week. the acupuncture inserted into the skin for 20 minutes and the intradermal acupuncture inserted and fixed on the same points for 48\~72 hours. severity of insomnia, anxiety, depression, quality of life, recognition, attention, and memory are assessed at the baseline, after the last treatment and at a week after the end of last treatment.

Eligibility criteria:
inclusion criteria: * male or female between the age of 18years and 65 years. * diagnosed as having insomnia using pittsburgh sleep quality index(psqi score\>5). * have no problems with communication (for example, reading, writing, listening, speaking). * provided written informed consent. exclusion criteria: * regular medication, herbal medication or health functional food for treating insomnia * presence of major neuropsychiatric disorder (for example, mental retardation, psychosis and severe mood disorder) * presence of inflammatory skin disease on the acupuncture site * presence of bleeding disorders or takes anticoagulant * presence of severe physical diseases that may preclude the safe use of acupuncture * enrolled in another clinical study in the past 1 month * pregnancy or breast feeding

Keywords: insomnia
efficacy of a gluten-free diet for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. the objective of this study is to compare the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and celiac-type symptoms.

fibromyalgia, a chronic pain disorder, is characterized by generalized chronic musculoskeletal pain that is usually accompanied by several other clinical manifestations that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue, mood disorders, and cognitive difficulties. many patients with fibromyalgia suffer from gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation, fatigue, pain and mood changes. this raises the possibility that some patients with fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten intolerance. on the other hand, the emerging evidence linking obesity with fibromyalgia and the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for weight loss among these patients. thus, the main objective of this study is to compare the efficacy of a gluten-free diet (gfd) with a hypocaloric diet (hcd) in patients with fibromyalgia that also experience celiac-type symptoms.

Eligibility criteria:
inclusion criteria: * adult patients diagnosed with fibromyalgia according to the 1990 american college of rheumatology diagnostic criteria. * patients who successfully complete the screening process for sufficient celiac-type symptoms * negative transglutaminase antibodies serological testing. * signed informed consent to participate exclusion criteria: * patients suffering from any disease that could prevent them from following any of the suggested diet protocols * current or previous history of substance abuse * pregnancy and lactation

Keywords: fibromyalgia celiac-type symptoms gluten-free diet hypocaloric diet
phase iii peg-intron in hiv-infected patients (study p00738)

Conditions: HIV Infections; AIDS

Summary: this is a randomized, double-blind, multicenter trial testing 2 doses of peg-intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced hiv-infected patients compared to placebo. the study will evaluate the efficacy and safety of peg-intron when added to stable optimized background antiretroviral therapy in this patient population.

this study will randomize 675 patients (225 in each of the 3 arms) to either: peg-intron 1mcg; 3mcg or placebo, at 90 centers worldwide. each center will enroll approximately 10 patients. study drug will be added to optimized background anti-retroviral therapy of patients whose hiv rna is incompletely suppressed by their therapy (hiv rna 400-50,000 copies/ml) after 2-6 months. a single dose reduction of 50% will be allowed for toxicity. an interim analysis will be conducted when 50% of patients have completed 24 weeks of therapy. the study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. the primary endpoint is change in hiv rna from baseline to week to assess efficacy. durability of response will be assessed at 48 weeks.

Eligibility criteria:
inclusion criteria: * hiv positive * history of virologic failure on at least 2 antiretroviral regimens including exposure to at least one nrti, one nnrti and one pi * hiv rna \>400-\<50,000 copies/ml * laboratory parameters: platelet count (75,000u/l, hemoglobin \>9gm/dl, absolute neutrophil count \>1,000/ul, sgot/sgpt\<5xuln. exclusion criteria: * current ribavirin therapy * subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention * females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures * concomitant use of immunosuppressants or cytotoxic agents * history of seizure disorder requiring use of anticonvulsants

Keywords: peg-intron treatment experienced
tracking outcomes and practice in pediatric pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: the topp-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (ph) to gain further insights in the disease course and long-term outcome of ph in childhood. patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. the topp-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in peph and the reasons for changes in treatment strategy. the topp-2 registry uses the new clinical classification of ph as outlined at the 5th world symposium for pulmonary hypertension (wsph) in nice 2013 and includes new characterizations for children with ph. the registry is planned and implemented under the scientific leadership of the association for pediatric pulmonary hypertension (peph), independently from the financial sponsors. all enrolled patients will have a follow-up period of 18 months.


Eligibility criteria:
inclusion criteria: * patient must be an incident patient, i.e.newly diagnosed with ph * age at time of diagnosis is at least 3 months and less than 18 years * patients must present with ph belonging to one of the following categories * group 1 according to updated nice clinical classification * group 3 according to updated nice clinical classification * group 4 according to updated nice clinical classification * group 5 according to updated nice clinical classification * ph confirmed by heart catheterisation (hc) * at hc, the patient must present with mean pulmonary arterial pressure (pap) of at least 25 mmhg at rest, a pulmonary vascular resistance index (pvri) equal to or below 3 wood units\*m\^2 and mean pulmonary arterial wedge pressure (pawp) below or equal to 15 mmhg * in case of congenital heart disease (chd) patients who had undergone palliative procedure or repair to close systemic to pulmonary shunt, the diagnosis of ph must have been confirmed by hc at least 6 months after surgery/palliative procedure took place * for patients with pah-chd open shunt, only those considered not operable due to advanced pulmonary vascular disease are eligible * patients to be included into the registry, and/or their legal guardians, must give informed consent. where applicable patients will be asked for their written assent * participating sites must agree to adhere to the recommendations of the wsph 2015 nice, pediatric taskforce. exclusion criteria: * patients belonging to group 2 according to updated nice clinical classification
evaluation of efficacy, safety and tolerability of targretin capsules in patients with advanced or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study evaluates the use of targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic non-small cell lung cancer (nsclc) in patients who have not yet received chemotherapy for their lung cancer.

this study evaluates the use of targretin capsules (bexarotene) in combination with carboplatin and paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). half of the patients are randomly assigned to receive targretin capsules once daily in addition to the chemotherapy. the other half is randomized to receive a standard platinum-containing chemotherapy without targretin capsules.

Eligibility criteria:
patients must have: * pathologic (histologic or cytologic) confirmation of nsclc * stage iiib with malignant pleural effusion or stage iv disease * at least one measurable or evaluable nsclc lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy * ecog performance status 0 or 1 * adequate organ system function * fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of targretin capsule therapy). patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months) patients must not have had: * brain metastasis * prior chemotherapy for nsclc * prior platinum-based chemotherapy for any indication

Keywords: nsclc targretin retinoid bexarotene
short-term effects of the simultaneous use of two physiotherapeutic methods in the treatment of adolescent idiopathic scoliosis - pilot study

Conditions: The Spirometry;; The Strength of Respiratory Muscles - MIP, MEP;; Kyphosis (Plurimeter-V); The Angle of Trunk Rotation in Thoracic Part

Summary: the assessment of influence joint physiotherapy (dobomed and omt kaltenborn - evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy.


Eligibility criteria:
inclusion criteria: * girls aged 10 to 16 * one arc right side curve * cobb range 12 - 40 degrees exclusion criteria: * bigger cobb range * double arc curve * no parent approval * lack of cooperation

Keywords: manual therapy dobomed exercise spirometric test
a systems approach to immunotherapy biomarker identification within the postoperative wound-healing microenvironment in patients with gastroesophageal cancer

Conditions: GastroEsophageal Cancer

Summary: the purpose of this research is to collect surgical drain fluid and blood from patients who have undergone surgery for gastric or esophageal cancer, and to analyze the fluid and blood using a variety of laboratory techniques for molecular markers capable of predicting response to immunotherapy.


Eligibility criteria:
inclusion criteria: * patients undergoing esophagectomy or gastrectomy for gastroesophageal cancer. * adult males and females at least 18 years of age * ability to complete testing in the protocol and attend study visits * able and willing to consent to protocol * adequate organ function absolute neutrophil count (anc) ≥1.5 x 103/μl platelets ≥100 x 103/μl hemoglobin \>9.0 g/dl total bilirubin (\ 3 g/dl creatinine ≤1.5 mg/dl exclusion criteria: * female patients who are pregnant or breast-feeding * concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. * life-threatening intercurrent illness * anticipated poor compliance * prisoners or subjects who are involuntarily incarcerated * persons with decisional incapacity/cognitive impairment * any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study * subject is enrolled in a separate interventional clinical trial
a multi-center study of rehabilitation to stable chronic obstructive pulmonary disease (copd) patients

Conditions: COPD; Inflammation

Summary: this is a multi-center prospective follow-up study. * to choose the stable copd patients in community * to compare different modes of exercise (cycling and walking) * to compare the effect of different exercises on the quality of life,exercise endurance,dyspnea and depression

this is a multi-center prospective follow-up study.more than 20 hospitals participate the research. more than 300 stable copd patients will be recruited.it is a two-year study. there are four groups, cycling and walking group(c-wg),cycling and non-walking group(c-nonwg),walking and walking group(w-wg),walking and non-walking group(w-nonwg). 1. all patients from four groups will finish baseline investigation and blood sample, including informed consent,questionaires(sgrq,crdq,mrcq,depression scale,etc.),spirometry,6mwt,mip,mep,bmi,crp,tnf,il-8, etc.patients in c-wg and c-nonwg will finish cardiopulmonary test. 2. patients receive 8 weeks training program, includes upper and lower extremities endurance exercises and respiratory muscle endurance exercises. patients in both cgs cycling at cycle ergometry. patients in w-wg and w-nonwg walking instead. all patients receive training program twice per year, for two years. patients were supervised by physicians or nurses at hospital while they are training. 3. in the non-training period, patients in w-wg and c-wg will continue to walk at community, supervised by nurses who call them every month. the other two groups(c-nonwg and w-nonwg) do not receive special requirement on exercise. 4. telephone call interview will give to patients every month to find whether they have acute exacerbation. patients are asked to record their activities during daytime in the diary cards. 5. all patients will finish investigation and blood sample after one year and two year,including questionaires,spirometry,6mwt,mip,mep,bmi,crp,tnf,il-8, etc.patients in cg will finish cardiopulmonary test.

Eligibility criteria:
inclusion criteria: * according to gold, patients who are diagnosed as copd, lung function at ii or iii grades (ii:50%≤fev1\<60%pre；iii:30%≤fev1\<50%pre）； * 40≤age≤75 years old； * don't have acute exacerbation in the past one month； * spo2 \> 88% at rest； exclusion criteria: * diabetes,blood glucose don't control well; * vascular diseases(vasculitis,deep venous thrombosis,varicose veins, etc); * joint diseases which may affect activities; * cerebrovascular diseases which may affect activities; * unstable angina during the past 1 month of acute myocardial infarction in the past 6 months; * severe arrhythmia; * cardia insufficiency; * hypertension which don't control well(systolic pressure\>160mmhg and/or diastolic pressure\> 100mmhg); * chronic liver or renal insufficiency; * cognitive handicap.

Keywords: copd rehabilitation quality of life inflammation