Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of eschscholtzia californica in treating primary insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the aim of this trial was to assess the efficacy and safety of eschscholtzia californica (ec) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.


Eligibility criteria:
inclusion criteria: * male or female above 18 or below 65 years old * diagnosis of psycho-physiologic insomnia, according to the criteria of dsm-iv (diagnostic and statistical manual - version iv) * written informed consent exclusion criteria: * patient who is already taking other investigational drugs or who has taken part in another trial during the past three months * patient who has an history of psychiatric diseases, such as: * anxiety disorders; the score of the hama (hamilton anxiety scale) must be \< 10 * depression according to the dsm iv criteria; the score of the hamd (hamilton depression scale) must be \< 10 * mania * schizophrenia * dementia * patient who has an history of neurologic diseases, such as: * parkinson syndrome * crania cerebral trauma post syndrome * brain tumor * fibromyalgia * patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic * patient with an hypersomnia or a sleep apnea syndrome * patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea * patient with a restless leg syndrome * patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial * breast feeding or pregnant female, or female with no efficient contraception method * patient with non-stabilised thyroid dysfunction * patient with a known allergy to eschscholtzia californica or its compounds * patient with alcohol or drug dependency * patient drinking tea, coffee or coca-cola after 4 p.m.
the roles of age, comorbidity, and telomere length in lung cancer treatment and prognosis

Conditions: Lung Cancer

Summary: the investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. the change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, uv, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as ha-ras. the cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

Eligibility criteria:
inclusion criteria: 1. patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy. 2. the diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study. exclusion criteria: includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.

Keywords: lung cancer telomere length comorbidity eastern cooperation oncology group (ecog) chemotherapy
dermotaxis v/s loop suture technique for closure of fasciotomy wounds : a study of 50 cases

Conditions: Inexpensive Closure of Fasciotomy Incisions Without the Need for Skin Grafting

Summary: the fasciotomy incisions lead to large, unsightly, chronic wounds after surgical intervention. the classic management was split thickness skin grafting but it leads to insensate skin with 23% of people upset by the appearance of the wound and 12% forced to changed occupation. since no skin loss has occurred with the fasciotomy and utilizing the dermal properties of creep, stress relaxation and load cycling closure can be achieved in a better way. our hypothesis is that using dermatotraction approximation could be done using inexpensive equipment readily available in any standard operating room.

25 cases each of fasciotomy will be closed either by dermotaxis or loop suture technique with the inclusion criteria being closed fractures, no concomitant skin loss, fracture related compartment syndrome and fasciotomy within 36 hrs. the fasciotomy incision will be either closed in a single stage by loop suture technique or gradually by dermotaxis once the edema settled between 3-5 days. the results will be graded as excellent if approximation could be achieved, good if sutures have to be applied for protective care and poor if they have to be grafted. in dermotaxis (singhs skin traction) method two parallel kirschner wires (1.5mm) will be passed through the dermis on either side of the wound margins and interconnected by compression device consisting of threaded rod having two blocks and compression knob. gradual compression will be applied daily at the rate of 1 turn/12hours on both sides of the wound. the loop suture technique involves using corrugated drains and ethilon no.1. it is an extension of the purse string suture technique where a surgical suture is passed as a running stitch in and out along the edge of a wound in such a way that when the ends of the suture are drawn tight the wound is closed. two corrugated drains (1 \& 2) will be anchored to the skin adjacent to the fasciotomy incision using ethilon no.1. then the sutures will be passed from one edge of the wound through the skin and corrugated drain to the other in an alternating fashion.

Eligibility criteria:
inclusion criteria: * the inclusion criteria being closed fractures, no concomitant skin loss, fracture related compartment syndrome and fasciotomy within 36 hours. exclusion criteria: * the exclusion criteria was open fractures, skin loss, non-fracture related compartment syndrome and presentation after 36 hours

Keywords: inexpensive, fasciotomy
prophylactic pancreatic duct stenting in acute necrotizing pancreatitis

Conditions: Acute Necrotizing Pancreatitis

Summary: since the majority of patients with necrotizing pancreatitis will experience a leak from the pancreatic duct during their course of disease resulting in intra- and peripancreatic fluid collections, it is reasonable to hypothesize that placement of a ductal stent may prevent some of the late complications and morbidity associated with pancreatic necrosis. this prospective, randomized, controlled multicenter trial investigates the role of early prophylactic ductal stenting in acute necrotizing pancreatitis. the purpose of the study is to determinate the safety and feasibility of early prophylactic pancreatic duct stenting in necrotizing pancreatitis in reducing complications, length of stay in hospital and in in-tensive care unit compared to the traditional treatment.


Eligibility criteria:
inclusion criteria: in patients with suspected necrotizing pancreatitis a pancreatic protocol 3-phase contrast enhanced (ce) ct shall be performed. since a very early ct may underestimate the extent of pancreatic necro-sis, it is recommended to wait at least 72 hours after the onset of symptoms before ct is done. the cect may be repeated if the initial ct shows no necroses and the clinical course continues to indicate a severe case. mri may be used instead of ct in case of contraindication to intravenous contrast due to renal failure. if cect reveals pancreatic necrosis affecting the head, neck, or body of pancreas and the necrosis is suspected to include the main pancreatic duct an informed consent to participate in the study is ob-tained, after which the patient will be randomized to either a) the control group with traditional treat-ment (i.e. at the discretion of each participating center) or to b) the intervention group with same treatment as in the control group plus erp and pd-stenting. patients with isolated necrosis of the tail will not be included in the study. exclusion criteria: all consecutive patients (age between 18-75 years) admitted to the participating centers for acute pan-creatitis with an area of non-enhancing pancreatic parenchyma on ct believed to represent necrosis are prospectively enrolled in the study. at initial presentation the age, gender, etiology of the pancreatitis, clinical and laboratory findings will be recorded. patients with malignancies and patients from whom an informed consent to participate in the study cannot be obtained will be excluded. -

Keywords: acute necrotizing pancreatitis ercp pancreatic stenting
3d bio-structures for g.i. post-surgical defects

Conditions: Fistula

Summary: the study is focused on evaluating the safety and efficacy of using vascular stromal tissue, derived from autologous adipose tissue, and subjected to microfragmentation and emulsification (stromal vascular fraction micro-emulsion - tsvfem), in the treatment of chronic gastrointestinal fistulae (cgf). tissue regeneration will be stimulated using 3d bio-printed scaffolds, enriched at implantation with mesenchymal stem cells derived from patients' adipose tissue; injection of tsvfem and scaffold placement will be performed endoscopically. the study proposes to use 3d bioprinting to create customized polymeric bioinks (gels) on supporting scaffolds that can serve as a framework for the growth and development of the patient's cells. this approach aims to promote tissue regeneration and integration, repair extensive cgf and restore the proper microbiota. a small portion of the patient's tsvfem will be injected in a bioreactor into the scaffolds and used for evaluation of the ability of the scaffolds to support cell proliferation, migration, and differentiation, as well as secretion of cytokines and growth factors and the immunological response. also, to analyze the effect on cells and microbial species, the intestinal microbiota will be analyzed in a bioreactor under different dynamic conditions on the growth and differentiation of the mscs contained in tsvfem, on the bio-printed scaffolds and the immunological results.


Eligibility criteria:
inclusion criteria: * patients with cgf at any level that can be approached endoscopically and for whom the possibility of conventional conservative treatment is ruled out, or all possible conservative or surgical treatments have already been performed without benefit, or in whom the reiteration of such treatments is contraindicated, because of life-threatening, and/or possible complications, and/or disabling outcomes. exclusion criteria: * patients who have not given informed consent to the procedure; * patients with entero-enteral cgf, * patients who have therapeutic options of other type.
the efficacy and safety of alemtuzumab in auotoimmune cytopenias

Conditions: Autoimmune Cytopenias

Summary: the majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (itp), autoimmune hemolytic anemia, autoimmune neutropenia (ain) and pure red cell aplasia, will respond to conventional immunosuppressive therapy with or without splenectomy. there is, however, a group of patients with refractory or chronically relapsing autoimmune cytopenias causing life-threatening hemorrhages, infections or anemia. further problems include the short- and long-term side-effects of corticosteroids, and the potential toxicity of immunosuppressive and cytotoxic agents. an alternative and less toxic approach in these patients may be the treatment with campath-1h, a humanized igg monoclonal antibody specific for the cd52 antigen and present on human lymphocytes and monocytes. the main effect of campath-1h is on t cell and it results in a prolonged and profound depletion of the cd4 and cd8 subpopulations, particularly the cd4 population, and this might "reset" the immune system without the need for total immune ablation.therefore, this study is designed to investigate safety and efficacy of repeated campath treatment cycles in autoimmune cytopenia.in order to minimize possible side effects of accumulating campath, the 3 treatment cycles will be administered in consecutively reduced doses.


Eligibility criteria:
inclusion criteria: 1. patients must have a diagnosis of the following autoimmune cytopenias: immune thromobocytopenia purpura (itp) autoimmune hemolytic anemia (aiha) autoimmune neutropenia (ain) pure red cell aplasia (prca) and 2. patients must have refractory disease according to the following criteria 1. not respond to steroids or 2. need prednisolone more than 15 mg/d for maintenance therapy 3. complete work up for baseline evaluation and measurement 4. age \> 18 years 5. patient's free written inform consent exclusion criteria: 1. patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab 2. patients with poor performance status (ecog criteria of 3-4) 3. serologic evidence of human immunodeficiency virus exposure 4. patients with active uncontrolled infection. patients that are hiv positive or test positive on hbs or hcv antigens. 5. pregnant or lactating women 6. serious medical or psychiatric illness which prevent informed consent 7. patients who are likely to lost to follow up (eg, unwilling or difficult to return, cannot be contacted) 8. patients with active malignancies

Keywords: alemtuzumab in autoimmune cytopenias
plasma citrulline in preterm with nec

Conditions: NEC; Citrulline

Summary: aim of study

introduction

Eligibility criteria:
inclusion criteria: * preterm neonates \< 35 weeks preterm neonates\< 2kg preterm neonates diagnosed with necrotizing enterocolitis exclusion criteria: * renal dysfunction inborn error of metabolism congenital malformation
glans penis augmentation by hyaluronic acid for treatment of premature ejaculation

Conditions: Premature Ejaculation

Summary: this randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using hyaluronic acid in the treatment of premature ejaculation in compare with placebo .


Eligibility criteria:
inclusion criteria: * occurrence of ejaculation in patients with lifelong premature ejaculation (ll pe) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (a pe), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy exclusion criteria: * erectile dysfunction * hypo or hyperthyroidism * hypogonadism * hyperprolactinemia * drug abuse * psychiatric disorders or related medications

Keywords: premature ejaculation ielt hyaluronic acid glans penis augmentation
oncology research information exchange network (orien) lung cancer study

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: the moffitt cancer center and patientslikeme.com (plm), an online patient community, are working together to better understand the patient's entire lung cancer experience, both inside and outside the doctor's office. by combining the data that is captured by their care team in the clinic with the data participants enter at their home on patientslikeme.com, the investigators hope to improve patient-physician treatment decisions, so that the patient's personal treatment goals and quality of life have the highest chances of being fulfilled.

the aim of the study is to assess the real-world patient experience by evaluating the patients' quality of life, treatment toxicities, and clinical measures over a 6-month period. the ultimate goal of this research is to improve patient-physician treatment decisions, so that the patient's personal treatment goals and quality of life have the highest chances of being fulfilled. aim 1. to track the toxicities/side-effects of fda approved molecular targeted agents, immunotherapies, and combinations of treatments for nsclc in a clinical setting for six months. aim 2. to assess the impact of these treatment regimens on patient toxicities, symptoms, function, and quality of life, after adjustment for clinical factors and patient characteristics during the 6 month follow-up period.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age * diagnosed with metastatic (stage 3b/4) non-small cell lung cancer (nsclc) * the total combined sample size must include at least 100 people who received one or more treatments of pd-1/pdl-1 inhibitor treatment (immunotherapy), and 50 patients who received an epidermal growth factor receptor tyrosine kinase inhibitor (egfr-tki). patients receiving any other treatments will be tracked for treatment outcomes, as well as to serve as comparison participants during data analyses of outcomes associated with pd-1/pdl-1 or egfr-tki). * consented separately to the total cancer care (tcc) protocol * have access to the internet * willing to enroll in the free online health tracking and patient community "patientslikeme" exclusion criteria: * patients enrolled in phase i clinical trial protocols * patients enrolled in phase ii, iii or iv clinical trials involving blinded therapies (patients in open label trials will be eligible)

Keywords: nsclc carcinoma, non-small-cell lung lung diseases thoracic neoplasms
special drug use investigation - assessment of efficacy and safety in treating secondary infection of chronic respiratory disease

Conditions: Anti-Infective Agents

Summary: the objective of this study is to assess the efficacy and safety of avelox tablet 400 mg (hereinafter as "avelox") in treating secondary infection of chronic respiratory disease.it is a local prospective and observational study of patients who have received avelox tablets for laryngopharyngitis, tonsillitis, bronchitis acute, pneumonia, secondary infection in chronic respiratory diseases, sinusitis. a total of 500 patients are to be enrolled and assessed during the period of treatment with avelox.


Eligibility criteria:
inclusion criteria: * patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings) who meet the following criteria: * 20 years old or older * with infection of mild or moderate severity * patients who meet the following criteria immediately before starting the therapy: ≥37°c of body temperature, expectoration of purulent or mucopurulent sputum, and either white blood cell count ≥8,000/mm3 or crp ≥0.7 mg/dl exclusion criteria: * patients who are contraindicated based on the product label.

Keywords: avelox laryngopharyngitis tonsillitis bronchitis acute pneumonia secondary infection in chronic respiratory diseases sinusitis
computer aided diagnosis of colorectal neoplasms during colonoscopic examination

Conditions: Colon Polyp

Summary: an nbi-based diagnosis requires training and experience. we are developing a system of computerized image recognition, which can detect possible nbi features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.


Eligibility criteria:
inclusion criteria: the same as colonoscopy exclusion criteria: the same as colonoscopy
the benefits of intracytoplasmic morphologically selected sperm injection (imsi) in couples with unexplained infertility

Conditions: Pregnancy

Summary: the (motile sperm organelle morphology examination) msome allows the detection of sperm vacuoles that seems to be related to sperm dna damage. the investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

when routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. these couples present normal semen analysis. it has been reported that even infertile patients with normozoospermic parameters can have higher values of dna damage than fertile controls. it has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates. the motile sperm organelle morphology examination (msome) allows the detection of sperm vacuoles that seems to be related to sperm dna damage. the investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

Eligibility criteria:
inclusion criteria: * women of good physical and mental health * undergoing assisted reproduction as a result of unexplained infertility * women with regular menstrual cycles of 25-35 days * women with normal basal follicle stimulating hormone (fsh) and luteinizing hormone (lh) levels * women with body mass index (bmi) less than 30 kg/m2 * women with both ovaries and intact uterus exclusion criteria: * men with abnormal semen parameters according to the 2010 who values * women with polycystic ovaries * women with endometriosis * women with gynaecological/medical disorders * women or men with a positive result for sexually transmitted diseases * women who had received hormone therapy for at least 60 days preceding the study

Keywords: icsi imsi pregnancy sperm morphology unexplained infertility