Kornimate/medical-research-clean huggingface dataset:
hematopoietic stem cell transplantation for malignant infantile osteopetrosis

Conditions: Osteopetrosis

Summary: the purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic cells using chemotherapy regimen without total-body irradiation in children undergoing a hematopoietic stem cell transplant for malignant infantile osteopetrosis. the blood stem cells will be derived from either related donor or unrelated umbilical cord blood or haploidentical donor.


Eligibility criteria:
inclusion criteria: * diagnosis of osteopetrosis confirm by bone biopsy and radiographic imaging * age up to 5 year old exclusion criteria: * carbonic anhydrase ii (caii) deficiency osteopetrosis variant * creatinine clearance ≤ 40ml/min/1.73m\^2 or rta * bilirubin ≥ 3mg/dl * sgpt ≥ 500 u/l * current severe infection * evidence of cns involvement * morbidity such as blindness or deafness

Keywords: osteopetrosis hsct
study of the kinexconnect telerehabilitation system (kctrs)

Conditions: Osteoarthritis, Knee

Summary: a randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (cpm) and a tablet-based patient engagement application (kinexconnect) versus traditional outpatient physical therapy (pt) following total knee arthroplasty (tka).

the randomized study of the kinexconnect telerehabilitation system is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the united states. the study compares at-home telerehabilitation system versus traditional outpatient pt following total knee arthroplasty (tka). the telerehabilitation system involves a tablet-enabled patient engagement application, the kinexconnect app, to be used in conjunction with a continuous passive motion (cpm) machine.

Eligibility criteria:
inclusion criteria: 1. planned for a primary unilateral tka. 2. at least 21 years of age. 3. capable of understanding the study requirements and giving written informed consent. 4. willing and able to comply with either therapy program. 5. has easy access to caregiver support. exclusion criteria: 1. active range-of-motion (arom) \< 80 degrees in target knee. 2. unable to read and write in english. 3. lack of email capability to receive recovery trend information. 4. previous knee intervention in target knee. 5. previous knee joint infection in either knee. 6. received a revision tka (opposite knee). 7. planned for bilateral tka. 8. self-reported pregnancy. 9. reason for arthroplasty being for the treatment of fracture, infection or malignancy. 10. other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed. 11. unwilling to participate.

Keywords: arthroplasty knee replacement rehab at home virtual pt remote patient monitoring patient engagement tkr tka
the effect of laughter yoga on psychological well-being

Conditions: Laughter; Quality of Life

Summary: brief summary: the definition of individuals with disabilities, who are among the disadvantaged group, is defined by law no. 5378 as "those who have difficulties in adapting to social life and meeting their daily needs due to the loss of their physical, mental, spiritual, sensory and social abilities at various degrees due to any congenital or subsequent reason; and a person who needs protection, care, rehabilitation, counseling and support services" (law on the disabled). due to the fact that the conditions and needs of physically disabled women are not well expressed, they have not benefited enough from services such as education and health and they have faced difficulties. no study has been found in the world or in our country that examines the effect of laughter yoga on physically disabled women and their relatives. in this study, it is thought that the practice of laughter yoga can increase the psychological well-being and quality of life of physically disabled women and their relatives. aim: this study was planned to measure the effect of laughter yoga on psychological well-being and quality of life in physically disabled women and their relatives.

detailed description: method: the research was planned as a quasi-experimental study including pre-test, post-test and follow-up. the research will be carried out by reaching physically disabled women and their relatives affiliated to sinop disabled association. population and sample: disabled women living and their relatives in sinop in the sinop disabled association will form the universe of our study, and all individuals who have agreed to participate in the study and volunteered will form the sample. how the research was conducted: laughter yoga to be done will last eight weeks, once a week. each session of laughter yoga is planned to be approximately 40 minutes. personal information form, psychological well-being scale, sf-12 quality of life scale short form, psychological well-being scale and sf-12 quality of life scale as a post-test at the end of the laughter yoga were used for the physically disabled women and their relatives who agreed to participate in the study before starting the study. the short form and the psychological well-being scale and the sf-12 quality of life scale short form will be administered again in the follow-up (one month after the application has ended).

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * being woman, * not being mentally handicapped * having a physical disability * being a relative caring for a woman with a physical disability. exclusion criteria: * not being between the ages of 18-65, * to being male, * being mentally handicapped * not having a physical disability * not volunteering to participate in the research.

Keywords: laughter therapy psychological well being quality of life physically disabled women
thymidine kinase 1 in risk assessment for hereditary breast /ovarian cancer

Conditions: Breast Cancer; Ovarian Cancer

Summary: this study aimed to compare the activity of thymidine kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.

hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor brca1 and brca2 genes. products of these genes play an important role in the repair of dna double-strand breaks. mutations in brca1 and brca2 genes could impair dna repair. in resting or g1 cells, where the de novo synthesis of dna precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in dna repair. for this process a sufficient supply of deoxynucleotides and activity of thymidine kinase 1 are essential. tk1 is an important component of adaptive response of cells to dna damage. mutations in genes directly engaged in the dna repair process could lead to the accumulation of dna damage and in turn cause an adaptive cell reaction manifesting as permanently increased thymidine kinase 1 activity. a recently developed new high-sensitive assay divitum® allows to investigate the contribution of this enzyme to dna repair processes and to make a comparison of thymidine kinase 1 activity in women with normal and impared dna repair system.

Eligibility criteria:
inclusion criteria: * women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age; * women from family with more than three breast cancer cases diagnosed before the age 50; * women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer. exclusion criteria:• * pregnant women; * women with generalized cmv and hzv infections; * women with severe b12 deficiency and megaloblastic anaemia; * women with severe rheumatoid arthritis.

Keywords: thymidine kinase 1 brca1 and brca2 mutations hereditary breast/ovarian cancer
gs-5885, gs-9451, tegobuvir and ribavirin (rbv) in interferon ineligible or intolerant subjects with chronic genotype 1a or 1b hepatitis c virus (hcv) infection

Conditions: Chronic Genotype 1a or 1b HCV Infection

Summary: this is a phase 2 randomized, double-blind, placebo-controlled study of gs-5885, gs-9451, tegobuvir and ribavirin; gs-5885, gs-9451 and tegobuvir; gs-5885, gs-9451 and ribavirin in interferon ineligible or intolerant subjects with chronic genotype 1a or 1b hcv infection.


Eligibility criteria:
inclusion criteria: * adult subjects 18 and older with chronic hcv infection * liver biopsy results (performed no more than 3 years prior to screening) indicating the absence of cirrhosis * monoinfection with hcv genotype 1a or 1b * interferon ineligible or intolerant * body mass index (bmi) between 18 and 40 kg/m2 * use of highly effective contraception methods if female of childbearing potential or sexually active male * screening laboratory values within defined thresholds * has not been exposed to any investigational drug or device within 30 days of the screening visit * able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments exclusion criteria: * prior treatment of hcv with any direct-acting antiviral (whether approved or experimental) * decompensated liver disease or cirrhosis * co-infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or another hcv genotype * history of difficulty with blood collection and/or poor venous access * pregnant or nursing female or male with pregnant female partner * chronic liver disease of a non-hcv etiology * suspicion of hepatocellular carcinoma * clinically-relevant drug abuse

Keywords: hepatitis c hcv rapid virologic response sustained virologic response direct acting antiviral combination therapy tegobuvir treatment naïve hcv rna polymerase inhibitor protease inhibitor interferon intolerant interferon ineligible gs-9190 gs-9451 gs-5885
comparing 150cm oagb with 150cm biliopancreatic limb rygb. a non-inferiority trial

Conditions: Bariatric Surgery Candidate; Obesity; Obesity, Morbid

Summary: the purpose of this study is to assess the safety and efficiency of oagb compared to rygb

rationale: to compare two different types of gastric bypass operations on surgical outcome. objective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness. study design: a multicentre, open label, non-inferiority randomized controlled trial study population: patients are eligible for inclusion if their body-mass index (bmi) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (bmdt) and are aged 18-65. intervention: group 1: one anastomosis gastric bypass with 150cm biliopancreatic limb. group 2: roux-en-y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb. main study parameters/endpoints: primary endpoint: % excess bmi loss at two years secondary endpoints: metabolic status nutritional status comorbidity remission qol complications or serious adverse events (sae's)

Eligibility criteria:
inclusion criteria: * body-mass index (bmi) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) * a positive evaluation by our bmdt exclusion criteria: * presence of h. pylori, resistant to eradication therapy * chronic diarrhoea * history of previous bariatric or extensive abdominal surgery
use of usg in difficult airway in obese

Conditions: Obesity

Summary: introduction and purpose: obesity is an increasing public health problem all over the world. obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. obesity is frequently encountered in elective and emergency surgical procedures and causes more difficulties in airway management. difficult airway, characterized by difficult mask ventilation and difficult intubation, is especially common in obese and morbidly obese patients. some studies show that the measurement of anterior neck soft tissue thickness at the level of the vocal cords plays an important role in estimating difficult laryngoscopy in obese patients. difficult intubation is envisaged in patients with pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the level of the vocal cord. in this prospective observational study, it is aimed to measure the preoperative anterior cervical soft tissue thickness with 3 parameters by usg in obese patients undergoing elective surgery, and to evaluate the relationship of these values with the han scale and cormack-lehane classification and their effectiveness as an indicator of difficult airway.

materials and methods: 157 patients who will undergo elective surgery under general anesthesia, ages between 18-80, bmi ≥ 30 kg/m2, asa i-ii were included in the study. during the preoperative evaluation, patients' gender, age, height, weight, type of surgery, bmi, neck circumference, thyromental distance (tmm), sternomental distance (smm), hyomental distance (hmm), neck extension, mouth opening and distance between incisors were measured and tooth structure was evaluated. osas was evaluated based on the asa physical condition score and ahi. mallampati classification was recorded. upper lip bite test was performed. ultrasonographic measurements were made with the patient in the supine position and the head and neck in a neutral position. the han scale was used to evaluate difficult mask ventilation. the laryngoscopy image was evaluated and recorded with the cormack-lehane classification, and ≥2b was accepted as difficult laryngoscopy.

Eligibility criteria:
inclusion criteria: * elective surgery, ages between 18-80 bmi over 30, asa i-ii exclusion criteria: * facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history.

Keywords: obesity ultrasound difficult airway
efficacy and safety of hydeal-d vaginal pessaries application on the treatment of vaginal atrophy in post-menopause women

Conditions: Vulvovaginal Atrophy

Summary: this study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.


Eligibility criteria:
inclusion criteria: * postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum fsh levels \>40 iu/l, or had been surgically postmenopausal for more than 6 months) * women between 45 and 75 years of age. * vaginal ph ≥5 * vulvovaginal atrophy with vhi \< 15 * at least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity * women with active sex lives * patients who give written informed consent to participate in the trial exclusion criteria: * enrollment in other clinical trials within the previous 1 month. * patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week * patients in previous treatment with either oral or topical hormonal products within 1 month. * patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (bv); or history of vulgovaginal contact allergy. * patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors. * positive history of hypersensitivity hyaluronic acid or to any component of the medical device. * women with no active sex lives * women who do not give informed consent; * any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient

Keywords: hyaluronic acid post-menopause
changes in hematological parameters with glycemia control in type 2 diabetes

Conditions: Poorly Controlled Diabetes Mellitus

Summary: there is a systemic low-grade chronic inflammation in diabetes, and research suggests that this inflammation plays a vital role in the development of diabetic complications. macrovascular complications, which are associated with atherosclerosis, are recognized as a chronic inflammatory disease. in this study, the aim was to evaluate the potential alteration in hematologic inflammatory markers among patients with poorly controlled type 2 diabetes subsequent to the enhancement of diabetes management.

patients who were referred to the diabetes outpatient clinics and had hba1c levels equal to or greater than 10% were enrolled in this study. detailed medical histories, comorbidities and medication usage (including both regular and new prescriptions), adherence to dietary recommendations, and occurence of recent infections were collected. additionally, the patients' biochemical and hematological data were collected. after a three-month period, follow-up interviews with the same patients were conducted to inquire about any changes in medication usage, experienced illnesses, and hospital admissions. based on the changes in hba1c levels during this three-month period, the patients were divided into three equal groups. the baseline and third-month leukocyte counts, neutrophil counts, lymphocyte counts, and platelet counts for these groups were recorded. furthermore, the neutrophil/lymphocyte ratio, lymphocyte/monocyte ratio, platelet/lymphocyte ratio, monocytes/hdl-cholesterol ratio, and platelets/hdl ratio for each group were analyzed.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * having type 2 diabetes * giving consent to the study * hba1c level \>=10 % exclusion criteria: * presence of acute infection * presence of other diseases that can cause inflammation * hematological diseases * acute metabolic decompensation * not being able to come to follow-ups * presence of non-thyroid endocrine disease * application of oncologic treatment * leukocyte count \>12 000

Keywords: type 2 diabetes glycemic control neutrophils neutrophil/lymphocyte ratio lymphocyte/monocyte ratio platelet/lymphocyte ratio monocytes/hdl-cholesterol ratio platelets/hdl ratio
a study to provide roactemra/actemra (tocilzumab) to patients with multicentric castleman's disease who demonstrated benefit from previous roactemra/actemra treatment

Conditions: Castleman's Disease

Summary: this open-label, single center study will provide roactemra/actemra (tocilizumab) to a maximum of 4 patients with multicentric castelman's disease who have demonstrated benefit from roactemra/actemra in study mra004us (chugai pharma usa) without major toxicities or significant adverse events. patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to roactemra/actemra in protocol mra001us, maintained clinical benefit in mra004us, and completion of mra004us * life expectancy \> 12 weeks * zubrod performance status \</= 3 exclusion criteria: * serious toxicity including anaphylactic reactions to tocilizumab during the mra004us trial * any treatment for multicentric castleman's disease except for corticosteroids within 2 weeks prior to day 1 * active infection requiring iv antibiotics for \> 1 month and not resolving at least 1 week prior to day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed * active viral infection within 28 days prior to day 1 * treatment with any investigational agent other than roactemra/actemra within 30 days prior to baseline
spd489 as adjunctive treatment in adults with negative symptoms of schizophrenia

Conditions: Negative Symptoms of Schizophrenia

Summary: to assess the safety and efficacy of spd489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.


Eligibility criteria:
inclusion criteria: * subject has diagnosis of schizophrenia for at least 2 years * subject has persistent predominant negative symptoms * subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months * subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications * subject has been clinically stable and is in the non-acute phase of illness exclusion criteria: * subject has clinically notable positive symptoms * subject is considered to be treatment refractory * subject has current history of substance abuse/dependance * subject is considered a suicide risk or risk to harm others
study to validate telemetric ecg systems for first dose administration of fingolimod (start)

Conditions: Multiple Sclerosis

Summary: this study evaluated bradycardiac events during first dose observation of fingolimod in ms patients.


Eligibility criteria:
key inclusion criteria: * subjects with relapsing remitting ms. * patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy. * patients who had been previously on 2nd line therapies. it was understood that these patients satisfied the above mentioned criteria listed under a. in the past. this also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the start study) but discontinued treatment due to medical reasons. - or patients with rapidly evolving severe rrms (e.g. \> 2 relapses with disease progression in one year and \> 1 gd-enhancing lesion or with a significant increase in t2 lesions compared to a recent mri). key exclusion criteria: * immunocompromised patients * active infections * pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception * presence of malignancy (other than localized basal cell carcinoma of the skin).

Keywords: multiple sclerosis ms fingolimod gilenya ecg bradyarrythmia conduction abnormalities first dose observation
special investigation for long-term use of sildenafil (regulatory post marketing commitment plan)

Conditions: Pulmonary Hypertension

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first sildenafil(revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * patients need to be administered sildenafil(revatio) in order to be enrolled in the surveillance. exclusion criteria: * patients not administered sildenafil(revatio).