Kornimate/medical-research-clean huggingface dataset:
the effect of ultrasound-guided modified pectoral nerves block versus ketamine plus magnesium infusion on analgesic profile in breast cancer surgeries

Conditions: Postoperative Pain

Summary: background: postoperative pain is one of the greatest patient concerns following surgery. however, general anesthesia cannot provide adequate postoperative pain control and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation. hypothesis: the investigators assume that both ultrasound guided modified pecs block and combination of ketamine and magnesium sulphate infusion can achieve better analgesia in major breast cancer surgery in the form of reducing total amount of intraoperative fentanyl requirement and reducing postoperative morphine requirement and improvement of postoperative vas scores both at rest and during shoulder movement so we plan this study to evaluate this assumption

surgery on the chest wall is relatively common and can be associated with significant postoperative discomfort and pain; and one of the most common surgical sites on the chest wall is the breast, with the main indication for breast surgery being breast cancer. breast cancer has continued to be the most common cancer in females, accounting for approximately 31% of all newly detected cancer cases in the female population, worldwide. (1, 2) thousands of patients undergo surgery in the mammary and axillary regions every year, and these procedures tend to cause significant acute pain and may develop in to cases of chronic pain in 25-60% of cases. (3) pain can be controlled using systemic opioids which have a respiratory depressant effect and causing nausea and vomiting. also can be controlled using epidural catheter that can cause haemodynamic instability, so we are searching about how to devrease pain with less complications.

Eligibility criteria:
inclusion criteria: * female patients with american society of anesthesia classification(asa) ii physical status undergoing major breast cancer surgery with axillary evacuation under general anesthesia. * patients' age from18 to 65 years. * body mass index (bmi) are from 20 to 40 kg/m2. exclusion criteria: * pregnant patients * patients having sensitivity or contraindication to test drugs or regional anesthesia. * severe respiratory or cardiac disorders. * history of psychological disorder. * chronic pain . * significant liver or renal insufficiency. .
multi-country, multi-center cohort study of anti-mullerian hormone profile in asia pacific infertile patients

Conditions: Infertility

Summary: this study is to detect the infertile couple (women) anti-mullerian hormone (amh) profile in major subgroups such as poly cystic ovarian syndrome (pcos), endometriosis, etc via age intervals and ethnic difference.

to consecutively enroll infertile couple (women) who are undergoing their first controlled ovarian stimulation cycles. to mainly compare the inter-ethnic difference in age-specific amh profile in unexplained infertility, male factor infertility, pcos, endometriosis etc. subgroups. to detect the influence of past or present smoking on age-specific amh levels to study the influence of body mass index (bmi) on age specific amh levels

Eligibility criteria:
inclusion criteria: * diagnosed as infertile couple * naive patients who plan to enter their first ovarian stimulation cycles * women among 20-43 years old exclusion criteria: * systematic disease that impact amh (eg. systemic lupus erythematosus (sle), crohn's disease etc.) * chemotherapy history * alcohol abuse * currently taking oral contraceptive pills
early access program using alpha 1 antitrypsin infusion for patients with steroid refractory acute gvhd after hematopoietic stem cell transplantation (hsct)

Conditions: Acute-graft-versus-host Disease; Steroid Refractory Acute Graft Versus Host Disease; Graft-versus-host-disease; Graft Vs Host Disease; Alpha 1-Antitrypsin Deficiency; Alpha-1 Proteinase Inhibitor; Alpha-1 Protease Inhibitor Deficiency; Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant

Summary: an early access program for patients with steroid refractory acute gvhd after hematopoietic stem cell transplantation. this program is available for female and male who are recipients of allogenic hsct and who have been newly diagnosed with acute gvhd.

glassia (human alpha-1 proteinase inhibitor (a1pi), also known as human alpha-1 antitrypsin, kamada-aat or kamada-api) is a, liquid, ready-to-use preparation of human a1pi. alpha-1 proteinase inhibitor belongs to the family of serine proteinase inhibitors and is primarily produced in the liver and secreted into the circulation. in addition to its anti-proteinase activity, a1pi showed to have anti-inflammatory, anti-apoptotic and immunomodulatory properties (1-4). glassia is an injection solution prepared from human plasma collected from healthy volunteer blood donors in accordance with food and drug administration (fda) and european medicines agency (ema) regulations. glassia was approved in the united states (us) in july 2010 and is indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of alpha1-pi (alpha1-antitrypsin deficiency).

Eligibility criteria:
inclusion criteria: * this program is available for patients who suffer from steroid refractory acute gvhd after hsct, or for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable. * the disease indication for which the participant required hsct must be in remission * acute graft-versus-host disease (agvhd), including lower gi involvement (modified * international bone marrow transplant registry (ibmtr) severity stage 1 to 4 \[\>500 ml diarrhea/day\]), with or without other organ system involvement. * for women of childbearing potential, had a negative serum or urine pregnancy test within 14 days prior to enrolment. exclusion criteria: * participant with manifestations of chronic gvhd * participant with acute/chronic gvhd overlap syndrome * participant whose gvhd developed after donor lymphocyte infusion * participant with severe sepsis involving at least 1 organ failure * participant who is seropositive or positive in the nucleic acid test for human immunodeficiency virus (hiv) * participant with active hepatitis b or c * if female, participant is pregnant or lactating at the time of enrollment, or has plans to become pregnant during the program
analysis of the parameters obtained on stabilometric platform in patients with pd

Conditions: Parkinson's Disease; Disturbance; Balance, Labyrinth; Other Falls

Summary: objective: to analyze different parameters in patients with parkinson's disease (pd) obtained through the use of a stabilometric platform and compare them with those of a control population. to interpret the data in order to find some postural instability indicators that can become useful to build a rehabilitation strategy for balance disorders in pd.

background: posture and balance are the foundation on wich upright stance and walking are executed. postural instability is the impairment in balance that compromises the ability to maintain or change posture such as standing and walking. it is considered to be one of the cardinal features of pd. in such patients it is present even at diagnosis and worsens with disease progression. it correlates with falls representing a major source of disability and reduced qol in pd. in this course, the study of balance is important to identify patients who can benefit from specific rehabilitative treatment. objective: to analyze different parameters in patients with pd obtained through the use of a stabilometric platform and compare them with those of a control population. to interpret the data in order to find some postural instability indicators that can become useful to build a rehabilitation strategy for balance disorders in pd.

Eligibility criteria:
inclusion criteria: * pd according to gelb et al., in hoehn-yahr stage 3, with the ability to walk without any assistance, who had fallen in the last year at least 2 times, with mini-mental state examination score ≥26. * healthy volunteers exclusion criteria: * atypical parkinsonism * patients with cerebro-vascular disorders or other neurological conditions including cognitive impairment. * patients with relevant comorbidity or vestibular/visual dysfunctions limiting locomotion or balance.

Keywords: stabilometric platform postural instability
a regulatory post marketing surveillance (rpms) study of ryzodeg® flextouch® (insulin degludec /insulin aspart) to evaluate safety and effectiveness in patients with diabetes mellitus in routine clinical practice in korea

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to collect information about safety and effectiveness of ryzodeg® flextouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.


Eligibility criteria:
inclusion criteria: - the decision to initiate treatment with commercially available ryzodeg® flextouch® 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 - signed 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 - age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (type 1 or type 2) and who is scheduled to start treatment with ryzodeg® flextouch® based on the clinical judgment of their treating physician as specified in the korean-prescribing information (k-pi) exclusion criteria: - patients who are or have previously been on ryzodeg® flextouch® therapy - known or suspected hypersensitivity to ryzodeg® flextouch®, the active substance or any of the excipients - previous participation in this study. participation is defined as having given informed consent in this study - female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by korea regulation or practice) - mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
caffeinate chewing gum on ice hockey performance

Conditions: Caffeine; Placebo

Summary: the purpose of this study was to examine the impact of caffeinated chewing gum on the physical performance of elite ice hockey players in a partial sleep deprivation state.

this study used a randomisation crossover design with a single-blind, double-blind experimental design. the participants were randomly assigned to either a caffeinated chewing gum trial (caf) or a placebo trial (pl).

Eligibility criteria:
inclusion criteria: * 1. 6 years of professional ice hockey training, * 2. 6 months of continuous training, * 3. 3 months of recovery from sports injuries such as strains and sprains exclusion criteria: * 1. non-specialised ice hockey player. * 2. has not trained regularly for the past 6 months. * 3. has recovered from an athletic injury. * 4. have been recovering from a sports injury for less than 3 months, or have epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.

Keywords: exercise performance fatigue index
treatment of hidradenitis suppurativa with eth 755nm alexandrite laser

Conditions: Hidradenitis Suppurativa

Summary: patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the alexandrite hair removal laser. the other side will serve as the control.

patients with bilateral disease will be chosen to participate in the study. patients will be advised to discontinue any prior systemic hs treatments two weeks before their first laser session as a wash out period. one side of the patient will be chosen as the treatment side, the other as an intrinsic control. each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. patients will then participate in a follow-up clinic visit two months after completion of their last treatment. in between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. at each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. the treatment side will be treated with the laser and adjusted according to skin type as follows: skin type i-ii (fair caucasian): fluence: 30j/cm2 skin type iii (darker caucasian, light asian): fluence: 25 j/cm2 skin type iv (mediterranean, asian, latin): fluence: 18 j/cm2 skin type v (light skinned black, darker mediterranean): fluence: 16j/cm2 skin type vi (dark skinned black): fluence 14 j/cm2 a spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. the treatment area will not exceed 15cm x 15cm. if the patient cannot tolerate treatment with the alexandrite laser, the patient will be terminated from the study. following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. clinical evaluation and photographs will determine improvement.

Eligibility criteria:
inclusion criteria: * age 18-65 * patients with hidradenitis suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement. exclusion criteria: * pregnant patients or patients planning to get pregnant during the time of the study * patients on systemic treatment for hidradenitis suppurativa * patients with photosensitivity disorders * patients unable to tolerate the laser treatments * intake of a photosensitive medication

Keywords: hidradenitis suppurativa hidradenitis laser
phase ii study of eloxatin+5-fu/lv in patients with unresectable hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: primary objective: to determine the tumor response rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of eloxatin+5-fu/lv secondary objective: to evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of eloxatin+5-fu/lv


Eligibility criteria:
lists of inclusion and exclusion criteria: * patients must have histologically confirmed hepatocellular carcinoma * patients must have measurable disease by ct scan * have not received previous palliative systemic chemotherapy for metastatic disease. (adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.) * patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (hepatic artery infusion, trans-artery embolization or trans-artery chemo-embolization) or at least 4 weeks after the last radiotherapy/ablation/ percutaneous ethanol injection to the target lesion. * who 0-2 grades (karnofsky performance score ≥ 70) * patients must have adequate organ and marrow function: * neutrophilus ≥ 1.5 x 10\^9/l * platelets ≥ 75 x 10\^9/l * asparagine aminotransferase, alanine aminotransferase \< 2.5 x upper normal limit(unl) * total bilirubin ≤ 1.5 x unl * international normalized ratio \< 1.5 * child stage a or b * creatinine ≤ 1.5 x unl exclusion criteria: * documented allergy to platinum compound or to other study drugs. * active gastro-intestinal bleeding and active haematologic malignancy * previous liver transplantation. * patients concomitantly receiving any other anti-cancer therapy. * patients who are receiving any other study treatments. * pregnant or lactating women or women of childbearing potential without proper contraceptive methods. * history of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. * central nervous system metastasis * other serious illness or medical conditions * neuropathy ≥ grade 2 the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
clinical trial of intravenous infusion of fucosylated bone marrow mesenchyme cells in patients with osteoporosis

Conditions: Osteoporosis; Spinal Fractures

Summary: the purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis by a prospective, single-center, open, non-randomized and unblinded clinical trial.


Eligibility criteria:
inclusion criteria: * patients with established osteoporosis according to standard clinical criteria. * patients who give their written informed consent to participate in the study consent. * meet all the inclusion criteria exclusion criteria: * patients with concomitant systemic disease in the opinion of the investigator. * patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis. * current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin. * patients with genetic disorders that are associated with secondary osteoporosis: hemochromatosis, hypophosphatasia, osteogenesis imperfecta, ehlers-danlos syndrome, marfan syndrome, riley day, porphyria, storage diseases syndrome. * patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation. * transplant patients: bone marrow, kidney, liver, heart, lung. * patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction. * patients participating in a clinical trial in the last 6 months. * patients with positive serology for hepatitis b, hepatitis c or hiv. * patients with inability to understand informed consent. * patients who are pregnant or breast-feeding actively. * patients physically fertile, defined as all women physiologically capable of becoming pregnant, unless they are using reliable methods of contraception.
snore positive airway pressure trial

Conditions: Non-Apnoeic Snorers

Summary: this study will aim to assess the acceptance of the snore pap system as a treatment concept for snore. the study will subjectively assess participant and bed partner acceptability and usability of the snore pap system and objectively assess participant compliance with the snore pap system.


Eligibility criteria:
inclusion criteria * participants willing to provide written informed consent * participants who can read and comprehend written and spoken english * participants who are ≥ 18 years of age * participants are cpap naïve * participants who are self/ partner reported snorers * participants whose apnealink study results demonstrate snore * participants who are willing to use nice system in place of current non prescribed methods for alleviating snore * participants have a bed partner * participant's bed partner willing to answer assessment questionnaire exclusion criteria * participants previously diagnosed with obstructive or central sleep apnoea * participants whose apnealink home study indicates ahi ≥6 * participants who are pregnant or breastfeeding * participants who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury) * participants with severe bullous lung disease, history of pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery or trauma. * participants who cannot participate for the duration of the trial * participants who are established on bi-level support therapy * participants currently using a prescribed medication/ device to alleviate snore * participants who are physically unable to comply with the protocol- no access to internet to conduct online visits with researcher or unable to attend clinic for visit
application of high-flow nasal oxygen in cesarean section

Conditions: Fetal Acidemia

Summary: the study propose that the using the high-flow nasl oxygen to provide oxygen for maternal can improve the fetal acidemia and the neonatal outcomes during cesarean section with combined spinal-epidural anesthesia.

maternal oxygen supplementation is widely used intrauterine resuscitation technique in clinical, which can improve fetal oxygenation and prevent fetal acidemia. the incidence of hypotension is high in cesarean section with combined spinal-epidural anesthesia. hypotension contributes to insufficient perfusion of uterus and placenta, resulting in decreased fetal oxygen supply and neonatal acidemia. high flow nasal oxygen have a better improvement oxygenation of patients by providing high flow oxygen airflow with heating and humidification through nasal cannula.

Eligibility criteria:
inclusion criteria: * an elective cesarean section in beijing tongren hospital * ≥37 weeks' gestation * american society of aneshesiologists（asa） i-iii * aged 18 to 45 years old * the fasting time is 6-8h, and the water restriction time is ≥2h * anesthesia: combined spinal-epidural anesthesia * agree to the study and sign the informed consent exclusion criteria: * fetal or placental abnormalities are known * maternal has complications * maternal bmi ≥40 kg/m2 * history of difficult intubation or known difficult airway * contraindications for hfno such as nasal lesions or structural changes * gastric reflux disease

Keywords: high-flow nasal oxygen cesarean section oxygen umbilical artery acidemia
trial of levetiracetam in patients with primary brain tumors and symptomatic seizures who undergo surgery

Conditions: Primary Brain Tumor; Epilepsy

Summary: the purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * suspected primary brain tumor by imaging * planned bioptical or cytoreductive surgery of the tumor * symptomatic epilepsy * karnofsky performance score ≥ 70% * women with child bearing potential must perform sufficient contraception * sufficient haematologic, hepatic and renal function by laboratory testing exclusion criteria: * treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery * known allergic reaction to levetiracetam or other serious side effects * known, not tumor-induced, epilepsy * previous brain surgery * dementia * participation in another clinical trial * addiction to drugs or alcohol * pregnant or breast feeding women