Kornimate/medical-research-clean huggingface dataset:
efficacy of acupuncture in patients with acute intracranial hemorrhage

Conditions: Intracranial Hemorrhages

Summary: investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.

stroke is a major cause of death and disability. according to the ministry of health and welfare in taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in taiwan in 2020. stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. this study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. subjects will be divided into two main groups by random assignment. the intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). the treatment frequency was 3 times a week for at least one week. consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment

Eligibility criteria:
inclusion criteria: * diagnosis of hemorrhagic stroke by a specialist * age over 20 years and below 85 years * gcs between 5-13 exclusion criteria: * intracranial hemorrhage resulted from vascular anomalies * pregnant patients * intracranial tumor related hemorrhage * other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury * organ damage or terminal illness (heart or kidney failure or malignancy)
validity and reliability of the dual-task questionnaire

Conditions: Multiple Sclerosis

Summary: it is important to increase the independence of multiple sclerosis (ms) patients in activities of daily living. almost all activities of daily living require managing many activities at the same time. for example, walking or standing while talking on the phone. there is a need for easily applicable, reliable and valid scales to evaluate dual-task performance in ms patients. therefore, the aim of this study is to establish the turkish cultural adaptation, validity and reliability of the dual-task questionnaire scale in ms patients. this study included a total of 50 patients with ms \[age (18-65) years\]. dual-task questionnaire (dtq), timed up and go test (tug) with dual-task and nine hole peg test (9-hpt) with dual-task were applied to the patients. the second evaluation (retest) was carried out by the same physiotherapist one week following the first evaluation (test) in order to measure test-retest reliability.

this study included patients with ms between 0-5,5 score according to the extended disability status scale (edss). dtq was used to assess the frequency of difficulties associated with daily tasks involving the dual-task. additionally tug with dual-task and 9-hpt with dual-task were applied to the patients. an experienced physiotherapist applied all these tests. in order to measure test-retest reliability, a retest was carried out by the same physiotherapist one week following the first evaluation. the construct validity of dtq was tested by pearson's correlation coefficient.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple sclerosis * must be able to ambulatory status (expanded disability status scale score ≤ 6 ) * no relapse in the last 3 mounts exclusion criteria: * orthopedic problems * visual, perception, and hearing problems

Keywords: multiple sclerosis dual-task validity reliability
pilot observational study and safety analysis of fl nourish capsules in cancer patients in remission

Conditions: Cancer; Cancer Survivor

Summary: this is a single-centre, observational prospective study of cancer patients in remission administering fl nourish capsules (flnc), a proprietary chinese medicine herbal supplement, for the treatment of symptoms associated with qi deficiency and blood stasis syndrome.

consultation data will be analysed from up to 24 cancer patients in remission receiving routine treatment at singapore thong chai medical institution. each participant will visit the institution in accordance with the protocol which includes up to 9 months of fl nourish capsule (flnc) use and up to 8 consultation visits. participants will be evaluated based on consultation data, questionnaire data, routine blood test data and self-reporting of adverse events or severe adverse events. as this is a non-interventional observational study, all participants would have received flnc prescriptions according to routine diagnostic and prescribing standards, and there were no additional visits required aside from routine follow up consultations.

Eligibility criteria:
inclusion criteria: * aged 21-80; * cancer diagnosis ≤ 5 years; * received treatment with no current evidence of recurrence, with predicted life expectancy of 12 months and above; * on regular follow-up with lab tests scheduled every 1-9 months; * recent (\<=3 months) blood test report(s) available on first study visit * diagnosed with the tcm syndrome of qi deficiency and blood stasis by the primary physician: experience 2 major symptoms coupled with typical tongue and pulse conditions; 2 major symptoms and 1 possible symptom coupled with tongue and pulse conditions; and 1 major symptom and at least 2 possible symptoms coupled with tongue and pulse conditions; exclusion criteria: * on active cancer treatment such as iv chemotherapy or radiotherapy or oral targeted therapy (excluding hrt and oral chemotherapy); * scheduled for iv chemotherapy, radiotherapy or surgery within the next 1 year from recruitment date; * diagnosed with active disease of the liver, kidney, brain, blood, blood vessels; with mental health conditions or are mentally incapacitated; * pregnant women.

Keywords: cancer herbal medicine traditional chinese medicine chinese herbal medicine tcm complementary alternative fatigue cancer-related fatigue
the role of vitamin d in the pathophysiology of chronic failure

Conditions: Vitamin D Deficiency; Chronic Heart Failure

Summary: patients will undergo at baseline and regular intervals: * clinically indicated bloodwork/urine and echocardiogram testing * biomarker studies upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. normal and mild vitamin d levels will receive no treatment while severe vitamin d deficiency will be randomized (50/50) to receive no treatment or vitamin d treatment. they will be seen in the heart failure clinic every 6 months. the patients will be followed for 26 months.

the inclusion criteria for the study is: * an ef ≤40% within the last 12 months before recruitment * established diagnosis of heart failure * \>18 years of age * patients will vitamin d levels of sufficient, mild deficiency and severe deficiency the exclusion criteria is: * hypercalcemia * known hypersensitivity to vitamin d * patient unwilling to comply with study requirements * any other disease other than heart failure that can alter the patients quality of life over a period of 6 months * women of child bearing potential * a patient currently taking vitamin d * severe renal impairment estimated glomerular filtration rate (egfr) \<30

Eligibility criteria:
inclusion criteria: * an ejection fraction (ef) ≤40% within the last 12 months before recruitment * established diagnosis of heart failure * \>18 years of age * patients with vitamin d levels of sufficient, mild deficiency and severe deficiency exclusion criteria: * hypercalcemia * known hypersensitivity to vitamin d * patient unwilling to comply with study requirements * any other disease other than heart failure that can alter the patients quality of life over a period of 6 months * women of child bearing potential * a patient currently taking vitamin d * severe renal impairment egfr \<30
a pragmatic assessment of influenza vaccine effectiveness in the dod

Conditions: Influenza; Influenza-like Illness; Influenza Vaccines

Summary: a total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).

this four-year, pragmatic, prospective study will compare the effectiveness of licensed egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza vaccine, in the prevention of laboratory-confirmed influenza infection in active duty members, military retirees, and other dod beneficiaries. military treatment facilities (mtfs) in the united states will participate in this protocol. enrollment will be restricted to adults (≥18 years and older) who are preparing to receive seasonal influenza vaccination at participating dod sites. subjects will be randomized to receive one of the three licensed influenza vaccines types for evaluation of effectiveness. there is no exclusion for pregnancy, as none of these licensed products are contraindicated in pregnant women.

Eligibility criteria:
inclusion criteria: 1. eligible for care in department of defense medical facilities (defense enrollment eligibility reporting system eligible) 2. ≥18 years of age. 3. at a participating military treatment facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination. 4. able to speak english and able to provide informed consent 5. able to receive and respond to texts and/or emails, or a military recruit exclusion criteria: 1. adults intending to receive or who have received the current seasons flumist vaccine (laiv) 2. adults who have already received a flu vaccine within the current season 3. individual who cannot receive a flu vaccine or standard dosing due to another medical condition 4. allergic to gentamicin, polymyxin and/or neomycin 5. individuals who fail to meet the inclusion criteria

Keywords: influenza vaccine
cannabidiol: a novel intervention for cannabis use problems?

Conditions: Cannabis Use Disorder

Summary: the purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (dsm-5) will be recruited from the community. stage one aims to identify the most effective dose (medmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. stage two will determine whether the med identified in stage 1 can offer an effective treatment for cannabis dependence.


Eligibility criteria:
inclusion criteria: * aged between 16 and 60 years old. * meet dsm-5 criteria for moderate cannabis use disorder (≥4 dsm-5 criteria) * express desire to quit using cannabis within the next four weeks, * have ≥1 previous failed quit attempt. * smoke tobacco with cannabis, * test positive for recent cannabis use according to urine analysis, * vital signs within healthy limits and have capacity to give consent exclusion criteria: * not willing to use effective contraception from when consent is taken to 6 weeks after treatment has stopped * positive pregnancy test or breastfeeding * allergies to the investigational medicinal product (imp) or placebo and its excipients * \>twice/month use of other illicit drugs * outside normal body mass index (bmi) * a physical health problem deemed clinically significant * the use of current prescribed psychotropic drugs * current or prior self-reported diagnosis of a psychotic disorder * non-english speakers due to verbal assessments.
learningrx cognitive training for adhd

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the purpose of this investigation is to conduct a series of case studies on the impact of learningrx cognitive training on cognitive skills, brain structure, and daily functioning for participants with adhd.

using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from learningrx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for adhd.

Eligibility criteria:
inclusion criteria: * age 15-22 previously diagnosed with adhd * high school students or college students with a prior diagnosis of adhd living in the greater colorado springs area exclusion criteria: * no braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
insulin resistance in atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: the aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis.

the aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis. easi and scorad values and disease duration of atopic dermatitis patients are calculated during the examination. homa-ir blood test result is compared with the results.

Eligibility criteria:
inclusion criteria: * atopic dermatitis patients confirmed by a dermatologist exclusion criteria: * patients younger than 2 years * patients older than 80 years * atopic dermatitis patients without homa-ir result

Keywords: atopic dermatitis insulin resistance
a study of nivolumab in participants with squamous cell carcinoma of the head & neck (scchn) - patient reported outcomes (pro)

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (scchn) since its approval, and to describe the health related quality of life (hrqol) among participants treated with nivolumab in a real-world setting.

this is a phase 4 prospective chart review study with patient reported outcome (pro) administration. the study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (scchn) and are being treated with nivolumab. eligible participants will be enrolled and observed from enrollment up to eight weeks. demographic and clinical characteristics will be collected at enrollment. pros will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Eligibility criteria:
inclusion criteria: * diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (scchn) * age ≥18 years at time of nivolumab treatment initiation * investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic scchn prior to enrolment in the study * charts/records include treatment start date of nivolumab * provide consent and is willing to self-complete on-site patient reported outcomes (pros) on at least one occasion exclusion criteria: * currently enrolled in an interventional clinical trial for their scchn * received systemic treatment for any other primary cancer within 6 months of study enrolment

Keywords: bms-936558 health related quality of life metastatic nivolumab opdivo® patient reported outcomes recurrent squamous cell carcinoma of the head and neck volume-pro
the arthroscopic labral excision or repair trial (alert)

Conditions: Acetabular Labrum Tear

Summary: this study compares two established surgical treatments for acetabular labral tears. patients will be prospectively recruited and randomised to either labral repair or debridement. all patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months.

study design study design this will be a two-arm randomised controlled parallel group superiority study and will take place in a hospital setting. stratification will be performed for sex and age by means of a minimisation technique during randomisation for each subject entering the trial. study population: adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears demonstrated on mri arthrogram but without radiographic evidence of oa ie: kellgren \& lawrence grade less than 2 randomly selected from the nuffield orthopaedic centre outpatient clinics. arm 1 arthroscopic acetabular labral repair. arm 2 arthroscopic acetabular labral resection 48 patients per arm (total 96 patients) will be selected from outpatient clinics and the operative waiting list (pre-operative assessment clinics) at the nuffield orthopaedic centre, oxford. the surgeries will be conducted using routine instrumentation in use at the centre. study procedures recruitment all patients will undergo surgery in accordance with established practice regardless of their treatment allocation. arthroscopy will be performed using standard anterior and lateral portals for insertion of instruments. all patients will undergo arthroscopic evaluation of the entire joint. subsequent procedures will vary according to treatment allocation: * arm 1 - labral repair - acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. if evidence of fai is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer). * arm 2 - labral resection - the acetabular labral tear will be identified and its' limits defined. the torn portion of labrum will be resected to a stable edge. as with arm 1 there will be treatment of fai if identified.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study. * male or female, aged between 18 and 75 years. * symptomatic labral tear with evidence of labral tear on mri. * no radiographic evidence of oa (kellgren-lawrence grade \< 2) exclusion criteria: * previous ipsilateral hip surgery * irreparable labral tear * previous fracture of femoral neck or acetabulum * female patient who is pregnant * established osteoarthritis (kellgren-lawrence ≥ 2) * hip dysplasia
endometrial polyps regression with progesterone therapy

Conditions: Endometrial Polyp

Summary: this prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle

in premenopause, 25% of endometrial polyps regresses spontaneously in 1 year. according to guidelines, given that most premenopausal polyps are not malignant, there is an option for expectant approach with no surgical intervention. studies on the efficacy of medical treatments for endometrial polyps are also recommended by gynaecologic societies, with the aim of finding cost-saving not invasive strategies to manage this common pathology. up to now, nobody has investigated the effect of progestin administration on polyps, but molecular and clinical data suggest that the antiestrogenic effect of this hormone can be exploited to increase and speed-up their regression rate. our preliminary results on the effect of three months of progesterone demonstrated a regression rate of 47,5% in women treated vs 12,5% in those don't receiving treatment. accordingly, in this prospective randomized study we aim to compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle

Eligibility criteria:
inclusion criteria: * ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment * signed informed consent exclusion criteria: * estrogenic and\\or progestinic therapy two months before the enrollment * tamoxifen therapy * pelvic inflammatory disease * gynaecologic neoplasia * previous chemotherapy and radiotherapy * autoimmune diseases, chronic disease, metabolic, and endocrine (hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease) * menopause * hypogonadotropic hypogonadism * drugs causing menstrual irregularities
a study of second-line treatment with apatinib after tace in advanced hepatocellular carcinoma patients

Conditions: Hepatocellular Carcinoma

Summary: this study is designed to evaluate the efficacy and safety of tace combined with apatinib in treating advanced hepatocellular carcinoma. the primary endpoint is progression-free survival (pfs), 3-month pfs, 6-month pfs and 1-year pfs.


Eligibility criteria:
inclusion criteria: * patients with a histologic or cytologic diagnosis of hepatocellular carcinoma * have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment * the previous chemotherapy and the present trial registration must be at least 2 weeks apart. and they must have recovered from any toxicity of a previous chemotherapy * patients with child pugh class a \& b disease are eligible for the study * patients with barcelona clinic liver cancer stage b or c are eligible for the study * eastern cooperative oncology group performance score (ps): 0-2 * life expectancy of at least 12 weeks * hepatitis b virus dna\<2000 iu/ml * adequate organ function meeting the following: * bone marrow: absolute neutrophil count ≥1.5×109/l (1500/mm3); platelet ≥ 75×109/l; hemoglobin ≥9 g/dl * liver: serum bilirubin ≤ 1.5 ×uln, ast and alt ≤ 5 ×uln, alb ≥ 29 g/l * kidney: cr ≤1.5 ×upper limit of normal * within 7 days prior to the start of therapy, women of child-bearing potential must undergo a pregnancy test, which must be negative; men of child-bearing potential: contraceptive measures must be adopted during treatment and within 8 weeks afterward * subjects who understand and voluntarily signed a written informed consent form exclusion criteria: * previous locoregional therapy within 4 weeks prior to enrollment * diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma * history of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma * prepared for liver transplantation * patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, iii-iv level cardiac insufficiency, severe liver and kidney dysfunction) * a previous history of interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence * use of cyp3a4 inhibitor within 7 days or cyp3a4 inducer within 12 days prior to enrollment * patients with central nervous system metastases or brain metastasis * previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia * pregnant or lactating women * patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment

Keywords: apatinib second-line treatment hepatocellular cancer tace