Kornimate/medical-research-clean huggingface dataset:
amniotic membrane for dacryocystorhinostomy

Conditions: Nasolacrimal Duct Obstruction; Dacryocystorhinostomy

Summary: this study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.

naso-lacrimal duct obstruction (nldo) causes epiphora, recurrent dacryocystitis, and skin fistulas. its incidence increases with age. dacryocystorhinostomy (dcr) is considered the standard treatment for nldo. authors describe similar success rates between external or endoscopic approaches. the former uses a skin approach, through which an osteotomy is made, allowing access to the lacrimal sac and subsequently to the middle meatus of the nasal cavity. on the other hand, endoscopic surgery uses an endonasal route to create a fistula towards the lacrimal sac, with the benefit of not generating visible scars in patients. the success of both surgeries depends on creating a wide osteotomy and the preservation of the mucosa around it, reducing the risk of scarring and stenosis of the ostium formed. some authors suggest that limiting the inflammatory process localized to the osteotomy may improve the surgical success rate. the use of mitomycin c (mmc) has been reported, with limited results due to variability in the concentration and methods of drug used. amniotic membrane (am) has been used in ophthalmology, such as in pterygium surgery, chemical trauma, and inflammatory diseases of the ocular surface. in these contexts, am limits the inflammatory response, promotes re-epithelialization, and reduces fibrosis. am epithelial cells do not express hla-a, b, c, or dr antigens on their surface, and therefore do not present a risk of rejection by the immune system. this study aims to compare the success rate of external dcr with and without amniotic membranes in patients with nldo.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * diagnosis of nasolacrimal duct obstruction or score ≥ 2 on the munk scale * patients able to undergo general anesthesia * patients able to keep follow-up * patients willing to participate in the study and signed informed consent exclusion criteria: * patients with ocular surface diseases that affect surgical outcomes, such as blepharitis, lacrimal punctum epithelization, kissing punctae, facial nerve palsy, allergic conjunctivitis, etc * patients with eyelid malpositions * patients diagnosed with systemic inflammatory diseases, such as granulomatosis with polyangiitis, sarcoidosis, etc * previous history of facial trauma with nasal bone fractures * pregnancy and lactation

Keywords: nasolacrimal duct obstruction dacryocystorhinostomy amniotic membrane
a dose-ranging study of the safety and efficacy of adx415 in the treatment of essential hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine a safe and effective dose of adx415 for the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * mild to moderate hypertension * age 18-75 years, inclusive exclusion criteria: * clinically significant illnesses or abnormalities upon evaluation * current treatment with 3 or more antihypertensive meds * presence of type i or uncontrolled type ii diabetes * presence of alcohol or drug abuse

Keywords: hypertension high blood pressure htn addrenex
the role of tcm on eras of rectal cancer patients

Conditions: Rectal Cancer

Summary: this study is to investigate the role of traditional chinese medicine (tcm) on the postoperative recovery of rectal cancer patients.

the hypothesis is that tcm can decrease the postoperative complications for rectal cancer. so the study is to investigate the role of traditional chinese medicine (tcm) on the postoperative recovery of rectal cancer patients. patients enrolled in this study will be randomized into two groups with tcm intervention or placebo. the intervention will be described below. primary endpoint is postoperative complications.

Eligibility criteria:
inclusion criteria: * signed written consent form; * age from 18 to 75 years old; * pathological diagnosis as rectal adenocarcinoma; * undergo laparoscopic curative surgery; * patients' tcm syndrome accords with thoses of spleen deficiency syndrome; exclusion criteria: * patients undergo non-curative surgeries; * participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control; * participants with severe dysfunction of heart, liver and kidney, who could not receive tcm treatment; * women who are pregnant or breastfeeding; * participants have mental illness or have difficulty in language communication and are unable to complete the study; * participants could not cooperate with this researcher for other reasons.

Keywords: eras integrative medicine acupoint application compliance quality of life
study to improve the treatment of epilepsy (site)

Conditions: Epilepsy

Summary: the purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs.

background. the aim of the treatment with antiepileptic drugs (aeds) is to achieve seizure freedom without causing side effects. assessment of side effects is difficult. they may start insidiously, the patient may not associate certain complaints with the use of aeds, or the treating physician does not take enough time to discuss this topic during the limited time of a visit in the outpatient department. we know from clinical trials that side effects occur in a substantial group of patients. we do not know whether we deal with this possible complication in an adequate way in clinical practice. study objective. to study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life. study design. a randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged. relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy. patients who do not report relevant side effects will be followed for 13 months (arm a) in which two visits are scheduled, after 7 and 13 months respectively. the patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate (arm b) or to ignore the results of the questionnaire and continue treatment unchanged (arm c). investigations will be repeated in both groups after 7 and 13 months after the initial visit.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * treatment: antiepileptic drugs for epilepsy * no change in medication during last 6 months * no obvious clinical reason to change medication immediately exclusion criteria: * concurrent disease or disorder that might interfere with the conduct of the study * inability to comply to the protocol * impaired intellectual functioning, leading to inability to comply to the protocol and complete the necessary questionnaires

Keywords: epilepsy antiepileptic drugs side effects quality of life
efficacy and safety study of mci-186 for treatment of amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the primary objective of this study is to confirm the efficacy of 60 mg of mci-186 via intravenous drip once a day in patients with als based on the changes in the revised als functional rating scale (alsfrs-r) scores after 24 weeks administration in double-blind, placebo-controlled manner. and in addition, this study will be performed to examine the safety of mci-186 to als patients.


Eligibility criteria:
inclusion criteria: * patients who are defined as "definite als," "probable als" or "probable-laboratory-supported als," met diagnostic criteria revised el escorial for airlie house. * patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life. * patients of less than 3 years after the onset of als. * patients whose progress of the condition during 12 weeks before administration meet other requirements. exclusion criteria: * patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, severe heart disease, severe renal disease and so on, or they need to be administered antibiotics to infection. * patients who complain the difficulty in breathing caused by deteriorating the respiratory function. * patients with such complications as parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone. * pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. * patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present. * in addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Keywords: amyotrophic lateral sclerosis free radical scavenger
a pilot cohort study of risk factors and novel methods of skin lesion assessments in adults with atopic dermatitis, alopecia areata, psoriasis or vitiligo

Conditions: Alopecia Areata; Vitiligo; Atopic Dermatitis; Psoriasis

Summary: the objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. the study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. the study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. the study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. a total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment.


Eligibility criteria:
inclusion criteria: * adult subjects \>18 years of age at screening. * previous diagnosis by a physician of atopic dermatitis, psoriasis, vitiligo, or alopecia areata. * visible lesions and willingness to photograph weekly using their smartphone * availability of a smartphone exclusion criteria: * has any physical attributes or skin conditions that in the opinion of the investigator might interfere with the evaluation of lesions (i.e., pigmentation, tattoos, extensive scarring, excessive hair growth or acne) * has other clinically relevant illness that could interfere with healing of lesions (e.g. keloid scaring) * current or previous malignant disease, including malignant melanoma and basal cell carcinoma, within 5 years * some patients may have more than one of the four conditions. this is not an exclusion criterion per se but must be recorded.
the reliability and validity of the ankylosing spondylitis performance index (aspi) in enthesitis-related arthritis

Conditions: Enthesitis Related Arthritis; Enthesitis Related Arthritis, Juvenile

Summary: this study assesses the test-retest reliability, construct validity, and minimal detectable change of the ankylosing spondylitis performance index (aspi) in assessing the physical function of patients with enthesitis-related arthritis (era).

enthesitis-related arthritis (era), which is considered the counterpart of adult spondyloarthropathies, is a human leukocyte antigen (hla) b27-related subtype of juvenile idiopathic arthritis (jia) characterized by enthesitis and arthritis, which can also affect the sacroiliac joints and axial spine. compared to other jia categories, era patients tend to have higher pain intensity, lower physical functionality, and poorer health status. maintaining or improving physical functionality is one of the primary treatment goals for era patients. physical functionality is also considered an important outcome measure for assessing disease course and effectiveness of treatment. when the literature is examined, it is seen that self-report-based questionnaires are used more frequently, and performance-based measurements are used less in the evaluation of era patients. the ankylosing spondylitis performance index (aspi) is a physical performance test that consists of a combination of three reliable tests (bending, putting on socks, and standing up from the floor) developed from the bath ankylosing spondylitis functional index (basfi). it is reported that applying aspi can provide more objective information about the improvement in physical functionality and a better estimate of the patients' abilities. aspi has significant potential in this disease group, considering factors such as the fact that it was developed in adult spondyloarthropathy patients, which is the equivalent of era. however, its psychometric properties must be appropriate for the aspi to be used in clinical settings and research. to our knowledge, no studies have been conducted in the current literature on the validity and reliability of the aspi in era patients. therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimal detectable change of the aspi in assessing the physical function of patients with era.

Eligibility criteria:
inclusion criteria: * being diagnosed with enthesitis-related arthritis (era) according to the international league of associations for rheumatology (ilar) classification * being between the ages of 7-18 * volunteering to participate in research exclusion criteria: * advanced heart/lung/liver/kidney disease, neurological disease and malignancies * having undergone major orthopedic surgery * the presence of moderate to severe mental problems that will negatively affect participation * not volunteering to participate in the study
ultrasonic evaluation of carbon dioxide laser effects on patients with genitourinary syndrome

Conditions: Genitourinary Syndrome of Menopause

Summary: the aim of the study was to evaluate the efficacy of vaginal carbon dioxide laser treatment in patients with genitourinary syndrome of menopause on the improvement of vulvovaginal atrophy (vva) and stress urinary incontinence (sui) by objective parameters and in particular to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a new objective tool of assessment.


Eligibility criteria:
inclusion criteria: * age \<75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months) * negative papanicolaou test (pap) performed within 12 months before enrolment. and one of the following: * presence of vulvovaginal atrophy \[vaginal health index (vhi) \< 15\] * initial urinary incontinence based on patient history = 1 (according to the "stamey incontinence score of stress urinary incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence) * standardized stress provocation test exclusion criteria: * age \>45 years * the presence of vaginal lesions (active or in the previous 30 days). * genitourinary tract infection. * abnormal uterine bleeding. * use of hormone replacement therapy up to 6 months before enrolment. * history of photosensitivity disorder or use of photosensitizing drugs. * genitals prolapse (grade ii - iii according to the pelvic organ prolapse quantification) * a serious or chronic condition that could interfere with study compliance.
dynamic versus static night splinting of plantar fasciitis

Conditions: Plantar Fascitis

Summary: the investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

a physical rehabilitation device for the treatment of a medical condition of the foot known as plantar fasciitis includes a splint which is connected to the toe and ankle of a patient. static splint is the use of inelastic components to apply torque to a joint in order to statically position it as close to end range as possible. a dynamic splint uses a tension spring that is integrated into a brace, usually via a mechanical hinge. the tension spring can be adjusted for more or less tension to achieve range of motion goals with less pain. the investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

Eligibility criteria:
inclusion criteria: * demographic - over 18 years of age and ambulatory without a gait aid with no history of narcotic use * diagnosis - unilateral or bilateral acute (\< 6 months of pain) plantar fasciitis (i.e., heel pain that increases with weightbearing, "first step pain": heel pain that occurs after a period of non-weightbearing, such as in the morning when arising from bed or when arising after prolonged sitting; the pain is improved after a few minutes walking but will worsen again with prolonged weightbearing, tenderness over the medial calcaneal tuberosity at the insertion of the plantar fasciitis) * permitted - icing, nsaids( ibuprofen), custom shoe inserts, diagnostic ultrasound exclusion criteria: * demographic - under 18 year of age, requires a gait aid for ambulation; if not covered by insurance, * diagnosis of - arthritis of the ankle, midfoot, or forefoot; inflammatory arthritis; gout; turf toe; hallux rigidus; hallux limitus; sesamoiditis; tendonitis or tendinopathy; prior tear or rupture of the plantar fascia; fibromyalgia, neuralgia, or neuropathy; peripheral vascular disease; prior trauma to the heel, fracture of the calcaneus; infection; corn; callus; ingrown nail. * patient with history of symptoms for over 6 months * refractory to prior splint-based treatments * prior injection of the plantar fascia * prior surgery on the plantar fascia * narcotic use
effect of healing on rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the hypothesis is that healing may influence the patient's general status by altering psychological as well as other body functions of importance for the rheumatoid arthritis. this is tested in a three group design with a control group and two groups receiving healing with or without a healer present. the study is randomized and double blind.

the central claim of healers is that this process facilitates self-healing in the patient. spiritual healing includes several categories, including 'therapeutic touch' and 'intercessory prayer', and the healing may be attributed to god, spirits, universal forces or energies, biological healing energies residing in the healer, or self-healing powers or energies thought to reside latent in the healed organism. the highly controversial hypothesized effects of distant or spiritual healing contradict our traditional sense of reality and are in conflict with what is generally viewed as being in correspondence with modern science.

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent exclusion criteria: * not able to arrange own transport, language problems
prediction of response to iucd associated menorrhagia using doppler

Conditions: Women's Health: Amenorrhea/Dysmenorrhea

Summary: studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having iucd associated menorrhagia


Eligibility criteria:
inclusion criteria: * women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after iucd "copper t 380 a" insertion exclusion criteria: * history of bleeding tendency * history of abnormal uterine bleeding due to other causes * history of active liver disease * history of antiplatelet or anticoagulant intake in the last month * history of thyroid disease * history of endometritis * history of allergy to nsaids * adenomyosis * women having contraindications to use nsaids e.g. peptic ulcer * insulin dependant diabetes mellitus
study of dc-cik to treat npc

Conditions: Nasopharyngeal Carcinoma

Summary: concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (npc). however, relapse remains the major cause of treatment failure. a series of studies reported that dendritic and cytokine-induced killer cells (dc-cik) have a broad anti-tumor spectrum. we suppose that dc-cik will improve the prognosis of npc. in this study, the patients with npc will be treated with dc-cik cells after concurrent of chemotherapy and radiotherapy. the purpose of this study is to evaluate the efficacy of dc-cik for npc.

about 60 patients with staging ⅱ-ⅲ of npc, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group a (receive dc-cik treatment) or group b (just regularly follow up), and the randomize ratio will be 1:1. patients in group a will receive 2-3 cycles of dc-cik cells treatment (every 4 weeks). patients in group b will have no anti-tumor therapy.

Eligibility criteria:
inclusion criteria: 1. patients with staging ⅱ-ⅲ of npc; 2. patients who had completed concurrent of radiotherapy and chemotherapy; 3. patients who have a life expectancy of at least 12 weeks; 4. eastern cooperative oncology group (ecog) performance status was 0-1; 5. the bone marrow functioned normally (wbc \> 4.0×109/l, hb \> 120 g/l, plt \> 100×109/l); 6. the ecg results were normal, and the liver and kidney were functional. exclusion criteria: 1. patients who had distant metastases by imaging studies; 2. patients with uncontrolled infection; underlying disease that was severe or life-threatening; 3. patients who were pregnant or lactating; 4. ecog perform status ≥ 2; 5. patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Keywords: npc,dc-cik
study to determine the effectiveness of antiviral combination therapy to treat hepatitis c virus (hcv) infected patients who have previously failed standard of care

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to determine whether bms-650032 and bms-790052 in combination alone, together with ribavirin, or together with interferon and ribavirin are effective in the treatment of hepatitis c in patients who have not responded to prior therapy.


Eligibility criteria:
inclusion criteria: * male and female subjects ages 18 to 70 years * hcv-infected genotype 1 null responders to current standard of care * expansion cohorts a1 and a2 are restricted to patients infected with hcv genotype 1b only. exclusion criteria: * evidence of a medical condition associate with chronic liver disease other than hcv * history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis * history of cancer within 5 years of enrollment * history of gastrointestinal disease or surgical procedure (except cholecystectomy) * history of clinically significant cardiac disease * history of glucose-6-phosphate dehydrogenase (g6pd) deficiency * documented cirrhosis within 12 months prior to dosing * positive for human immunodeficiency virus (hiv) or hepatitis b virus (hbv) * pregnant