Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate safety and efficacy of kam1403 gel to treat radiation dermatitis

Conditions: Radiation Dermatitis

Summary: the main purpose of this study is to demonstrate the safety and efficacy of kam1403 gel in reducing the symptoms of mild to moderate radiation dermatitis. efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the kam1403 gel treated group versus a group of subjects treated with the aloe vera gel (the control group). in addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. safety will be determined by the number and severity of adverse events device-related.


Eligibility criteria:
inclusion criteria: * female above 18 years of age * diagnosed with breast cancer and scheduled to receive postoperative radiotherapy * treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed. * schedule for breast radiotherapy (rt) to a dose of 50 gy in 2 gy/fx, for 5 weeks and then a boost to the lumpectomy cavity. * minimum of 3 weeks from chemotherapy to start of radiation therapy. * patient agrees to use only the test products during the study period exclusion criteria: * tumor involvement of the skin * patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions * patient has a previous history of allergy to the ingredients of the tested formulations * paget's disease of the nipple. * pregnant or lactating females
endogenous glucose production in patients with glycogen storage disease type ia

Conditions: Glycogen Storage Disease Type IA

Summary: glycogen storage disease type ia (gsdia) subjects retain a limited capacity for endogenous glucose production (egp). to date, the origin of residual egp in gsdia patients is unknown. either increased glycogen debranching or lysosomal glycogen breakdown can account for residual egp in gsdia. innovative treatments for gsdia (e.g. aav8-mediated gene therapy and mrna therapy) are being developed.therefore, longitudinal minimally-invasive monitoring of outcomes after therapeutic interventions in gsd ia subjects becomes warranted. the primary objective is to test the feasibility of egp quantification in adult gsdia subjects by stable isotopes after a single oral \[6,6-2h2\]glucose dose. secondary objectives are to compare egp assessed by a single oral \[6,6-2h2\]glucose dose (a) in gsdia patients versus matched healthy participants, (b) among gsdia patients, (c) in the pre-prandial state versus the fed state, (d) in the controlled hospital setting versus the home setting. data collected from the continuous glucose monitoring data will also be compared

study design: an investigator-initiated human pilot-study. study population: ten adult subjects with gsdia and ten age and gender-matched healthy subjects. interventions: three experiments will be performed for each subject. during the first in hospital experiment, two oral d-\[6,6-2h2\]glucose loads will be performed 2 hours before breakfast and at lunchtime, respectively. the third oral d-\[6,6-2h2\]glucose load will be performed at home (random time). capillary blood samples will be collected on filter paper at specific time points after each oral d-\[6,6-2h2\]glucose load. during the experiments, subjects will be monitored by subcutaneous continuous glucose monitoring (cgm).

Eligibility criteria:
inclusion criteria: * the diagnosis should be confirmed by g6pc mutation analysis * age above 16 years * stable medical condition before the start of the test procedures exclusion criteria: * age \< 16 years * intercurrent illness * recent history of hospitalization due to hypoglycemia * pregnancy * history suggestive of diabetes or fasting intolerance * first grade family member with a confirmed diagnosis associated with fasting intolerance
pentoxifylline as an adjunctive in treatment of negative symptoms in chronic schizophrenia

Conditions: Schizophrenia

Summary: the aim of this study to evaluate the efficacy and safety of pentoxifylline, the novel phosphodiesterase inhibitor, as an adjunctive to risperidone in alleviating the negative symptoms of schizophrenia.

there is some evidence for the role of phosphodiesterase (pde) signaling system in pathophysiology of schizophrenia making this system a potential target for therapeutic agents. pdes are a family of enzymes that hydrolyse cyclic nucleotides and thus play a key role in regulating intracellular levels of the second messenger cyclic adenosine monophosphate (camp) and cyclic guanosine monophosphate. pentoxifylline (ptx) is a methylated xanthine derivative and a pde inhibitor that is fda-approved for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. it is known to inhibit platelet aggregation, increase erythrocyte flexibility or deformability, and reduce blood viscosity. the rationale for its use in schizophrenia is that it competitively inhibits pdes, resulting in increased camp levels, the activation of protein kinase a (pka), the inhibition of il and tnf-α synthesis, and reduced inflammation. furthermore, there is growing evidence to support the inflammatory hypothesis of schizophrenia, the investigators will also explore whether cytokine levels mediate the response from pentoxifylline treatment.

Eligibility criteria:
inclusion criteria: * ages between 18-40 years * males \& females * patients between the ages of 18 and 53 who met the diagnostic criteria for schizophrenia according to the diagnostic and statistical manual of mental disorders, fourth edition, text revision (20), with a minimum disease duration of two years. * stable on risperidone for a minimum of 8 weeks * clinically stable for at least 4 weeks prior to study. * willing to give informed consent. * able to take medication orally. exclusion criteria: * acute, unstable, significant or untreated medical illness beside schizophrenia; * pregnant or breast-feeding females; * history of substance abuse or dependence in the past 3 months. * known contraindication to pentoxifylline treatment. * any serious or life-threatening medical conditions or neurological problem, severe extrapyramidal symptoms, history of abnormal bleeding, presence of hypothyroidism, renal disease, cardiovascular problems, rising liver transaminases to 3 times the upper limit of normal or higher
the clinical efficacy and safety of iguratimod in ra and early ra patients for 6 months treatment

Conditions: Arthritis, Rheumatoid

Summary: this study is designed to observed prospectively the efficacy and safety of 6 months treatment of iguratimod alone, or with methotrexate (mtx), hydroxychloroquine (hcq) and prednisone step by step on chinese rheumatoid arthritis (ra) and early rheumatoid arthritis (era) patients who were naïve or shown insufficiency response or intolerance to dmards. if volunteered, patients who completed the 6-month study can continue to follow our plans for 24 months.

this study will enroll 200 cases of rheumatoid arthritis (ra) and early rheumatoid arthritis (era) patients in china, who are naïve or shown insufficiency response or intolerance to dmards. the participants plan to be treated with iguratimod alone, or along with methotrexate (mtx)/ hydroxychloroquine (hcq) / prednisone (pred) step by step for 6 months if participants are in medium or high disease activity (das28≥3.2). participants can choose to continue the study up to 24 months.the efficacy and safety of 6 months and 24 months iguratimod treatment in ra and era patients will be evaluated with das28-esr and other disease activity indices.

Eligibility criteria:
inclusion criteria: - 1. ra: patients diagnosed based on 1987 acr classification criteria for rheumatoid arthritis(ra); 2. era: subjects diagnosed by the 2010 american college of rheumatology/european league against rheumatism (acr/eular); or by 2012 chinese classification criteria of early rheumatoid arthritis (era), and not match the 1987 acr criteria for ra. 3. age ≥16 years; 4. extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of ra patients are stable or no significant progress; 5. patients can be naïve to any dmards, or relapse due to dmards drug suspended; 6. patients have a history of using csdmards including csdmards（methotrexate，leflunomide, hydroxychloroquine, sulfasalazine, tacrolimus) , any biologic dmards（tnfi，tocilizumab or tofacitinib），glucocorticoid (prednisone，methylprednisolone) or chinese traditional medicine（including tripterygium glycosides, sinomenine）for 3 months, but couldn't achieve clinical remission or intolerance； exclusion criteria: 1. patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis b; 2. platelet counts(plt) \<80 x 10\^9 / l, or white blood cell (wbc) \<3 x 10\^9 / l; 3. propionate acid aminotransferase (alt) or aspartate aminotransferase (ast) is two times higher than the upper limit of normal; 4. renal insufficiency: serum cr ≥ 176 umol / l; 5. pregnant or nursing women (breastfeeding) ； 6. patients has a history of malignancy (cure time in less than 5 years); 7. patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction; 8. other comorbidities that cannot be treated with immune suppressants. in addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.

Keywords: iguratimod
the effects of different treatment schemes on cognitive function of patients with idiopathic membranous nephropathy

Conditions: Mild Cognitive Impairment; Idiopathic Membranous Nephropathy

Summary: this study intends to apply prospective, open, single-center, randomized controlled study to evaluate the cognitive status of patients with idiopathic membranous nephropathy and the influence of different treatment schemes on the cognitive status of patients with idiopathic membranous nephropathy, and explore the possible pathophysiological mechanism by using brain magnetic resonance imaging technology.

proteinuia is an independent risk factor for cognitive dysfunction and dementia. there is no relevant research on whether patients with idiopathic membranous nephropathy with normal renal function are complicated with cognitive impairment. in the process of clinical diagnosis and treatment, it was observed that the cognitive function of patients with idiopathic membranous nephropathy decreased significantly after treatment compared with that before treatment. however, there is no clinical study to confirm this phenomenon at present, and the causes of cognitive function damage are not clear. this study intends to apply prospective, open, single-center, randomized controlled study to evaluate the cognitive status of patients with idiopathic membranous nephropathy and the influence of different treatment schemes on the cognitive status of patients with idiopathic membranous nephropathy, and explore the possible pathophysiological mechanism by using brain magnetic resonance imaging technology, so as to fill the research gap of clinical cognitive status of idiopathic membranous nephropathy and provide theoretical basis for better clinical treatment scheme selection and prevention of cognitive impairment.

Eligibility criteria:
inclusion criteria: * patients with nephrotic syndrome and normal renal function. * patients with idiopathic membranous nephropathy diagnosed by pathology. * not received hormone or other immunosuppressive treatment in the past six months. exclusion criteria: * unable to treat patients with hormones and immunosuppression. * patients with definite intracranial diseases such as previous cerebral infarction and cerebral hemorrhage; * patients who have been diagnosed with cognitive decline or dementia in the past; * patients with claustrophobia or have other contraindications for magnetic resonance imaging, such as pacemakers and metal foreign bodies in the body. * pregnant and lactating women
the effect and safety of moxibustion therapy for overactive bladder patients

Conditions: Overactive Bladder; Hyperthermia; Urinary Frequency or Urgency Adverse Event; Lower Urinary Tract Symptoms

Summary: this pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (oab) patients.

patients who diagnosed as overactive bladder aged 20 to 75 years old will be divided into two groups, one is moxibustion-therapy and the other is waiting-list group. patients who belong to moxibustion therapy group will be treated moxibustion for 12 times by a korean medicine doctor. patients who belong to waiting-list group will be prohibited to get any treatment including moxibustion for relieve the symptoms of overactive bladder, and the same moxibustion therapy with moxbiustion-therapy group will be conducted after 4 weeks. overactive bladder symptom score (oabss), overactive bladder-validated 8-question (oab-v8) will be measured to evaluate the effectiveness. the number of side effect will be measured to evaluate the safety. the skin temperature of cv4, sp6 and lr3, and the tympanic temperature will be measured to study treatment mechanism.

Eligibility criteria:
inclusion criteria: 1. aged from 20 to 75 years old 2. submit written consent 3. no deficit to notify the hotness promptly and exactly 4. diagnosed with overactive bladder 5. suffering the oab symptoms during greater than or equal to 3 months exclusion criteria: 1. malignancy 2. obstructive disease of urinary tract 3. cystocele, vaginocele or rectocele 4. urinary tract infection finding on urine analysis 5. diabetic mellitus 6. sensory disturbance 7. pregnancy, possibility of pregnancy or planning to pregnancy 8. problems to communication due to any medical problem such as cognitive dysfunction 9. getting other treatment of either traditional korean medicine or conventional medicine for overactive bladder 10. psychiatric disorder or severe systemic disease.

Keywords: moxibustion
study of the mtor inhibitor temsirolimus (cci-779) to treat ovarian cancer with ca125 only relapse

Conditions: Ovarian Cancer

Summary: the primary objective of this study is to determine the efficacy of temsirolimus in patients with ovarian cancer with ca125 only relapse after first-line platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: 1. histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the following histological types:serous, endometrioid, mucinous, clear cell, low differentiation. 2. age 18 years or older 3. patients should have received first-line platinum based chemotherapy 4. documented ca125 progression according to gcic criteria. 5. no evidence of measurable or evaluable disease. 6. provision of written informed consent 7. ecog ps 0-2 8. life expectancy of greater than 12 weeks 9. wbc\>4000/μl, platelets \> 100,000/μl and a hemoglobin level \> 9.5 g/dl. adequate baseline hepatic function, defined as a total bilirubin level \ 60 ml/min. 10. all females of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment and use effective contraception during the period of therapy. 11. at least one month from the last chemotherapy administration. 12. provision of adequate paraffin-embedded tumor tissue for translational studies (optional). exclusion criteria: 1. other histological types (germ cell, granulose tumors etc) 2. history of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. history of clinical and electrocardiographically documented myocardial infarction within the last 6 months from study entry 3. any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) 4. pre-existing motor or sensory neurotoxicity grade 2 according to the who criteria (intolerable paresthesia and/or marked motor loss or worse) 5. history of any treatment for ca125 relapse 6. known, severe hypersensitivity to temsirolimus or any of the excipients of this product 7. other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 8. any unresolved chronic toxicity greater than ctc grade 2 from previous anticancer therapy 9. as judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 10. alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 2.5 times the ulrr. 11. active infection or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial/ receive protocol treatment 12. concomitant use of cyp3 a inducers (phenytoin, carbamazepine, rifampicin, barbiturates or st john's wort) should be avoided and as should treatment with strong cyp 3a inhibitors 13. treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
efficacy and safety of insulin degludec/insulin aspart in insulin-naïve subjects with type 2 diabetes using two dosing regimens

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia and north america. the aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (idegasp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2) * insulin naïve subjects (allowed are: previous short term insulin treatment no longer than or equal to 14 days in total; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total) * current treatment: metformin alone or metformin in any combination of 1 or 2 additional oads (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (tzds) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily * hba1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) * bmi (body mass index) below or equal to 45 kg/m\^2 * ability and willingness to adhere to the protocol including self measurement of plasma glucose exclusion criteria: * treatment with glp-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2) * recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator (trial physician) * previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period * known or suspected hypersensitivity to trial products or related products * the receipt of any investigational drug within 4 weeks prior to randomisation (visit 2) * anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
therapeutic neuroscience education in individuals with fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study was to investigate the effects of therapeutic neuroscience education (tne) in individuals with fibromyalgia (fm). the study included 25 females with fm, randomly separated into two groups as the intervention group (clinical pilates exercises+tne, n=11) and the control group (clinical pilates exercises, n=14).


Eligibility criteria:
inclusion criteria: * age between 18-65 years, * female gender, * a vas of at least 40mm to report the pain intensity of the last week, * having been diagnosed with fm for at least 1 year to present a range of somatic and cognitive symptoms in addition to widespread pain, * using a fixed dose of medication for at least the past 6 months (serotonin noradrenaline reuptake inhibitors \[ex, duloxetine, milnacipran\]; alpha 2-delta receptor ligand \[ex, pregabalin\]; gabapentinoids). exclusion criteria: * the presence of another disease which may affect the physical condition, * cognitive impairment at a level preventing cooperation, * being pregnant, * inability to understand or speak turkish, * concurrent autoimmune or inflammatory disease, * the presence of a central nervous system disease (eg multiple sclerosis, parkinson's disease), * serious psychiatric conditions (eg, psychotic disorders) that would prevent participation, * participation in a rehabilitation program in the past year, * have been exercising regularly for 6 months, * not participating in at least 75% of treatments.
evaluation of practices at the university hospital of nancy in the context of surgery during pregnancy

Conditions: Surgery; Pregnancy Complications; Pregnancy Related

Summary: about 2% of pregnant women are going through from surgery during pregnancy. these are mainly represented by emergencies like abdominal conditions such as appendicitis. pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late. the management of these patients is therefore complex and the literature is poor on the subject.

in the chru of nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy. the aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.' the aim is also to describe the consequences of the surgery and analyse the end of the pregancy

Eligibility criteria:
inclusion criteria: * women going through pregnancy exclusion criteria: -
different fractionation schedules of radiotherapy to the primary tumour in metastatic hormone sensitive prostate cancer

Conditions: Prostate Cancer; Radiotherapy Side Effect; Metastatic Cancer

Summary: de novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. two different fractionation schedules will be tested.

patients with de novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. the internationally accepted fractionation schedule is 3 gy (gray) x 19-20 over a course of 4 weeks. there is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. we will test if the schedule of 6.1gy x 6 compares to standard of 3 gy x 19 with regard to patient reported side-effects.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. histological confirmed prostate cancer 3. indication for early palliative radiation therapy of low burden metastatic prostate cancer. low burden as defined by modified chaarted trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes 4. baseline e-prom exclusion criteria: 1. high burden metastatic prostate cancer including all with visceral mets. 2. unable to comply with study procedures. 3. other diseases or medication that will put the patient at risk for more toxicity from radiotherapy 4. radiation treatment start later than nine months after the prostate cancer diagnosis. 5. severe micturition problems, ipss \> 20 ( international prostate symptom score)

Keywords: metastatic prostate cancer radiotherapy primary tumor