Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of shr3824 in combination with metformin in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to obtain information on efficacy and safety of shr3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese type 2 diabetes. efficacy and safety will be evaluated by comparing the effect of shr3824 with metformin to placebo with metformin when given in oral doses.

a phase iii clinical study on efficacy and safety of shr3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). the 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening. evaluation of efficacy: compared with the group of placebo combined with metformin, hba1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the shr3824 with metformin group

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of type 2 diabetes mellitus; * patients with type 2 diabetes mellitus treated with metformin monotherapy for ≥ 8 weeks and poor glycemic control, metformin dose stabilized ≥1500mg / day; * fpg\<=15mmol/l; * hemoglobin a1c levels \>=7.0% and \<=10.5%; * body mass index (bmi) 19 to 35 kg/m2; exclusion criteria: * type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.); * past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy); * systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period; * history of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period; * past or current history of malignant tumor; * past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms; * pregnant women, lactating mothers, or women of childbearing potential; * any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
a long-term study to evaluate the safety of asoprisnil and estrogen administration to postmenopausal women

Conditions: Postmenopause

Summary: the objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with premarin® 0.625 mg

the objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in study m00-198. pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.

Eligibility criteria:
inclusion criteria: * successful completion of study m00-198 * continued good general health * negative urine pregnancy test exclusion criteria: * history of known or suspected cancer other than basal cell carcinoma in last 5 years * history of reproductive endocrine disorder * submucous or other symptomatic fibroid which would confound efficacy * ovarian mass * ongoing treatment with an excluded medication * stenosis of the cervix * any abnormal lab result the study-doctor considers significant.

Keywords: postmenopausal amenorrhea hormone replacement therapy hrt asoprisnil estrogen replacement therapy, postmenopause
cohort research on wilson's disease

Conditions: Wilson's Disease

Summary: wilson's disease (wd) is an inherited disorder that causes abnormal copper accumulation in the brain and/or liver. some people develop neurological or psychiatric symptoms whereas other develop liver disease. the reasons for this are unclear but genetic factors are likely to contribute. current treatment, using copper-binding medications, is required lifelong. some respond well but others suffer debilitating side-effects or deteriorate despite treatment, leading to disability or the need for liver transplantation. in the first part of this study the main aim is to identify genetic factors that determine whether someone with a diagnosis of wd will develop neurological involvement or not. the investigators will invite 500 adults with wd across the uk to take part. participants will be asked to complete an online questionnaire and provide a saliva sample for genetic testing using a collection kit sent via post. identifying these genetic factors would significantly advance our understanding of the disease and may provide new targets for drug discovery or help guide more personalised approaches to treatment. in the second part of this study the main aim is to develop new ways to monitor the effect of wd on the brain using tests. copper levels in blood and urine, currently used to monitor the disease, are unreliable and do not necessarily reflect ongoing brain damage. the role of mri scans, cerebrospinal fluid tests or other measures of brain damage, commonly used in other neurological disorders, is unclear. the investigators will therefore follow a group of 40 patients using clinical assessments and a combination of neurological tests, including novel imaging and laboratory techniques, over 24 months. developing new approaches to monitoring the effect of wd on the brain will enable better prevention of neurological disability and be essential for demonstrating the effectiveness of new treatments, such as gene therapy, in clinical trials in the future.


Eligibility criteria:
inclusion criteria (part 1 and part 2): * diagnosed with wilson's disease * age 16 years or over * living in the uk exclusion criteria (part 2): * participant has another medical or psychiatric illness that would interfere in completing assessments * participant is pregnant

Keywords: genetic modifiers biomarkers
intraocular pressure and tolerability study of preservative-free prostaglandins (bimatoprost and latanoprost) on glaucoma and ocular hypertension: european, multicentric, investigator-led, single masked study

Conditions: Glaucoma; Ocular Hypertension

Summary: bimatoprost 0.03% preservative free monodose eye drops solution (budpf) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. this new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma, or ocular hypertension, and that are sensitive to preservatives. the individual active component of budpf, bimatoprost is an established therapeutic agent with well documented iop efficacy (1). prostamides, such as bimatoprost, are believed to lower iop mainly by increasing uveoscleral outflow. the comparator, preservative free latanoprost 0.005% unit dose (ludpf, eg. monoprost®), was recently launched in a number of countries in europe and contains latanoprost in a new preservative free formulation. it is clinically important to compare these newly entered preservative free products with respect to tolerability and efficacy. a better tolerability combined with maximum efficacy will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to the glaucoma patient by providing enhanced compliance and real-world iop-lowering efficacy. the hypothesis of the study is that monodose bimatoprost is more effective than monodose latanoprost by at least 1 mmhg. (aibili applied for an unrestricted grant from allergan to perform this study)


Eligibility criteria:
inclusion criteria includes: * ocular hypertension, pseudoexfoliation glaucoma (xfg) or primary open-angle glaucoma (poag) patients that have been on a preserved prostaglandin monotherapy for at least 6 weeks. at prescreening and screening visit the iop is less than or equal to 21 mm hg in both eyes. exclusion criteria includes: * any ocular condition that are of safety concern, visual field defects with an md value above -12db, a closed/barely open anterior chamber angles or history of acute angle closure on either eye, ocular surgery within the past three months on either eye; glaucoma surgery within the past 6 months on either eye, ocular inflammation/infection occurring within three months prior to pretrial visit on either eye, pigmentary glaucoma or neovascular glaucoma on either eye, topical ocular medication that can interfere with study medication on either eye and known hypersensitivity to any component of the trial drug solutions and participation in any other clinical trial, involving an investigational drug within one month prior to pretrial visit

Keywords: glaucoma ocular hypertension preservative-free prostaglandins
comparing different suturing techniques on the post-operative morbidity after removal of impacted mandibular third molar

Conditions: Swelling; Trismus

Summary: this study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group.

third molar surgeries are mostly associated with pain, swelling and limited mouth opening, referred to as post-operative morbidity. wound closure technique is an operative factor which is associated with reduced post-operative morbidity. in the total wound closure, the mucoperiosteum is hermetically sealed whereas in the partial wound closure, a window or opening is left to allow for secondary healing. this study therefore compares the effect of partial and total wound closure techniques after surgical extraction of impacted mandibular third molar teeth in reducing the swelling and limited mouth opening.

Eligibility criteria:
inclusion criteria: * all patients undergoing surgical removal of mesioangular impacted mandibular third molar. * healthy patients (asa i) or patients with mild systemic disease with no functional limitations (asa ii). * patients who are not allergic to the drugs and local anesthetic agent used in the surgical protocol. exclusion criteria: * patients having systemic conditions that might have an effect on the bone growth or periodontal healing. * patients who are on antibiotics premedication or any drugs that might affect wound healing.

Keywords: impacted third molar suturing post-operative morbidity
a study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with radiation therapy followed by pemetrexed in patients with inoperable non-small-cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: the primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.


Eligibility criteria:
inclusion criteria: * inoperable non small cell lung cancer * no weight loss greater than 10% in 3 months prior to enrolling in trial * adequate kidney function * adequate liver function * adequate lung function exclusion criteria: * previous surgery to remove lung tumor * previous chemotherapy or radiation therapy or lung cancer * inability to take vitamin supplementation * heart attack within past 6 months * active infection
randomized pilot study comparing two vacuum-wound-dressings for open abdomen treatment

Conditions: Open Abdomen; Temporary Abdominal Closure

Summary: the primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen. secondary purpose is the comparison of feasibility and economic aspects.


Eligibility criteria:
inclusion criteria: * patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible exclusion criteria: * technical reasons * unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique
the indonesia iccu registry: a multicenter cohort of intensive cardiovascular care units patients in indonesia

Conditions: Cardiovascular Diseases; Acute Coronary Syndrome; Heart Failure; Heart Disease, Coronary; Infections; Sepsis; Stroke; Shock; Chronic Kidney Diseases

Summary: patients in the intensive cardiovascular care unit (iccu) often present with cardiovascular disease (cvd) issues accompanied by various non-cardiovascular conditions. however, a widely applicable scoring system to predict patient outcomes in the iccu is lacking. therefore, developing and validating scores for predicting iccu patient outcomes are warranted. the aims of the indonesia iccu (one iccu) registry include developing an epidemiological registry of iccu patients and establishing a multicentre research network to analyse patient outcomes.this nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 indonesian hospitals with iccu facilities. recorded data will encompass demographic characteristics, physical examination findings at hospital and iccu admission, diagnoses at iccu admission, therapy, intervention, complications on days 3 and 5 of in-iccu care, in-hospital outcomes, and 30-day outcomes. the one iccu is a large, prospective registry describing the care process and advancing clinical knowledge in iccu patients. it will serve as an investigational platform for predicting the mortality of iccu patients.

this prospective cohort registry study protocol comprised all consecutive primary medical iccu admissions across one speciality hospital and nine general hospitals in indonesia. the participating hospitals include the specialized national cardiovascular center harapan kita in jakarta and nine general hospitals: dr. sardjito general hospital in yogyakarta, dr. wahidin sudirohusodo general hospital in makassar, h. adam malik general hospital in medan, dr. saiful anwar general hospital in malang, dr. m. djamil general hospital in padang, dr. iskak general hospital in tulungagung, prof. ngoerah general hospital in denpasar, prof. dr. r. d. kandou general hospital manado, and dr. kariadi general hospital semarang. each participating hospital will contribute data for all consecutive medical iccu admissions for a period of 2 years, from 2021 to 2023. the participating hospitals were carefully selected to represent all regions of indonesia.

Eligibility criteria:
inclusion criteria: * patients admitted to the iccu * aged 18 years or older * provide consent to participate in the study exclusion criteria: - postoperative management following cardiac surgery
which type of transcutaneous electrical nerve stimulation is more effective in myofascial pain syndrome?

Conditions: Myofascial Pain Syndromes

Summary: the aim of this project is to compare the effects of conventional, burst and modulated tens primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in mas treatment.

myofascial pain syndrome (mas) is a regional pain syndrome characterized by trigger points detected by one or several muscle groups and reflected pain manifestation caused by palpation of these points. transcutaneous electrical nerve stimulation (tens) is a physical therapy modality that provides an analgesic effect by delivering a controlled low voltage electrical current to the nervous system through electrodes placed on the skin. knowledge on how modulation parameters such as frequency, wave width and form alter tens activity are limited.

Eligibility criteria:
inclusion criteria: * having a diagnosis of myofascial pain syndrome according to the criteria defined by travell and simons exclusion criteria: * the onset of symptoms is less than 3 months * severe cervical disc hernia, radiculopathy or myelopathy * stage 3-4 cervical degeneration * tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease * cardiac pacemaker * diagnosed with fibromyalgia syndrome * kyphoscoliosis * acute trauma history * having had previous brain or shoulder surgery * injections for mas and / or physiotherapy programs in the last 3 months * pregnancy

Keywords: myofascial pain syndromes transcutaneous electrical nerve stimulation
optimizing dosing strategies in oral iron supplementation

Conditions: Iron Deficiencies; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment

Summary: the goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency. the main question the study aims to answer is: does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? participants will receive oral iron supplementation every second day with double the standard dose (intervention group). researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose. participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).


Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * ≥18 years of age * iron deficiency: ferritin \<30 µg/l * hemoglobin ≥ 80 g/l * crp \< 5 mg/l exclusion criteria: * refusal of study participation, * regular administration of erythropoietin * oral or intravenous iron supplementation \<12 weeks prior to investigation * contraindications to intervention medication (tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate * blood transfusion or donation \<12 weeks prior to investigation * active chemotherapy * inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject. note due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (mm/dd/yyyy): anemia (as defined by the who): hemoglobin \<130 g/l for men, hemoglobin \<120 g/l for women, hemoglobin \<110 g/l for pregnant women

Keywords: iron deficiency anemia oral iron supplementation iron supplementation gender differences
extension to cqti571a2102 to evaluate long-term safety, tolerability and efficacy of imatinib in severe pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: this study was an extension to study cqti571a2102 and was to evaluate the long-term safety, tolerability and efficacy of qti571 (imatinib) in severe pulmonary arterial hypertension patients.


Eligibility criteria:
inclusion criteria: * patients who completed in cqti571a2102 clinical trial including all study completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct exclusion criteria: * patients with left ventricular ejection fraction (lvef) \< 45% * patients with thrombocytopenia, platelet count \< 50 x109/l (50 x 103/µl). * patients with uncontrolled systemic arterial hypertension, systolic pressure \> 160 mmhg or diastolic pressure \> 90 mmhg. * patients with a qtcf \> 450 ms for males and \> 470 ms for females in the absence of right bundle branch block. other protocol-defined inclusion/exclusion criteria may apply

Keywords: pulmonary arterial hypertension imatinib 6mwd
tumor necrosis factor-alpha inhibition using etanercept in chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Summary: the hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (cfs/me), including also patients with no clinical response after b-cell depletion therapy using the anti-cd20 antibody rituximab, may benefit from tumor necrosis factor-alpha inhibition using etanercept as weekly subcutaneous injections.


Eligibility criteria:
inclusion criteria: * chronic fatigue syndrome/ myalgic encephalomyelitis (cfs/me) * moderate and serious cfs/me severity * age 18-66 years * informed consent exclusion criteria: * patients with fatigue, not fulfilling criteria for cfs * pregnancy or lactation * previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ * previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease. * demyelinating disease, such as multiple sclerosis. * heart failure. * endogenous depression. * lack of ability to comply to the protocol. * multi-allergy with risk of serious drug reaction * reduced renal function (creatinine \> 1.5 x unl) * reduced liver function (bilirubin or transaminases \> 1.5 x unl) * hiv positivity. evidence of clinically significant infection. previous viral hepatitis with risk of reactivation. high risk of opportunistic infections. latent tuberculosis must be treated before inclusion.

Keywords: chronic fatigue syndrome cfs myalgic encephalomyelitis (me) cfs/me tumor necrosis factor-alpha tnf-alpha etanercept
frozen embryo transfer pregnancy outcomes prediction by microbiome

Conditions: Infertility; Microbiome

Summary: this study intends to explore the correlation between cervical microbiome, gut microbiome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Eligibility criteria:
inclusion criteria: 1. infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle; 2. female age: 20-45 years old; 3. single frozen-thawed blastocyst transferred 4. endometrial thickness ≥7mm on the day of luteal transformation 5. written informed consent. exclusion criteria: 1. women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura presence of autoimmune disease; 2. untreated hyperprolactinemia, thyroid disease, adrenal disease 3. antibiotic use within the past 7 days; 4. current or recent (within 3 months) drug abuse, including alcohol and tobacco; 5. refused or unable to comply with protocol requirements; 6. participation in any experimental drug study within 60 days prior to screening.