Kornimate/medical-research-clean huggingface dataset:
rct evaluating effects of cosmos caudatus (ulam raja) in t2dm patients

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: the purpose of this study is to determine whether cosmos caudatus is effective as an adjuvant therapy for type 2 diabetes mellitus.

background: cosmos caudatus (c. caudatus) ethanol extract has been reported to have extraordinary high antioxidant capacity compared to other plants. furthermore it has been shown to reduce the plasma blood glucose and lipid profile significantly in an animal model. however, no study has been reported on its effectiveness in human. therefore, we plan to conduct a randomized controlled trial to evaluate the effectiveness and safety of c. caudatus on glycemic status, oxidative stress markers, inflammatory markers, lipid profile in patients with type 2 diabetes. besides, metabolomics approach will be carried out to compare the metabolite changes between diabetic c. caudatus treated and control patients. methods: a single-center randomized, controlled, two-arm parallel design clinical trial will be carried out in malaysia. this study enrol 92 patients diagnosed with type 2 diabetes. diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are c. caudatus treatment group and control group. both groups will be compared on the primary and secondary outcomes at baseline, 4, 8, and 12 weeks. the serum and urine metabolome of both groups will be examined using proton nmr spectroscopy. discussion: the study will provide insights into the potential beneficial effect of c. caudatus in type 2 diabetic patients. in addition, the therapeutic effect of c. caudatus towards type 2 diabetes will reflect as a change of metabolite profile in urine and serum.

Eligibility criteria:
inclusion criteria: 1. confirmed type 2 diabetes with at least 6 months diagnosis 2. bmi between 18.5-40 kg/ m2 3. able to comply to the study protocol 4. they are treated with stabilized dose of oral diabetic agents exclusion criteria: 1. pregnant and lactating 2. have any gastrointestinal disorder that interferes the bowel function, severe hepatic or renal disease (dialysis), an infection that requires antibiotics within three weeks 3. they are currently on insulin regimen. 4. individuals on the following drugs which will possibly have herb-drug interaction: anticoagulant such as warfarin and aspirin, corticosteroids (prednisolone), fluoroquinolones (ciprofloxacin, levofloxacin), doxorubicin, cisplatin, cyclosporine, and digoxin

Keywords: type 2 diabetes mellitus cosmos caudatus ulam raja metabolomic profiling antioxidant
the laparoscopic right colectomy with intracoroporeal anastomosis

Conditions: Colon Cancer

Summary: this is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.

the design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis. postoperative complications in both groups will be recorded in accordance with the clavien-dindo classification. the level of postoperative pain will be registred according to the visual analogue pain scale (vas). also the investigators will study the time of activation of patients, patient self-care scope according to the bartell scale, postoperative hospital stay will be assessed.

Eligibility criteria:
inclusion criteria: * patients age is 18 years and older * patients with right colon cancer * informed agreement exclusion criteria: * carcinomatosis * primary tumor stage t4b * refusal of anastomosis * refusal of the patient to participate in the study

Keywords: right colon cancer laparoscopic right colectomy intracorporeal anastomosis
hemophilic knee arthropathy virtual reality

Conditions: Hemophilia; Knee Arthropathy

Summary: this study intended to examine the effect of a physical rehabilitation program incorporating kinect-based virtual reality on gait characteristics, functional ability, and physical activity level in adolescents with hemophilic knee arthropathy.

the usage of virtual reality in clinical practice as an alternative for conventional procedures has recently sparked the interest of health professionals. virtual reality is a type of computer technology that provides simulated sensory feedback to allow children to participate in activities and events that are comparable to those they could face in real life. it can be used therapeutically to enhance strength, range of motion, coordination, mental concentration, problem solving, decision making, balance, and gait.

Eligibility criteria:
inclusion criteria: * moderate hemophilia * bilateral involvement of the knee joint * medically stable and received their factor replacement therapy * free from contracture or congenital anomalies * didn't have persisting, disabling pain. exclusion criteria: * recent bleeding episodes * severe radiological abnormalities such as bone erosions, degeneration, bone ankylosis, or joint subluxation * engagement in a regular exercise program in the past six months * the unwillingness to stick to the training schedule
goal directed mechanical ventilation aimed at optimal lung compliance

Conditions: Acute Respiratory Failure; ARDS

Summary: patients with acute respiratory failure exhibiting decreased respiratory system compliance with hypoxemia or carbon dioxide retention are often difficult to ventilate with current guidelines that limit applied plateau pressure yet, these guidelines do not take into consideration chest wall mechanics. the investigators sought to determine whether partition of the respiratory system into its components by measuring esophageal pressure and thus assessment of pleural pressure, would help in patients with acute respiratory failure to identify the factors contributing to low respiratory system compliance.

identifying the dominant factor affecting respiratory system compliance by measuring transpulmonary pressure may better direct and optimize mechanical ventilation. thus, instead of limiting mechanical ventilation by plateau pressure, peep and inspiratory pressure adjustment would be individualized specifically for each patient's lung compliance as indicated by transpulmonary pressure. the main goal of this approach is to specifically target transpulmonary pressure instead of plateau pressure, and therefore achieve the best lung compliance with the least transpulmonary pressure possible.

Eligibility criteria:
inclusion criteria: * to be included in the study a prerequisite of high peak inspiratory pressure (plateau pressure of up to 30 cmh2o) had to be present, and at least one of the following four inclusion criteria had to be met. 1 - low total respiratory system compliance (ct), defined as less than 50ml/cmh2o. 2 - p/f ratio of less than 300. 3 - need for a peep greater than 10 cmh2o to maintain sao2 of \> 90%. 4 - pco2 over 60 mmhg, or ph less than 7.2 that is attributed to respiratory acidosis. exclusion criteria: * patients with any of the following were excluded from the study. previous lung or chest wall surgery, previous esophageal surgery, known achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.

Keywords: ards esophageal pressure pleural pressure pulmonary compliance
a multicenter, double-blind study to evaluate the effect of pretreatment with a daily dose of sildenafil on the as-needed efficacy of viagra in men with erectile dysfunction and type 2 diabetes

Conditions: Erectile Dysfunction; Diabetes Mellitus, Type 2

Summary: to determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (phase i) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (phase ii). to assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the self-esteem and relationship (sear) questionnaire.


Eligibility criteria:
inclusion criteria: patients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for the duration of the study, and have a hbalc of less than or equal to 10 at screening. type 2 diabetic patients currently on insulin or on combination therapy with an oral hypoglycemic agent were not excluded. exclusion criteria: excluded were subjects who had taken more than 6 doses of any pde5 inhibitor and/or had taken their last dose less than 4 weeks prior to the screening visit; subjects with resting sitting and/or standing hypotension (bp \ 170/110mmhg); and subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (tia), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation in the last 3 months.
effects of abatacept in patients with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

subcutaneous (sc)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * rheumatoid arthritis (ra) diagnosis less than 6 months * crp \> 3 mg/l or erythrocyte sedimentation rate (esr) ≥ 28 mm/h * at least 3 swollen and 3 tender joints * anti-citrullinated protein antibodies (acpa) positive exclusion criteria: * at risk for tuberculosis * have acute infection * have chronic or recurrent bacterial or serious latent viral infection * history of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma * previous treatment with any conventional or biologic disease-modifying anti rheumatic drugs (dmard)
evaluating clinical outcomes of treatment effectiveness for children and adults with adhd

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: to evaluate clinical effectiveness of medication treatment for adhd. it is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

this is a prospective, long-term, observational study of routine clinical care. the study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the provincial adhd program. the study is designed for systematic follow-up of children and adolescents, diagnosed with adhd irrespective of comorbidity or whether they elect to receive medication treatment. evaluations occur every 6 months for 24 months. the population to be examined is children and adolescents with a diagnosis of adhd, aged 6 to 18 inclusive (at baseline), referred to the provincial adhd program for clinical assessment. no studies have been conducted that have evaluated the outcome of core adhd symptoms in a clinic setting. metaanalysis of clinical trials of medication treatment for adhd have suggested an effect size of approximately 0.8. because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. two hundred patients will be enrolled in this study with primary measure of effectiveness being change in adhd symptoms.

Eligibility criteria:
inclusion criteria: meet dsm-iv criteria for adhd exclusion criteria: none

Keywords: adhd effectiveness
a phase 1 safety study in adults with schizophrenia

Conditions: Schizophrenia

Summary: this study will determine the safety, tolerability, and pharmacokinetics (pk) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of alks 3831.


Eligibility criteria:
inclusion criteria: * has a body mass index (bmi) of 18.0-35.0 kg/m\^2, inclusive * has a primary diagnosis of schizophrenia * capable of understanding and complying with the procedures, requirements, and restrictions of the protocol. * appropriate for outpatient treatment * agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile * willing and able to provide government-issued identification * is in good physical health * agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study * additional criteria may apply exclusion criteria: * is currently pregnant or breastfeeding * initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase schizophrenia symptoms * poses a current suicide risk at visits 1 or 2 * has a history of poor or inadequate response to treatment with olanzapine * has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months. * requires or has had electroconvulsive therapy (ect) treatment in the 6-month period prior to visit 1 * has a diagnosis of alcohol or drug use disorder (with the exception of nicotine) * has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to visit 1 and/or anticipates a need to take opioid medication during the study period. * has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening * tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines. * has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists. * additional criteria may apply

Keywords: schizophrenia alkermes alk 3831 samidorphan
radial shock waves for functional disability in stroke

Conditions: Ischemic Stroke

Summary: this is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. a total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (efd) of approximately 0.07 mj/mm2. the sham group will receive identical treatment, except for the fact that no energy flux will be applied.


Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis: magnetic resonance imaging (mri) or computed tomography (ct) scan indicating stroke in the territory of the middle cerebral artery; * 6 to 24 months after stroke date; * stability observed in clinical medical evaluation * granting of written informed consent to participate in the study exclusion criteria: * individuals with a score lower than 24 on the mini-mental test; * previously documented strokes * pregnancy * patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study * bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy * psycho-affective disorder that prevents adherence * joint pain that occurs within the movement range of therapies
luma light system proof of concept study in subjects with mild to moderate psoriasis

Conditions: Psoriasis

Summary: this is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet b (nbuvb) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. four interpatient arms will be used to compare the efficacy of combination of nbuvb with an occlusive dressing to the light alone and to dressing alone and no treatment. ten patients will be enrolled in this 6 weeks study.


Eligibility criteria:
inclusion criteria: * male or female of any race, 18 to 65 (inclusive) years of age. * verbal and written informed consent obtained from the subject. * has a clinical diagnosis of mild to moderate psoriasis at the screening and baseline visits. * has an iga score of 2 or 3. * target plaque assessment (tpa) score between 6-9 and a score of at least 2 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling) * has at least 4 plaques of at least 10 cm2 with tpa scores not differing from each other by a score of more than 1 * is in good general health as determined by the investigator based on the subject's medical history, vital signs and physical examination. * females of childbearing potential must have negative urine pregnancy test results. * females of childbearing potential agree to use acceptable methods of contraception from the screening visit continuously until 30 days after end of treatment. * subject agrees to use only the sponsor provided cleanser and lotion during the study period. * subject is willing and able to return for all study visits. exclusion criteria: * presence of psoriasis that was previously treated with prescription medications prior to the screening visit and was non-responsive to treatment, as determined by the investigator. * presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the investigator. * female who is pregnant, nursing an infant, or planning a pregnancy during the study period. * treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the baseline visit, or concurrent participation in another clinical trial with an investigational drug or device. * history of melanoma. * subject has any medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
an extension trial to investigate long-term treatment with transdermal rotigotine in idiopathic restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: this is a multicenter, open-label trial to assess safety and tolerability of rotigotine (spm 936) in subjects with idiopathic restless legs syndrome (rls), administered at an optimal dose for up to 1 year. subjects who successfully completed the maintenance period and the taper period of sp792 are allowed to enroll in this trial. all subjects will begin the titration period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. the maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose. a subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the maintenance period. a taper period is provided to allow for safe, gradual withdrawal from trial medication


Eligibility criteria:
inclusion criteria: * idiopathic restless legs syndrome exclusion criteria: * subject has an ongoing serious adverse event from sp792 that is assessed to be related to the trial medication by the investigator and/or the sponsor. * subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent. * subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.

Keywords: idiopathic restless legs syndrome
assessing the neurological outcomes after atrial fibrillation ablation for rhythm control

Conditions: Atrial Fibrillation; Stroke

Summary: a prospective, non-blinded, multi-center study to assess the impact of early catheter ablation (ca) in patients with a new diagnosis of atrial fibrillation(af) at the time of stroke. 100 patients will be enrolled.

a prospective, non-blinded, multi-center study to assess the impact of early ca in patients with a new diagnosis of af at the time of stroke. at least 100 patients who meet the inclusion and exclusion criteria will be randomized 1:1 to receive early ca or soc (standard of care). the primary outcome will be the functional neurologic outcomes, including mrs (modified rankin scale) and qol(quality of life), recurrence, major bleeding, and mortality after stroke for each group. secondary outcomes will be changes in cognitive assessment, success of rhythm control, recurrent hospitalizations, and cumulative cardiovascular outcomes. participants will be followed at 3, 6, 9, and 12 months following the discharge date to measure these outcomes, and the study will enroll for one year. the primary endpoints will be functional recovery and enrollment.

Eligibility criteria:
inclusion criteria: * ages \>18 and able to provide consent. * presenting with an acute stroke and new-onset af * modified rankin score (mrs) \< 6 * must be able to undergo some form of cardiac monitoring \[implantable loop recorder (ilr), electrocardiogram (ecg), holter monitor\] to quantify af burden exclusion criteria: * patients \< 18 years of age * unable to provide consent, including mrs = 6. * not able to read and write at an 8th-grade level \[to complete afeqt and eq-5d surveys\] * positive b-hcg * will not follow up with our practice/clinic afterward. * cannot tolerate oac or aad for any reason. * cannot undergo ca for any reason.
efficacy and safety of actonel® after denosumab discontinuation in postmenopausal osteoporosis women

Conditions: Postmenopausal Osteoporosis

Summary: to evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year


Eligibility criteria:
main inclusion criteria: 1. postmenopausal women 2. patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year main exclusion criteria: 1. any contraindication to risedronate 2. those evaluated as inappropriate at the discretion of the investigator