Kornimate/medical-research-clean huggingface dataset:
continuous glucose monitoring to measure effect of glycemic index

Conditions: Type 1 Diabetes Mellitus

Summary: background: post-prandial hyperglycemia is common in people with type 1 diabetes. objective: the aim was to determine the impact of low vs high glycemic index (gi) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring. design: seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. in one experiment, both meals had a low gi; in the other, high gi. meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.

a total of 14 diet studies (each with two meals) were completed in three men and four women. all subjects completed two diet studies in which two meals were served 195 minutes apart. on one study day, two high gi (\> 75) meals were given, and on the other study day, two low gi (\< 30) meals were given. the low gi and high gi meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. the order of the study treatment (high or low gi) was randomized. subjects were not informed as the gi of any meal.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes mellitus * patients on insulin pump therapy exclusion criteria:any patient who was * pregnancy * cardiovascular, cerebrovascular, kidney, or liver disease * uncontrolled chronic medical conditions * oral or parenteral corticosteroid use * immunosuppressant use * visual or physical impairments that impede the use of a continuous glucose monitoring device * insulin or glucagon allergy * hypoglycemia unawareness * requirement of greater than 200 units of insulin per day * gastroparesis * any prior gastric surgery * an allergy to any food items served.

Keywords: glycemic index diabetes mellitus continuous glucose monitoring
the effect of injection site cooling on pain experienced after the administration of cntx-4975-05 into the knee

Conditions: Osteoarthritis, Knee

Summary: a clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.


Eligibility criteria:
cohort 1 key inclusion criteria: * subject is aged between 18 and 45 years, inclusive. * subjects body mass index (bmi) is between 18 and 32 kg/m\^2, inclusive and subject's weight is greater than or equal to 50 kg. * subjects must be in good health, in the opinion of the investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ecg). cohort 1 key exclusion criteria: * subject has had a clinically significant illness that has not completely resolved in the four weeks before screening. * subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial. cohorts 2-4 key inclusion criteria: * subject is aged between 45 and 75 years, inclusive. * subject's bmi is between 18 and 32 kg/m\^2, inclusive and subject's weight is greater than or equal to 50 kg. * subject has a diagnosis of bilateral moderate to severe painful knee oa (subjects will be required to have a score on pain with walking in the previous 24 hours, of 4 to 9, inclusive nprs 0-10). the condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study. cohorts 2-4 key exclusion criteria: * subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening. * subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial. * subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed. * subject has used topical medications applied to the knee for oa pain (including capsaicin, lidocaine, prescription or otc medications) from 90 days prior to screening through to dosing. * subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing. * subject currently uses opioids for any condition other than oa knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).

Keywords: osteoarthritis knee pain
asthma during pregnancy; impact of severity

Conditions: Bronchial Asthma

Summary: bronchial asthma (ba) may affect pregnancy and this affection may increase with increasing asthma severity. this study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome

this was prospective study conducted in sohag university hospital ( obstetric outpatient clinic, chest outpatient clinic and emergency department ).this study aimed to detect the effect of baseline asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome in the setting of advancements in the management and pharmacotherapy of asthma compared with that previously

Eligibility criteria:
inclusion criteria: * pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department. exclusion criteria: * patients with chest diseases other than bronchial asthma and patients with cardiac disease.

Keywords: bronchial asthma asthma pregnancy asthma severity
letrozole vs. clomiphene citrate in patients with anovulatory infertility

Conditions: Infertility

Summary: objective: to compare the effectiveness of letrozole and clomiphene citrate (cc) in patients with anovulatory infertility. design: open, prospective, randomized, parallel group, multicentric, comparative trial. setting: out patient clinics of infertility centers in india. patient(s): fifty-five patients with anovulatory infertility were recruited. twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given cc. both drugs were given orally on days 3-7 of menstrual cycle. intervention(s): letrozole, cc, ovulation induction, vaginal micronized progesterone, iui.

main outcome measure(s): occurrence of ovulation, endometrial thickness and pregnancy rates.

Eligibility criteria:
inclusion criteria: * females with anovulatory infertility 20-38 years of age. * diagnosis of anovulatory infertility as established by standard criteria. * normal pelvic usg and bilateral tubal patency * willingness and giving written informed consent. exclusion criteria: * uterine and adnexal pathology e.g. leiomyomata * ovarian cyst * hyperprolactinaemia * hyperthyroidism or hypothyroidism\* * fsh \>9miu/ml (during early follicular phase).\* (as per chemoluminescence method) * previous surgery related to genital tract as per history * appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy * impaired hepatic /renal function * diabetes mellitus/random blood sugar- \> 140mg/dl * drugs likely to interfere with ovulation * alcohol intake as per history * history of hypersensitivity to the study drug or to its excipients * planned travel outside the study area for a substantial portion (\>5 days) of the study period by potential participants * lack of willingness to give informed written consent * participation in any clinical study within the preceding 1 month

Keywords: letrozole clomiphene citrate anovulatory infertility ovulation induction
chinese medicine for treating chronic pharyngolaryngitis

Conditions: Chronic Pharyngolaryngitis (Disorder)

Summary: a randomized, double-blinded, placebo-controlled clinical trial using a chinese medicine formula in treating chronic pharyngolaryngitis. subjects will be randomized into a treatment group or placebo group for 8 weeks, and then followed by an 8-week post-treatment visit.

chronic pharyngolaryngitis (cp), also known as chronic pharyngitis, is defined as the inflammation of the pharynx, which is at the back of the throat. cp is a common disease characterized by dry throat, sore throat, pharyngeal itching, dry cough, and difficulty in swallowing. in western medicine, common treatment regimens for cp include lozenges, antibiotics, lasers, and cryotherapy. however, the above treatment modalities may not be effective, and the disease is likely to bounce back repeatedly. chinese medicine has been used for the treatment of cp for a long time. many studies have shown that treatment using chinese herbal medicine is effective in relieving the symptoms of cp. this study is to evaluate the efficacy and safety of oral qingyan lihou decoction in relieving the clinical symptoms of patients with cp.

Eligibility criteria:
inclusion criteria: * 18 years of age or above (chinese subjects only); * persistent symptoms of pharyngitis (sore throat, globus, dry throat, dry cough, throat irritation) for more than 3 weeks; * determined to be the following chinese medicine syndromes by registered chinese medicine practitioners (rcmps): wind-heat invading the upper-jiao, or phlegm heat or yin deficiency; * visual analog scale (vas) score for pain ≥ 50 mm; * numeric rating scale (nrs) ≥ 6; and * be able to give voluntary written informed consent. exclusion criteria: * known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases; * concomitant use of steroids, nonsteroidal anti-inflammatory drugs (nsaids), anticoagulants, and immunotherapy within the past week; * impaired hematological profile and liver / renal function exceed the upper limit of the reference value by 2 times; * known allergic rhinitis; * known gastroesophageal reflux disease (gerd); * known cancer or suspected cancer of throat/oesophagus; * mechanical obstruction of the throat accountable for the symptoms; * known alcohol and/or drug abuse; * known allergic history to any chinese herbal medicines; and * subjects who are known pregnant or lactating.
a study of mg-k10 in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study evaluates the preliminary efficacy of mg-k10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase iii clinical trials.

this study is a multicenter, randomized, double-blind, placebo-controlled phase ii study. it is planned to enroll approximately 160 adult patients with moderate-to-severe ad uncontrolled by topical therapy, who will receive multiple subcutaneous injections. the study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).

Eligibility criteria:
key inclusion criteria: 1. aged 18 - 70 years (inclusive), male or female; 2. patients diagnosed with ad according to american academy of dermatology consensus criteria (2014) for at least 6 months prior to screening and meet the following criteria: * easi score ≥ 16 at the screening and baseline visits; * iga score ≥ 3 at the screening and baseline visits; * ad affected body surface area (bsa) percent ≥10% at the screening and baseline visits; * documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks; key exclusion criteria: 1. subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect ad evaluation; 2. subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring; 3. subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant； 4. patients with ocular diseases that are not suitable for enrollment by the investigator； 5. use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)； 6. use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for ad treatment within 1 week prior to randomization; 7. chest x-ray or ct examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection； 8. history of parasitic infection or travel to endemic areas (south america and africa) half a year prior to screening。

Keywords: atopic dermatitis
type 1 diabetes extension study

Conditions: Type 1 Diabetes Mellitus; T1DM; T1D

Summary: this is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected itn new-onset type1 diabetes mellitus studies with immunomodulatory agents (t1dm, t1d). this observational study will: * follow participants to determine how long they continue to produce insulin, and * will also assess how changes in the immune system over time relate to the ability to produce insulin. this information could help design better therapies for type 1 diabetes in the future.

depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. evaluation visits will include: * overall health assessments * blood and urine collections * mixed meal tolerance test (mmtts) for certain participants, per protocol.

Eligibility criteria:
inclusion criteria: * prior participant in an immune tolerance network (itn) executive committee approved t1dm study. * ability to sign informed consent/assent (as applicable for children). exclusion criteria: * any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or * inability to comply with the study visit schedule and required assessments.

Keywords: insulin glucose intolerance
oto-104 for the treatment of meniere's disease

Conditions: Meniere's Disease

Summary: the purpose of this study is to evaluate the effectiveness of oto-104 for the treatment of meniere's disease.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of unilateral meniere's disease by 1995 american academy of otolaryngology - head and neck surgery (aaohns) criteria and reports active vertigo for the 2 months prior to the study lead-in period. * subject has experienced active vertigo during the lead-in period. * subject has documented asymmetric sensorineural hearing loss. * subject agrees to maintain their current treatments for meniere's disease while on-study. * subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study. exclusion criteria: * subject is pregnant or lactating. * subject has a history of immunodeficiency disease. * subject has a history of previous endolymphatic sac surgery. * subject has a history of previous use of intratympanic (it) gentamicin in the affected ear. * subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. * subject has experienced an adverse reaction to it injection of steroids. * subject has used an investigational drug or device in the 3 months prior to screening. * subject has previously been randomized to a trial of oto-104.

Keywords: meniere's disease vertigo definitive vertigo vertigo episodes vertigo frequency tinnitus hearing loss aural fullness
darbepoetin alfa mds companion protocol

Conditions: Myelodysplastic Syndrome (MDS)

Summary: the primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (eoatp) of the darbepoetin alfa mds 20090160 (nct01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.

this is a phase 3b, multi-centre, open-label, single-arm companion study to the mds 20090160 study (nct01362140) for the treatment of anaemic patients with mds. participants who completed the active-treatment period of the darbepoetin alfa mds 20090160 study and met the eligibility criteria could be enrolled into this study to continue treatment of darbepoetin alfa for up to 73 weeks or until progression to acute myelogenous leukemia (aml), whichever occurs first.

Eligibility criteria:
inclusion criteria: * subject or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/ procedures being initiated; * subject must continue long term follow up within parent study (20090160); * subject must have an ongoing clinically relevant erythroid response as assessed by the investigator using current response criteria (ie, international working group (iwg) response criteria); exclusion criteria: * transfusion dependence defined as receiving a total of ≥ 4 units of red blood cell (rbc) transfusion in the previous 8-week period prior to enrolment; * known diagnosis of acute myelogenous leukemia (aml) or marrow collagen fibrosis; * known refractory anaemia with excess blast-2 (raeb-2); * known diagnosis of intermediate-2 or high risk mds per international prognostic scoring system (ipss); * subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in the mds 20090160 study or planning to receive such agents during the study; * other protocol defined inclusion and exclusion criteria may apply.

Keywords: myelodysplastic syndrome (mds) darbepoetin alfa low risk mds intermediate-1 risk mds international prognostic scoring system (ipss)
effect of thoracic snags on vitals among individuals with forward head posture

Conditions: Neck Pain

Summary: to determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic snags in individuals with forward head posture.

forward head posture (fhp) leads to abnormal activation of neck muscles. this leads to respiratory complications and changes in blood pressure. due to regional interdependence upper thoracic spine can restrict the movement of cervical spine thoracic spine is is closely related to sympathetic nervous system. t1-t5 spinal sympathetic neurons provide sympathetic innervation to the vessels that supply to the heart tissues and upper portion of the body. thus, thoracic mobilization can regulate main body vitals as well as other visceral activities that maintain homeostasis there is a manual therapy technique called sustained natural apophyseal glides (snags) in which patient performs active movements along with the passive movements performed by the physiotherapist. it not only has biomechanical efficacy which includes pain reduction and improvement in rom, but it also has neurophysiologic effects. previous studies lack to provide how thoracic snags can affect vitals. thus, this study aims to determine the effect of thoracic snags on vital signs, including heart rate, blood pressure, respiratory rate, and oxygen saturation . furthermore, this research will add to growing body of knowledge that how thoracic snags can influence the correction of forward head posture

Eligibility criteria:
inclusion criteria: * both males and females * age 30-50yrs. * craniovertebral angle \<50° * mild to moderate neck pain ranging between 3-6 on nprs scale. * individuals with normal vitals: * heart rate (60-100 beats per minute) * respiratory rate (12-20 breaths per minute) * systolic bp (100- 139mmhg)(30). * diastolic bp (70-89 mmhg) (30). * oxygen saturation ≥96% exclusion criteria: * history of cervical/thoracic spine surgery * cardiopulmonary disorder or hypertension ≥140/90mmhg (30). * vertebral instability * smokers * any infection or tumor

Keywords: forward head posture vitals snags craniovertebral angle
stereotactic body radiation therapy (sbrt) for invasive breast cancer patients not undergoing definitive surgery

Conditions: Breast Cancer

Summary: this is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (sbrt) as a treatment for breast cancer in patients who do not get surgery. the study will accrue 15 patients who will be treated to a dose of 40 gy over the course of 5 fractions in the stony brook university hospital department of radiation oncology. the subjects will then have a follow up time of 5 years.


Eligibility criteria:
inclusion criteria: * age \>/= 18 * biopsy proven invasive carcinoma of the breast * clinical t1-t4 invasive carcinoma * cancer is deemed unresectable with no possibility of future resection or the patient is a poor surgical candidate as determined following evaluation by a surgeon. * women who are not post-menopausal should have a negative urine or serum pregnancy test. women of childbearing potential must agree to adequate contraception for the duration of study participation. * ability to understand and willingness to sign a written informed consent document * life expectancy \> 6 months * patient is to be treated at stony brook university hospital exclusion criteria: * women with a known pregnancy, positive serum pregnancy test, or currently breastfeeding as well as women of childbearing potential unwilling or unable to use an acceptable method of birth control (including abstinence or barrier method of birth control) to avoid pregnancy for the duration of the study. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * breast implant in the breast to be treated with sbrt * insufficient breast imaging to judge clinical stage * inability to receive study treatment planning and treatment secondary to body habitus * inability to understand or unwillingness to sign a written consent document * life expectancy \< 6 months * children (\< 18 years of age) * uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with study requirements