Kornimate/medical-research-clean huggingface dataset:
effect of sitagliptin on polycystic ovarian syndrome patients

Conditions: Polycystic Ovary Syndrome

Summary: the study aims to determine the proposed positive influence of sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of polycystic ovary syndrome and subsequent infertility

study design : a prospective randomized controlled trial. a total of 80 infertile adult females aged between 18 and 45 years currently diagnosed with polycystic ovary syndrome , meeting the diagnosis of rotterdam criteria be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be included in the study. the study will include two groups; each group consists of 40 patients:- group a : control group group b : test group ( will receive sitagliptin at a dose of 100 mg every 24 hours

Eligibility criteria:
inclusion criteria: polycystic ovary syndrome usually diagnosed based on the rotterdam criteria if 2 of 3 criteria are present: 1. oligo- and/or anovulation 2. hyperandrogenism (ha) (clinical and/or biochemical) 3. polycystic ovary morphology (pcom) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume \>10 cm3). exclusion criteria: 1. congenital adrenal hyperplasia 2. brittle control of a thyroid disorder 3. diabetic on metformin or any another antidiabetic drugs affecting insulin resistance 4. chronic kidney disease 5. liver dysfunction 6. documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.lipid lowering consumption

Keywords: polycystic ovary syndrome sitagliptin
a study to evaluate the efficacy and safety of k-285 compared with menthol gel for the treatment of delayed onset muscle soreness (doms) in the lower extremity

Conditions: Acute Pain

Summary: the purpose of this study to evaluate the efficacy and safety of k-285 compared with menthol gel for the treatment of delayed onset muscle soreness (doms) in the lower extremity.


Eligibility criteria:
inclusion criteria: * subject must provide informed consent before any study-specific evaluation is performed. * subject is male and female aged 18 to 35 years, inclusive. * subject has a body mass index of 18 to 32 kg/m2, inclusive. * subject meets all inclusion criteria outlined in the clinical study protocol. exclusion criteria: * subject has a job (e.g., movers, construction workers) that requires regular lifting or involvement of the lower extremities. * subject has restless leg syndrome, a chronic pain condition, a history of intermittent claudication, or has taken any medication (e.g., analgesic medication, sleep medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months to treat a chronic pain condition, or has another painful physical condition in a lower extremity that, in the opinion of the investigator, may confound study assessments. * subject has received oral or topical analgesic medications within 14 days before the screening visit. * subject meet any other exclusion criteria outlined in the clinical study protocol.
plicated laparoscopic adjustable gastric banding (lap band)

Conditions: Weight Loss

Summary: this is a dual site, prospective study which will compare plicated-laparoscopic adjustable gastric banding (plagb) to standard labg (slagb) to identify significant differences in bariatric surgical outcomes * weight loss * co-morbid disease resolution


Eligibility criteria:
inclusion criteria: subjects must meet the following criteria to be eligible for study entry: * age between 18 - 80 years, and * severely or morbidly obese: * bmi \> 35, or * bmi \> 30 + co-morbid obesity related disease condition * without any contraindications to bariatric surgery, and * without any metabolic or medically correctable causes for obesity (eg. untreated hypothyroidism, prader-willi, etc.) * patients who have had previous lagb surgery requiring revision for complications such as slippage, stalled weight loss or weight regain exclusion criteria: subjects meeting the following criteria will be excluded from study entry: * any patient not meeting the inclusion criteria * patients with any major medical problems contraindicating surgery * patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, prader-willi, etc.) * patients who elect to undergo a surgery other than a plagb or slagb * pregnant or planning pregnancy within 12 months * alcohol or drug addiction * established infection anywhere in the body at the time of surgery * previous history of other bariatric surgery (except lagb) * family or patient history of autoimmune disease

Keywords: co-morbid disease resolution
non-invasive evaluation of lymphoma patients based on artificial intelligence and pet/mri

Conditions: Lymphoma; Non Hodgkin Lymphoma; Follicular Lymphoma

Summary: 18f-fdg pet/mr imaging protocol integrating advanced mr vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. the aim of this prospective study is to develop an automatic artificial intelligence-based tool for the assessment of early response to treatment and evaluation of residual masses in patients with lymphoma. specific objectives are: 1. to evaluate the added value of 18f-fdg pet/mri compared with pet/ct in imaging lymphoma. 2. to optimize pet/mr imaging protocol for lymphoma assessment. 3. to develop an automated tool for staging patients with lymphoma. 4. to develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma. 5. to develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.


Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the pet/ct is the imaging modality of choice)/ 2. patients aged 18 years or older of both sexes. 3. patients treated at tel-aviv sourasky medical center. exclusion criteria: 1. pregnancy, 2. contraindication to mri or to intravenous gadolinium injection.

Keywords: lymphoma non hodgkin lymphoma follicular lymphoma
poem: long vs short myotomy for achalasia. rct

Conditions: Achalasia

Summary: per-oral endoscopic myotomy (poem) is increasingly used for the treatment of achalasia. in published series, a 12cm-poem is usually performed. surgical myotomy is typically shorter (8cm). the clinical efficacy of both procedure is comparable. this study intends to investigate if clinical outcomes of poem depends on the length of esophageal myotomy, in patients with classic-type achalasia (type i and type ii according to chicago classification)

peroral endoscopic myotomy myotomy (poem) has been recently introduced for treatment of achalasia, based on technical developments from notes (natural orifice translumenal surgery). the technique includes the incision of the mucosa in the esophageal body, the submucosal dissection of the distal esophagus and the creation of a submucosal tunnel in the distal esophagus and proximal gastric body, and the esophageal myotomy. the procedure is performed transorally, using a flexible endoscope. in published series, a 12cm-poem is usually performed. surgical myotomy is typically shorter, being protracted for about 8cm. the clinical efficacy of poem and surgical myotomy is more likely to be similar according to the most recent published series. in this randomized controlled trial (non-inferiority trial) we evaluate the outcomes of poem according to the length of the esophageal myotomy. patients with type i and ii achalasia will be randomly assigned to one of the two groups, long--myotomy (lm) and short--myotomy (sm). patients in the lm-group will receive a 12cm-long poem (including 3cm on the stomach); in the sm-group patients will undergo a poem extended for 7 cm (including 3cm on the stomach). during follow-up, high resolution manometry (hrm), esophageal ph-monitoring study and esophagogastroduodenoscopy (egd) will be regularly performed and symptoms assessed with the use of the eckardt score (ecks). the main hypothesis is that the results of a sm are not inferior to the results of a lm. calculated sample size is 200 patients

Eligibility criteria:
inclusion criteria: 1. diagnosis of achalasia (type i and ii) 2. age \> 18 3. signed informed consent 4. patient accepts to undergo scheduled follow-up after poem 5. eckardt score \> 3 6. asa i-ii-iii exclusion criteria: 1. prior surgical treatment of achalasia (previous endoscopic balloon dilation or botox injection are not exclusion criteria) 2. pregnancy or nursing 3. current alcohol or drug addiction. 4. mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator make the subject a poor candidate for this study. 5. severe congenital or acquired coagulopathy or inr \> 1.6 6. participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial. 7. hepatic cirrhosis w/ or w/o portal hypertension w/ or w/o esophageal varices 8. eosinophilic esophagitis or barrett esophagus 9. esophageal strictures

Keywords: peroral endoscopic myotomy endoscopy poem submucosal endoscopy
a study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with thyroid eye disease

Conditions: Thyroid Eye Disease

Summary: the purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (sc) satralizumab, a recombinant, humanized anti-interleukin-6 (il-6) receptor monoclonal antibody, in participants with thyroid eye disease (ted).


Eligibility criteria:
inclusion criteria: - clinical diagnosis of ted based on cas exclusion criteria: * decrease in cas or proptosis of \>≥ 2 points or ≥ 2 mm, respectively, in the study eye between screening and study baseline (day 1) * requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator * identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study * any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study * pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab

Keywords: ted
surveillance study of respiratory syncytial virus infection (rsv) in subjects < 24 months of age

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to collect clinical outcome and nasal viral load information.

there is no vaccine available to prevent respiratory syncytial virus disease; however, a humanized monoclonal antibody is approved for the prevention of respiratory syncytial virus infection in pediatric patients at high risk of disease (eg, pre-term infants, congenital heart disease, and chronic lung disease). beyond this high-risk group, infection is common in otherwise healthy infants and can be severe, leading to hospitalization and while uncommon, death. each year in the united states, approximately 100,000 respiratory syncytial virus-related hospitalizations occur in low risk infants. currently, treatment of infants suffering from respiratory syncytial virus disease is limited to supportive care with the goal of maintaining adequate oxygenation and nutrition. the availability of a novel anti-respiratory syncytial virus therapeutic that reduces the number of hospitalizations related to respiratory syncytial virus infection would fulfill an unmet medical need in the pediatric population. for maximum effect, such a treatment should be administered as early as possible in the course of infection. accordingly, the opportunities for early intervention with an anti-respiratory syncytial virus therapeutic are in the outpatient setting, prior to hospitalization. however, the incidence of respiratory syncytial virus-related hospitalization, as well as the natural history and viral dynamics of respiratory syncytial virus infection, remain undefined in the outpatient setting. a better understanding of the prevalence of respiratory syncytial virus infection and subsequent hospitalization rates among symptomatic infants as well as the early disease course of respiratory syncytial virus infection will help in the design of clinical trials needed to assess the efficacy of an anti-respiratory syncytial virus therapeutic developed by gilead sciences.

Eligibility criteria:
inclusion criteria: * \< 24 months of age * ≥ 35 weeks gestational age at birth * signs of acute respiratory tract infection \< 5 days * ability to contact parent or legal guardian for follow up exclusion criteria: * ongoing respiratory tract infection * lung disease * heart disease * respiratory syncytial virus medication in the last 6 months * participation in a study with investigational medicinal product in the last 28 days

Keywords: respiratory syncytial virus rsv
study evaluating streptococcus pneumoniae serotype carriage rate for nasopharyngeal carriage in filipino children

Conditions: Pneumonia, Bacterial

Summary: evaluation of the carriage rate of streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of streptococcus pneumoniae serotypes


Eligibility criteria:
inclusion criteria: * healthy children aged between 2 months and 5 years attending the well baby clinic in hospital. * informed consent obtained from parents or legal guardian.

Keywords: bacterial otitis media pneumoniae sepsis bacteremia meningitis streptococcus pneumoniae carriage rate
prevalence, impact and reversibility of acute diaprhagmatic dysfunction in acute respiratory detresse

Conditions: Respiratory Distress Syndrome,Adult

Summary: the diaphragm is a fine striated muscle with both extra respiratory and respiratory functions. it does most of the breathing work in interaction with the accessory respiratory muscles, the rib cage and the abdomen. its activity can be measured by the transdiaphragmatic pressure generated by the magnetic stimulation of phrenic nerves (gold standard). it has been shown in the literature that diaphragmatic ultrasound, via the measurement of diaphragmatic excursion and especially the thickening fraction, is an easily accessible, non-invasive, reproducible and relevant technique for evaluating acute diaphragmatic dysfunction in resuscitation patients. the objective of this project is to evaluate the prevalence of diaphragmatic dysfunction at admission in patients hospitalized in intensive care / respiratory intensive care unit for hypercapnic and/or hypoxic acute respiratory distress and requiring ventilatory support by non-invasive ventilation or high flow oxygen therapy. a subgroup analysis will then be carried out on 3 populations: * hypercapnic exacerbation of chronic obstructive pulmonary disease * hypoxic acute respiratory distress on infectious lung disease * acute pulmonary edema


Eligibility criteria:
inclusion criteria: * hospitalization for acute respiratory distress management * etiological diagnosis either: * exacerbation of chronic obstructive pulmonary disease * infectious pneumonitis * acute pulmonary edema * need for a ventilatory support by either: * non-invasive ventilation * high flow oxygen therapy (flow rate \> 40l/min and oxygen inspired fraction \> 40%) * mask oxygen therapy with flow rate \> 5l/min exclusion criteria: * exacerbation of interstitial pathology / pulmonary fibrosis * deformation of the thoracic cage * neurodegenerative pathology * need for oro-tracheal intubation from the beginning for mechanical ventilation * contraindication to non-invasive ventilation * patients undergoing diaphragmatic rehabilitation * immunocompromised patients * history of known diaphragmatic dysfunction
cognitive-behavioral therapy vs. nutrition counseling for avoidant/restrictive food intake disorder

Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)

Summary: this study is a randomized controlledlinical trial, assessing the efficacy of cognitive- behavioral therapy (cbt-ar) and nutrition counseling for avoidant/restrictive food intake disorder (arfid) for children and adolescents (ages 10-18 years).


Eligibility criteria:
inclusion criteria: * males and females ages 10-18 years old * current arfid * normal tsh or free t4 levels to rule out thyroid disease as cause of symptoms * negative celiac screening panel indicating no active celiac disease as cause of symptoms * fluency and literacy in english exclusion criteria: * bmi \< 5th percentile for sex and age * pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit * current/history of psychosis * substance/alcohol use disorder (active within the past month) * medical instability requiring inpatient care according to the american psychiatric association 2023 treatment guidelines for eating disorders * laboratory abnormalities indicating a need for higher level of care * complete lack of oral intake (suggesting a need for inpatient care) * tube feeding (suggesting a need for tube weaning) * active suicidal/homicidal ideation with intent or plan * contraindications to mri * history of major gastrointestinal tract surgery or serious medical condition (e.g., cancer) * medical history of intellectual disability * illiteracy
phase ii dose-ranging study of orthoderm patch for patients with tennis elbow

Conditions: Tendonitis

Summary: the purpose of the study is to evaluate the effectiveness and safety of the use of low-dose nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow.

chronic tendonitis remains difficult to treat. nitric oxide has been demonstrated to stimulate tenocytes to proliferate, differentiate and produce matrix components including collagen. studies have demonstrated that nitroglycerin transdermal patches, which release nitric oxide, reduce pain and increase function in patients with chronic tendonitis. the purpose of the present study is to examine the efficacy of three dose levels of nitroglycerin, compared to placebo, in reducing pain and increasing function in patients with chronic (greater than three months' duration) lateral epicondylitis.

Eligibility criteria:
inclusion criteria: * males \>18 yr and \< 70 yr * bmi \< 38 * chronic lateral epicondylitis (symptomatic \> 3 mo) * pain on provocation \>/- 4 on 11 point scale exclusion criteria: * patients on other pain medications * bilateral elbow pain * any humerus elbow or forearm fracture or surgery * signs of injury other than lateral epicondylitis * any concomitant disease or pain of the upper extremity * orthostatic hypotension * patients taking mao inhibitors, phosphodiesterase inhibitors, adrenergic agents * pregnant or nursing women

Keywords: tendonitis nitroglycerin nitric oxide lateral epicondylitis
resource availability following critical illness

Conditions: Quality of Life

Summary: the purpose of this qualitative study is to explore the vital issues in recovery of qol from the perspective of survivors of critical illness and understand these patients' views on rehabilitative services in the united states (u.s.). the theoretical framework for this study is max weber's rational choice theory (rct). the research questions will focus on understanding post-icu qol and the patients' experience with rehabilitative services following critical illness. a phenomenological study design is being employed, using semi-structured individual interviews with critical illness survivors. data from the interviews will be coded for thematic analysis. the implications for social change include defining the meaning of qol for an icu survivor and improving healthcare policies for the therapies necessary to return survivors to a life worth living.

the purpose of this qualitative study is to understand the patient perception of qol after surviving critical illness and how survivors can help illuminate gaps in current health policies to provide better recovery resources for this growing population. the central research questions are: rq1: what are the issues important to preserve quality of life from the perspective of critical illness survivors? rq2: how do survivors of critical illness describe rehabilitative services after discharge?

Eligibility criteria:
inclusion criteria: * critical illness survivors within 18 months of icu discharge * minimum 48 hours of mechanical ventilation * ability to read and understand english * over the age of 18 exclusion criteria: * emotional or psychological inability to participate in a 30-min interview * not meeting inclusion criteria

Keywords: survivor qol resources
safety and efficacy study of once daily controlled release pregabalin in the treatment of patients with postherpetic neuralgia

Conditions: Post Herpetic Neuralgia

Summary: the purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (shingles)


Eligibility criteria:
inclusion criteria: * patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash. * at screening (v1) and enrollment (v2), patients must have a score of greater than or equal to 4 on the pain numeric rating scale (1 week recall period). * at enrollment (v2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4. * male or female of any race, at least 18 years of age, and using appropriate methods of contraception exclusion criteria: * creatinine clearance \<30 ml/min (estimated from serum creatinine). * skin conditions in the affected dermatome that could alter sensation * pregabalin use in the last 30 days. subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. patients who had not responded to pregabalin

Keywords: control release pregabalin in post herpetic neuralgia
very long term vhi voice outcome after mtis

Conditions: Laryngeal Paralysis

Summary: long term assesment of voice outcome after montgomery thyroplastie by performing a survey of operated patients using the voice handicap index scale


Eligibility criteria:
inclusion criteria: * patients presenting uvfp of neurogenic origin treated by mtis \> 2 years before inclusion. * no superior limit in terms of years. * age 18-80 years at the time of mtis * no other treatment before mtis other than resorbing material injection laryngoplasty (maximum twice) * no further voice treatment after mtis except speech therapy. * vhi or vhi-10 performed before mtis and within the 6 months after mtis. in case of multiple post-op vhi tests, only the earliest post-op. vhi test will be taken into account * vhi tests validated for the utilized language exclusion criteria: * patient not able to answer vhi questionnaire personally * post mtis new health condition affecting the voice tract and/ or the respiratory function. * post mtis appearance of other voice/ vocal cord pathology