Kornimate/medical-research-clean huggingface dataset:
brief shame intervention study

Conditions: Shame; Social Anxiety Disorder

Summary: the current project will develop and test a brief 2-session shame intervention in individuals diagnosed with social anxiety disorder (sad). using a non-concurrent multiple baseline design, the investigators will determine whether the brief shame intervention leads to reductions in trait self-reported shame and state shame in response to an in vivo stressor task. the investigators will also evaluate the effect of changes in shame on trait sad symptoms.


Eligibility criteria:
inclusion criteria: -≥ 18 years old * fluent in english, in terms of verbal and written competence * meet diagnostic criteria for social anxiety disorder (as assessed by the diagnostic interview for anxiety, mood, and ocd and related neuropsychiatric disorders; tolin et al., 2016) * have elevated levels of shame (i.e., score 1 sd above the test of self-conscious affect-3 \[tosca-3\] means reported by an unselected undergraduate sample \[m = 33.62, sd = 8.64\]) * endorse a desire to decrease their levels of shame and/or social anxiety. exclusion criteria: * currently receiving cognitive-behavioral therapy specifically for social anxiety or shame * have begun taking or had a change in dosage of psychotropic medication in the past six weeks * do not achieve baseline stability
lispro mix 25 vs. glargine in type 2 diabetics

Conditions: Diabetes Mellitus Type 2

Summary: in patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

the objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Eligibility criteria:
inclusion criteria: * males or females who have type 2 diabetes between 1 and 10 years * have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes * have not been on insulin treatment within 3 months before entry into the study * have a hemoglobin a1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at visit 1 * have a body mass index below 40 kg/m² exclusion criteria: * receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to visit 1 * have a known allergy to insulin * have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory * have known proliferative retinopathy * have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study

Keywords: diabetes diabetic insulin humalog lantus glargine lispro
trial of minocycline to treat children with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this is a single center study at the uc davis mind institute in patients age 3.5-16 years of age with fragile x syndrome (fxs), funded by a national fragile x foundation grant. it is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. we are investigating its use in fxs because it lowers matrix metalloproteinase 9 (mmp9) levels, which are high in fxs, and it also strengthens brain connections in the animal models of fxs. we hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile x patients.

this is a single center study at the uc davis mind institute in patients age 3.5-16 years of age with fragile x syndrome (fxs), funded by a national fragile x foundation grant. it is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. we are investigating its use in fxs because it lowers matrix metalloproteinase 9 (mmp9) levels, which are high in fxs, and it also strengthens brain connections in the animal models of fxs. we hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile x patients. the aim of this study is to carry out a double-blind placebo controlled trial of minocycline treatment in children with fxs who are 3.5 to 16 years of age. at baseline, we will assess behavior and perceptual and cognitive development. after the children have been treated for 3 months with either minocycline or placebo, they undergo the same baseline testing. they will then cross over and be treated for a second 3 months. we will carry out testing again at the end of the second 3 month period. we will also assess the side effects of minocycline treatment throughout the study.

Eligibility criteria:
inclusion criteria: * must have fragile x syndrome with molecular documentation * current pharmacological treatment regimen has been stable for at least 4 weeks exclusion criteria: * subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study * subjects who are unable to take oral medication * subjects who have been on minocycline previously * subjects who are allergic to minocycline or tetracyclines * subjects who are pregnant * subjects with history of lupus or hepatic dysfunction

Keywords: fragile x syndrome minocycline targeted treatment
sexombc2 non interventional study

Conditions: Breast Cancer; Quality of Life; Sexual Behavior

Summary: the study is composed of three paper self-questionnaires to be filled in by the patients included at distance (\> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires. after verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the icl for a follow-up consultation as part of their regular care. the patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. she will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. after this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the icl, in order to express, if they wish, their opposition to participating in the study. if she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. the completion of the questionnaires will be completely anonymous. the data of those who object to the use of their data will be deleted from the database. after the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. the interviews are not mandatory. the time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. as the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.


Eligibility criteria:
inclusion criteria: * major woman * patient with metastatic breast cancer, either initially or secondary metastatic breast cancer * rh+/her2- tumor * patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment * patient diagnosed with metastatic breast cancer 6 months or more * who 1 or 2 patient * postmenopausal or not * patient able to understand the french language exclusion criteria: * patient who\>2 * patient undergoing chemotherapy * her2+ or triple negative tumor * male * patient diagnosed with breast cancer less than 6 months ago * patient under guardianship, curatorship or safeguard of justice
hysteroscopy with fundus uterus scratching incision vs office hysteroscopy before et with donor eggs

Conditions: Hysteroscopy, Oocyte Recipients

Summary: a prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.

a prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. the study populations will be constituted by oocyte recipients. study group: hysteroscopy with fundus endometrial incision control group: office hysteroscopy without any endometrial injury

Eligibility criteria:
inclusion criteria: * oocyte acceptors * age 30-50 * embryo transfer with hormone replacement therapy * embryo transfer within 6 months of hysteroscopy exclusion criteria: * previous uterine pathology * sperm sample \<1mil/ml * leiomyoma * septate uterus

Keywords: hysteroscopy fundus endometrial incision oocyte acceptors pregnancy outcome uterine scratching
diagnostics and quality of life with eia and eilo

Conditions: Exercise Induced Asthma; Exercise Induced Pharyngeal Collapse

Summary: the purpose of this study is to investigate the quality of life of subjects suffering from dyspnoea while exercising and quantify the number of diagnoses of exercise induced asthma (eia) and exercise induced laryngeal obstruction (eilo) in our outpatient clinic using an exercise-challenge in a cold-chamber and an exercise-challenge with continuous laryngoscopy.

in this study investigators want to characterize and investigate the quality of life of all patients consulting the outpatient clinic for pediatric pulmonology suffering from dyspnoea while exercising. besides standard diagnostics (bodyplethysmograph, spirometry, exhaled no, skin prick test) subjects will take part in an exercise-challenge in a cold chamber at 2-4°c. subjects showing symptoms of exercise-induced asthma will get a treatment with ics/laba for six weeks. all patients should fill out a symptom diary. on suspicion of an eilo, subjects not showing symptoms in the first exercise-challenge in the cold chamber and all subjects without improvement after eia treatment will take part in a second exercise-challenge in the cold chamber with continuous laryngoscopy. if eilo is proved by laryngoscopy, speech therapy is recommended. to investigate the symptoms and the quality of life of these patients, all patients and there parents should answer symptom and quality of life questionnaires (child behavior checklist (cbcl/4-18), youth self-report (ysr 11-18), asthma control test, (act) dyspnea index (di)) at every visit. there are yearly follow ups of these patients for five years in order to collect long-range prognosis.

Eligibility criteria:
inclusion criteria: * written agreement * age: \>=8 and \<= 18 * exercise induced dyspnea * at least two training session per week * lung function before physical exercise fvc \>= 75% and fev1 \>= 70% exclusion criteria: * age \ 18 * lung function: forced vital capacity (fvc) \< 75% and forced expiratory pressure in one second (fev1) \< 70% * inability to understand the range oft the study * chronic asthma with systemic cortisone therapy * chronic asthma with high dose cortisone inhalation \>500 micrograms fluticasone equivalent * intake of long acting beta-agonists (laba) 48 h before examination * acute severe infection (pneumonia) within the last 4 weeks * intake of leukotriene-antagonists 48h before examination * other chronic diseases or infections (hiv, tbc) * pregnancy

Keywords: exercise induced asthma (eia) exercise induced laryngeal obstruction (eilo) quality of life exercise challenge in cold chamber (ecc) continous laryngoscopy while exercising (cle)
evaluating clinical outcomes for determining the optimal delay to skin incision under walant

Conditions: Hand Surgery; Orthopedic Surgery

Summary: further studies are needed to establish the effects of walant in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. therefore, this study aims to identify the best interval time to perform elective hand surgeries using walant technique, document clinical outcomes and identify potential complications

to propose the optimal time delay from the injection to skin incision for most walant surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also postoperative pain scores and complication rates to determine if there is a difference between performing the walant technique with a waiting interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss, pain scores, and complications. initiate the use of walant technique and its application in practice of orthopaedic residents in east avenue medical center

Eligibility criteria:
inclusion criteria: 1. . signed consent form 2. elective hand surgeries 3. minor hand surgeries 4. adult male/female ages 18 and above 5. multiply injured exclusion criteria: 1. no consent 2. multiply injured patient 3. traumatic hand injuries 4. known allergic reaction to either epinephrine or lidocaine. 5. known heart condition 6. patients on anticoagulants 7. patients diagnosed with bleeding disorders
sglt-2 inhibition, metabolomics and cardiovascular/kidney disease

Conditions: Type 2 Diabetes Mellitus

Summary: this study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (t2dm). the participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.

in this study, we hypothesize that metabolomics changes that occur in patients with t2dm after initiating sglt2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with sglt2i. also, we propose that the study of the specific metabolome associated with the treatment with sglt2i could help identify the possible metabolites and molecules that reduce cvd (cardiovascular disease) and renal disease in patients with t2dm. the participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.

Eligibility criteria:
inclusion criteria: * age 18-75. * bmi 27-39.9 kg/m2. * t2dm on treatment with metformin and inadequate metabolic control (defined as hba1c≥6.5 -7%). exclusion criteria: * pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test) * breastfeeding * intolerance/allergy to dapagliflozin. * treatment with antidiabetic drug other than metformin. * impaired kidney function: estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2 (calculated using the ckd-epi formula). * patients with established cardiovascular disease. * previous or current history of cancer of any kind. * uncontrolled hypertension (systolic blood pressure≥160 mmhg or diastolic blood pressure≥110 mmhg, despite adequate antihypertensive treatment). * history of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels\> 2.0 mg / dl or got/gpt levels three times higher than normal upper limit. * known hiv infection or active hbv or hcv infection. * other serious underlying diseases, which could affect the patient's ability to participate in the study. * reduced life expectancy (\<12 months) due to advanced or terminal concomitant diseases. in addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.

Keywords: metabolomics dapagliflozin
transgender cohort study of gender affirmation and hiv-related health

Conditions: HIV/AIDS; STI; Gender Dysphoria; Transsexualism; Gender Identity; Depression, Anxiety

Summary: this observational research study will evaluate medical gender affirmation delivered in primary care as an intervention to reduce disparities in hiv-related outcomes (e.g., low rates of prep uptake for hiv-uninfected patients, high rates of viral suppression for hiv-infected patients) for transgender patients in two urban federally-qualified community health centers.

this observational, longitudinal prospective cohort study will evaluate whether medical gender affirmation delivered in primary care improves hiv-related outcomes for transgender patients. medical gender affirmation therapies-hormones and surgical interventions-are medically necessary treatments shown to improve psychological functioning and quality of life for transgender patients. it is not yet known whether these treatments improve hiv-related outcomes over time because studies providing the best evidence of medical gender affirmation's clinical effectiveness do not examine hiv-related outcomes in transgender adult patients. to fill this gap, the proposed study will prospectively evaluate the effects of medical gender affirmation delivered in primary care on hiv-related outcomes in a multi-site clinic-based cohort of 4,500 diverse transgender patients from two urban u.s. health centers who are leaders in transgender healthcare. transgender adult primary care patients at fenway health in boston, ma and callen-lorde community health center in new york city, ny will be enrolled over 12 months and followed prospectively for 12 months. bio-behavioral data will be linked, including electronic patient-reported outcomes (baseline, 6-month, 12-month assessments), and electronic health record (ehr) data.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * have a gender identity differing from their assigned sex at birth (verified at screening via two-step method cross-categorizing natal sex and gender identity); * current or new primary care patient at fenway health or callen-lorde community health center (primary care patients are defined as those who had at least one medical visit in a 12-month period); * able to read, speak, and understand english and/or spanish; * willing and able to provide informed consent. exclusion criteria: * under 18 years of age; * unable to read, speak, and understand english and/or spanish; * unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of consent.

Keywords: transgender hiv/aids gender affirmation prep
decreasing long-term opioid use in cancer survivors

Conditions: Pain; Chronic Pain; Cancer Pain; Survivorship

Summary: this is a feasibility pilot trial assessing a behavioral intervention for chronic pain among disease-free cancer survivors to decrease long-term opioid dependence.

to assess the feasibility and acceptability of implementing brief acceptance and commitment therapy for chronic pain (act-cp) in a survivorship clinic.

Eligibility criteria:
inclusion criteria: * diagnosis of cancer of any type, currently in remission, having completed active primary therapy. patients on oral adjuvant hormone therapy will still be eligible. * completed active therapy must have been curative in intent (for example stage iv cancer patients such as head and neck cancer patients treated with curative intent are eligible). * self-reported cancer pain for \>= 3 months * opioid use \>= 5mme/day (morphine milligram equivalents) as prescribed by physician for cancer-related pain for at least 6 months beyond completion of their cancer treatment * vcuhealth system patient exclusion criteria: * history of opioid use prior to cancer diagnosis * anyone with prior history of substance use disorder or currently enrolled in a methadone program * anyone with schizophrenia or bipolar disorder * current utilization of psychotherapy services for pain, depression, anxiety, and/or ptsd * cognitive concerns that would prevent meaningful engagement in treatment * inability to converse in english * lack of working telephone and internet connection (must have at least one or the other) * anyone found to have progression of cancer * anyone diagnosed with cancer recurrence or new cancer during their study period * documented diagnosis of or positive screen for current substance use disorder (score \>5 on the drug abuse screening test-10 \[dast-10\]) * anyone scoring \>=8 on ort indicating very high risk for opioid abuse

Keywords: commitment therapy