Kornimate/medical-research-clean huggingface dataset:
effects of flibanserin on the pre- and post-menopausal female brain

Conditions: Hypoactive Sexual Desire Disorder

Summary: the purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work dr. stephanie cacioppo has done in which desire was not manipulated. in the present project, dr. stephanie cacioppo is manipulating desire through flibanserin (addyi) vs. placebo and she will be measuring subjective sexual desire as a manipulation check. the investigators will address this goal using a double-blind randomized outpatient design and determine the pre-post neurobehavioral change in the flibanserin group and investigate the extent to which flibanserin normalizes brain activity in premenopausal women with hsdd and the extent to which regional brain activation is associated with changes in symptoms and behavior (as measured with self-report measures of sexual desire and/or eye-tracking movements).

hypoactive sexual desire disorder (hsdd) is the most common sexual complaint in women. over the past 8 years, dr. stephanie cacioppo has developed and validated the desire intention task, in which individuals are instructed to indicate as rapidly and as accurately as possible whether or not each visually presented stimulus (e.g., attractive persons of the opposite sex) is sexually desirable to them at the moment of the experiment. flibanserin (addyi) is a new medication approved by the fda for the treatment of hsdd in pre-menopausal women. the investigators propose a study using the dit to determine the extent to which flibanserin normalizes brain activity in women with hsdd and the extent to which regional brain activation is associated with changes in symptoms and behavior.

Eligibility criteria:
inclusion criteria: * female * ages 21-45 or 51-74 * pre- or postmenopausal * dsm-5 diagnosis of hypoactive sexual desire disorder (hsdd) * right-handed exclusion criteria: * male * pregnant women * nursing women * post-menopausal women * women who report not being able to stop drinking alcohol during the duration of the study * currently taking psychotropic medication * history of seizures or neurological disorders * under hormonal therapy * current or past diagnosis of cancer * any unstable medical illnesses * lifetime history of bipolar disorder, schizophrenia, or psychotic disorder * current or recent (past 3 months) substance abuse or dependence * current or recent (past 3 months) clinical depression * currently taking any medications that have/may have unfavorable interactions with flibanserin

Keywords: hsdd (hypoactive sexual desire disorder) eeg (electroencephalogram)
myofascial induction in breast cancer survivors

Conditions: Pain; Breast Cancer

Summary: the purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

background: to investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity. methods: randomized, single-blind, placebo-controlled cross-over study. twenty-one enrolled participants who had a diagnosis of breast cancer stage i-iiia and had completed adjuvant therapy except hormonal treatment. the study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. the interventions consisted of a myofascial induction (experimental group) or placebo pulsed shortwave therapy (control group). the main outcome measures were: visual analogue scale for pain and anxiety, shoulder-cervical goniometry for range of motion, profile of mood states for psychological distress and attitudes toward massage scale.

Eligibility criteria:
inclusion criteria: * had a diagnosis of breast cancer (cancer stage i-iiia) * was between the ages of 25 and 65 * had completed adjuvant therapy except hormonal treatment exclusion criteria: * had cancer recurrence

Keywords: neck shoulder manual therapies
capecitabine or observation for patients with pt1n+m0 or pt2-3n0m0 gastric adenocarcinoma undergoing r0 resection

Conditions: Gastric Cancer

Summary: gastric cancer (gc) is one of the most common and lethal malignancies in asia. for early (stage t1) gc, it has been found by analyzing surgical specimens that \~5% of cancers have lymph node metastasis. for patients with stage t2-3n0m0 gcs, there is a considerable probability of micro-metastasis. while the us national comprehensive cancer network (nccn), the japanese gastric cancer association (jgca), and the european society for medical oncology (esmo) guidelines recommend adjuvant therapy for most patients with resected \>t1n0 gcs, the recommendations vary regarding postsurgical treatment for patients with stage t1n+m0 or t2-3n0m0 disease. the jgca guidelines do not recommend postsurgical chemotherapy for this patient population, while the esmo support the adjuvant treatment. the nccn has not offered a definitive recommendation on this issue. through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected t1n+m0 or t2-3n0m0 gc. the first-line chemotherapy regimen for gc is fluorouracil plus platinum. among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. this large multicenter phase iii randomized controlled trial is led by department of gastrointestinal surgery, the first affiliated hospital of anhui medical university, and carried out in multiple chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage t1n+m0 or t2-3n0m0 gc undergoing r0 resection.


Eligibility criteria:
inclusion criteria: * microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the esophagogastric junction); * cancer stage pt1n+m0 or pt2-3n0m0; * radical r0 resection; * retrieved lymph node number ≥15; * without hepatic, peritoneal, or other distant metastasis; * aged 18-70 years; * no other cancer-directed therapy except primary cancer resection; * good tissue and organ function: white blood cell count ≥4000/mm3; neutrophil count ≥1500/mm3; platelet count ≥100000/mm3; total bilirubin ≤25.7 μmol/l or within 1.5 times the upper threshold; aspartate transaminase (ast) and alanine transaminase (alt) within 2.5 times the upper threshold; creatinine within 1.25 times the upper threshold; creatinine clearance rate \>60 ml/min; * no serious cardiovascular or cerebrovascular disease; * no concomitant or previous malignancies; * enrolled within 6 weeks after resection; * eastern cooperative oncology group (ecog) score ≤2; * clavien-dindo morbidity score 0-2; * patient informed consent. exclusion criteria: * the need to take phenytoin or coumarin anti-coagulates; * allergic to capecitabine or fluorouracil; * known dpd activity deficiency (dpyd gene mutation); * pregnant or breeding women; * all others contradictory to the items listed in the inclusion criteria.
duloxetine for post laparoscopic shoulder pain

Conditions: Post Laparoscopic Shoulder Pain

Summary: despite recent advances in minimal invasive surgery, postoperative pain control remains a challenge for both surgeons and anesthesiologists . currently, laparoscopy has an obvious favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is minimally invasive, has less pain, and needs less postoperative analgesic use compared with open surgeries . shoulder pain is a frequent problem following laparoscopic procedure

many patients may feel much more discomfort from their shoulder pain than incision pain . post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and phrenic nerve by local acidosis and irritative effect of carbon dioxide during pneumoperitoneum or distention forces on the diaphragm. duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant . it is used to treat major depressive disorder in adults. duloxetine is also used to treat general anxiety disorder. it is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain). duloxetine is also used to treat diabetic neuropathy. previous studies focused on the use of gabapentin and pregabalin (both are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and since duloxetine is an antineuropathic pain medications we assume its use will ameliorate diaphragmatic irritation and hencepost laparoscopic shoulder pain.

Eligibility criteria:
inclusion criteria: * pre-menopausal females * patient consent * patients with asa class i-ii * elective gynecological laparoscopy exclusion criteria: * body mass index ≥ 40 * consuming any pain killers routinely within 48 hours before the surgery * smoking, drug abuse * patients with major psychiatric disorders, epilepsy or history of convulsion * any known kidney or hepatic disorders * history of any other pervious laparotomy, laparoscopy, or other pelvic manipulation or pathology except normal vaginal delivery * history of chest or mediastinal surgery or pathology * recent flu (six weeks before surgery) * suspected to malignancy as pathology * those who complained from shoulder pain just before surgery in the first visual analog scale assessment.
a study of safety and pharmacokinetics of repeated dose of micafungin as antifungal prophylaxis in children and adolescents who undergo hematopoietic stem cell transplant

Conditions: Fungal Infections

Summary: the study will evaluate pk and safety of two dose levels of micafungin (fk463) as antifungal prophylaxis in children and adolescents undergoing hsct

this is a prospective, multi-center, open-label, repeat-dose pharmacokinetic study that contains two treatment (micafungin 1.0mg/kg and 1.5mg/kg) dose groups. subjects will be enrolled according to age and stratified by weight to receive either 1.0mg/kg (weight \> 25kg) or 1.5mg/kg ( weight \< 25kg) micafungin. children (4 months to \< 2years, 2 to 5 years and 6 to 11 years) and adolescents (12 to 16 years) undergoing hsct who require antifungal prophylaxis will be enrolled

Eligibility criteria:
inclusion criteria: * institutional review board (irb)-approved written informed consent / assent (as applicable) and hipaa authorization must be obtained from the subject (as able) and /or subject's parent/legally authorized representative prior to any study-related procedures * subject has sufficient venous access to permit administration of study drug, collect pharmacokinetic samples and monitor laboratory safety variables * female subject of childbearing potential must have a negative pregnancy test within 72 hours prior to the first dose of study drug, and if sexually active agree method of birth control per investigator judgment for the duration of the study * subject (when able) and /or subjects parent/legally authorized representative agree to comply with the study requirements and with the concomitant medication restrictions * subject plans to undergo a hsct exclusion criteria: * subject has evidence of significant liver disease as defined by aspartate transamine (ast/sgot), alanine transaminases (alt/sgpt) 10 times the upper limit of normal (uln) and total bilirubin or alkaline phosphatase \> 5 times the uln * subject has concomitant medical condition that in the opinion of the investigator and /or medical monitor precludes enrollment into the study * subject with evidence of an active systemic or disseminated fungal infection prior to enrollment * subject has a history of anaphylaxis, hypersensitivity, or any serious reactions to the echinocandin class of antifungals * subject had received treatment with an echinocandin within one week prior to first dose of study drug * subject status is unstable and subject is unlikely to complete required study procedures * female subject is pregnant or nursing. females of childbearing potential must avoid becoming pregnant while receiving study drug

Keywords: antifungal prophylaxis hematopoietic stem cell transplant hsct micafungin
acceptance and commitment therapy (act) for combating the effects of race-related stress among black adolescents

Conditions: Race-related Stress; Depression, Anxiety; Quality of Life; Stress Reaction

Summary: the current study seeks to build on previous research that demonstrates the efficacy of acceptance and commitment therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support black adolescents and young adults in coping with race related stress. the study will consist of a small, purposeful, non-randomized sample (n = 30) of clients enrolled into a 10-session acceptance and commitment therapy group. the group will be offered as part of regular clinical care at the division of adolescent and young adult medicine. three consecutive groups will be run with approximately 8-10 participants in each group over the next year.


Eligibility criteria:
inclusion criteria: * identify as black/african american * english-speaking exclusion criteria: * prisoners or youth in detention centers will be excluded. * not capable of participating meaningfully in the assent/consent process. * being at significant risk for suicide and self-injury * currently experiencing psychosis * having severe health concerns that will impact study participation or attendance

Keywords: black african american adolescents acceptance and commitment therapy race-related stress racial trauma coping
a study of gs-5423 and gs-2872 in combination with capsid inhibitor lenacapavir in virologically suppressed adults with hiv-1 infection

Conditions: HIV Infections

Summary: the goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bnabs) (teropavimab (formerly gs-5423) and zinlirvimab (formerly gs-2872)) with lenacapavir (len) in virologically suppressed adults with hiv-1 infection. the purpose of this study is to evaluate the efficacy of switching to a regimen of len, teropavimab, and zinlirvimab, versus continuing on baseline oral antiretroviral therapy (art) as determined by the proportion of participants with human immunodeficiency virus-1 (hiv-1) ribonucleic acid (rna) ≥ 50 copies/ml at week 26.


Eligibility criteria:
key inclusion criteria: * on stable oral antiretroviral therapy (art) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. a change in art regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (vf) (eg, tolerability, simplification, drug-drug interaction profile) is allowed. * no clinically significant documented historical resistance to the current art regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including m184v or ≤ 2 thymidine analog mutations (tams: m41l, d67n, k70r, l210w, t215y, and/or k219q). * plasma hiv-1 rna \< 50 copies/ml at screening visit 2. * documented plasma hiv-1 rna \< 50 copies/ml for ≥ 12 months preceding screening visit 2 (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml). virologic elevations of ≥ 50 copies/ml (transient detectable viremia or "blips") prior to screening are acceptable. * proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol gs-us-536-5816 within 24 months prior to screening. * screening cd4+ t-cell count ≥ 200 cells/μl at screening visit 2. key exclusion criteria: * comorbid condition requiring ongoing immunosuppression. * evidence of hepatitis c virus (hcv) infection (prior infection cleared spontaneously or with treatment is acceptable) * evidence of current hepatitis b virus (hbv) infection regardless of hbv surface antigen status, at the screening visit 2. * history of opportunistic infection or illness indicative of stage 3 hiv disease. note: other protocol defined inclusion/exclusion criteria may apply.
emotion regulation interventions for alcohol-related sexual aggression

Conditions: Sexual Aggression; Heavy Drinking

Summary: rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. the goal of this research is to evaluate the efficacy of two brief online emotion regulation interventions for reducing alcohol-related sexual aggression in heavy episodic drinking young men with a sexual aggression history. previous research suggests that emotion regulation difficulties are associated with both alcohol consumption and aggressive behavior. despite the potential prevention utility of improving sexually aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual aggression, this approach has yet to be explored. thus, this study evaluates the effects of two brief online er interventions - cognitive restructuring and mindfulness - on men's emotion regulation during a sexual aggression-related analogue. additionally, these effects will be evaluated during both sober and intoxicated states through a laboratory- based alcohol administration experiment.


Eligibility criteria:
inclusion criteria: * single * male * age 21-30 * heterosexually active within past year * heavy episodic drinker * self-reported history of sexual aggression exclusion criteria: * history of alcohol problems * medical condition or medications that contraindicate alcohol consumption
bioavailability study of bia 5-453

Conditions: Hypertension; Congestive Heart Failure

Summary: the purpose of this study was to compare the bioavailability and tolerability of bia 5-453 under fasted and fed conditions.

this was a single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. subjects received a single oral 200 mg dose of bia 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. treatment periods were separated by a washout interval of 2 weeks or more.

Eligibility criteria:
inclusion criteria: * aged between 18 and 45 years, inclusive. * had a body mass index (bmi) between 19 and 30 kg/m2, inclusive. * were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ecg. * had negative tests for hbsag, anti-hcvab and hiv-1 and hiv-2 ab at screening * had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period. * had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period. * were non-smokers or smoked ≤ 10 cigarettes or equivalent per day. * was able and willing to give written informed consent. exclusion criteria: * had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. * had a clinically relevant surgical history. * had a clinically relevant family history. * had a history of relevant atopy or drug hypersensitivity. * had a history of alcoholism or drug abuse. * consumed more than 14 units of alcohol a week. * had a significant infection or known inflammatory process at screening or admission to the first treatment period. * had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period. * used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion. * used any investigational drug or participated in any clinical trial within 3 months prior to screening. * participated in more than 2 clinical trials within the 12 months prior to screening. * donated or received any blood or blood products within the 3 months prior to screening. * was a vegetarian, vegan or with medical dietary restrictions. * could not communicate reliably with the investigator. * was unlikely to co-operate with the requirements of the study. * was unwilling or unable to give written informed consent.
dose-escalation trial of preoperative radiotherapy and concurrent chemotherapy in locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: the aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of yprc with tolerable toxicity, using imrt (concomitant boost technique).

the hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.

Eligibility criteria:
inclusion criteria: * pathologically proven diagnosis of adenocarcinoma of the rectum * clinically determined to be stage t3 or t4,n0-n2, and m0 -staged by mri or transrectal ultrasound of the rectum * patients who are medically operable and who have resectable adenocarcinoma of the rectum at least \<11cm from the anal verge * adequate liver/renal and haematological function. * eastern cooperative oncology group (ecog) performance 0-2 * age ≥ 18 years * full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: * absolute neutrophil count (anc) ≥ 1,800 cells/mm3 * platelets ≥ 100,000 cells/mm3 * haemoglobin ≥ 8.0 g/dl * serum creatinine within normal institutional limits * bilirubin within normal institutional limits * ast and alt \< 2.5 x the iuln * patient must sign study specific informed consent prior to study entry exclusion criteria: * prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable. * prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * any evidence of distant metastases (m1) * a synchronous primary colon carcinoma

Keywords: rectal cancer imrt radiation dose escalation