Kornimate/medical-research-clean huggingface dataset:
n-3 polyunsaturated fatty acids (pufa) supplementation in young women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: this is a dietary intervention study designed to assess the impact of long chain (lc) n-3 polyunsaturated fatty acids (pufa) in young women with polycystic ovary syndrome (pcos). considering that lc n-3 pufa have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of pcos, it was hypothesised that dietary supplementation with lc n-3 pufa would have a beneficial therapeutic impact.

polycystic ovary syndrome (pcos) is a chronic condition affecting young women of reproductive age. long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. lc n-3 pufa have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with pcos. the aim of this study was to explore the impact of lc n-3 pufa on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with pcos.

Eligibility criteria:
inclusion criteria: * had a positive diagnosis of pcos as defined according to the nih criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. clinical criteria included hirsutism with a ferriman-galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (dheas) greater than the laboratory reference range. * were between the ages of 18 and 40 exclusion criteria: * were under 18 years or greater than 40 years old, * were non-caucasian * were pregnant, lactating or trying to conceive * had a body mass index (bmi) \ 50kg/m2 * had a recent illness or any chronic illness likely to influence results * were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents * were taking nutritional supplements * consumed greater than 2 portions of oily fish per week

Keywords: pcos
evaluation of hospitalization for anorexia nervosa (evaluation de l'apport de l'hospitalisation pour anorexie mentale : evalhospitam)

Conditions: Anorexia Nervosa

Summary: the objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. the primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).

this study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). the study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). the five treatment modalities to be studied are: 1. discharge weight objectives. 2. the practice of a separation period. 3. the use of clear nutritional and dietary objectives (cognitive/behavioural). 4. the intensity of family involvement in treatment. 5. stabilisation phase before ending inpatient treatment.

Eligibility criteria:
inclusion criteria: * all patients who accept participation between 8 and 50 years old, consecutively hospitalized for a dsm iv diagnosis of anorexia nervosa in one of the departments participating in this research by necessity of physical condition (bmi \< 15, rapid weight loss) or psychological condition * parents of participating patients still living with their parents who accept participation exclusion criteria: * refusal of research * patients who do not speak french * patients with a related somatic illness (diabetes, crohn's disease, metabolic illness) * patients not covered by social security health insurance

Keywords: anorexia nervosa treatment inpatient efficacy outcome
evaluation of new custom made hearing product technology and shell modification

Conditions: Hearing Loss, Bilateral or Unilateral

Summary: the purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.

this is a controlled, single blinded comparative study which is conducted monocentric at phonak headquarters in staefa. the purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. the results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.

Eligibility criteria:
inclusion criteria: * only adult participants between 18 and 99 years * lnformed consent as documented by signature (appendix lnformed consent form) * ability to fill in a questionnaire conscientious * healthy outer ear (w/o previous surgical procedures) exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product, * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist * massively limited dexterity * psychological problems * central hearing problems
efficacy study of rituximab after asct in high-risk diffuse large b-cell lymphoma

Conditions: CD20-Positive Large B-Cell Lymphoma

Summary: rituximab vs observation after high-dose consolidative first-line chemotherapy (hdc) with autologous stem cell transplantation in poor risk diffuse large b-cell lymphoma.

this is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of rituximab after asct in patients aged 18 to 59 years with previously untreated high-risk (aa-ipi 2 or 3 ) diffuse large b-cell lymphoma . the duration of the treatment period is approximately 25 weeks and patients are followed until death. from 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ace and 241 to acvbp. among the 331 patients, in complete response (cr+cru) after induction, who received hdc, 269 were randomized (r2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130). the final analysis was performed in june 2005.

Eligibility criteria:
inclusion criteria: * patient with histologically proven cd20+ diffuse large b cell lymphoma (who classification). * aged from 18 to 59 years, eligible for transplant. * patient not previously treated. * age adjusted international prognostic index equal to 2 or 3. * having previously signed a written informed consent. * women of childbearing potential currently practicing an adequate method of contraception. exclusion criteria: * any other histological type of lymphoma. * any history of treated or non-treated indolent lymphoma. * central nervous system or meningeal involvement by lymphoma. * contra-indication to any drug contained in the chemotherapy regimens. * poor renal function (creatinin level\>150mmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * poor bone marrow reserve as defined by neutrophils \< 1.5 g/l or platelets \< 100 g/l, unless related to bone marrow infiltration. * any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * any serious active disease (according to the investigator's decision). * hiv, htlv1 or hbv related disease. * any organ transplantation before inclusion. * pregnant women.

Keywords: diffuse large b cell lymphoma rituximab autotransplant
modified scrt followed by tislelizumab plus capox for locally advanced rectal cancer

Conditions: Mid-low Rectal Cancer

Summary: to explore the complete response (cr) rate of modified short-course radiotherapy combined with capox and tislelizumab for locally advanced mid-low rectal cancer

in the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. combining pd-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.

Eligibility criteria:
inclusion criteria: * age 18-75 years, any gender. * pathologically confirmed rectal adenocarcinoma. * baseline mr stage t3-4/n+. * distance from anal verge ≤12cm. * no distant metastasis. * karnofsky performance status ≥70. * adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy. * microsatellite/mismatch repair status mss/pmmr. * no prior chemotherapy or any other anti-tumor treatment before inclusion. * no prior immunotherapy. * ability to comply with the study protocol during the study period. * signed written informed consent. exclusion criteria: * pregnant or lactating women. * pathological diagnosis of signet ring cell carcinoma. * history of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ. * uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication. * clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, new york heart association (nyha) class ii or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see appendix 12), or history of myocardial infarction within the past 12 months. * organ transplant recipients requiring immunosuppressive therapy and long-term steroid users. * patients with autoimmune diseases. * severe uncontrolled recurrent infections or other severe uncontrolled comorbidities. * subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/l; absolute neutrophil count (anc) .≥1.5×10\^9/l; platelets ≥100×10\^9/l; alt, ast ≤2.5 times the upper limit of normal; alp ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/l. * known deficiency of dihydropyrimidine dehydrogenase (dpd). * allergy to any investigational drug components.

Keywords: short-course radiotherapy capox pd-1 monoclonal antibody
dmd voice: qualitative interviews with patients and caregivers

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: the purpose of this study is to understand dmd functional losses or abilities and their association with independence and quality of life from the perspective of individuals with dmd and/or and their caregivers. this is a qualitative interview study in which individuals with dmd and/or their caregivers will be asked to participate in a semi-structured, approximately 60- minute interview. interviews will focus on functional abilities and independence. caregivers and boys with dmd will be interviewed. this study includes no treatment nor intervention; however, some participants are being treated by a drug that is approved in the u.s. and the u.k. and under investigation in other geographies.


Eligibility criteria:
inclusion criteria: subsample a - patients eligible participants for subsample a must: * have been treated with givinostat for at least 2 years * be at least 10 years of age with signed consent of a parent or legal guardian * be currently taking givinostat * willing and able to participate in a video and/or audio recorded interview subsample a - caregivers eligible caregivers for subsample a must: * be a parent or legal guardian of an individual with dmd that has been taking givinostat for at least two years * willing and able to participate in a video and/or audio recorded interview subsample b - caregivers eligible caregivers for subsample b must: * provide care to an individual with dmd who is unable to raise their hands above their head as confirmed by the caregiver * reside in the united states or canada * able to read, speak, and understand english * willing and able to participate in a video and/or audio recorded interview have access to a stable internet connection exclusion criteria: -

Keywords: duchenne givinostat
phase ii pilot study of early cortisol replacement to prevent bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: objectives: i. estimate the efficacy of cortisol replacement therapy during the first 12 days of life for prevention of bronchopulmonary dysplasia. ii. estimate the effect of cortisol replacement therapy on the signs of acute adrenal insufficiency. iii. evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations and on the ability of the adrenal gland to respond to acth. iv. determine the effect of this replacement therapy on markers of inflammation in lung lavage fluid and peripheral blood leukocytes.

protocol outline: this is a randomized, double blind, placebo controlled study. hydrocortisone therapy iv or placebo begins no later than 48 hours after birth and continues every 12 hours for 12 days. hydrocortisone is given at 2-4 times the basal cortisol secretion rate. tracheal lavage on intubated babies is performed at start of study and on day 4 of life to assess concentrations of inflammatory markers. if larger babies show appropriate response to acth by 15-17 days and the less mature babies show a decreased response, then a longer course of therapy is proposed for future studies.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * at risk for development of bronchopulmonary dysplasia --patient characteristics-- * hematopoietic: no congenital sepsis * hepatic: no structural defect of liver * renal: no agenesis or structural defect of a kidney * cardiovascular: no structural defect of the heart * metabolic: no diabetic mothers (e.g., preexisting insulin dependent, noninsulin dependent, and gestational diabetes) * pulmonary: no structural defect of the lung * other: newborn birth weight must be 500 to 999 g and have endotracheal tubes in place at 12 hours of age eligible if treatment can be given before 48 hours of postnatal life no major congenital anomaly causing significant defect in major organ system

Keywords: bronchopulmonary dysplasia cardiovascular and respiratory diseases neonatal disorders rare disease
asymmetric lack of knee flexion as a symptom of dlm in children

Conditions: Highlights a New Clinical Sign Which Point Out a Meniscus Posterior Luxation Because of a MCA-type DLM

Summary: highlighted during the clinical examination of a knee flexion asymmetry, and related to the intraoperative meniscal observations on dlm. search for a link between asymmetric bending defect and posterior shift in mca-type dlm. analysis of all patients with symptomatic dlm.


Eligibility criteria:
inclusion criteria: * \< 18 yo * symptomatic discoid lateral meniscus exclusion criteria: * osteochondritis dissecans (ocd) * asymptomatic and partial dlm observed during arthroscopic exploration for other reasons * revision knee surgery

Keywords: discoid lateral meniscus children instability arthroscopy repair lack of flexion flexion block knee
a trial of somatostatin with endoscopic variceal ligation (evl) in control of acute variceal bleeding

Conditions: Acute Bleeding Esophageal Varices; Portal Hypertension; Cirrhosis

Summary: background: efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. however, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (evl) improves the efficacy of evl. aim: to compare evl plus somatostatin versus evl plus placebo in control of acute variceal bleeding. patients and methods: consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. after emergency evl, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. primary endpoint was treatment failure within 5 days. treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of portal hypertension * having hematemesis and/or melena within 24 hour prior to admission * source of bleeding should be esophageal varices exclusion criteria: * non-cirrhotic cause of portal hypertension * age \ 75 years * hepatic encephalopathy grade 3 or 4 * renal failure with serum creatinine \>2 mg/dl * any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers) * patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding * patients already received evl or est elsewhere during the current episode of bleeding prior to presenting to our hospital * patients with history of surgery for portal hypertension or tips * concomitant severe cardio-pulmonary disease * concomitant malignancy * hvpg not possible within 24 hrs of presentation * patients refusing to participate in the study.

Keywords: variceal bleeding endoscopic therapy band ligation somatostatin vasoactive drugs octreotide
a study to evaluate the long-term safety of astegolimab in participants with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (copd) who have completed the 52-week placebo-controlled treatment period in parent studies gb43311 or gb44332.


Eligibility criteria:
inclusion criteria: * completion of the 52-week treatment period in either parent gb43311 or gb44332 exclusion criteria: * withdrawal of consent and/or premature discontinuation from parent study * any permanent discontinuation of study drug in parent study * significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment * any new diagnosis of asthma according to the global initiative for asthma guidelines or other accepted guidelines since enrolling in the parent study * any new clinically significant pulmonary disease other than copd (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study * any new unstable cardiac disease, myocardial infarction, or new york heart association class iii or iv heart failure since enrolling in the parent study

Keywords: chronic obstructive pulmonary disease, copd
long-term study of hydrocodone bitartrate controlled-release capsules in subjects with chronic pain

Conditions: Chronic Pain

Summary: this phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (hc-cr) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. long-term maintenance of hc-cr efficacy will be evaluated.

subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Eligibility criteria:
inclusion criteria: * subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain * subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone * subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months * females subjects of childbearing potential must have a negative urine pregnancy test at the screen visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period. * subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition * subjects must voluntarily provide written informed consent exclusion criteria: * any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (aes) * a medical condition that, in the opinion of the investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug * a surgical procedure for pain within the last 3 months * uncontrolled blood pressure, i.e., a sitting systolic blood pressure \>180 mm hg or \ 120 mm hg or \<50 mm hg at screening * a body mass index (bmi) \> 45 kg/m2 * a hospital anxiety and depression scale (hads) score of \>12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled * a clinically significant abnormality in clinical chemistry, hematology or urinalysis

Keywords: chronic pain