Kornimate/medical-research-clean huggingface dataset:
tislelizumab combined with chemotherapy and relayed radiotherapy in first-line treatment of es-sclc

Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Summary: to explore the efficacy and safety of tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer


Eligibility criteria:
inclusion criteria: 1. age≥18 years old, male or female, signed informed consent form (icf); 2. eastern cooperative oncology group (ecog) performance status of 0 or 1; 3. histologically or cytologically confirmed es-sclc; 4. no prior systemic treatment for es-sclc; 5. at least one measurable (recist 1.1) chest lesion capable of 15gy/5f irradiation; 6. adequate hematologic and end organ function; exclusion criteria: 1. active leptomeningeal disease or uncontrolled, untreated brain metastasis; 2. prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-pd-1), anti-pd-l1, or anti cytotoxic t lymphocyte associated antigen 4 (anti ctla-4) antibody; 3. was administered a live vaccine ≤ 4 weeks before treatment; 4. active autoimmune diseases or history of autoimmune diseases that may relapse; 5. any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment; 6. with a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases; 7. severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection; 8. received therapeutic oral or intravenous (iv) antibiotics within 2 weeks prior to starting treatment;
observational study of patients using novomix® 30 or levemir® for treatment of type 1 or type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using novomix® 30 or levemir® under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes, including newly diagnosed * age: levemir® above 6 years * age: novomix® above 18 years exclusion criteria: * current treatment with novomix® 30 or levemir®
a study of mf101 in postmenopausal women

Conditions: Hot Flushes; Vasomotor Symptoms

Summary: this phase 3a study is designed to assess the safety and efficacy of mf101 on the frequency of moderate to severe hot flushes in postmenopausal women.

menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. new, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed. mf101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of mf101 on the frequency of moderate to severe hot flushes in postmenopausal women. approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of mf101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria (limited): * confirmed postmenopausal women aged 40-65 * provide written informed consent exclusion criteria (limited): * history of malignancy, with the exception of certain types of skin cancer or cervical cancer * known carrier of brca1 or brca2 * abnormal mammogram or breast examination suggestive of cancer within 9 months of screening * endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids) * clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents * history of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (ibs or ibd), or unexplained weight loss * active liver disease or gall bladder disease * history of chronic hepatitis b, hepatitis c, hepatitis within 3 months, or hiv infection * use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes * use of selective receptor modulators (serms), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (ssris), selective norepinephrine reuptake inhibitors (snris), gabapentin or clonidine within required wash-out timeframes * chronic use of morphine or other opiates
screening mammography and latinas: a multilevel intervention

Conditions: Breast Cancer

Summary: ¡fortaleza latina! is a multi-level randomized trial to increase participation in mammography screening among latinas who seek care at a community health center in western washington. in partnership with the partnering community health center, we have obtained lists of women patients aged 42 to 74 years old who had not had a mammogram in the last two years and resided within defined radii of the four clinics. baseline and one year follow-up surveys will be obtained by in person home interview. participants are randomized within clinic to intervention or comparison group. the intervention consist of two motivational interviewing sessions, one in person in the home, and one telephone follow-up. the study hypothesis is that a higher proportion of participants in the motivational interviewing arm will obtain a screening mammogram within the study period than those in the comparison arm.

breast cancer is the most common cancer among hispanic women in the united states (us) and five-year survival from breast cancer is lower in hispanic than in non-hispanic white women. this reduced survival has a number of potential causes, but differential screening rates may be a partial explanation, since hispanic women have lower breast cancer screening rates than non-hispanic white women. the overall purpose of the study is to develop and evaluate a culturally-appropriate intervention aimed at increasing screening mammography rates in a clinic-based sample of predominantly mexican american women in western washington. the recruitment goal of the fortaleza latina study is approximately 500 latina women aged 40-74 who have had a clinic visit within the past 5 years, but no recent mammogram, from the four selected community health center clinics. after providing informed consent and completing a baseline assessment, eligible women are randomly assigned to intervention or comparison group, within clinic. the individual-level intervention implements motivational interviewing (mi) in two participant encounters. mi is a direct counseling style, led by a promotora (lay health advisor), that elicits behavior change by helping participants explore and resolve ambivalence. of the 2194 women contacted by field interviewers, a total of 710 surveys have been completed; of these, 542 were eligible and have been randomized and enrolled into the fortaleza latina study (279 intervention, 263 usual care).

Eligibility criteria:
inclusion criteria: * hispanic/latina ethnicity * have been seen in one of the 4 community clinics in the past 5 years * have not had a mammogram within the past two years * residing within 20 miles of one of the participating clinics exclusion criteria: * participants who do not match the eligibility criteria listed above * medical record verified recent mammogram

Keywords: breast cancer cancer disparities latino women hispanic women mammography multi-level intervention
a new alternative to traditional hysteroscopy

Conditions: Intrauterine Diseases; Myomas; Polyps

Summary: hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. the development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. recently gubbini et al. developed a mini-resectoscope feasible for "see\&treat" hysteroscopy. the objective of the study is to compare the new 16 fr mini28 resectoscope by gubbini with traditional 22 fr resectoscope and bettocchi 15 fr hysteroscope for the treatment of uterine cavitary lesions. the investigators enrolled 401 women affected by endometrial polyps and/or g0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by gubbini (142 women) and bettocchi hysteroscope (132 women). operating time, distension media delivered, dismiss time and discomfort experienced were recorded.


Eligibility criteria:
inclusion criteria: * women between 18-75 years of age * endometrial polyps and/or g0 myomas smaller than 3 cm of diameter

Keywords: endometrial pathology
extended-dose chloroquine (ecq) for resistant falciparum malaria among afghan refugees in pakistan

Conditions: Malaria, Falciparum

Summary: the purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive afghan refugees in northwest frontier province (nwfp), pakistan or justification for discontinuation of the policy.

to determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among afghan refugees, 163 falciparum patients from three afghan refugee camps were recruited into 3-day (cq 25mg/kg) or 5-day (cq 40mg/kg) treatment arms and followed for up to 60 days.

Eligibility criteria:
inclusion criteria: * slide-confirmed infection with p. falciparum only * initial parasite density of 1000-100,000 asexual parasites/μl * absence of severe malnutrition * ability to attend stipulated follow-up visits and easy access to facility * informed consent provided by patient or parent/guardian * absence of history of hypersensitivity reactions to cq exclusion criteria: * infants under six months old * pregnancy or lactation * underlying chronic severe illness * patients with other febrile illnesses * parasitaemia outside the range of 1000-100,000 asexual parasites/µl * severe malaria

Keywords: clinical trial chloroquine refugees afghanistan pakistan
heme and non-heme iron intakes, gut microbiota, and influence on host iron absorption

Conditions: Anemia, Iron Deficiency; Iron Overload

Summary: the femicrobiome study will evaluate gut microbiome features and their relationships with dietary iron absorption in healthy adults. the investigators hypothesize that (1) the gut microbiota can be shaped by the heme and non-heme fe content of the diet and that (2) this will influence individual variation in dietary fe absorption.

iron is an essential micronutrient ingested as either heme iron (from animal products) or non-heme iron (from both plant and animal sources). humans have no regulatable means of eliminating absorbed iron, necessitating tight control of dietary iron absorption. likewise, native microbes have evolved efficient iron sensing and utilization pathways to scavenge iron from the gastrointestinal environment, resulting in a competition for iron between the host and their microbiota. as growing numbers of americans adopt plant-based diets, heme iron intakes are markedly reduced. this may shift the gut microbiome as some gut microbiota cannot independently synthesize heme and require host dietary heme sources to support their heme-dependent functions. animal data have recently discovered that other gut microbiota respond to a low iron. to date, significant knowledge gaps exist on the interplay between dietary iron sources, native gut microbes, and iron utilization in humans. in the femicrobiome study, study investigators will recruit 120 adults who habitually ingest plant-based diets or habitually ingest diets containing animal protein (e.g., beef, pork, chicken, fish, and seafood). iron absorption will be measured by using an in vivo, functional approach based on stable iron isotopes (i.e., 57fe). study participants will consume 57fe (as ferrous sulfate) in the fasted state followed by two standardized meals. two weeks after iron dosing, a blood sample will be collected from each participant and the amount of 57fe incorporated into red blood cells will be measured using magnetic sector thermal ionization mass spectrometry. a stool sample will be collected near the time of 57fe consumption. dna will be extracted from this stool sample and sequenced using a high-depth shotgun metagenomic approach.

Eligibility criteria:
inclusion criteria: * healthy adults * age between 18- 40y * non-smoking * not currently taking vitamin, mineral, prebiotic, and probiotic supplements. * females: premenopausal and not pregnant or lactating * no preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) * body mass index (bmi) between 18 - 27 kg/m2. exclusion criteria: * bmi \ 27 kg/m2, * age \ 40y, * smoking * pregnancy, lactating * have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/steroid use/ medication use of medications known to impact iron status, iron utilization or inflammatory status * currently take vitamin, mineral, prebiotic, and probiotic supplements. * recently received antibiotic treatment
a clinical trial to evaluate the safety, efficacy, and immunogenicity of dr-5001

Conditions: Respiratory Tract Diseases

Summary: this is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral dr-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.

the study will be conducted at two sites and will include a minimum of 4 visits. the overall study duration for participants will be approximately 8 weeks. study participants will undergo acute respiratory disease evaluation that will include a throat swab and a blood draw. each participant will also be contacted in six months for follow-up information.

Eligibility criteria:
inclusion criteria: * military recruit in training * male or female; if female, must be of non-childbearing potential or with a documented negative pregnancy test \</= 72 hours prior to study medication administration and agree not to become pregnant exclusion criteria: * female nursing an infant or planning on nursing during the study * immunosuppressed for any reason, including past (within last 6 months) or current treatment with immunosuppressive therapy * known allergy to any component of the vaccines and/or placebo tablets * immunocompromised sexual partner or immunocompromised individuals in home

Keywords: acute respiratory disease prevention adenovirus
effects of succinylcholine on nonintubated thoracoscopic surgery

Conditions: Tumor of Lung Parenchyma; Complication of Ventilation Therapy; Atelectasis

Summary: a safe and effective surgical environment is important for nonintubated thoracoscopic surgery. the investigators hypothesize that mini-dose succinylcholine can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery.

background: nonintubated thoracoscopic surgery is the frontier of modern minimal invasive thoracic surgery. a safe and effective surgical environment is established via an iatrogenic open pneumothorax producing the operated lung fully collapsed. however, the initial respiratory response to open pneumothorax is both tachypnea and carbon dioxide rebreathing, which would jeopardize the quality of collapse of the operated lung and delay the performance of intrathoracic vagal block. intravenous opioid is effective to attenuate ventilatory responses but herein with risk of persistent respiratory depression. methods: the investigators hypothesize that mini-dose succinylcholine 0.15 mg/kg can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery. in a prospective, randomized, double-blind study design, 30 patients will be allocated to receive either succinylcholine (n=15) or placebo (n=15) in the beginning of open pneumothorax. the effectiveness of succinylcholine will be measured by the surgeon's evaluation of the quality of lung collapse, while the safety will be evaluated by determination of arterial blood gases within 20 minutes of one-lung spontaneous breathing. expected results: mini-dose succinylcholine can facilitate early lung collapse without jeopardizing the ventilatory function during nonintubated thoracoscopic surgery with one-lung spontaneous breathing, which may make nonintubated thoracoscopic surgery easier and safer.

Eligibility criteria:
inclusion criteria: * adults patients with lung tumors and elective for unilateral thoracoscopic surgery. exclusion criteria: * over weighted, body mass index \> 26 kg/m2. * previous thoracic surgery on the attempted operative side. * hypoventilation syndrome requiring positive pressure ventilatory support or oxygen at home. * relevant systemic disease, including heart failure, liver failure, renal failure with an american society of anesthesiologists (asa) class above 3. * difficult airway management. * pregnancy. * contraindications for succinylcholine, including family history of suspicious malignant hyperthermia, hyperkalemia, or other neuromuscular diseases.

Keywords: nonintubated video-assisted thoracic surgery (vats)
docetaxel/prednisone plus fractionated 177lu- j591 antibody for metastatic, castrate-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to test the effectiveness of the experimental drug, 177lu-j591 antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant prostate cancer.

this research is being done because the standard treatments for metastatic prostate cancer that is growing despite medical or surgical therapies are not curative. existing treatments, such as the docetaxel used as part of this study, may work temporarily, but unfortunately the cancer continues to grow. this test drug, 177lu-j591, is designed to seek out prostate cancer cells and deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of prostate adenocarcinoma. * patient must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. * serum testosterone \< 50 mg/ml. * patients who have previously received docetaxel must meet both of the the following criteria: * reason for docetaxel discontinuation must not have been progression of disease while receiving drug (i.e. progression of cancer must have been after docetaxel discontinuation) and * all docetaxel-related toxicities must have resolved to \< grade 1 (with the exception of alopecia) and the pt must be eligible by other criteria exclusion criteria: * use of red blood cell or platelet transfusions within 4 weeks of treatment. * use of hematopoietic growth factors within 4 weeks of treatment.-prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment. * bone scan demonstrating confluent lesions involving both axial and appendicular skeleton ("superscan"). * prior radiation therapy encompassing \>25% of skeleton.prior treatment with 89strontium or 153samarium containing compounds (e.g. metastron®, quadramet®). * platelet count \<150,000/mm3. * absolute neutrophil count (anc) \<2,000/mm3. * hematocrit \<30 percent or hemoglobin \< 10 g/dl. * abnormal coagulation profile (pt or inr, ptt) \> 1.3 x upper limit of normal (unless on therapeutic anticoagulation). * -serum creatinine \>2.5 mg/dl. * ast (sgot) \>2.5x uln. * bilirubin (total) \>1.5x uln. * serum calcium \>11 mg/dl. * active serious infection. * active angina pectoris or new york heart association class iii-iv. * ecog performance status \>2. * life expectancy \<6 months. * deep vein thrombosis and/or pulmonary embolus within 1 month of study entry. * other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study. * prior anti-psma monoclonal antibody therapy with the exception of prostascint®. * prior investigational therapy within 6 weeks of treatment. * known history of hiv. * known history of myelodysplastic syndrome or leukemia

Keywords: castrate-resistant prostate cancer crpc
building resiliency among caregivers of curvivors and metavivors

Conditions: Stress; Cancer Diagnosis; Distress, Emotional

Summary: the main purpose of this research study is to assess the feasibility and participants' satisfaction of the stress management and resiliency - relaxation response resiliency program (smart-3rp) and compare this treatment with smart-3rp versus referral to a group-based, online support group to see which is better for improving resilience and decreasing distress of participants with cancer and their caregivers. the name of the study intervention involved in this study is: smart-3rp (virtual, mind-body group treatment program).

this pilot, randomized controlled trial assesses the feasibility, acceptability, and efficacy of the stress management and resiliency - relaxation response resiliency program (smart-3rp) for improving resiliency and decreasing distress among caregivers and cancer survivors compared to enhanced usual care. participants will be randomly assigned into one of the study groups: smart-3rp versus referral to a group-based, online support group. randomization means that a participant is placed into a group by chance. participation in this study is expected to last about 180 days. it is expected about 96 people made up of 48 patients and 48 caregivers will take part in this research study. the national institutes of health (nih) is supporting this research by providing funding.

Eligibility criteria:
inclusion criteria for patients: * english speaking adult patients with cancer (18 years or older) * treated at mgh, who are either within approximately: * 3 months to 3 years after completing potentially curative therapy for cancer diagnosis including surgery, radiation, and/or chemotherapy or other novel therapies (e.g., immunotherapy, biological therapy). patients can be on long- term maintenance hormonal or biological therapy at the time of enrollment. * 6 months to 3 years after diagnosis of metastatic disease with an expected prognosis of \>1 year as confirmed by the treating oncology clinician * able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study exclusion criteria for patients: * prognosis less than one year as determined by the treating oncology clinician * active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the treating oncology clinician * patients without a caregiver who is willing to participate inclusion criteria for caregivers: * adult caregiver (age 18 years or older). * identified by the patient as the spouse/partner or family member/friend.

Keywords: stress stress management cancer survivors cancer diagnosis emotional distress