Kornimate/medical-research-clean huggingface dataset:
cbt4cbt with spanish alcohol users

Conditions: Alcohol Use Disorder

Summary: specific aims are as follows: * to adapt our existing cbt4cbt program for use with spanish-speaking alcohol users in a web-based platform * to conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding cbt4cbt-spanish to treatment as usual in a community based treatment program in a population of 90 spanish-speaking individuals who meet current criteria for alcohol use disorder * to evaluate the long-term durability and/or delayed emergence of treatment effects through a six month follow-up after termination of the study treatments. given previous evidence regarding the durability of standard clinician-delivered cbt and computer-assisted cbt4cbt, we hypothesize that cbt4cbtspanish will be significantly more effective than standard treatment alone through the follow-up.

the investigators will conduct a stage 1 randomized clinical trial evaluating the program in which 90 spanish-speaking individuals with alcohol use disorder will be randomized to (1) standard outpatient counseling at the hispanic clinic (st; typically consisting of weekly individual and group supportive counseling) or (2) cbt4cbt-spanish as an adjunct to st. other aspects of the trial will parallel those in the investogators completed trial of the english version of cbt4cbt-alcohol to facilitate comparability across studies. treatments will be delivered over an 8-week period with a 6-month follow-up to assess durability and/or delayed emergence of treatment effects. the primary outcome measure will be percent days of abstinence (pda) by week. secondary outcomes include percent heavy drinking days and number of individuals with no heavy drinking days in the last 4 weeks of treatment. participants will be 90 individuals seeking treatment for alcohol use at the hispanic clinic of cmhc. the clinic treats a heterogeneous population, where 42% of those in the co-occurring treatment program report alcohol as their principal substance related issue and 43% are women. as reported above, the investigators have demonstrated the ability to recruit, randomize, retain, and follow-up high numbers of closely related samples in this setting.

Eligibility criteria:
inclusion criteria: 1. are 18 years of age or older. 2. are applying for outpatient alcohol treatment, with some alcohol use in the past 30 days 3. speak spanish as their preferred or principal (most commonly spoken) language. 4. are sufficiently stable for 8 weeks of outpatient treatment 5. can commit to 8 weeks of treatment and are willing to be randomized to treatment 6. are willing to provide locator information for follow-up. exclusion criteria: 1. have an untreated bipolar or schizophrenic disorder 2. have a current legal case pending such that incarceration during the 8 week protocol is likely 3. meet dsm-5 criteria for another current substance use disorder (other than nicotine).
effects of a cognitive rehabilitation program: a neurocognitive study

Conditions: Schizophrenia

Summary: schizophrenia is known to be associated with cognitive dysfunction which increasing evidence suggests has consequences for functional adaptation and which cause difficulties in social re-integration after hospitalization. the investigators propose a large scale, multicentric study (7 centres from the hermanas hospitalarias del sagrado corazón de jesús network) aimed at answering outstanding questions concerning the effectiveness of cognitive estimulation therapy for schizophrenic cognitive impairment. specifically, the study will examine a) issues related to the size of the effect compared to treatment as usual and compared to a control intervention; b) generalizability of improvement to cognitive function and social cognition in daily life; and c) the durability of therapeutic gains after the end of treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three treatment conditions: a computer- assisted cognitive estimulation program (n=64), non-structured time on computer (n=64) and treatment as usual (n=64). a battery of neurocognitive tests of memory and executive function, including 'ecologically valid' measures, will be administered by blind evaluators at baseline, after 6 months of cognitive estimulation, and after 6 months follow-up. symptoms, social functioning and self-esteem will be also be assessed at baseline, after the treatment and at follow-up.


Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder fulfilling the diagnostic and statistical manual of mental disorders (dsm-iv) criteria diagnosis * estimated premorbid intelligence quotient (iq) in the normal range * chronic illness (i.e. duration ≥two years) * relative clinical stability (i.e. the patients had not experienced any recent exacerbation of symptoms). exclusion criteria: * history of brain trauma * alcohol or substance abuse/dependence within the previous six months.

Keywords: schizophrenia rehabilitation cognition
comparison of primary and secondary prevention of postpartum hemorrhage at the community level in egypt

Conditions: Postpartum Hemorrhage

Summary: the objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (pph) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of pph. the significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of pph care using misoprostol.1. the study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent * vaginal delivery * agrees to participate in follow-up interview * agrees to have pre- and post-hemoglobin taken * delivery at woman's home or at the primary health unit (phu) exclusion criteria: * too advanced into active labor to provide consent * known allergy to misoprostol and/or other prostaglandin * pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
topotecan vs. topotecan + etoposide vs.topotecan + gemcitabine in ovarian cancer therapy

Conditions: Ovarian Cancer

Summary: determination of total survival under topotecan monotherapy, topotecan + etoposide and topotecan + gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

in germany ovarian cancer belongs to the most frequently forms of cancer in the female population. the prognosis for women with a platin refractory ovarian cancer is very bad. the median survival time amounts for less a year. especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in germany topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a topotecan monotherapy and two topotecan combinations. both combination agents show efficacy alone against solid cancer using from topotecan different mechanism resulting in different main side effects. total survival, remission rates, time ti progression and quality of life are the main criteria investigated.

Eligibility criteria:
inclusion criteria: * patient with recurrent ovarian cancer * second-line chemotherapy * \> = 18 years of age * ecog \< = 2 exclusion criteria: * ecog \> 2 * patients with more than one chemotherapy in anamneses

Keywords: ovarian cancer
a study of single and multiple doses of lp-003 in healthy adult participants

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of lp-003 in healthy volunteers. the study will be conducted in 2 parts: part 1, the single ascending dose (sad) is the first in human (fih) study of lp-003 and part 2, multiple ascending dose (mad).


Eligibility criteria:
inclusion criteria: 1. healthy males or females aged 18 through 50 years 2. male subjects must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a bmi between 19.0 and 28.0 kg/m² (inclusive). 3. male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs. 4. the subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent. 5. the subjects were able to communicate well with the researchers and complete the study according to the protocol. exclusion criteria: 1. people who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food. 2. patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results. 3. patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period. 4. any history of infection within 14 days prior to administration. 5. a person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration. 6. pregnant and lactating women. 7. hepatitis b surface antigen, hepatitis c virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies a positive person. 8. patients who have received any biological agent (including antibodies or derivatives such as omalizumab) within 16 weeks prior to administration (or 5 half-lives, selecting the longer time period). 9. participants who had participated in other clinical trials within 3 months prior to screening. 10. the investigator deems any condition unsuitable for study participation.
therapeutic education in very young children with diabetes mellitus

Conditions: Type 1 Diabetes; Diabetes Mellitus

Summary: diab-educ tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. the investigators plan to include 300 type 1 diabetic children in 10 french hospitals.

general frame : 1 inclusion / randomization visit and delivery of the educational tool for patients of the "therapeutic education" arm, then follow-up visits every 6 months during 24 months. v0 - inclusion / randomization visit - verification of eligibility - clinical examination and data report - blood samples for lab tests (hba1c assay)- collection of signed consent form- diab-educ questionnaire (diabetes knowledge, treatment, quality of life, hypoglycaemia and emergency situations, parental stress)- randomization - education tool explanation and delivery by the physicians to parents randomized in " experimental " arm m6 - visit at 6 months- clinical examination and data report- blood samples for lab tests (hba1c assay) m12 - visit at 12 months- clinical examination and data report- blood samples for lab tests (hba1c assay)- diab-educ questionnaire m18 - visit at 18 months- clinical examination and data report- blood samples for lab tests (hba1c assay) m24 - visit at 24 months- clinical examination and data report- blood samples for lab tests (hba1c assay)- diab-educ questionnaire

Eligibility criteria:
inclusion criteria: * children with type 1 diabetes aged 1 to 6 years * disease evolution more than 1 year * hba1c \> 8% or at least one acute accident (hypoglycemia or ketosis) during the last year * specific information given to parents from the physicians and consent form signed by the parents * physical examination of the children at enrolment- patient affiliated with or receiving health insurance exclusion criteria: * non-insulin dependent diabetes * monogenic diabetes (mody) * severe co-morbidities- cognitive disabilities or psychosocial disadvantage compromising the therapeutic education * children whose parents have a disorder of comprehension or expression of the french language * patients included in another interventional trial

Keywords: diabetes children disease management ketosis hypoglycemia parents education
a safety and tolerability study of sch 721015 in patients with transitional cell carcinoma of the bladder (study p03816)

Conditions: Bladder Neoplasms

Summary: the purpose of this first-in-human study is to determine the safety and tolerability of sch 721015 in subjects with transitional cell carcinoma of the bladder.

a nonrandomized, open-label, rising-dose, parallel-group, multi-center study of sch 721015 in patients with papillary bladder cancer, or carcinoma in situ that is refractory to bacillus calmette-guerin. subjects will receive a single intravesical administration of sch 721015 with sch 209702 in a total volume of 75 ml with a 1-hour dwell time. subjects who at 3 months post administration demonstrate a complete response (cr on cystoscopy/biopsy and cytology) and who did not experience dose-limiting toxicity will be allowed to receive a second intravesical administration at the same dose level.

Eligibility criteria:
inclusion criteria: * histologically proven recurrent transitional cell carcinoma of the bladder, stage tis, ta. * patients with recurrent t1 disease who do not wish to have cystectomy. * subjects must have failed at least two prior courses of bcg with or without recombinant interferon alpha administration. * at least 3 months must have passed since last intravesical treatment for bladder carcinoma. * subjects must be 18 years of age or older. * life expectancy of at least 3 months. * adequate performance status (karnofsky score \>=70%). * adequate laboratory values. exclusion criteria: * suspected hypersensitivity to interferon alpha. * subjects with organ transplants. * any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as: * history of psychosis or presence of poorly controlled depression; * cns trauma or active seizure disorders requiring medication; * significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months; * poorly controlled diabetes mellitus (hba1c \>10.0%); * unstable chronic pulmonary disease requiring hospitalization or emergency room visit within the last 3 months; * immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis). * history of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration. * untreated bladder infection. * positive for hepatitis bsag or hiv ab or hepatitis c. * immunosuppressive therapy within the last 3 months. * bcg therapy or intravesical therapy within 3 months. * traumatic catheterization within 1 month.
assessment of quality of life in disorders of the pelvic floor

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to compare the touch-screen version of the pfdi-20, pfiq-7, pisq 12 and sf-36 french questionnaires to their paper versions. the investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.


Eligibility criteria:
inclusion criteria: * the patient has pelvic organ prolapse * the patient requires a surgical intervention within the next 4 to 8 weeks * the patient understands and reads french * the patient is affiliated with a social security system * the patient has given consent exclusion criteria: * the patient refuses to participate * the patient is under guardianship
metastatic leiomyosarcoma biomarker protocol

Conditions: Leiomyosarcoma

Summary: leiomyosarcoma (lms) is one of the most prevalent soft tissue sarcomas (sts) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. a minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. a biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. circulating tumor dna (ctdna) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. blood samples will be collected prior to and during and chemotherapy, and analyzed for ctdna and for mutations in genes that are associated with increased risk of developing sarcoma. tumor tissue will be collected and analyzed for changes in genes. digital images of the sarcoma from ct or mri scans obtained during treatment will be obtained for advanced radiomic analysis. study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.


Eligibility criteria:
inclusion criteria: * patients with unresectable or metastatic leiomyosarcoma (lms). there is no age requirement * receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel * target lesions per recist 1.1 * optional archival tumor tissue including 1 h\&e-stained slide and unstained tumor tissue \[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of ffpe sample\] available for study research

Keywords: ctdna biomarker radiomics
how vitamin d analogues affect endothelial cells in patients on dialysis

Conditions: Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Summary: patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. vitamin d analogues have been shown in observational studies to have mortality benefit for these patients. this study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.


Eligibility criteria:
inclusion criteria: * stage 5 chronic kidney disease * hyperparathyroidism (pth\>300) requiring vitamin d therapy * age 18-80 years old * ability to provide informed consent exclusion criteria: * subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy * subjects with contraindications or allergy to vitamin d * subjects currently on vitamin d therapy or a history of vitamin d therapy in the previous 60 days * serum phosphorus \> 6 * serum calcium \> 10.5 * contraindications to nitroglycerin (such as being on sildenafil)
integration of health coaching and diabetes education in type 2 diabetes mellitus management at primary health care

Conditions: Type2 Diabetes; Diabetes Mellitus, Type 2; Endocrine System Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders (Including Diabetes Mellitus); Diabetes Mellitus

Summary: type 2 diabetes mellitus is a chronic disease with increasing incidence globally. it needs a comprehensive and continuous management approach that includes five pillars: education, nutritional management, physical activity, pharmacological treatment, and monitoring. to achieve good glycemic control, prevention of complications, and good quality of life as diabetes management goals, patients' capability to properly navigate diabetes management is a key. one evidence-based model to empower patients' self-management abilities is diabetes education and health coaching. diabetes management at primary health care needs special concern since they play an important role in initial and continuing care for diabetes patients in the community. therefore, the implementation of diabetes education and health coaching in primary health care is expected to improve the self-management abilities of people with diabetes

a randomized control trial, pre and post study involving 180 subjects randomized into 2 arms: * control : received education in group * intervention : received education group + personal health coaching education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes. health coaching was given by a coach, a healthcare professional who undergo training to become a coach. health coaching delivered as face to face between subjects and coach. laboratory examination, anthropometric measurement, echocardiography, electrocardiography, heart rate variability measurement, diabetic eye screening, and questionnaire collected at baseline, 3 and 6 months after intervention

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * \>= 18 years old * willing to follow the research by signing an informed consent exclusion criteria: * patients with cognitive disease (such as dementia) * patients with hearing or sight problem * unable to live independently on daily basis

Keywords: type 2 diabetes mellitus diabetes education health coaching
intradermal (id) botox in the treatment of facial fine lines

Conditions: Facial Fine Lines

Summary: the main objective of this study is to assess safety and tolerability of intradermal (id) botox in participants with facial fine lines.


Eligibility criteria:
inclusion criteria: * a female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study (eg, for at least 90 days after receiving study intervention). * participant must have sufficient visual acuity without the use of eyeglasses (contact lans use acceptable) to accurately assess their facial lines, in the opinion of the investigator. * participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active covid-19 infection. * be nonsmoking and a nonuser of cannabis and nicotine-containing products, or have not smoked or used cannabis or nicotine-containing products, including e-cigarettes, within the previous 2 years. exclusion criteria: * known immunization or hypersensitivity to any botulinum toxin serotype. * any medical condition that may put the participant at increased medical risk with exposure to botox including diagnosed myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function. * rosacea, skin infection, or any other skin disease or disorder that would represent a safety concern and/or interfere with the ability to either administer treatment or assess the treatment effect, as determined by the investigator.

Keywords: facial fine lines,botox,onabotulinum toxin a