Kornimate/medical-research-clean huggingface dataset:
a phase iia clinical study to assess the efficacy and safety of gensci048 in patients with moderate to severe endometriosis-associated pain

Conditions: Endometriosis-related Pain

Summary: this study is designed to evaluate the safety and efficacy of gensci048 for moderate to severe endometriosis-associated pain treatment.


Eligibility criteria:
inclusion criteria: 1. pre-menopausal female participants, between 18 and 49 years of age, inclusive, at the time of signing informed consent. 2. participants must have a diagnosis of endometriosis within 10 years before screening. 3. have moderate to severe endometrial related pain. 4. have at least one regular, natural menstrual cycles (ranging from 21 to 35 days (inclusive)) before and during the screening period. 5. agree to switch from her usual analgesic medication to only that which is permitted in the study from the screening period to the end of treatment and agree to stop using other treatments for endometriosis. 6. agree to use non-hormonal contraception from the time of signing the informed consent until 4 weeks after the last dose of the study medication. exclusion criteria: 1. participants who have previously received hysterectomy and/or bilateral oophorectomy, or plan to undergo these procedures during the study period. 2. participants who suffer from chronic pelvic and/or non-pelvic pain that is not caused by em and require chronic analgesia or other chronic treatment, which is expected to affect the assessment of eap. 3. pelvic ultrasound screening indicating a need for surgery or suspicion of malignancy. 4. participants with abnormal and undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening. 5. participants who plan to schedule elective surgery during the study; or those who have had a surgery within 4 months prior to screening and need ongoing pain management. 6. history of severe depression or post-traumatic stress disorder within the two years prior to screening, or history of any other severe mental disorder at any time. 7. history of drug or alcohol abuse within the six months prior to screening. 8. participants who have participated in any other interventional clinical trial (including clinical trials of drugs and devices) within 1 month prior to screening. 9. have used a prohibited long-acting anesthetic or immediate-release anesthetic for more than 2 consecutive weeks for the treatment of endometriosis associated pain in the 6 months prior to screening. 10. participant is pregnant, breast feeding, or planning a pregnancy.
a clinical trial evaluating jyp0035 capsule monotherapy in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the goal of this phase i clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the jyp0035 capsule in patients with advanced solid tumors. the main questions it aims to answer are: * what is the safety profile of jyp0035 when administered to these patients? * how does jyp0035 capsule behave in the body pharmacokinetically? participants will: * receive escalating doses of jyp0035 capsule during the dose-escalation phase (part-1). * continue with the identified dose in the dose-expansion phase (part-2). as this is a single-arm study, there is no comparison group.


Eligibility criteria:
inclusion criteria: * patients voluntarily participate in the clinical trial and sign the informed consent form * age 18 years and above (inclusive), and below 75 years of age (inclusive), with no gender restrictions * ecog(eastern cooperative oncology group)performance status of 0 or 1 * expected survival time of ≥3 months * during the screening period, female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of the study drug * participants agree to use reliable contraception methods from signing the informed consent form until 6 months after the last dose of the study drug. this includes, but is not limited to: abstinence, vasectomy in males, female sterilization, effective intrauterine devices, and effective contraceptive medications exclusion criteria: * participants have not recovered to normal or ≤ grade 1 from any adverse events and/or complications caused by any previous treatments before the first administration of the study drug, excluding hair loss and pigmentation * patients with imaging (ct or mri) showing tumor invasion into major blood vessels (such as the aorta, pulmonary arteries and veins, vena cava, etc.) * patients who have had clinically significant cardiovascular or cerebrovascular diseases within 6 months before the first administration, which, in the investigator's judgment, may interfere with the patient's full participation in the study; atrial fibrillation; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention * patients who had history of type 1 diabetes, type 2 diabetes, or gestational diabetes * individuals with other malignancies or with a history of other malignant tumors * individuals with a history of severe allergies, or who are allergic to any active or inactive ingredients of the study drug * pregnant or breastfeeding patients * researchers consider participants unsuitable for this clinical study due to any clinical or laboratory abnormalities or other reasons
post operative pain control using ropivacaine and the on-q system in the adult pectus excavatum patient

Conditions: Pectus Excavatum

Summary: pectus excavatum (pe) is a common chest wall deformity where the sternum is displaced posteriorly. in severe cases, surgery is performed to correct the defect. in recent years, minimally invasive surgery with the placement of stainless steel support bars has been increasingly performed in patients over the age of 17 years. because of the decreased malleability and tremendous pressure required to hold the chest wall in the corrected position, post-operative pain control has been a significant problem in this patient population. thoracic epidurals are commonly employed however mean hospitalizations of up to 7 days have been required before adequate pain control on oral analgesics is obtained and patients are suitable for discharge. it is hypothesized that using the on-q system (i-flow corporation, lake forest ca) with bilateral intercostal catheter infusion would provide adequate post operative pain control with a significantly shorter hospital length-of-stay than thoracic epidural. total use of narcotics for 1 week following surgery would also be less with the on-q system versus epidural.

subjects meeting eligibility criteria were randomized to one of two arms for postoperative pain control: the on-q system versus epidural. all subjects had additional pain management as per standardized protocol including subject controlled intravenous analgesia with morphine equivalent narcotics for a maximum of 48 hours at which time the subject was transitioned to oral pain medications. subjects using less than 5 mg of morphine in the first 24 hours after surgery were transitioned to oral pain medications at 24 hours. after transition to oral analgesia, subjects with continued pain assessment greater than 5 were administered intravenous morphine equivalents by nursing staff until pain assessments were less than 5. on-q catheters could have been maintained for up to 6 days. discharge of subjects with catheters in place was planned. the catheter was removed in the out-patient clinic if the subject was discharged before the 6th day. subjects with epidural had their epidural discontinued at 72 hours. data was recorded for each subject by site personnel while the subjects remained hospitalized, but were recorded in a journal by subjects after discharge up to postoperative day 7.

Eligibility criteria:
inclusion criteria: * patients who are scheduled for repair of their pectus excavatum with minimally invasive (mirpe) placement of steel or titanium braces at mayo clinic arizona * must be able to take oral medications preoperatively and postoperatively. exclusion criteria: * american society of anesthesiology class iv or higher * allergic to ropivacaine or other local anesthetics * nsaid allergy * specific epidural contraindication * currently using opioids, sedatives, or hypnotics * are pregnant as verified by preoperative pregnancy testing * inability to place an epidural, patient refusal for epidural, or failure of an epidural to be properly placed or maintain proper placement for adequate pain control.
first heroes: engaging fathers in the first 1000 days

Conditions: Obesity, Childhood; Overweight and Obesity; Social Determinants of Health; Physical Activity; Feeding Behavior; Sleep; Diet Habit

Summary: the first heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations. this study is a two-arm, randomized controlled trial recruiting from massachusetts general hospital (mgh) obstetrics practices. this study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. each mother-father dyad participating will be randomly assigned to one of two arms: 1. obstetric and pediatric standard of care + new parent engagement intervention arm or; 2. obstetric and pediatric standard of care + safety control arm.


Eligibility criteria:
inclusion criteria: * parental dyads must meet the following criteria: * pregnant females and father of the baby, both aged ≥ 18 years * singleton pregnancy * planned involvement during the first year of the child's life * planning to receive post-partum and pediatric care for child at any pediatric practice within the massgeneral brigham (partners) healthcare system * ability to speak in english or spanish * capable of giving consent exclusion criteria: * dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20 week ultrasound. * mothers who intend on raising a child alone without any participation from the father of the child.

Keywords: overweight obesity social determinants of health maternal-child health
89zr-j591 anti-prostate-specific membrane antigen monoclonal antibody in patients with glioblastoma multiforme

Conditions: Glioblastoma

Summary: the purpose of this study is to test a new imaging agent called 89zr-j591 (stands for humanized antibody called j591, that is attached to a radioactive material called zirconium-89) in patients with glioblastoma multiforme.


Eligibility criteria:
inclusion criteria: * patient age \> 25 years old and \< 80 years old * patients with reoccurrence of brain tumor * the principal investigator or co-pi must review mri and ct findings based on the radiologic assessment provided they meet the following imaging criteria (as established in the clinical trial 09-177): or * patients with newly diagnosed gbm and one of the following options: * eligible for surgery after the last research scan. * significant residual disease after initial surgery * the principal investigator or co-pi must review mri and ct findings and agree with the presence of significant residual disease * treatment (non-surgical) naïve * karnofsky performance score ≥ 70 exclusion criteria: * laboratory values: * serum creatinine \>2.5 mg/dl. * ast (sgot) \>2.5x uln. * bilirubin (total) \>1.5x uln. * serum calcium \>11 mg/dl. * pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done). * if an initial biopsy demonstrates neoplasm other than gbm * presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject. * presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements * prior treatment. * 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.

Keywords: 89zr-j591 15-002
impact of a process optimizing the decision to continue or stop cancer treatments in patients with advanced non-small cell lung cancer.

Conditions: Carcinoma, Non-Small-Cell Lung; Advanced Cancer

Summary: sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. comparison between a first period, period (a), of care as usual and a second period, period (b), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.

we propose to study the optimization of this decision process in an advanced non-small-cell lung carcinoma (nsclc) population, with a performance status (ps) ≥ 2 (median survival of approximately 3 months) piloting iteratively (before each decision to continue treatment) a process consisting of an evaluation framework (30 items to be answered by the oncologist with the patient), consolidating: 1. clinical parameters; 2. doctors' expectations regarding the continuation of anticancer treatment; 3. patient expectations and preferences; 4. the possibility of referring the patient to a supportive care specialist and strengthening home care. the process triggers a dialogue between the patient and the oncologist, based on facts and seeks objectivity, ultimately allowing a shared decision. in this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven non-small-cell lung carcinoma (nsclc) including nsclc with oncogene addiction. 2. stage iv or iib/iiic non irradiable (8th classification tnm, uicc 2015) 3. patient having completed at least one line of chemotherapy in the context of metastatic disease (or in the context of locoregional disease if the last chemotherapy was less than 6 months ago). 4. ecog performance status ≥ 2. 5. age ≥ 18. 6. written informed consent. 7. patient capable, according to the investigator, to comply with the requirements of the study. exclusion criteria: 1. small cell lung cancer (including mixed forms). 2. patient with nsclc for whom a decision has already been made to permanently discontinue all systemic cancer treatment. 3. impossible follow up for geographical, social or psychological reason. 4. inability to answer a questionnaire (language or neurological barrier). 5. patient under guardianship. 6. patient being treated in a therapeutic trial. 7. patient not covered by social security. -

Keywords: cancer therapy last days of life optimization device
negative pleural suction for tube thoracostomy in patients with chest trauma

Conditions: Hemothorax; Pneumothorax; Hemopneumothorax; Chest Injury Trauma Blunt; Chest Injury Trauma; Chest Injury Penetrating Wound

Summary: the purpose of this study is to determine whether the use of negative pleural suction in tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or hemothorax in patients with chest trauma.


Eligibility criteria:
inclusion criteria: * pneumothorax after penetrating o blunt chest trauma * hemothorax after penetrating o blunt chest trauma * hemopneumothorax after penetrating o blunt chest trauma * require tube thoracostomy exclusion criteria: * invasive mechanical ventilation * emergent surgery (thoracoscopy, open thoracotomy) * chronic pulmonary diseases (copd, crpd) * severe traumatic brain injury * glasgow coma scale upon arrival \<8/15
a study of ly900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes

Conditions: Diabetes Type 1

Summary: the purpose of this study is to evaluate the compatibility and safety of ly900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months. * using an insulin pump with 'rapid-acting insulin' for at least 6 months and using the same rapid-acting insulin for at least the past 30 days. * have experience using continuous glucose monitoring (cgm) or flash glucose monitoring (fgm) for at least 60 days during the past 12 months. * have hemoglobin a1c values ≤8.5%, as determined by the central laboratory at screening. * have a body mass index (bmi) of ≤35 kilograms per meter squared at screening. * have been using the minimed 530g or 630g (us) or the minimed 640g (eu) insulin pump for at least the past 30 days. exclusion criteria: * have had more than 1 emergency treatment for very low blood glucose in the last 6 months. * have had more than 1 emergency treatment for poor glucose control (hyperglycemia or diabetic ketoacidosis) in the last 6 months. * have significant insulin resistance defined as having received a total daily dose of insulin \>1.2 units per kilogram (u/kg) at screening, as determined by the average total daily insulin dose over the 3 days prior to screening divided by weight in kilograms based on investigator review of the participant's pump history. * have significant lipohypertrophy, lipoatrophy, or scars within the subcutaneous tissue in areas of infusion or have a history of abscess at an infusion site within the last 90 days prior to screening. * are receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than rapid-acting analog insulin via csii in the 90 days prior to screening. occasional pen or syringe injection of insulin is allowed, for example, due to pump malfunction or unexplained hyperglycemia not responsive to pump correction bolus. * taking certain diabetes medications that are not allowed for study participation. * have major problems with heart, kidneys, liver, or have a blood disorder. * have had or are now being treated for certain types of cancer that prevents study participation.

Keywords: insulin pump
long-term follow-up of halt-c sustained virological responders

Conditions: Hepatitis C; Hepatocellular Carcinoma; Ascites; Variceal Hemorrhage; Death

Summary: the hepatitis c antiviral long-term treatment against cirrhosis (halt-c) trial is a multicenter clinical trial conducted to assess the effects of long-term antiviral drug therapy on the progression of liver disease in patients who have advanced chronic hepatitis c and have not responded to prior therapies. chronic hepatitis c is a long-lasting viral infection affecting the liver that may lead to permanent liver damage and cirrhosis (replacement of healthy liver cells by scar tissue). if left untreated, a proportion of patients with chronic hepatitis c will be at risk for complications of liver disease. the drug therapy in the halt-c trial was designed to clear the hepatitis c virus from the patient s system in order to prevent or mitigate these potential complications. the purpose of this research is to determine if patients with chronic hepatitis c who experienced clearance of hepatitis c virus (known as a sustained virologic response, or svr) during the halt-c trial have developed any complications of their liver disease. this study will include 180 subjects who participated in the initial phase of the halt-c trial and experienced an svr. the participants will visit the national institutes of health for an in-person study visit. during the visit, patients will have blood drawn for lab tests to monitor the progress of their liver disease, and may be asked to undergo an ultrasound examination of the liver to detect any abnormalities that may be attributed to liver cancer. patients will also answer questions about their medical history particularly any outcomes or events related to their hepatitis c that have occurred since the halt-c trial and may be asked to sign a release of information to allow researchers to obtain medical records from other clinics or physicians where they have received treatment. ...

subjects who have achieved a sustained virologic response during their participation in the multicentered halt-c clinical trial for treatment of chronic hepatitis c are being invited to return for a single clinic visit to assess whether any decompensation events (e.g. ascites, varicela hemorrhage, hepatic encephalopathy) or hepatocellular cancer has occurred. subjects able and willing to return to the nih will undergo standard clinical examinations, questionnaires and an ultrasound examination of the liver, to assess the status of their hepatitis c. data will be pooled from all of the 10 clinical centers, analyzed and compared to an age and gender matched control group of nonresponder subjects who participated in the halt-c trial. a data coordinating center (new england research institutes) will conduct the data analysis. this will be a descriptive natural history study.

Eligibility criteria:
* inclusion criteria: patients who developed a virological response at week 20 of the halt-c study. exclusion criteria: none

Keywords: hepatitis c sustained virological response halt-c peginterferon and ribavirin hcv rna