cyrilzakka/clinical-trials huggingface dataset:
Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma

Patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (G-202) even though patient no longer meets the criteria to be a part of the main treatment study. Patient's cancer responded well to receiving G-202 in the main study and will receive G-202 at the same dose given in the main study.


Eligibility Criteria:
Inclusion Criteria:

* History of hepatocellular carcinoma
* Participation in prior research study where G-202 was administered
* Tolerance of G-202 treatment
* Demonstration of stable disease

Exclusion Criteria:

* Disease progression
* Occurrence of unacceptable toxicity
Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

To determine the best parameters with various leads to cover back and leg pain and provide best pain relief

Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.

Eligibility Criteria:
Inclusion Criteria:

* spinal cord stimulator implant within last 3 weeks
* NRS \> 6
* at least 22 years old
* patients who agree not to add or increase their pain medications during the study

Exclusion Criteria:

* patients with prior spinal cord stimulators
* pregnancy
* infusion pump
* history of substance abuse or dependency in last 6 months
The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on maintenance of oxygenation and removal of carbon dioxide during apnoeic period in pediatric patients undergoing general anesthesia with rigid bronchoscopy


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
* 2. Patients aged 7 or younger who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria:

* 1. Patients undergoing extracorporeal membrane oxygenation (ECMO)
* 2. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
* 3. Patients with current maxillofacial trauma or basal skull fracture
* 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
* 5. Extremely low birth weight infant and premature infant less than 28 weeks gestation age
* 6. Patients who had previously undergone rigid bronchoscopy / surgery
* 7. If the parent of subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Treatment of Rhinitis With Intranasal Vitamin E

Many beneficial effects of vitamin E have been described, but vitamin E supplementation by mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. The investigators will evaluate the effect of vitamin E directly applied to the lining of the nose in individuals with moderate to severe rhinitis by symptom questionnaires.

Vitamin E has health promoting properties that are attributed to its anti-oxidant action and its ability to stabilize cell membrane and promote restoration of the skin barrier function. The beneficial effects of the topical vitamin E applied to the skin have been firmly established and many skin care products now contain vitamin E, whereas the purported benefits cannot be achieved by oral intake of vitamin E. Recently oral vitamin E was shown to be ineffective in the management of allergic rhinitis, which reminisces the clinical experience in dermatology. The failure of oral vitamin E could result from the relatively low local concentration that are not sufficient to scavenge the reactive oxygen species generated in the inflammatory process and restore the consequent epithelial damage to the nasal mucosa in rhinitis.The effect of topical vitamin E applied intranasally to the mucosa has never been studied. It stands to reason that higher local concentrations can be achieved by topical application of vitamin E directly to the nasal mucosa, which may confer the same positive effects observed with its direct application to the skin. We will perform a single center, prospective, randomized, double-blind, placebo-controlled, clinical trial to investigate the role of topical alpha-tocopherol in oil applied to the nasal mucosa 3 times per day with a q-tip on the subjective symptoms of rhinitis over the course of a 4-week period.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of rhinitis and symptom severity score of 25 or higher on the self-administered Rhinosinusitis Questionnaire (range of 0, i.e. absence of any symptom, to 50, which indicates the most severe symptom in each category)

Exclusion Criteria:

* Inability to give informed consent, comprehend questions or instructions and complete questionnaires
* Recent change (within 2 weeks) in the medications that may affect nasal or sinus symptoms (intranasal or systemic glucocorticosteroids, mast cell stabilizer, antihistamines, decongestants, leukotriene antagonist, antibiotics, preparations containing thyroid or sex hormones, alpha-blocking agents)
* Intranasal use of oil- or gel-based products
Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM

This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

1. Aged 19 and above
2. Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
3. Patient diagnosed with ASCVD

   * Myocardial Infarction (MI)
   * Acute coronary syndrome (ACS)
   * History of Coronary revascularization(Percutaneous Coronary Intervention, PCI)
   * History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures
   * Stroke or Transient ischemic attack (TIA)
   * Peripheral Arterial Disease (PAD)
   * Stable Angina
4. Written informed consent

Exclusion Criteria:

1. Type 1 diabetes
2. HbA1c \> 8.5% at screening
3. Fasting triglyceride ≥ 400 mg/dL at screening
4. History of muscular disease or rhabdomyolysis due to use of statin
5. Hypersensitive to rosuvastatin or ezetemibe
6. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:

   ① Severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2)

   ② ALT, AST \> 3x ULN or history of active liver disease

   ③ CPK \> 3x ULN
7. Those participating in clinical trials of other drugs
8. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children

The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents.

Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant increases in mortality, length of stay, and cost of medical care (McFarland, 2006). Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (McFarland, 1998). A promising tool in this area is the probiotic Lactobacillus reuteri

Eligibility Criteria:
Inclusion Criteria:

* 3 - 18 years of age
* Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea
* The signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older
* Available throughout the study period
* No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used)
* Subject or parents/guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol

Exclusion Criteria:

* Three or more soft and unformed or watery stools per day at admission
* Receiving chemotherapy or radiation therapy
* Diagnosis of inflammatory bowel disease
* Enteral or parenteral nutrition only
* Requiring care in an intensive care unit
* Status post-bowel resection during hospitalization
* Receiving antibiotics four weeks prior to hospitalization
* Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases)
* Pregnancy
* Lack of possibility to store the study product in a temperature below 25°C during the hot season of the year
A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients

This is a multi-center randomized controlled trial comparing the effectiveness of community health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low socioeconomic status to improve their health outcomes.

Community Health Workers (CHWs) have the potential to improve chronic disease outcomes among patients with low socioeconomic status (SES). Yet, widespread use of CHWs has been hampered by lack of standardized, scalable and evidence-based models. Our community-academic-health system team used participatory action research with low-SES patients to design IMPaCT (Individualized Management for Patient-Centered Targets). A randomized controlled trial (RCT) of 446 hospitalized patients with varied diseases demonstrated that a 2-week dose of IMPaCT improved access to care, mental health, activation, and quality of communication, while reducing recurrent hospital readmissions. We have adapted IMPaCT for use among low-SES primary care patients with multiple chronic conditions.

This RCT is designed to evaluate the newly adapted IMPaCT model in 3 primary care settings - academic, federally qualified health center, and VA. Upon enrollment in the trial, patients will collaboratively set a chronic disease management goal with their primary care provider. Patients will then be randomized to collaborative goal-setting versus goal-setting augmented by 6 months of support from an IMPaCT CHW. Follow-up will be conducted at 6- and 9- months post-enrollment.

The study design is a single-blinded, 2- armed, multi-site randomized controlled trial involving three clinic sites and 444 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient of specific practice (Mutch/St.Leonards Court, Spectrum, PVAMC) for at least 1 yr defined as having one office visit within preceding 12 months
* Resident of home ZIP code including ANY of the following 19104, 19131, 19139, 19142, 19143, 19145, 19146, \& 19151
* Has 2 or more of the following conditions: 1. Obesity: BMI30 2. HTN: ICD9 relating to HTN from EMR problem list or EMR ICD9 encounter diagnosis x2) 3.DM: ICD9 relating to DM from EMR problem list or EMR ICD9 encounter diagnosis x2) 4. tobacco (from EPIC Social History/Vital Signs)
* Has at least one poorly controlled condition based on the most recent value prior to enrollment: Obesity (BMI\>=35); HTN (SBP \>= 160); DM (HgBA1c \>=9); Tobacco Use (\>0 cigarettes)"
* Is uninsured, insured by Medicaid, or dually eligible for Medicare and Medicaid or VA Insurance
* Has a scheduled appointment at a study clinic in the future.
* Community Health Workers/CHWs/IMPaCT Partners involved in the care of patients of the three practices will be included in the qualitative portion of this study.

Exclusion Criteria:

* Will not provide informed consent for this study.
* Does not have the capacity to provide informed consent for this study.
* Previously enrolled in this study.
* Currently enrolled in another study focusing on chronic disease management.
* Currently has a CHW
* No one will be excluded on the basis of sex or race.
Infant Environment Study

This study evaluates the effect of a music enhancement program to strengthen the motivation to engage in music related behaviors rather than eating in infants who are high in motivation to eat. Half the participants will participate in a Music Together Program, while the other half will participate in a Play Date control. For both groups, participants will attend 34 weekly sessions for one year, and 12 monthly sessions the next year, in 6 cohorts.

Obesity is a disorder of positive energy balance in which energy intake exceeds energy expenditure. The motivation to eat is a basic human need, which is present at birth. One factor that may lead to increased energy intake is the imbalance between the motivation to eat and the motivation to engage in other behaviors. The motivation to eat versus engaging in other behaviors can be operationalized as the relative reinforcing value of eating versus alternative behaviors.

A strong motivation to eat instead of engaging in alternative behaviors has been related to increased energy intake in adults. The motivation to eat is cross-sectionally and prospectively related to obesity in children, adolescents, and adults, and cross-sectionally related to weight status in infants. Shifting the balance from high motivation to eat to increased motivation to engage in alternative behaviors can reduce energy intake, and may be protective against weight gain.

A structured program to enhance music engagement in infants who are strongly motivated to eat can shift their choice from food to music. This study will expand on this preliminary research and examine long-term effects of this intervention in infants who are highly motivated to eat.

Eligibility Criteria:
Inclusion Criteria:

* High food reinforcement

Exclusion Criteria:

* born preterm (\<37 weeks gestation)
* a low birth weight (\< 2500 grams)
* known developmental delay(s)
* subject's mother was \< 18 years old at the time of pregnancy
* not yet eating finger foods
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study


Eligibility Criteria:
Inclusion Criteria:

All subjects:：

* Signing the informed consent forms；
* 18 years to 65 years (inclusive)；
* Body mass index should be between 18 and 30 kg/m2 (inclusive)；
* No medication was used before screening，or stable medication for 4 weeks.

Normal liver function：

* Clinical laboratory tests during the screening period were normal，or the abnormality has no clinical significance.

Hepatic impaired subjects:

* Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
* Liver damage due to primary liver disease.

Exclusion Criteria:

All subjects:

* Subject known or suspected of being sensitive to the study drugs or its ingredient；

Normal liver function：

* Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
* Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.

Hepatic impaired subjects:

* Suspected or diagnosed as liver cancer or with other malignant tumors;
* Drug induced liver injury，acute liver injury，liver transplantation history.
* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Coca-cola's Clinical Effects on Gastric Phytobezoars

Consecutive patients suffering from gastric phytobezoars were divided into 3 groups (Group 1, Group 2 and Group 3) according to the phytobezoars' formation time and each group was further subdivided into control and intervention group according to whether Coca-Cola was admitted. All patients in intervention group dieted Coca-Cola whereas patients in control group refused to drink Coca-Cola and had willing to receive the emergently gastric fragmentation.

Consecutive patients were enrolled and were divided into Group 1(the formation time of phytobezoars was less than 7 days), Group 2(the formation time of phytobezoars was from 7 days to 14 days) and Group 3 (the formation time of phytobezoars was more than 14 days) according to the formation time of phytobezoars and each group was subdivided into control group (who refused to diet Coca-Cola and chose emergent fragmentation with gastroscopy) and intervention Group (who had a willing to diet Coca-Cola) from 1st Jan, 2017 to 1st Dec 2021. The current protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University (QYFYWZLL 26293). The patients in intervention group all dieted Coca-Cola to treat gastric phytobezoars, 250ml-500ml/2 h till to sleeping time according to personal health conditions and life habits. Pay more attention to the stools and assess if the bezoars had excreted. The Coca-Cola dieting period of intervention group 1 was 3 days, intervention group 2 was 5 days and intervention group 3 was 7 days. The patients would go through an endoscopy once the Coca-Cola dieting therapy was over. The patients who chose emergently endoscopic fragmentation was enrolled in control Group. All patients endorsed the digital informed consent and bring the medical records before endoscopy. Statistical analysis was performed with SPSS version 22(IBM, Inc. Armonk, NY, USA). ANOVA or independent samples t-test was used for analysis of continuous variables. P \< 0.05 was taken as statistical meaning.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed by abdominal CT or gastroscope;
* years older than 12;
* no contraindications;
* have willingness to diet Caco-cola to treat gastric bezoars;
* choose the emergent endoscopy whose bezoar formation time are more than 2 weeks;

Exclusion Criteria:

* Gastroscopy contraindications;
* choose the emergent endoscopy whose bezoar formation time are shorter than 2 weeks;
* years younger than 12 years;
Vaginal Repair of Post Cesarean Istmocele

20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.

METHODS:

* Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
* Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:

  1. Distance from the external cervical os to the lower end of the isthmocele (A)
  2. Distance from the external cervical os to the upper end of the isthmocele(B)
  3. Length of the isthmocele (B-A)
  4. Residual myometrial thickness (the least) of the isthmocele.
* Routine preoperative workup.
* The technique:

  * Postmenstrual
  * Spinal anesthesia
  * Sterilization of the perineum and vagina
  * Cervical dilation up to 8mm using Hegar's dilators
  * Marking the previously measured points A \& B
  * Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
  * The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
  * Hemostasis is performed using diathermy.
  * The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
* The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
* Sexual intercourse is avoided for 4 weeks postoperative
* postoperative transvaginal ultrasound follow up; at 1 month postoperative.
* Data will be statistically analyzed and results will be tabulated.

Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with symptomatic post cesarean isthmocele.
* should present with abnormal uterine bleeding .

Exclusion Criteria:

* presence of any other uterine pathology,
* presence of adnexal pathology,
* presence of malignancies,
* presence of pregnancy,
* presence of infection in the lower genital tract ,
* general cause of bleeding
* women not accepting the procedure,
* women not consented
PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

This phase I trial studies the side effects of positron emission tomography (PET)/computed tomography (CT) in evaluating response to chemotherapy in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PRIMARY OBJECTIVES: I. Study fludeoxyglucose \[18F\] 2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine (FMAU) (fluorine F 18-clevudine ) in 10 patients with known breast cancer to obtain data on safety, circulating metabolite, tumor imaging feasibility, and radiation dosimetry. II. Assess the potential utility of FMAU-PET in the imaging evaluation of chemotherapeutic response in 15 patients with breast cancer. OUTLINE: Patients receive fluorine F18-clevudine intravenously (IV) over 1 minute and then undergo PET/CT scan at baseline. Patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment. After completion of study treatment, patients are followed up at 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for Aim 1:
* Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard care
* Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU

Inclusion criteria for Aim 2:

* Have been diagnosed with a HER2+ invasive cancer of the breast
* Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care
* Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU

Exclusion Criteria:

* Have undergone chemotherapy or radiation therapy within the previous one month
* Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure
* Patients who have had surgery at the site of the suspected lesion within 1 month