cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel plus capecitabine in Chinese patients with advanced gastric carcinoma.

There are clinical trials showed that taxane is optional for the treatment of gastric cancer. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional taxane. This study is designed to find the maximum tolerated dose and dose limiting toxicity of liposomal paclitaxel combined with capecitabine in Chinese patients with advanced gastric carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 75
* Histologically or cytologically documented gastric adenocarcinoma and esophagus-gastro adenocarcinoma of metastatic or advanced stages with/without measurable tumor according to RECIST standard
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Patients who are expected to live at least 3 months
* No prior systemic chemotherapy with advanced stereo- tumor before the recruitment(recidivist/ metastatic without perioperative chemotherapy at least 6m)
* No Previous anaphylactic reaction to hormone
* Obtaining informed consent
* Patients may comply with the study protocol
* Laboratory tests: Absolute neutrophil count (ANC) ≥2,000/mm³, Platelet count ≥100,000/mm³, Hemoglobin ≥9.0 g/dL, Serum creatinine≤1.5 x the institutional upper limit of normal (ULN), Creatinine clearance≥50ml/min，Total bilirubin≤1.5 x the institutional upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN. In the case of known liver metastasis, ALT and AST（SGOT） ≤1.5 x ULN.

Exclusion Criteria:

* Active uncontrolled central nervous system metastasis
* No adequate organ function or known disease :

  * myocardial infarction
  * active heart disease
  * neuropathy or mental diseases including dementia or epilepsy
  * blind、deaf、dumb or extremity disability
  * known infection
  * active diffuse intravascular coagulation
  * known infection with hepatitis virus
* Pregnant or nursing,fertile patients would not use effective contraception during study treatment
* Prior clinically significant gastrointestinal tract disease , that would influence obviously capecitabine to absorb,including the ability to swallow by the attending physician
* No other active malignancies except that in complete remission with squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or no recrudescence for at least 2 year from the time a response was first documented
* Having other study medication within 4w
* Having radiation therapy or operation within 4w
* Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)
* Peripheral nerve disease ≥ 2
* Previous anaphylactic reaction to Capecitabine and Paclitaxel or diluents bases
* Absence of dihydropyrimidine dehydrogenase
* Patients not suitable determined by the attending physician.
Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Non-small Cell Lung Cancer

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A\*2402 restricted epitope peptides URLC10, CDCA1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

URLC10 and CDCA1 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A\*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.

Eligibility Criteria:
Inclusion Criteria:

Disease characteristics

1. Advanced or recurrent non small cell lung cancer
2. Second line or later therapeutic status

Patient characteristics

1. ECOG performance status 0-2
2. Life expectancy \> 3 months
3. HLA-A\*2402
4. Laboratory values as follows 1500/mm3\<WBC\<15000/mm3 Platelet count\>75000/mm3 Bilirubin \< 3.0mg/dl Asparate transaminase \< 99IU/L Alanine transaminase \< 126IU/L Creatinine \< 2.2mg/dl
5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
2. Pregnancy (woman of child bearing potential)
3. Active and uncontrolled infectious disease
4. Adrenal cortical steroid hormone dependent status
5. Decision of unsuitableness by principal investigator
Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies

It is important for patients treated with anti-EGFR therapies to get access to cosmetic options to preserve their skin condition during treatment. Anti-EGFR therapies are known to fragilize epidermis and to provoke rashes; which often lead to treatment discontinuation.

The aim of this study is to demonstrate that the Onco-Rash cream is able to preserve skin condition without side effects. Decreasing skin toxicity is expected to improve patients' life and facilitate treatment follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* Patient naive from anti-EGFR treatment (gefitinib, erlotinib, afatinib, cetuximab panitumumab, osimertinib, alectinib et crizotinib, etc).
* NSCLC (non-small cell lung cancer) patients eligible to anti-EGFR as first line treatment (gefitinib, erlotinib,afatinib, etc)
* Colorectal cancer patients eligible to anti-EGFR as first line treatment (cetuximab, panitumumab,....)
* Head and Neck/ENT (Ear, Nose Troat) cancer patients eligible to anti-EGFR as first line treatment (cetuximab,...)
* Signed informed consent
* Social security affiliation

Exclusion Criteria:

* Pregnant or Breastfeeding patient
* Patient in age to procreate without an efficient contraceptive method
* Patient with previous experience of allergic or irritative contact dermatitis to components of the studied product
* Patient with dermatologic conditions that cannot permit the study of skin toxicity of anti-EGFR
* Patients under radiotherapy 8 days prior the inclusion date
* Patient under immunotherapy 8 days prior the inclusion date
* Patient with local or systemic antibiotic treatment for acne 8 days prior the inclusion date
* Patient with antihistamines treatment 8 days prior the inclusion date
* Patients taking NSAIDs or corticoids as chronic medication or that took NSAIDs or corticoids 5 days prior the inclusion date
* Participation to another interventional study
* Patient with an altered ECOG (Eastern Cooperative Oncology Group) state ( \>2)
* Patient deprived of liberty or subjected to guardianship
* Impossibility to track and follow patient for geographical, social or psychiatric reasons.
Web-Based CBT Protocol for Treatment of Selective Mutism

The main aim of this study is to examine the effectiveness of a web-based CBT protocol (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The researchers hypothesized that the Meeky Mouse program would be associated with higher frequency of speaking behaviors, lower levels of anxiety, greater improvements in clinician-rated severity of mental illness, and higher clinician-rated improvement scores at post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* 6-12 years old
* primary clinical diagnosis of Selective Mutism
* confirmed diagnosis of Selective Mutism by structured clinical parent interview
* fluent in English

Exclusion Criteria:

* below average intellectual functioning
* the presence of autism and schizophrenia
Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

Guided bone regeneration (GBR) using bone graft and barrier membrane is a well-established technique for augmentation of atrophic alveolar ridges. There are many techniques for ridge augmentation involves the use of bone grafting materials, barrier membranes, possibly some tenting/fixation screws the stability of bone graft, space maintenance, angiogenesis, and tension free primary suture are essential for success.

Common techniques introduced for horizontal ridge augmentation are Guided Bone Regeneration (GBR), there are many techniques for ridge augmentation involves the use of bone grafting materials, barrier membranes, possibly some tenting/fixation screws. For successful GBR, stability of bone graft, space maintenance, angiogenesis, and tension free primary suture are essential. Space maintenance with particulate bone graft should be provided during healing period. However particulate bone graft is easily migrated when grafted on the large horizontal bone defect. To reconstruct large bony defect or for the 3-dimensional ridge augmentation, bone tack on the collagen membrane or titanium mesh is required to contain particulate bone graft during healing but these procedures are surgically time consuming and technique sensitive.

Sticky bone is biologically solidified bone graft which is entrapped in fibrin network. Sticky bone graft doesn't scatter because particulate bone powders are strongly interconnected each other by fibrin network.

Eligibility Criteria:
Inclusion Criteria:

* Inadequate facial bone obviating prosthodontically planned implant placement in the maxilla
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Significant bone-related illness or pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally).
2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)

The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.

The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.

Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.

The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.

The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.

Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.

The antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin.

Endpoints:

1. Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing.
2. To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT
3. Establish and validate a routine for measurement of vital antiinfectives.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to ICU in need of antiinfectives:

   1. in need of CRRT
   2. without acute kidney failure
2. requirement for antiinfectives\> 72 hrs
3. Age \> 18 yrs
4. signed informed consent

Exclusion Criteria:

1. Acute or chronic renal failure not in need of CRRT
2. Age \< 18 yrs
Insulin Infusion in the Hospital Wards

Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in health could also apply to patients that have high blood sugars in various other non-critical care areas of the hospital as well. However, the data that shows improvement in health outcomes has been collected from wards that have a lower patient to provider and patient to nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We hypothesize that tight blood glucose control will provide the same benefits for patients in non-intensive care units settings but that these protocols may lead to a higher incidence of hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients.

This study aims to determine the clinical outcome of patients treated with insulin infusion as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart review of patients treated with insulin infusions in non-critical wards at Emory University Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* All subjects over 18 years of age that received intravenous insulin treatment on general medical and surgical wards at Emory University Hospital during the period of 7/1/2004 to 6/30/2005
The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.

The study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. Subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. It is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older age
* Severe cardiogenic shock requiring the initiation of VA-ECMO therapy
* Stabile hemodynamic state and oxigenation with VA-ECMO and vasoactive support
* Informed written consent (due to the nature of the study, from a legally eligible relative of the patient)

Exclusion Criteria:

* Younger than 18 years of age
* Unstable hemodynamic state or suboptimal oxigenation despite established VA-ECMO and vasoactive support
* Severe neurological damage or confirmed brain death at the time of enrollment which squarely indicates therapy limitation and poor short-term outcome
* Transesophageal echocardiography is contraindicated
* Suboptimal echocardiographic window
Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair

This study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for pelvic organ prolapse (POP) on pelvic anatomy using dynamic magnetic resonance imaging (MRI) of the pelvis.

Approximately 1 in 11 women will undergo surgery for POP by age 80 years. POP occurs due to a defect or weakness of the pelvic floor, resulting in the herniation of pelvic organs through the vagina. The goal of surgical interventions has historically been thought to restore normal pelvic anatomy. Restoration of pelvic anatomy has been demonstrated following pelvic reconstructive surgery by way of significantly improved postoperative Pelvic Organ Prolapse Quantification (POPQ) scale measurements. Furthermore, improved POPQ measurements have also been shown to be positively correlated with improved patient satisfaction.

More recently, attention has turned toward using imaging studies to describe the postoperative anatomical changes seen in pelvic reconstructive surgery. The purpose of this study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for POP on pelvic anatomy using dynamic MRI of the pelvis.

The primary aim is to compare postoperative dynamic pelvic MRI measurements to preoperative measurements in patients who undergo prolapse repair vaginally including anterior, posterior and intraperitoneal vaginal vault suspension repairs for POP.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* English-speaking
* Undergoing anterior, posterior and intraperitoneal vaginal vault suspension by a physician at Cincinnati Urogynecology Associates, TriHealth for the treatment of symptomatic POP
* Concomitant procedures such as hysterectomy, suburethral sling, bilateral salpingectomy or salpingooophorectomy
* Willingness to participate in study

Exclusion Criteria:

* Unwillingness to participate in the study
* Pregnancy
* Contraindication to pelvic MRI, such as a metal implanted device (excluding titanium) or claustrophobia
* Previous surgery for apical prolapse such as sacrocolpopexy or vaginal vault suspension, or transvaginal mesh for prolapse
* Physical or mental impairment that would affect the subject's ability to complete the dynamic MRI, including patient's with dementia or those who have impaired mobility
* Known findings that may distort pelvic anatomy, such as a pelvic mass, congenital anomaly, or history of pelvic radiation
Post-market Assessment of Biodesign Dural Repair Grafts

The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.


Eligibility Criteria:
Inclusion Criteria:

1. Planned use of the Biodesign Dural or Duraplasty Graft.

Exclusion Criteria:

1. Age \<18 years
2. Unable or unwilling to provide informed consent
3. Life expectancy \<6 months
Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose


Eligibility Criteria:
Inclusion Criteria:

* Patients With A Diagnosis Of Primary Hypercholesterolemia And
* Who Are Defined As Being "High Risk" (10-Year Risk Of Coronary Artery Disease \> 20 % Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis Disease)
* And Have Not Reached Their Recommended Ldl-C Target Levels Of 2.5 Mmol/L While On A Statin Alone

Exclusion Criteria:

-
Physical Activity and Basal Metabolic Rate in Postmenopausal Women

The primary purpose of this study is to expand research on the effects of physical activity on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training program. The investigators will measure BMR by indirect calorimetry and normalize it across subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will be compared: an intervention group (no previous participation in regular exercise, newly enrolled in this study's 16 week training program), and a long-term athlete group (have engaged in at least 5 hours of exercise per week for the past 10 years or longer). A secondary aim is to generate an equation for the prediction of BMR from fat free mass in physically active postmenopausal women, to be applied to hypotheses in biological anthropology. The investigators expect to find at baseline that, controlling for fat free mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention group. At 16 weeks the investigators expect no change in BMR for the long-term group, while BMR will have increased in the intervention group. At the same time, the investigators expect to find that after completing the training regimen, the intervention group will have BMR similar to that of the long-term athletes.


Eligibility Criteria:
Inclusion Criteria:

* naturally postmenopausal (i.e. non-surgically)/\> 1 year since last menstruation
* FSH \> 30 mIU/ml
* estradiol-17β \< 25 pg/ml

Exclusion Criteria:

* smoker, abuser of alcohol/other drugs
* hypo- or hyperthyroid (serum TSH \< 0.3 or \> 5.5 microU/ml, respectively)
* underweight or severely obese (BMI \< 18.5 or \> 35 kg/m2, respectively)
* weight instability within the past six months (±\> 5% of body weight)
* hormone replacement therapy within the past six months
* history of metabolic, respiratory or cardiovascular disease
* high blood pressure
* contraindication for maximal aerobic testing as determined by PAR-Q questionnaire and physician's examination
Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf

This is a retrospective and prospective, observational mixed-methods (quantitative and qualitative) cohort study of patients who are treated with either Ofatumumab or Ocrelizumab that will be recruited and followed up for one year to collect their profiles across the Gulf countries.

This study will be conducted retrospectively (for patients who had their first treatment initiated on either Ofatumumab or Ocrelizumab before study start and from 2019 onwards) and prospectively (for patients who are initiated on either drug during the active recruitment period which spans for one year after the start of the first data collection) using data collected in a standardized manner.

Index date (baseline): Defined as the date of the first treatment initiated on either Ofatumumab or Ocrelizumab Index period: The patients fulfilling the inclusion criteria will be identified during the recruitment period (01-Jan-2019 to 01-April-2023 or up to 1 year after the start of the active recruitment period).

Eligibility Criteria:
Inclusion Criteria:

* Males and Females.
* Age 18 to 65 years.
* Confirmed RMS diagnosis as per the 2017 updated McDonald's criteria (Thompson et al., 2018).
* Having their first dose of either drugs during the index period (2019 onwards and up to 1 year since start of the active recruitment period).
* The decision to initiate either drug should be based on the patient's disease and taken by the treating physician before the decision of inviting the patient to participate in the study.
* The patient agreed and provided informed consent on the use of his/her de-identified data.

Exclusion Criteria:

* Patients below 18 years or above 65 years.
* Pregnant females.
* SPMS and/or PPMS patients.
* The patient's refusal to be included in the study.