cyrilzakka/clinical-trials huggingface dataset:
Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

Primary objective:

To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis

Secondary objectives:

1. To determine the overall objective response rate (ORR)
2. To determine the progression free survival, and duration of objective response
3. To evaluate the overall survival (OS)
4. To assess the safety profiles

This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design.

Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal.

Recruitment period: 10 months

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proved breast cancer
* Relapse/recurrent brain metastasis progression after brain radiotherapy
* Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI)
* Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed
* Performance status of ECOG 0, 1, 2
* With normal left ventricular ejection fraction and normal ventricular contractility
* Age 21 years or older
* Life expectancy equal or longer than 3 months
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin
* Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study
* Prior liposomal doxorubicin treatment
* Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
* Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
* Brain metastases defined as meninges metastases
* Presence of serious concomitant illness which might be aggravated by study medication:

  * Uncontrolled infection (active serious infections that are not controlled by antibiotics)
  * Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
  * History of ventricular arrhythmia or congestive heart failure.
* Presence of abnormal left ventricular ejection fraction
* Hematopoietic function as defined below:

  * Hemoglobin\<10g/dl
  * ANC\< 1,500/uL
  * Platelets\<100,000/uL
* Organ function as defined below:

  * Total bilirubin \>1.5 × ULN
  * ALT / AST\>3 × ULN (\>5.0 x ULN if hepatic metastasis)
  * Creatinine \>1.5 × ULN
* Mental status is not fit for clinical trial
* Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method
Changes in the Distribution of Mitochondria During Oocyte Maturation

Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. The aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent ICSI but did not become fertilized and are discarded.


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients needing IVF treatment

Exclusion Criteria:

* Patients not requiring the ICSI procedure
Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency

Peroperatively observative study in pediatric orthopedic center in Lyon, France.

50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of the medial meniscus associated with lesions of the anterior cruciate ligament.

All the patients need a reconstruction of the ACL because of chronic knee instability.

All the patients underwent a multi portal arthroscopy during the ACL reconstruction : anteromedial and anterolateral and after intercondylar and posteromedial.

The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the posterior horn of the medial meniscus which could be missed in MRI and anteromedial and anterolateral arthroscopy.

Statistics of this lesions are used to study prevalence and diagnosis capacity of this procedures.

First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar portal and after a posteromedial portal.


Eligibility Criteria:
Inclusion Criteria:

- Chronic knee instability with indicated surgery reconstruction

Exclusion Criteria:

* Pregnancy
* No preoperatively knee MRI
* Posteromedial or Intercondylar Portal Failure
* Social security system membership failure
* Refusal of consent of child or parents
Fibrin Melanoma Axillary Node Study in Patients With Melanoma

Primary Objective:

* To determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal.

Secondary Objectives:

* To determine the postoperative morbidity rate using fibrin sealant following axillary node dissection.
* To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model.
* To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.

Patients in this study are scheduled to have axillary node dissection as part of their surgery for treatment of their melanoma.

Within 2 weeks before entry into the study, patients will have a complete physical exam and medical history.

These patients will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in one group will receive TISSEEL applied externally to the dissected axillary area. Patients in the other group will receive no fibrin sealant.

For patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. At the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed.

The contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to M.D. Anderson Cancer Center, and during drain removal (unless these latter 2 dates are the same).

Follow-up wound exams will be performed by the local primary physician or in the M.D. Anderson Melanoma Clinic between 1-4 weeks and 6 weeks after surgery. Participation will be over at the 6-week follow-up.

THIS IS AN INVESTIGATIONAL STUDY. The sealant is FDA approved, though its use in this study is experimental. About 115 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Part I - Inclusion Criteria, patients that consent to participate.
2. Patients with melanoma who have undergone axillary dissection within the last six months as part of their surgical treatment will be considered for the study.

Exclusion Criteria:

1. Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins.
2. Patient has undergone prior radiation therapy to the operative site.
3. Patient is pregnant or lactating.
4. Patient is steroid dependent within prior 6 months.
5. Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
6. Patient has pre-existing lymphedema.
7. Patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.
Interventions for Patients With a Shortened Dental Arch

Dental services for large sectors of the population of the Western Cape (WC) Province of South Africa (SA) has been, and continues to be, limited to low-cost treatment options and emergency services, such as extractions at public health clinics. Replacement of missing teeth for the disadvantaged majority of the population is provided almost exclusively at the dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result of disease and the lack of restorative care and then having these replaced by a removable partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and quality of life of partially dentate adult patients with a reduced posterior dental arch and /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the posterior teeth with a removable prosthesis.

The aim of this research is to determine whether the daily functional needs and the quality of life of partially dentate adult patients with a reduced posterior dental arch will be satisfied and improved without having the posterior teeth replaced with a removable prosthesis, as compared to having the use of such prosthesis.

Objectives: To conduct a randomized controlled trial amongst partially dentate adult patients with a reduced posterior dental arch (3-5 pairs of posterior occluding pairs of teeth) and where these patients will be randomly assigned to one of two groups: one group would be provided with a metal- based removable partial denture (RPDP) to replace the posterior teeth, the other will receive no treatment.

Daily functioning ability and patient satisfaction between the groups (with/without RPDP) would then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Classic SDA
* Patients with a reduced posterior dental arch (from 3-5 posterior occluding teeth)
* Specific Age limits
* Remaining teeth periodontally sound
* Lost molars in one jaw
* Both canines and one premolar should be present

Exclusion Criteria:

* Exclude patients with Angle Class 2 or 3
* Signs of Temporo-mandibular disorders
* Compliance is a problem (Alcoholism/ drug addiction)
* Risk of over-eruption of teeth
* Patients wanting removable partial dentures
Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with sleep apnea hypopnea syndrome were included

Exclusion Criteria:

* Patients were excluded if they had nasal obstruction, significantly deviated nasal septum, nasal turbinate hypertrophy, or nasal polyps. Patients with uncontrolled heart failure, renal insufficiency, diabetes, or hyperthyroidism were also excluded. Patients were also excluded if taking medications that could affect upper airway muscle function, such as ben- zodiazepines and muscle relaxants.
A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors

This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Body weight ≥40 kilograms
* Life expectancy of at least 12 weeks
* Confirmed eligible HLA-A\*02 genotype and tumor with confirmed MAGE-A4 expression
* Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
* Measurable disease, according to RECIST v1.1
* Adequate hematologic and end-organ function
* Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy
* An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required

Exclusion Criteria:

* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
* Clinically significant cardiopulmonary dysfunction
* Clinically significant liver disease
* Poorly controlled Type 2 diabetes mellitus
* Active hepatitis B or C infection
* Positive test for human immunodeficiency virus (HIV)
* History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
* Active or history of autoimmune disease or immune deficiency
* Treatment with systemic immunosuppressive medications
* Prior allogeneic stem cell or solid organ transplantation
Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

The performance and clinical impact of two diagnostic systems will be evaluated using whole blood samples that are collected in parallel with samples for blood culture. As the rapid diagnostic systems will have the largest impact on severely ill patients (in need of a fast diagnosis) with bacterial infection, the evaluation will be performed in patients suspected of bacteraemia. During the study the new systems will be used in parallel with routine blood cultures. In alternating periods of 1 month, the results of the diagnostic system will be communicated to treating physicians (intervention) or not revealed (control). Blood culture results will be reported throughout the complete study period. Patients with suspected sepsis at the Emergency Department (ED), the department of infectious diseases/nephrology, and the department of haemodialysis will be included. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood sample (EDTA tube, 9 ml of blood) will be sampled for each routine set of blood cultures. In addition, the clinical data of the patients will be collected. The samples will be sent to the clinical laboratory where samples are tested with the new systems during regular working hours in batches of 8 samples per run (2-3 runs per day). On average, 10%-20% of the blood cultures drawn on the presumption of bacteraemia yield bacterial pathogens. Previous data show that 13% of patients yield positive blood cultures. Thus, in order to collect blood samples of 100 new episodes of bacteraemia approximately 1000 patients (2000 blood cultures + 1000 EDTA tubes) have to be collected for each system (2000 patients in total). The results of the systems will be used to evaluate the clinical utility of the system regarding time to antibiotic treatment change and bacteraemia management. The system will be used directly for the diagnosis of patients, resulting in a possible change of treatment strategy. However, routine blood culture practices will still be done during the whole study period.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of sepsis
* The drawning of blood cultures
* Age \>18 years

Exclusion Criteria:

* Children (\<18 years)
* Patients who are not hospitalized and sent home after ED admission
* Duplicate blood cultures from the same bacteraemia episode (7days between positives with the same organism, or 24h for different organisms)
* Patients from who blood cultures are drawn on Friday evening (17h) or Saturday during intervention periods
Effects of a Ketogenic Diet on Body Weight and Cardiovascular Risk Factors

This pilot study is a randomized, controlled clinical trial to compare anthropometric and metabolic changes associated with six months of weight management by means of a very low carbohydrate diet or a calorically-restricted low fat diet. We hypothesized that the low fat diet would be associated with more weight loss and improvement of cardiovascular risk factors than the low carbohydrate diet.

Low carbohydrate diets, including high-fat, 'ketogenic' diets, have moved to the forefront of popular diets promoted for weight loss in the United States. These diet plans have been aggressively marketed to millions of Americans every year. However, there has been virtually no rigorous study of low carbohydrate, high fat diets either with regard to efficacy in promoting weight loss or effects on cardiovascular risk factors. Because very low carbohydrate diets (i.e., the ketogenic diets) recommend increased intake of fat, and saturated fat, we hypothesized that following one of these diet plans could actually worsen important risk factors for cardiovascular disease. This is an issue of great importance because large numbers of people experiment with low carbohydrate diets despite not knowing their effects on blood pressure, plasma lipid levels, and glucose tolerance. Therefore, we have proposed a clinical trial to test our hypothesis. In this study, we will compare the effects of three months of a ketogenic diet (as promoted by Dr. Robert Atkins) with three months of a weight loss diet that conforms to the American Heart Association dietary guidelines in a group of 100 otherwise healthy obese subjects. During the course of the study, we will determine the effects of diet on 1) body weight, percent fat, and resting metabolic rate, 2) blood pressure, 3) plasma lipids, 4) measures of glucose tolerance, and 5) measures of psychological health and eating behaviors. This pilot study will provide the preliminary data needed to demonstrate the efficacy (or lack thereof) of a popular weight loss technique (i.e., the ketogenic diet) that is currently being criticized by professional organizations. Armed with preliminary data, the investigators plan to further investigate the long-term anthropometric and metabolic effects of ketogenic diets with a larger sample.

Eligibility Criteria:
Inclusion Criteria:

* Obese men and women with a BMI of 30-34 kg/m2, at least 18 years of age, who have had stable body weight (i.e., no gain or loss of \>5% of body weight) for the preceding six months, who have normal oral glucose tolerance, and who are able to commit to a six month study.

Exclusion Criteria:

* Pregnancy, lactation, active medical or mental illness requiring treatment, recent (within 1 year) use of appetite suppressing compounds, previous use of the ketogenic diet.
Nausea and Pain Prophylaxis During Thyroid Surgery

Postoperative pain and nausea may diminish a patient's wellbeing, and may also delay rehabilitation, as well as increase the total cost of care and treatment. Opioids are effective drugs for treatment of pain, but with the disadvantage of side effects such as somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing patients' postoperative need for opioids have been well-documented.

One non-opioid prophylaxis documented for various surgery is short-term treatment with corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain prophylaxis is not well-documented. In our study we will attempt to determine whether the aforementioned benefits of corticosteroids are valid for a group of patients undergoing thyroid surgery.

Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect and/or reduced use of opioids than placebo in patients undergoing elective throid surgery. Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without influencing the side effect profile.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia.
* Informed consent

Exclusion Criteria:

* Patients who use steroids
* Patients who use antiemetics
* Patients who use opioid analgesics
* Body weight \> 100 kg
* BMI \> 35
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Plaque psoriasis for at least 6 months
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy

Exclusion Criteria:

* Other forms of psoriasis
* History of recent infection
* Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria could apply
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans

We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. We therefore treated healthy non-obese men with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men, with and without a positive family history of schizophrenia.
* 20 kg/m2 \< BMI \< 26 kg/m2
* Age 20-40 years
* Fasting plasma glucose \< 6 mmo/L

Exclusion Criteria:

* FPG \> 6 mmol/L
* BMI \> 26 kg/m2
* Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
* Any significant chronic disease
* Renal, hepatic or endocrine disease
* Use of medication known to influence lipolysis and/or glucose metabolism
* Total cholesterol \> 7mmol/L and/or triglycerides \> 2 mmol/L
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Difficulties to insert an intravenous catheter
* Smoking (current)
* Severe claustrophobia (ventilated hood)
* Recent blood donation (within the last 2 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Extensive sporting activities (more than 10 hours of exercise per week)