cyrilzakka/clinical-trials huggingface dataset:
Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer

This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer.

This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer.

Approximately 58 women who have stable disease or responded to first line chemotherapy with at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled to this study and receive fulvestrant 500mg as a maintenance therapy. The treatment will continue until the objective disease progression or intolerable AE.

Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST (Response Evaluation Criteria in Solid Tumors ) 1.1. Safety will be monitored based on the frequency and severity of adverse events (AEs), as assessed by Common Terminology Criteria (CTC) grade version 4.0.

Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every 12 weeks for all patients until documented evidence of objective disease progression.

Reporting of SAEs (serious adverse events) to regulatory authorities will be done by the investigator in accordance with local regulations.

Eligibility Criteria:
Inclusion Criteria:

Provision of informed consent Histologically proven HR positive breast cancer

Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause \[National Comprehensive Cancer Network 2008\]):

Prior bilateral oophorectomy Age ≥60 years Age \<60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone and oestradiol in the postmenopausal range.

Patients have completed first-line chemotherapy for metastatic breast cancer The first-line chemotherapy must be given to patients with visceral disease or progressive disease requiring a fast response Responded(CR or PR) or stabilized(SD\>=24 weeks) to first-line chemotherapy for metastatic breast cancer The duration of 1st line chemotherapy for advanced breast cancer had been at least 4 cycles and at most 8 cycles WHO performance status 0, 1 or 2-

Exclusion Criteria:

* Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present) Prior hormonal treatment for metastatic breast cancer are not allowed More than one line of cytotoxic chemotherapy for metastatic breast cancer Her-2 positive Other malignant tumor (concurrent or previous). Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the study protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus
UCLA Tai Chi in a Community Setting Study

Although a number of studies have examined the effects of Tai Chi in older adult populations, few have methodically assessed its effects on vitality, fatigue and physical activity. Some studies have shown that fatigue relates to negative mood and poor health-related quality of life in older persons.

Tai Chi is an ancient Chinese form of calisthenics that utilizes the body's internal energy (chi), mind, and breathing; which may be a useful exercise for older adults in increasing their activity level. A twenty-four of Yang style of Tai Chi is a simple form of Tai Chi that is particularly well-suited for older adults. This proposed study to investigate the effects of a Tai Chi intervention on decreasing fatigue level, and increasing level of activity in healthy older adults.

The investigators research group has focused on the Tai Chi as a strategy to reduce stress and improve sleep, and their preliminary evidence suggest it strongly affects energy level and vitality. The investigators are focused on taking this intervention into the community testing its efficacy. The investigators preliminary data shows that Tai Chi is of benefit to older adults; however, this study will test whether their research findings are generalizable to community settings.

Tai Chi-naïve participants from Culver City Senior Center will receive a 10-week Tai Chi. The investigators will compare this group to a wait-list control group. All subjects will receive a packet of questionnaires of pre- and post-intervention vitality, fatigue and health-related quality of life. Subjects will also be given an activity monitor to wear for 2 days before they start the Tai Chi class and for 2 days after they complete the class, to determine if there is a change in general physical activity level.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Older adult \> 60 years of age

Exclusion Criteria:

* Older adults who have severe osteoarthritis or chronic pain disorders
* Non ambulatory
* Any condition that would adversely impact their participation in Tai Chi
Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence

Postoperative emergence delirium (ED) is a severe postoperative complication in paediatric anaesthesia. ED is defined as a state with psychomotor disturbance, perception disorder and state of excitation and anxiety. The incidence of ED in paediatric patients can be up to 80%. ED is associated with the increased morbidity of paediatric patients in the postoperative period. One of the potential triggers of ED is sevoflurane. Currently, there are only limited data about comparing the influence of anesthesiologic management on the ED incidence. The possible ED reduction could lead to reduced stay in a post-anaesthesia care unit (PACU), postoperative nausea and vomiting (PONV) incidence and the overall reduction of the postoperative adverse events incidence together with the higher satisfaction and the patients and the legal guardians.

This prospective randomized interventional single-blind study aims to compare the influence of the anaesthesiology management no the incidence of ED in the postoperative period in paediatric patients. Elective paediatric patients (2-10 years) scheduled for the planned adenoidectomy or adenoidectomy + micro-otoscopy/adenoidectomy + frenulum linguae discission will be included in the trial after signed informed consent form the legal guardian. In all patients, the 2 Eutectic Mixture of Local Anesthetics (EMLA) patch will be applied on the predefined skin area ( visible vein for venepuncture) between 45 minutes to 60 minutes before anaesthesia. The patients will be randomized at the operating theatre (allocation 1:1) into the experimental group (intravenous induction with propofol + opioid and anaesthesia maintenance according to this set bispectral index value with desflurane) and the control group (inhalation induction with sevoflurane mixed with air and oxygen and anaesthesia maintenance with sevoflurane). The primary aim of the study will be the incidence of ED defined by The Pediatric Anesthesia Emergence Delirium (PAED) scale, which will be measured at the , at the admission to PACU and in the 5th, 10th, 15th, 30th minute and at the moment of dismission from PACU. The secondary aim will be the time to oral intake (from the end of the surgery), the incidence of adverse events (PONV, bradycardia, hypotension), the need for concomitant medication (analgesic medication, sedative medication, antiemetic medication).

Eligibility Criteria:
Inclusion Criteria:

* age between 2-10 years
* signed informed consent
* paediatric patient for elective adenoidectomy, or adenoidectomy with micro-otoscopy and/or frenulum discission

Exclusion Criteria:

* allergy and hypersensitivity on local anaesthetics in EMLA patch, general anaesthetics, or soya beans or peanuts
* venepuncture refusal · neuromuscular disorder with the contraindication of inhalation anaesthetics
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis
* Requirement for fluid resuscitation

Exclusion Criteria:

* serum creatinine \> 300µmol/L
* Chronic renal failure
* Anuria lasting more than 4 hours
* Requirement for renal support
A Comparison of Adolescent Group Therapy and Transitional Family Therapy for Adolescent Alcohol and Drug Abusers

The purpose of this study is to compare the effectiveness of two psychosocially-based, manual-driven, behavioral modalities. One of these is a standardized version of the established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational and therapeutic components. The other is a state-of-the-art family therapy approach, Transitional Family Therapy (TFT), which integrates management of the current problem with exploration of multigenerational issues. Both approaches have been developed to expressly target adolescent alcohol problems.

Despite well-founded societal concerns over the use of illicit drugs by youth, alcohol use has persisted for decades as the number one adolescent substance abuse problem in the U.S. Further, research has shown that the earlier the onset of alcohol use, the more likely is a person to develop alcohol dependence later, during adulthood. Consequently, the need is clear for interventions which will arrest this process at the earliest point possible. Hence, interventions that mobilize a youth's social systems to help that young person deal with the problem, i.e., the family and peer systems, would make sense from a number of standpoints. Two primary modalities developed to deal with such issues are those examined here: family therapy and group therapy.

The participants were males and females, ages 13-17 at intake, with a DSM-IV diagnosis of either alcohol abuse or alcohol dependence. Following random assignment to condition, basic treatment in both conditions was based on a 12-session model and took approximately 3-4 months, followed by 1-2 aftercare sessions over an additional 1-2 months. The treatment was provided by therapists who were already working within the community (as opposed, for instance, to graduate students). Follow-up assessments were obtained at 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment, thus allowing determination of the extent to which treatment effects "held up" to a degree not attained by most of the previous outcome studies within this domain.

Comparisons: AGT and TFT are being compared on the extent to which their participants used alcohol, as well as other substances, during the three post-treatment periods. Other comparisons include school performance (grade point average), family relations/functioning, and involvement with the legal system.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 13-17 years of age at intake.
* Participants had a current DSM-IV diagnosis of either alcohol abuse or alcohol dependence.
* Participants signed a witnessed informed consent.
* Parent or custodian of each (adolescent) participant signed a witnessed informed consent.

Exclusion Criteria:

* Participants who met current DSM-IV criteria for bipolar disorder, psychotic disorder, or eating disorder.
* Enrollment in a residential substance abuse treatment program within 2 months prior to intake.
Comparison of Absorption of Vitamin K2

From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.

This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 20 and 30 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects receiving corticoϊd treatment
* Subjects using oral anticoagulants
* Subject with (a history of) soy allergy
* Subjects using vitamin K containing multivitamins or vitamin K supplements
* Subjects with anaemia or subjects who recently donate blood.
The 3P Trial: Preoperative Planning and Preparation of Complex and Rare Procedures in GI Surgery

The aim of the present study is to develop, implement a planning tool for rare and complex visceral surgical procedures. With the successful implementation of the planning tool the study will contribute to the improvement of intraoperative processes and their outcome in low volume surgery and offer an alternative to continued centralization of surgical care especially in case of geographical or disease specific premises.

The quality of the intraoperative process is still a blind spot, when it comes to clinical surgical research in the operating room. In contrast to pre and postop process optimization with tools like the World Health Organization (WHO) checklist or the Enhanced Recovery after Surgery (ERAS) protocol intraoperative processes tend to be poorly defined especially in rare and complex visceral surgery (e.g. esophageal, pancreatic rectal resection, sarcoma surgery, revisional bariatric surgery). This leads to delay, increased stress of the operating team and increased intraoperative mistakes and eventually increased complication rates. From previous investigations we know that step by step planning and briefing of the entire OR Team can reduce operative interruptions. With the development of a dedicated planning tool which allows to create and distribute step by step protocols for rare and complex visceral surgical procedures to the entire OR Team we hope to decrease delays and reduce OR time variance.

Objective: Development and implementation of a planning tool for rare and complex visceral surgical procedures.

Outcomes: Primary outcome: (delay/variability) operative times as defined as time from skin incision to skin closure

Secondary outcomes:

* Costs
* Influence of preoperative augmented planning on degree of and quality of teaching
* Level of stress of each operating team member
* Number of intraoperative mistakes
* Number and severity of intraoperative and postoperative complications

Eligibility Criteria:
Inclusion Criteria:

* age 18 and older,
* indication for a complex and rarely performed visceral surgical procedure (e.g. esophagectomy, Whipple operation, Gastrectomy, complex hepatobiliary surgery, multivisceral resections, rectal cancer surgery, revisional bariatric surgery),
* patient's written informed consent
* consent of the involved operating team

Exclusion Criteria:

* age younger than 18 years,
* Emergency surgery or a time from outpatient visit to the operation \<8 days.
Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer

While significant progress has been made in the treatment and prognosis of ovarian cancer, this progress has mostly shown benefits for younger women.

This study aims to understand two things: How body composition (the amount of muscle and water versus fat in in the body) affects the dose and side effects of chemotherapy; and the biological reason for the worse prognosis with aging. To get a good view of these effects, investigators are asking the help of both younger and older women for this project.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have one of the following: a) Histological or cytological diagnosis of high-grade serous ovarian, fallopian, or peritoneal cancer, stage III or IV; b) In the opinion of investigator, highly suspicious stage III or IV ovarian, fallopian, or peritoneal cancer (histologically confirmed non-serous ovarian, fallopian, and peritoneal cancers will be considered screening failures).
* At least one biopsiable lesion by CT/US or laparoscopy.
* Have not received previous treatment for ovarian cancer.
* Life expectancy of greater than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Karnofsky \>60%).
* Must have adequate organ and marrow function.
* Deemed eligible for neo-adjuvant chemotherapy with carboplatin and paclitaxel and surgery by their oncologist.
* Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Active second malignancy within last 2 years (except non-melanoma skin cancer or in situ carcinomas.
* Prior treatment for ovarian cancer.
* Potential participants with known brain metastases will be excluded from this clinical trial.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin and paclitaxel.
* Known allergy to carboplatin, paclitaxel, or cremophor.
* Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Women who are pregnant. Breastfeeding should be discontinued if the mother is treated with carboplatin and paclitaxel. These potential risks may also apply to other agents used in this study.
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin and paclitaxel or other agents administered during the study.
The Development of Tolerance to α1-Adrenoceptor Blockade With Chronic Carvedilol Treatment

There is now strong evidence from clinical trials that carvedilol therapy in heart failure is superior to therapy with metoprolol. Not only does carvedilol have superior effects on lipid profiles, insulin sensitivity, renal blood flow, and reversal of pathologic remodeling but also its use is associated with fewer deaths compared to metoprolol. These facts make it important to carefully define how metoprolol and carvedilol are pharmacologically different. One potential difference is α1-AR antagonism. If we demonstrate that these α1-AR effects are preserved with chronic therapy, then α1-AR blockade may have an important role in carvedilol favorably altering the natural history of heart failure. On the other hand, if we demonstrate that tolerance to the α1-AR blockade effect of carvedilol decreases with time, then it would be unlikely that this pharmacologic property contributes to the efficacy of carvedilol. In such a case other pharmacologic properties, such as antioxidant activity, would appear to be important. These results will help guide future studies into CHF and AR blockade.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 to 85 years
2. Symptomatic heart failure, NYHA class I to III
3. Left ventricular ejection fraction \< 0.40
4. Give written informed consent

Exclusion Criteria:

1. active myocarditis
2. congenital heart disease
3. uncorrected, hemodynamically significant stenotic valvular disease
4. hypertrophic cardiomyopathy
5. Asthma or other obstructive airway diseases requiring bronchodilators
6. Heart rate \< 60 beats/min, supine systolic blood pressure \< 85 mm Hg, supine diastolic blood pressure \> 90 mm Hg
7. Uncontrolled Hypertension (Systolic BP \>140 mmHg, Diastolic BP \> 90 mmHg).
8. Sick sinus syndrome, Mobitz type 2 second degree AV block or third degree AV block unless controlled with an artificial implantable pacemaker
9. NYHA functional class IV symptoms
10. Treatment with an excluded medication (see Excluded Medications below)
11. Myocardial infarction or coronary artery intervention (CABG or angioplasty) within three months
12. Unstable angina pectoris
13. Presence of any progressive systemic disease that would be expected to impact the patient's outcome over the time course of the study
14. Uncorrected endocrine disorders including primary aldosteronism, pheochromocytoma, hyperthyroidism, hypothyroidism, brittle type 1 diabetes mellitus
15. Evidence of significant renal disease (serum creatinine \> 2.5 mg/dl), or hepatic disease (transaminase level \> three fold higher than laboratory normal)
16. Symptomatic peripheral vascular disease
17. Inability or unwillingness to cooperate with study or give written informed consent
Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

The purpose of this research study is to investigate the effectiveness of Tysabri on cognitive fatigue in persons with Relapsing-Remitting Multiple Sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

The researchers aim is to investigate the effects of Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task and also on how cognitive fatigue changes as a function of duration of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-64
* Diagnosed with Relapsing-Remitting Multiple Sclerosis or a healthy volunteer
* If diagnosed with MS: has been newly prescribed Tysabri, but has not yet started taking the medication
* Can read and speak English fluently

Exclusion Criteria:

* History of head injury, stroke, seizures, or any other significant neurological event other than MS
* Flare up of MS symptoms within the past month
* History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments
* Left-handed.
* Not able to have an MRI