cyrilzakka/clinical-trials huggingface dataset:
Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance

The goal of this randomized, pragmatic clinical trial is to evaluate an endocrine therapy dose-frequency escalation strategy and its effects on tolerability and compliance. Participants will be randomized to standard daily dosing of endocrine therapy or endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily.

Breast cancer remains the most common cancer diagnosis and second leading cause of cancer death among Canadian women. Close to 70% of breast cancers are hormone-dependent and endocrine therapy is the mainstay treatment (such as tamoxifen, aromatase inhibitors and lutenizing hormone-releasing hormone analogs). Globally, endocrine therapy has led to the greatest benefit for breast cancer patients resulting in compelling reductions in breast cancer recurrence and mortality rates. Tamoxifen and aromatase inhibitors (e.g. letrozole, anastrozole and exemestane) can cause a variable degree of toxicity linked to estrogen deprivation such as: vasomotor symptoms (hot flashes and night sweats), arthralgia/joint stiffness, genitourinary symptoms (vaginal dryness, dysuria, urinary incontinence, recurrent urinary tract infections and pain during sexual intercourse), insomnia, weight gain, mood changes, cognitive dysfunction, fatigue and skin dryness. It is well acknowledged that endocrine therapy side effects can influence treatment adherence, compliance, and persistence. A systematic review of adjuvant endocrine treatment found that 41 to 72% of patients did not take the correct dosage at the prescribed frequency and 31 to 73% discontinued endocrine therapy. Treatment adherence and persistence are key issues in breast cancer, as early cessation or reduced compliance/adherence to hormonal therapy leads to reduced disease-free survival and increased mortality. Despite a plethora of studies aimed at reducing the side effects of endocrine therapy there is no clear evidence that any of them have resulted in improved adherence/compliance/persistence. In practice, it is common to see a clinician reducing dose-intensity or frequency when patients develop intolerable side effects from endocrine therapy, i.e. either using 10 mg instead of 20 mg of Tamoxifen daily, or an every other day schedule for aromatase inhibitors. However, this commonly used practice has not been evaluated in a prospective trial. The researchers propose to conduct the world's first prospective randomized clinical trial to evaluate a dose-frequency escalation strategy of endocrine therapy (meaning taking the dose every other day for 1 month and then daily) and its effects on adherence and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an early stage or locally advanced hormonal receptor positive breast cancer
* Plan to receive endocrine therapy
* Able to provide oral consent
* Willing and able to complete questionnaires as per study protocol

Exclusion Criteria:

* Metastatic cancer
* Adjuvant abemaciclib
Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring in Thoracic Surgery

Patients undergoing thoracotomy in thoracic surgery are prone to have complications of delayed recovery from general anesthesia and perioperative instable hemodynamics due to the relatively invasive procedures and patient's underlying morbidity. Therefore, intraoperative monitoring and corresponding management are of great importance to prevent relevant complications in thoracic surgery. This study aims to investigate the clinical benefits of two intraoperative monitoring techniques in patients undergoing thoracotomy surgery, including depth of anesthesia and minimally invasive cardiac output monitoring. First, M-Entropy system will be used to measure the depth of anesthesia and be evaluated regarding the effect of spectral entropy guidance on postoperative recovery. Second, we will apply ProAQT device in guiding goal-directed hemodynamic therapy and assess its impact on occurrence of postoperative pulmonary complications and recovery. In this study, we will conduct a factorial parallel randomized controlled trial and use the method of stratified randomization to evaluate both two monitoring technologies in the same patient group. The results of this study will provide important evidence and clinical implication for precision anesthesia and enhanced recovery after surgery (ERAS) protocol in thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.

Exclusion Criteria:

* Age \< 20 years
* Pregnancy
* End-stage renal disease
* Emergency surgery
* Presence of circulatory shock needing vasoactive drugs before surgery
* Any diagnosis of aortic diseases
* Cerebral vascular diseases or trauma
* High-degree cardiac arrythmia (e.g. atrial fibrillation)
* Uses of cardiac pacemaker or automated implantable cardioverter defibrillator
* New York Heart Association functional classification 4
* Long-term use of psychiatric medications
* Intraoperative blood loss \> 1 L
* Intraoperative blood transfusion
* Planned or unanticipated transferal to ICU for postoperative mechanical ventilation
* Patient refusal to participate
Prevalence of Malnutrition and Frailty Among the Urban Community Elderly in Bandung

The goal of this observational study is to learn prevalence of malnutrition and frailty in elderly in Community in Bandung. The main question it aims to answer:

what is the prevalence of malnutrition and frailty in elderly in Bandung community?

The increase in the number and proportion of the elderly population poses various challenges, especially in the health sector. The elderly tend to be more vulnerable to health problems, such as malnutrition and frailty. Data on the prevalence of malnutrition and frailty in the elderly can be used as a basis for taking preventive and treatment measures for both conditions. This study aims to determine the prevalence of malnutrition and frailty in the elderly in the Bandung City community.

Descriptive research with a cross-sectional approach was conducted on 71 elderly participants in the Bandung City community. The sampling method used was consecutive sampling. The study used the Mini Nutritional Assessment-Short Form (MNA-SF) questionnaire to assess malnutrition and the Kihon Checklist (KCL) to assess frailty.

Eligibility Criteria:
Inclusion Criteria:

* age above 60 years old
* domicile in Bandung City
* able to mobilize without assistive devices
* able to see and read
* willing to participate in the study

Exclusion Criteria:

* history of hospitalization within the previous month
* Mini Mental Status Examination ( MMSE ) score \< 24
Substance Use and Fitness

The purpose of this pilot study is to estimate the effect size of a contingency management procedure that reinforces walking at rates consistent with the American College of Sports Medicine recommendations of 10,000 or more steps per day in older adults. We expect that participants randomized to the contingency management intervention will increase walking to a greater degree than those assigned to a standard care condition.


Eligibility Criteria:
Inclusion Criteria:

* age 55 - 75 years
* currently not physically active
* willing and physically able as determined by physician approval to walk 10,000 steps per day
* blood pressure of 120-159 mmHg systolic or 80-99 mmHg diastolic
* willing to meet with research staff weekly for 12 weeks

Exclusion Criteria:

* psychiatric or physical illness that could interfere with participation
Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion Criteria:

* Age \> 70 years
* Severe cardiovascular or respiratory disease
* Pregnancy
* Previous surgical procedure for POP correction
Screening Diagnosis of Fall Risk After Stroke and Initial Intervention: A fNIRs Study

This is a functional near infrared spectroscopy (fNIRs) study designed to screen for risk of falls after diagnosis of stroke and initial intervention.

This was an initial screening and preliminary intervention study. Each subject underwent two models of simultaneous fNIRs-EEG testing during the sit-to-stand process, the first without any intervention and the second based on biofeedback (EMG feedback) during the sit-to-stand process. Initial screening of fall risk in post-stroke patients was performed by comparing differences in brain activation and brain network connectivity between patients and healthy subjects. Preliminary validation the effectiveness of the EMG feedback-based sitting and standing training for post-stroke patients by comparing the differences of brain activation, brain network connectivity, and electromyographic changes during the sit-to-stand process in the two models.

Eligibility Criteria:
Inclusion Criteria:

Stroke patients 1. Diagnosis of stroke confirmed by neuroimaging (CT or MRI) evaluation 2. 18-85 years old 3. Able to complete the sit-to-stand transition 4. Able to follow instructions to complete the trial 5. Patients who signed an informed consent form.

Healthy Subjects: 1. No abnormalities on cranial fMRI examination 2. 18-85 years old 3. Able to complete the sit-to-stand transition 4. Able to follow instructions to complete the trial 5. not taking medications. 6. Subjects who signed an informed consent form

Exclusion Criteria:

Stroke patients: 1. Inability to tolerate the test due to organic diseases 2. Serious mental illness that prevents them from cooperating with or tolerating the trial 3. Pregnant or lactating women 4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.

Healthy Subjects: 1. Inability to tolerate the test due to organic diseases 2. Serious mental illness that prevents them from cooperating with or tolerating the trial. 3. Pregnant or lactating women 4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial

Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It had been reported the effect of post-operative pain control in minor abdominal surgery, such as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.

outcome measures:

* Hemodynamic parameters (mean artery pressure, heart rate): recorded at time points of before induction of general anesthesia (baseline), after tracheal intubation immediately, after surgery started 1, 2, 3, 4, 5, 10, 15, 20, 25, and 30 min; then recorded them every 10 mins.
* Post-operative morphine consumption: recorded morphine consumption at the time intervals of post-operative 0\~6 h, 6\~12 h, 12\~24 h, 24\~36 h, and 36\~48 h ,respectively. The total amount of morphine consumption was also counted.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger

Exclusion Criteria:

* increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
* a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
Study to Determine Tolerability of Single Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers

The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males and females
* Age range from 21 to 50 years
* Broca Index: within 20% of their normal weight
* All female volunteers must use a safe contraception (i.e. oral contraception, spiral, sterilized)
* All female volunteers must have a negative pregnancy test
* Prior to admission to the treatment after giving his/her informed consent (in accordance with Good Clinical Practice (GCP) and local legislation) in writing each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG within 14 days before the administration of the test substance. Hematopoietic, hepatic and renal function test will be carried out in the laboratory. The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial
* Participation in another study with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 40g/day)
* Drug abuse
* Blood donation (\>= 100 ml) within four weeks prior to administration or during the trial
* Excessive physical activities within five days prior to administration or during the trial
* Any laboratory value outside the reference range of clinical relevance

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine pessary (IUP)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Prognostic Factor Analysis in Metastatic Esophageal Squamous Cell Carcinoma

Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP) chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line chemotherapy. Clinicopathologic variables and treatment outcome were retrospectively collected. we analysis treatment outcome of palliative chemotherapy in metastatic esophageal squamous cell carcinoma and make prognostic scoring system. The present study represents the largest series to analyze the treatment outcome of FP/XP chemotherapy in metastatic SCC. Risk-adapted stratification of treatment for subgroup of metastatic SCC patients should be actively pursued.


Eligibility Criteria:
Inclusion Criteria:

* recurrent, metastatic esophageal SCC
* received either FP or XP as first-line chemotherapy.

Exclusion Criteria:
Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate.

II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin.

Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days.

Patients are followed at 3 and 6 days after treatment.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria

No chronic or subacute symptoms (present for longer than 2 weeks)

--Prior/Concurrent Therapy--

At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin

--Patient Characteristics--

Renal: Urinary porphobilinogen at least 40 mg/24 hr

Other:

* Not pregnant
* Fertile female patients must use effective contraception during and 6 months before study
* No evidence that symptoms are due to another acute illness
* No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage
* No known sensitivity to heme preparation or tin mesoporphyrin
* No other medical condition that might increase risk to patient
The Effectiveness of Multimedia Education on Hypoglycemic Management.

The first phase of the research was to develop tools, including scales and multimedia, and the second phase was to carry out multimedia hypoglycemia education intervention measures. An experimental randomized controlled trial with a repeated measures design was conducted in second phase. Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education. Structural questionnaires were used for data collection. The study was to investigate the effectiveness of multimedia hypoglycemia education compared to conventional hypoglycemia education on knowledge, self-care behavior, fear of hypoglycemia, social support, quality of life, nursing hours, education satisfaction, and the recurrence rate of hypoglycemic events among patients with type 2 diabetes.

In the first phase, we created multimedia educational content on hypoglycemia and recruited 300 type 2 diabetes patients who had experienced hypoglycemic events from a medical center and a primary care clinic in southern Taiwan. The participants completed consent forms and questionnaires, and we conducted statistical analyses to develop and evaluate knowledge and behavior assessment tools. We obtained consent from 83 participants to enter the second phase, where they received hypoglycemia education and were then randomly assigned by computer to either the experimental group or the contrast group.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes and blood glucose levels below 70 mg/dL

Exclusion Criteria:

* patients with cognitive impairment, those who are unable to perform activities of daily living and those with severe or unstable medical conditions.
Can Habitus Adapted Length Based Body Weight Estimation be Improved by Adding Further Parameters?

The purpose of this prospective single center study is to investigate if the accuracy of length based body weight estimation by the already investigated algorithm (CLAWAR) can be improved by adding another parameter. For this study 500 patients are required to collect anonymized data (length, weight, age, mid upperarm circumference and patient habitus by visual estimation) for achieving a power of 80% during statistical analysis. The main hypothesis ist that CLAWAR's accuracy can be improved.

This prospective single center study is performed at the university children's Hospital zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for CLAWAR. Patient and parental information is performed during the pre-anaesthetic visit.

After written consent the patient will be included. Patient ́s length and weight will be measures earliest one day before data collection. Data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in Microsoft Excel and statistical analysis calculated with SPSS.

500 patients are needed for a power of 80%. Primary outcome parameter is the accuracy of length based weight estimation using either patient habitus by visual estimation or an improved version of the algorithm CLAWAR using the mid upperarm circumference.

Eligibility Criteria:
Inclusion Criteria:

* body length suitable with the investigated algorithm
* all patients aged 0 -16 years

Exclusion Criteria:

* already included in this study once
* missing patient or parental consent