cyrilzakka/clinical-trials huggingface dataset:
Changes of Diet, Physical Activity and Sleep Pattern and Their Effects on Glycemic and Weight Control in Hong Kong Chinese Obese Patients With Type 2 Diabetes After Bariatric Surgery Compared to Telephone Intensive Lifestyle Counselling

Nutrition therapy is recognized as one of the crucial components for the standard treatment of diabetes along with physical activity and drug therapy. Of note, dietary habits are culture specific and hence understanding the dietary intake, eating behavior and physical activity level of the local population is important to formulate effective nutrition and lifestyle strategies. Weight control is a major therapeutic challenge because many conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause weight gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing levels of free fatty acids from adipose tissues . Although intensive face-to-face lifestyle intervention program has showed that even modest weight loss in people with Type 2 diabetes (T2DM) who were overweight or obese was associated with improvements in glycemic control and associated conditions, it may not be feasible in public hospital setting in Hong Kong due to factors such as limited resources, scheduling, patient's employment and willingness for frequent travel to the clinic. Hence, alternative strategies such as a combination of face- to-face individual dietary and lifestyle consultation together with telephone intensive lifestyle reinforcement program will likely to be an useful strategy to engage those obese T2DM patients through frequent individual contacts. On the other hand, bariatric surgery has emerged as an impressive therapeutic option for poorly control obese T2DM patients.

Realizing there is a knowledge gap in understanding the lifestyle factors in the Hong Kong Chinese obese T2DM patients, we therefore propose to conduct a 1-year prospective clinical trial with two main objectives:

1. To study and compare the glycemic and weight improvement after bariatric surgery versus a telephone intensive lifestyle intervention program for 1 year in Hong Kong Chinese obese patients with type 2 diabetes.
2. To investigate the effect of lifestyle factors including dietary intake, eating behaviors and physical activity level on the glycemic and weight control of Hong Kong Chinese obese patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 65 years
2. Chinese ethnicity
3. BMI ≥27.5 kg/m2
4. Diagnosis of T2DM
5. No active cardiovascular diseases
6. ASA grade II or below (for the bariatric surgery group)
7. Able to read Chinese and give informed written consent

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. End-stage renal failure requiring dialysis or chronic kidney disease (CKD) stage 4 or above
3. Malignancy diagnosed within 3 years
4. Major psychiatric illness
5. Pregnancy or lactation
6. Significant anaesthetic risk ASA grade III or above (for the bariatric surgery group)
7. Any medical illness or condition as judged by the investigators as ineligible to participate the study
Machine Learning for Risk Stratification in the Emergency Department (MARS-ED)

Rationale

Identifying emergency department (ED) patients at high and low risk shortly after admission could help decision-making regarding patient care. Several clinical risk scores and triage systems for stratification of patients have been developed, but often underperform in clinical practice. Moreover, most of these risk scores only have been diagnostically validated in an observational cohort, but never have been evaluated for their actual clinical impact. In a recent retrospective study that was conducted in the Maastricht University Medical Center (MUMC+), a novel clinical risk score, the RISKINDEX, was introduced that predicted 31-day mortality of sepsis patients presenting to an ED. The RISKINDEX hereby also outperformed internal medicine specialists. Observational follow-up studies underlined the potential of the risk score. However, it remains unknown to what extent these models have any beneficial value when it is actually implemented in clinical practice.

Objective

To determine the diagnostic accuracy, policy changes and clinical impact of the RISKINDEX as basis to conduct a large scale, multi-center randomised trial.

Study design

The MARS-ED study is designed as a multi-center, randomized, open-label, non-inferiority pilot clinical trial.

Study population

Adult patients who are assessed and treated by an internal medicine specialist in the ED of whom a minimum of 4 different laboratory results (hematology or clinical chemistry, required for calculation of ML risk score) are available within the first two hours of the ED visit.

Intervention

Physicians will be presented with the ML risk score (the RISKINDEX) of the patients they are actively treating, directly after assessment of regular diagnostics has taken place.

Main study parameters

Primary

- Diagnostic accuracy, policy changes and clinical impact of a novel clinical risk score (the RISKINDEX)

Secondary

* Policy changes due to presentation of ML score (treatment policy, requesting ancillary investigations, treatment restrictions (i.e., no intubation or resuscitation)
* Intensive care (ICU) and medium care (MC) admission
* Length of admission
* Mortality within 31 days
* Readmission
* Patient preference
* Feasibility of novel clinical risk score

See our protocol paper, PMID 38263188

Eligibility Criteria:
Inclusion Criteria:

* Adult, defined as ≥ 18 years of age
* Assessed and treated by an internal medicine specialist (gastroenterologists included) in the ED
* Willing to give written consent, either directly or after deferred consent procedure (see section 11.2).

Exclusion Criteria:

* \<4 different laboratory results available (hematology or clinical chemistry) within the first two hours of the ED visit (calculation ML prediction score otherwise not possible)
* Unwilling to provide written consent, either directly or after deferred consent procedure (see section 11.2).
Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.

The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.

* Entry into the study : After informed consent, patients will be randomised into three groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS).
* Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.
* The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.
* After the end of neurostimulation sessions, patients will be followed for 1month.

Throughout their participation in the study, patients will complete their VNS report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation).

Patients will have 5 evaluation examinations:

* The first, one just before the beginning of the neurostimulation,
* The second, 1 month after the beginning of neurostimulation
* The third, 3 months after the beginning of neurostimulation
* And the last one, 1 month after the end of neurostimulation.

Eligibility Criteria:
Inclusion Criteria:

* Patient's written consent
* Patient suffering from an algoneurodystrophy for more than a year.
* Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
* Stable treatment for at least 1 month
* Patient non-responsive to pharmacological treatments
* VNS \> 3 at the time of screening

Exclusion Criteria:

* Drug addiction
* History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
* Intracranial ferromagnetic material or an implanted stimulator
* MRI contraindication
* Algoneurodystrophy due to a nervous lesion
* Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.


Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is \< 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis

The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 \[Appendix I\]), and have a prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time.
* Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive.
* Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.

Key Exclusion Criteria:

* Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005).
* Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
* Pregnant or nursing women.
* Participation within 6 months prior to study enrollment in any other drug, biologic, or device study.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
A Comparison of Controlled Ventilation With the V60 Non-Invasive Ventilator vs. Traditional Mask Ventilation

The purpose of this study is to determine whether an experienced anesthesia provider can adequately and/or easily mask ventilate an anesthetized patient with a commercial non-invasive ventilator device.

The purpose of this study is to determine whether an experienced anesthesia provider can adequately and/or easily mask ventilate an anesthetized patient with a commercial non-invasive ventilator device. The ventilator subject of this study is commonly used in the ICU and investigators aim to evaluate its usefulness in the OR. Investigators believe that the ventilator will ventilate with consistent breath rates, adequate tidal volumes and minimal airway pressures. The providers subjective scoring of ease or difficulty of ventilation with each device will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* adults between 18-74 years of age,
* ASA status I-III,
* presenting for elective surgery requiring general anesthesia at the University of Utah
* able and will to provide informed consent

Exclusion Criteria:

* oropharyngeal or facial pathology,
* risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease),
* known and/or documented difficulty placing an endotracheal tube in the past,
* limited neck extension or flexion,
* restrictive lung disease,
* personal or familial history of malignant hyperthermia
* known or predicted severe respiratory disease or compromise.
* Female subjects must have a negative urine pregnancy screen.
Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors.

II. Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of topotecan and paclitaxel.

Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study within 8-12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven solid tumor
* Measurable or evaluable disease
* Measurable disease defined as tumor outside prior radiotherapy fields and reproducibly measurable in 2 dimensions on physical exam, x-ray, CT, or MRI

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: 0 or 1
* Life expectancy: At least 12 weeks
* WBC at least 4,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 mg/dL
* AST less than 3 times normal
* Alkaline phosphatase less than 3 times normal
* Creatinine no greater than 1.5 mg/dL
* No poorly controlled angina
* No history of congestive heart failure
* No myocardial infarction within the past 6 months
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No concurrent prophylactic hematopoietic growth factors
* No concurrent medications altering cardiac conduction
Apatinib Plus IE Chemotherapy (Ifosfamide and Etoposide) for Relapsed or Refractory Osteosarcoma

Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.


Eligibility Criteria:
Inclusion Criteria:

* 1) histologically confirmed high-grade osteosarcoma;
* 2) initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
* 3) progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
* 4) measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
* 5) Eastern Cooperative Oncology Group performance status ≤ 2 ;
* 6) acceptable haematologic, hepatic, and renal function.

Exclusion Criteria:

* those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
* those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction\<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
* All patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
* weight loss of 20% or more before illness;
* brain or leptomeningeal metastasis;
* surgical procedure or radiotherapy within 4 weeks of enrollment;
* activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
* proteinuria or hematuria, denutrition with albuminemia \<25 g/L;
* women who were pregnant or breast feeding, other malignancy;
* positive HBV/HCV/HIV serology, and known allergy to the experimental agents.
LVEF Prediction During ACS Using AI Algorithm Applied on Coronary Angiogram Videos

Left ventricular ejection fraction (LVEF) is one of the strongest predictors of mortality and morbidity in patients with acute coronary syndrome (ACS). Transthoracic echocardiography (TTE) remains the gold standard for LVEF measurement. Currently, LVEF can be estimated at the time of the coronary angiogram but requires a ventriculography. This latter is performed at the price of an increased amount of contrast media injected and puts the patients at risk for mechanical complications, ventricular arrhythmia or atrio-ventricular blocks. Artificial intelligence (AI) has previously been shown to be an accurate method for determining LVEF using different data sources. Fur the purpose of this study, we aim at validating prospectively an AI algorithm, called CathEF, for the prediction of real-time LVEF (AI-LVEF) compared to TTE-LVEF and ventriculography in patients undergoing coronary angiogram for ACS.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by the participant
* Acute coronary syndrome
* Creatinine clearance ≥30 ml/min/m2 according to MDRD

Exclusion Criteria:

* Creatinine clearance \<30 ml/min/m2 according to MDRD
* No indication to perform TTE in the 7 days following coronary angiogram
* Right bundle branch block
* Suspected or confirmed left ventricular thrombus
* Suspected or confirmed aortic dissection
* Ventriculography not feasible
* No left coronary system angiogram
Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair

Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 yrs
* ASA I - III
* ACL surgery

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurologic deficit in the arm that is going to be operated
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
Obstetrics and Gynecology Residents and Experts' Knowledge of, Attitudes Toward, Practice Behaviors, and Self-confidence Levels of Caring for Lesbian, Bisexual, and Transgender (LBT+) Patients in Turkey; A Descriptive-cross Sectional Study

Obstetrics and Gynecology residents and experts' knowledge of, attitudes toward, practice behaviors, and self-confidence levels of caring for lesbian, bisexual, and transgender (LBT+) patients in Turkey; A descriptive-cross sectional study

There are various studies about LGBT people's problems while utilizing healthcare services and interactions with physicians in Turkey and other countries. There is a lack in the curriculum for obstetricians and gynecologists regarding LGBT individuals' healthcare problems. In this study, we tried to evaluate obstetrics and gynecology residents/experts' knowledge level about LGBT individuals, attitudes toward these sexual minority individuals in their clinical practices, practice behaviors and experience levels about this condition, and their confidence level about caring for sexual minority individuals by performing cross-sectional study using online survey platform.

Eligibility Criteria:
Inclusion Criteria:

* work actively as an Obstetrician and Gynecologist in Istanbul/Turkey

Exclusion Criteria:

* retired clinicians
* LGBT individuals working as Obstetrician and Gynecologist
Comparing Outcomes of Elbow Extension Tendon Transfers

Active elbow extension has significant functional benefits for individuals with tetraplegia. The proposed work will provide information to assess how effectively people are using their elbow extension tendon transfers, and whether one surgery works more effectively than the other. This study will provide recommendations to clinicians about the possibility of improving function after surgery using rehab techniques.

Voluntary control of elbow extension significantly improves functional abilities for individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via tendon transfer is considered a fundamental intervention that benefits the patient, even if other tendon transfers aimed at improving hand function are never performed. Presently, there are two common tendon transfer surgeries used to restore elbow extension following spinal cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps transfer. Both surgeries significantly improve voluntary elbow extension, although there is variability in the amount of control that is restored among patients. This study will directly compare the performance of the posterior deltoid transfer to the biceps transfer with regard to: voluntary elbow extension strength, the ability to activate the transfer, and neural factors associated with voluntary and involuntary control of individual muscles. These comparisons will be made in functionally relevant postures and will provide fundamental information that will improve clinical understanding of the capacity of each of these two procedures to restore elbow extension.

The fundamental hypothesis of this proposal is that an inability to maximally activate the transferred posterior deltoid and the transferred biceps significantly limits the elbow extension moment that can be produced.

Eligibility Criteria:
Inclusion Criteria:

* Cervical Spinal Cord Injury (C5-C7)
* Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery
* Biceps to Triceps Tendon Transfer at least one year post-surgery

Exclusion Criteria:

* Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including:

  * unhealed decubiti
  * use of baclofen pumps
  * existing infection
  * cardiovascular disease
  * significant osteoporosis (as indicated by a history of fractures following injury)
  * or a history of pulmonary complications or autonomic dysreflexia