cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
* Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
* Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start

Exclusion Criteria:

* Have any contraindication for the OAD that they have been using
* Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
* Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
* Have been treated with drugs that promote weight loss, within 3 months of screening
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
* Have previously completed or withdrawn from this study or any other study investigating exenatide QW
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Efficacy of a Herbal Formula for Bone Metastases

RATIONALE: Nearly 50% of patients with bone metastases develop one or more complications collectively termed skeletal-related events (SREs). The study herbal medicine might reduce the morbidities due to "Skeletal-related events" (SRES), and extend survival time.

PURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of "Skeletal-related events" (SRES), and survival time.

OBJECTIVES:

Primary Primary efficacy end points are SRE, general state and biomarkers. Secondary Survival rate and survival time Time to first SRE (since randomization) Biochemical markers Quality of Life: EQ5-D Pain control (Brief Pain Inventory)

OUTLINE:

Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone
* Confirmed diagnosis of metastatic breast cancer
* Radiographic proof of metastatic bone disease
* Informed consent obtained

Exclusion Criteria:

* Known history of primary bone tumors (benign and/or malignant)
* Prior use of bone modifying agents, including but not limited to zoledronic acid or denosumab within 12 months of study entry
* Active anti-cancer therapies in the form of cytotoxics or targeted therapies. \[Patients who are currently on hormonal therapies, including but not limited to tamoxifen, aromatase inhibitors and LHRH agonists/antagonists are allowed for study entry. Clarifications shall be sought from investigators if in doubt\].
* Significant drug hypersensitivity
* No informed consent signed
Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants

The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 mg under fasted conditions.

This is a single-center, randomized (study drug assigned by chance like flipping a coin), open-label (all people involved know the identity of the intervention), 4-way crossover (participants receive different interventions sequentially during the trial) study in healthy adult Taiwanese participants. All participants will be randomly assigned to 1 of the 4 different possible treatment sequences and will receive all treatments in the order specified by the randomization schedule. The study consists of a screening phase, an open-label treatment phase consisting of 4 single-dose treatment periods, and end-of-study or withdrawal assessments. During the open-label treatment periods, the participants will stay in the center until completion of the 72-hour pharmacokinetics \[PK\] (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) blood sample on Day 4. A 7- to 14-day washout period (period when receiving no treatment) will separate the open-label treatment periods. The safety and tolerability will be evaluated over the investigated dose range. The duration of participation in the study for an individual participant will be approximately 12 weeks.

Eligibility Criteria:
Inclusion Criteria: - Body mass index (BMI) between 18 and 25 kg/m², inclusive and a body weight of not less than 50 kg - Participants must utilize a medically acceptable method of contraception throughout the entire study period and for 1 month after the study is completed - Each participant will receive a naloxone challenge test for opioid dependency at screening. Only those participants who pass this challenge test will be allowed to continue in the study Exclusion Criteria: - History of or current clinically medical illness or any other condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results - Clinically significant abnormal values for hematology, clinical chemistry or urinalysis - Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) - Use of certain prescription or nonprescription medication, and consumption of products that may interfere with the study
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.

The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation.

A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.
* Patients with failed conservative treatment within 3 weeks since injury.
* Patient must be able and willing to complete the protocol required follow-up.
* Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.
* Patient must be in a good nutritional state

Exclusion Criteria:

* Delay of surgery for more than 3 weeks.
* Tumor induced fractures
* Patient is a prisoner.
* Pregnancy/ breast feeding
* Patient is a current alcohol or drug abuser.
* Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.
* Patient has an active infection.
* Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock.
* Patient is sensitive to foreign body material.
Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS)

The aim of this project is to reduce the risks of cataract surgery using the EyeSi simulator Axis 1: to model the learning curve of novice residents in Ophthalmology who follow the training program recommended by the "Collège des Ophtalmologistes niversitaires de France" (COUF) in order to help creating a "licence to operate" Axis 2: to evaluate the impact of sleep deprivation on the surgical performance of experienced residents in Ophthalmology

Axis 1 (15 residents): Learning curve Each resident will perform four 2-hour learning sessions, under the supervision of an experienced cataract surgery trainer. Each resident will perform a standardized assessment at the beginning of the first session with the collection of scores at each surgical stage and the calculation of an average score simulating a complete surgery. This standardized assessment will then be repeated at the end of each of the 4 training sessions. These five points of measurement will make it possible to produce a learning curve for each surgical stage and for the average score simulating a complete surgery.

Axis 2 (25 residents): Sleep deprivation

* 1st session: In order to include the "experienced" residents and to limit the bias related to the learning curve of the cognitive tests and the surgical procedure

  * 3 normed assessments in autonomy to determine the average score for each resident
  * 3 trials of the Test for Attentional Performance (TAP) with parallel versions to limit test-retest learning bias
* 2nd session: No sleep deprivation

  * Sleep assessment by actimetry the night before the session (MotionWatch 8©, camntech®, validated as an alternative method to the reference method which is polysomnography)
  * Epworth sleepiness score
  * Visual Analogue Scale for Self-Rated Fatigue
  * Attentional performance tests TAP
  * 3 standardized evaluations on Eyesi in the morning and in the afternoon
* 3rd session: sleep deprivation (\< 7 hours) after a working day

  * Sleep evaluation by actimetry the night before the session (MotionWatch 8©, camntech®)
  * Epworth sleepiness score
  * Self-rated visual analogue scale for fatigue
  * Attentional performance tests TAP
  * 3 Eyesi standardized evaluations in the morning and in the afternoon

Eligibility Criteria:
Inclusion Criteria:

* Novice resident in Ophthalmology (Axis 1)
* Experienced resident in Opthalmology (Axis 2 )

Exclusion Criteria:

* N/A
TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT

This no-profit, monocentric, prospective randomized controlled trial, aims to demonstrate the non-inferiority of continuous wound infusion (CWI) when compared to transversus abdominis plane (TAP) block for postoperative pain control after total abdominal hysterectomy.

After signing the informed consent, patients will be enrolled and randomly allocated into either the study group (CWI) or the control group (TAP). Both groups will receive standard general anesthesia. At the end of the surgery, the CWI patients will receive a preperitoneal catheter in the surgical wound and CWI of ropivacaine 2 mg/ml, 5 ml/h for 24 hours; with the TAP block patients will receive a bilateral, standard lateral TAP block with 5 mg/ml ropivacaine 24 ml per side. All patients will receive multimodal analgesia with ketorolac 30 mg e.v. plus 90 mg/24h IV, paracetamol 1g plus 1g TID, dexamethasone 0,1 mg/kg IV preoperatively, oxycodone 5 mg per OS upon request.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - III
* laparotomic hysterectomy with Pfannenstiel incision
* signed informed consent

Exclusion Criteria:

* ASA IV
* allergy to local anesthetics or other components of multimodal analgesia
* inability to walk or eat
Idiopathic Pulmonary Fibrosis Registry China Study

By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
* Aged 40 years and above at recruitment
* Willing and able to sign an informed consent

Exclusion Criteria:

* Inclusion in any interventional clinical trials
* Lung transplantation expected within the next 6 months.
Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth

This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.

The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.

Eligibility Criteria:
Inclusion Criteria:

* Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3).
* Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3).

Exclusion Criteria:

* Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.
The ISEO Biofeedback Tool During the Rehabilitation of Patients Treated for Rotator Cuff Tear

The present study addresses the issue about post-surgical recovery process, for patients arthroscopically treated for rotator-cuff tear. The aim of the research is to test the effectiveness of a new rehabilitation protocol that includes kinematic biofeedback with the motion analysis system ISEO.

The research includes at least 62 patients arthroscopically treated for the rotator cuff tear. For this purpose, two groups of patients of equal size are identified. The attribution of each patient to one of the two groups is random. The standard rehabilitation protocol is applied to the Control group (Group A), whereas the standard rehabilitation protocol integrated by proprioception exercises (physical therapist assisted) performed with ISEO is applied to the Experimental group (Group B). The primary objective is to verify if the ISEO system, used as a biofeedback tool, improves shoulder functionality and activity of patients arthroscopically treated for rotator cuff tear, both in the short (90 days from surgery) and in the medium term (6-12 months from surgery). All patients are longitudinally evaluated from the pre-surgery to a 6/12 months follow-up. Each evaluation includes both a clinical and an instrumented assessment of shoulder kinematics. The primary outcome tested is the Scapula-Weighted Constant-Murley Score, which represents a reformulation of the Constant-Murley Score, which is modified based on the quality of the scapular movement measured with ISEO.

Eligibility Criteria:
Inclusion Criteria:

* patients with rotator cuff injuries;
* asymptomatic contralateral shoulder, that can be considered as a reference for the differential evaluation;
* indication for arthroscopy;
* employees;
* rehabilitation executed at AUSL-Romagna.

Exclusion Criteria:

* irreparable injuries of the rotator cuff;
* contralateral painful shoulder;
* patients being treated for cancer in the last 6 months;
* patients with concomitant neurological pathologies;
* patients with spinal cord injuries;
* patients with cuff lesions with infectious processes;
* patients with severe scoliosis;
* patients with recurrent lesions of the cuff;
* patients with occupational diseases or work-related accidents;
* patients for whom the return to work cannot be reliably established.
Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery

In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.

Postoperative delirium is a serious and common (20% to 60%) complication in orthopedic surgery patients. In this study we investigate whether prophylactic administration of olanzapine can prevent delirium from occurring after knee or hip replacement in high-risk patients \> 65 years of age. This is a randomized, double-blind, single center, placebo-controlled study.

Eligibility Criteria:
Inclusion Criteria:

* High risk for delirium age \> 65 history of delirium medical comorbidities ability to give informed consent

Exclusion Criteria:

* Dementia Alcohol abuse Current use of an antipsychotic Allergy to olanzapine
Palliative Care for Patients with Dementia

A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.

The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.

Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Visits will combine a combination of video-teleconferencing technology and in person visits. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.

Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

Eligibility Criteria:
Inclusion Criteria:

* have advanced dementia, based on Global Deterioration Score (GDS)\>6
* impairment in at least one activity of daily living (ADL -which is inherent in this level of GDS)
* at least one hospitalization or ED visit within the last 12 months
* a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is associated with one of the four Mount Sinai sites in Manhattan
* a family caregiver willing to enroll
* a residence in Manhattan where they are currently living (not in a long-term care facility)
* capacity to consent or a legal representative available to provide consent
* fluency in English or Spanish, or their legal representative must be fluent in English or Spanish
* age \>64.

Exclusion Criteria:

* Does not have a family caregiver to enroll
* Does not reside in Manhattan outside of long-term care facility
* Does not have fluency in English or Spanish Doesn't
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer

Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

In accordance with NICE active surveillance guidelines, men:

* Who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
* With histologically confirmed low or intermediate risk prostate cancer, Gleason score ≤7 (3+4, not 4+3)
* With up to T2a clinical stage tumours
* With pre-treatment PSA ≤20 ng/mL
* Who are willing to participate in optimal active surveillance and provide written informed consent
* With life expectancy of ≥10 years

Exclusion Criteria:

Men:

* With unstable angina
* With uncontrolled hypertension
* With recent myocardial infarction (within the past 6 months)
* With pacemakers
* Already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
* With any other physical or mental limitation preventing participation in trial assessments
* Participating in other clinical trials which might bias the evaluation of the primary objectives of the present study