cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors for Successful Videolaryngoscopic Intubation Without Stylet

The investigators aimed to evaluate the predictive factors for successful videolaryngoscopic intubation without stylet.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years and older
* Patients undergoing general anesthesia for elective surgery and requiring endotracheal intubation

Exclusion Criteria:

* Patients with suspected cervical spine injury
* Patients requiring rapid sequence induction and intubation.
* Patients with airway disorders
* Body Mass Index \> 35 kg/m2
* Patients with a history of difficult intubation or, based on clinical judgment, anticipated difficult intubation
Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kgfor 14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment,in order to report the conversion ratio of primary ITP to chronic ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
6. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
7. Patients who are deemed unsuitable for the study by the investigator.
Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy

Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.


Eligibility Criteria:
Inclusion Criteria:

* CIPN as diagnosed by Oncology and/or neurology
* Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
* Pain severity greater than 4 out of 10 on a numeric rating scale of pain
* Pain chronicity greater than 6 months after the cessation of chemotherapy
* Failure of medical therapy, which must have included duloxetine
* Age 18 or greater

Exclusion Criteria:

* Platelet count less than 100k/mm3
* Spinal anatomy precluding placement of the SCS leads between T6 and T11
* Active infection
* Estimated Lifespan less than 1 year
* Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
* Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
* C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
* BMI ≤ 45.0 kg/m2

Exclusion Criteria:

* Urine albumin to creatinine ratio (UACR) \> 1,800 mg/g (203.4 mg/mmol/Cr)
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 2 mg/dL (34.2 μmol/l)
* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Peripheral Metabolic Function in Chronic Heart Failure Patients

Exercise intolerance is a major limiting symptom in patients with CHF. However the poor correlation between the hemodynamic parameters of left ventricular performance at rest and exercise performance has led to the concept that peripheral factors such as muscle perfusion and muscle metabolism play a role as determinants of exercise capacity.

The pathophysiology behind the breathlessness and fatigue experienced by CHF patients during exercise remains unclear. Recent evidence suggests that the peripheral skeletal muscle, which becomes abnormal in heart failure, is the source of afferent signals which disrupt normal patterns of cardiorespiratory control. When CHF patients exercise, an inappropriately strong sympathetic response further limits exercise tolerance by evoking larger than normal increases in peripheral sympathetic activation at a faster rate than in healthy individuals. A consequence of this exacerbated sympathetic response may be the further sympathetic restraint of blood flow to the active skeletal muscles resulting in hypoperfusion of the muscle vascular bed and fatigue. Small muscle mass exercise training increases muscle oxidative capacity and improves aerobic work capacity in CHF patients. A range of studies is proposed here that will provide an integrative view of the mechanistic basis behind exercise intolerance in CHF and relate the intramuscular metabolic status to the autonomic control of hemodynamics during exercise. An understanding of the mechanistic basis of the improved exercise tolerance with training, independent of improved resting cardiac function, will yield important information regarding the integrated control of blood flow and metabolic demand in CHF and highlight the importance of maintaining the integrity of the peripheral musculature in CHF.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) Class II - III
* Ejection fraction \<35%
* Heart failure as a result of previous myocardial infarction
* Optimal treatment (ACE-inhibitors, beta-blockers)
* Stable heart failure
* Patients with and without implantable cardioverter defibrillator (ICD)

Exclusion Criteria:

* Peripheral vascular disease with symptoms of atherosclerosis (intermittent claudication)
* Aneurysm in a. femoral
* Moderate to severe heart valve disease
* Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 \<60%
* Heart Failure Patients with Biventricular pacemaker (BVP)
* Serious heart rhythm disturbances (arrhythmias such as atrial fibrillation and frequent premature ventricular contractions)
* Myocardial infarction within the last month
* Unstable angina (angina pectoris)
* Renal failure (creatinine greater than 2.5 mg / dL)
* Severe systemic disease of the nervous system, pulmonary or other severe organ involvement
* BMI\> 30
* Pregnancy
Musical Intervention and Patient's Anxiety During Central Venous Catheter Insertion in the Intensive Care Unit

Intensive care unit patients who have to undergo central venous catheter insertion and are able to hear explanations and to gave consent, will be randomized to either usual care during catheter insertion or to a musical intervention added to usual care.

The primary objective will be to assess the patient's anxiety just after catheter insertion. Secondary outcome measures will be the patient-reported pain, the duration of catheter insertion, and the need for additional anxiolytic or sedative drugs during catheter insertion.

Patient informed consent will be obtained before any other study specific procedure.

Computer-generated randomization with 1:1 allocation ratio will be stratified by the site of catheter insertion (superior vena cava or femoral), and by the ventilatory status (patient mechanically ventilated or not). Block size, not known by the investigators, of 4 or 6 will be used. Randomization group for each patient will be kept concealed into sealed opaque envelops until inclusion once consent obtained.

Anxiety, the primary outcome measure, and pain related to the catheter insertion will be assessed using two distinct Visual Analogic Scales.

In the usual care group, the catheter will be inserted using the Seldinger method, under local anesthesia with 2% lidocaine, with ultrasound guidance, after proper skin antisepsis, surgical operator's hand washing and antisepsis, and use of sterile drapes, gowns and gloves.

In the intervention group, in addition to the usual care procedures as described above, a musical U-shaped session will be delivered to the patient through headphones, using a tablet computer and the "MUSIC CARE" music program, a validated program for use in health care.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized in the intensive care unit or high-dependency unit
* patient for whom a central venous catheter insertion is envisaged
* patient capable of hearing and understanding explanations and able to consent

Exclusion Criteria:

* severe hearing loss
* allergy to local anesthetic drug
* pregnancy
* lack of social security number
* patient under guardianship
* previous participation to the study
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma (AJCC Stage III)
* Prior failure of \>/= 1 prior treatment regimens for metastatic or unresectable melanoma due to disease progression or unacceptable toxicity and for whom no standard therapy is available
* Measurable disease according to RECIST criteria
* Adequate bone marrow, liver and renal function
* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception through the course of the study treatment and for 6 months after the last dose of study treatment

Exclusion Criteria:

* Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose of study treatment, or with any other anti-cancer therapy within 5 half-lives of the therapy prior to first dose of study treatment
* Known active infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds)
* Current Grad \>/= 2 toxicity (except alopecia or anorexia) from prior therapy
* Grade \>/= 2 peripheral neuropathy
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapies (or recombinant antibody-related fusion proteins)
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
* Evidence of significant uncontrolled concomitant disease or disorder
* Pregnant or lactating women
* Prior treatment with any other antibody-drug conjugate (ADC) compound containing monomethyl auristatin E (MMAE) for the treatment of melanoma
* Previous participation in a clinical trial within 30 days of the day of first study drug administration (Cycle 1, Day 1)
Tele-rehabilitation Intervention for People Post Hip Fracture - Randomized Controlled Trial (RCT)

Most surviving hip-fracture patients experience reduced mobility and lose their functional ability, which increases the risk of complications and rehospitalization. Post-discharge transitional programs to reduce readmissions have shown some success. Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. Considering the need for long-term follow-up care for people with hip fracture, in-home telerehabilitation could increase independence, decrease hospital stays and reduce the burden for caregivers.

The purpose of this three armed randomized controlled trial is to investigate the effectiveness of an intervention program based on telerehabilitation on ADL, QOL, depression and burden on caregivers compared to face-to-face home visits and usual care of community-dwelling older adults after hip fracture.

90 older people with hip fractures will be randomly assigned to a telerehabilitation group (N=30), face-to-face visits (N=30) and a control group.

The aim of the intervention is to improve the transition from rehabilitation units to community dwelling. It will include 10 videoconferencing/ face-to-face sessions from an occupational therapist in the presence of the primary caregiver. Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities


Eligibility Criteria:
Inclusion Criteria:

Older adults (age ≥60 years) post hip fracture - discharged from the inpatient rehabilitation unit of Herzog Hospital, Jerusalem, between January 2017 and December 2017.

Discharge from rehabilitation to a non-institutionalized setting. broadband or Wi-Fi in their home and must be able to operate an iPad independently.

FIM\>90 at discharge. Has a designated caregiver (a close friend, family member, or support worker) aged over 18, and a Hebrew, English or Arabic speaker, who will agree to cooperate in the research

Exclusion Criteria:

Aphasia. cognitive impairment (Montreal Cognitive Assessment scores : MOCA\<19 or MMSE\<21).

degenerative neurological diagnoses. current major depressive or psychotic disorder. other acute or chronic health condition that will influence their ability to participate in the study.
Effectiveness of a Nursing Intervention for Nurses Have Experienced Trauma: a Study Based on Swanson's Caring Theory

This study aimed to (1) develop an internet-based psychiatric nursing intervention, based on Swanson's theory of caring, and (2) examine its effects on functional health, resilience, social support, post-traumatic stress, depression, and anxiety.

This study was a randomized clinical trial(RCT) study with repeated measures to identify the effectiveness of an internet-based psychiatric nursing intervention. Participants were evaluated at the following time points: pre-test (pre), post-test (post-test 1, immediately after intervention), and follow-up (post-test 2, one month after the intervention) to assess the sustainability of the internet-based psychiatric nursing intervention.

Of the 112 women who enrolled in the study, 10 dropped out before post-test 1, resulting in 102 participants who completed all interventions and surveys.


Eligibility Criteria:
Inclusion Criteria:

1. nurse aged from 23 to 40 years
2. a PTS score of 64 or lower on the PTSD checklist for DSM-5 (PCL-5) developed by Weathers et al., revised by Weathers et al., and translated into Korean by Kim et al.,
3. nurse who can access the program through a computer or mobile
4. nurse who understand the purpose of the research and voluntarily agree to participate in the research.

Exclusion Criteria:

1. presence of psychiatric conditions with hallucinations and delusions
2. diagnosis of an intellectual disability that would make understanding the intervention procedure difficult. Although a standard cut-off was not present in the PCL-5, women who exceeded 80% (64 points) of the total score were excluded to rule out high-risk women with severe trauma.
European Study of Dronedarone in Atrial Fibrillation

The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic permanent AF (\>6 months) for which cardioversion is not considered and resting ventricular rate \> or equal 80 bpm at screening measured on a 6-seconds rhythm strip,

Exclusion Criteria:

* Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes
* Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted
* Clinically overt congestive heart failure at randomization
* Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug
* Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease
* Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.

Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.


Eligibility Criteria:
Inclusion Criteria:

* Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology.
* Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded).
* Patient's informed consent

Exclusion Criteria:

* Prior intrabdominal tumor surgery
* Other preexisting malignancies
* Hypersensitivity/allergy to dye (isosulfan blue)
* Pregnancy
* Breast-feeding
* No patient's informed consent
Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

This research is being done to compare the current standard of care for strength training for patients with Multiple Sclerosis to lightweight resistance training with blood flow restriction.

The purpose of this study is to compare the effectiveness of the current Multiple Sclerosis standard of care exercise recommendations to low-load resistance training with blood flow restriction on functional outcomes, strength, muscle size, and neuromuscular control in Multiple Sclerosis patients. This study involves completing 2 training sessions per week for 12 weeks as well as pre- and post-training assessment visits for a total of 29 visits over 14 weeks. All visits will be on UCF's campus with a member of the research team.

Eligibility Criteria:
Inclusion Criteria:

* Females between the ages of 18 to 55
* Diagnosed with Multiple Sclerosis
* Expanded Disability Status Score of 0 to 6.5
* Able to walk 10 meters without assistance
* Are willing to come in for all 29 testing visits over 14 weeks

Exclusion Criteria:

* No other known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
* Multiple Sclerosis relapse in the past 30 days
* Are not currently undergoing a rehabilitation protocol
* Are not currently seeking medical care for a chronic condition that could limit exercise capacity other than multiple sclerosis
* Are not currently pregnant
ClotTriever® Thrombectomy System Use-Result Survey in Japan

The objective of this survey is to determine the safety and efficacy of the ClotTriever Thrombectomy System under daily clinical practice after marketing approval in Japan.

This device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.


Eligibility Criteria:
This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.
Comparative Effects of Neuromuscular Training Vs Close Chain Exercises in Athletes With Post Operative ACL Injury

The aim of this study is to determine the effects of close chain exercises and neuromuscular training on pain, range of motion, strength and endurance in athletes with post operative ACL injury The study will be randomized control trial with the sample size of 36. Subjects will be enrolled according to inclusion and exclusion criteria. Patients will be divided into two groups, each with 18 patients. Group A will receive Neuromuscular training while Group B will receive Close chain exercises. The participants will receive treatment sessions over 6-week period. The treatment session will be of 60 minutes with a warm up and cool down period of 10 minutes. Outcome measures in both groups will be assessed by International Knee Documentation Committee Evaluation Form. Score for function, Numeric Pain Rating Scale (NPRS) for pain, Goniometer to measure range of motion, single leg hop, squats, triple jump test, push ups for strength and endurance respectively.

Objective of my study is to compare the effects of Neuromuscular Training vs Close Chain Exercises on pain, range of motion, strength and endurance in athletes with post operative ACL injury

Eligibility Criteria:
Inclusion Criteria:

* Athletes aged 18 to 35 years
* 6-9 months after ACL reconstruction
* Athletes who sustained unilateral ACL injury treated surgically
* Athletes returning to sports
* minimal to no knee effusion
* normal knee range of motion
* Willing to take post-operative exercise program

Exclusion Criteria:

* History of lower extremity fractures surgery or traumatic injuries
* Neuromuscular disease
* Systemic disease
* Patients who had history of prior knee surgery were excluded