cyrilzakka/clinical-trials huggingface dataset:
Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?

This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep

Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metabolic control . This study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control.

It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (CL) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting in poorly controlled type 1 diabetes adolescents.

Eligibility Criteria:
Inclusion Criteria:

12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents

Exclusion Criteria:

Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.

Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.

More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months

-
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx

Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.

The objective is to assess the feasibility (i.e. early toxicity) of an adaptive dose escalation through 18F-FDG-PET-based dose painting by numbers in 10 HPV negative patients with locally advanced squamous cell carcinoma of the oropharynx. Treatment will be delivered with Helical Tomotherapy® or volumetric-modulated arc therapy (VMAT). Dose adaptation will be performed at 2 time-points with per-treatment 18F-FDG-PET/CT scans.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay)
* T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration
* N0, N1, N2a, N2b node (AJCC/UICC 7th edition)
* No distant metastasis
* No contra-indication to concomitant chemotherapy
* World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 80.
* Provision of written informed consent

Exclusion Criteria:

* Patients with induction chemotherapy will not be eligible
* Previous or concurrent history of cancer, except basal cell skin carcinoma
* Second primary tumor at the time of diagnosis
* Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
* Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
* Pregnant or lactating women
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders

The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.

This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During open label treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients aged 6 to 15 years.
* Patients with "neurodevelopmental disorder" diagnosed by using DSM-5.
* Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months
* Patients who are out-patient, not hospitalized patient.
* Signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed IC or informed assent obtained from the patient themselves.

Exclusion Criteria:

* Patients with at least severity in either Conceptual area, or Social area, or Practical area of intellectual disability have judged more than " the most severe" by using DSM-5.
* Patients who took melatonin (including supplement) in history.
* Patients who had taken Ramelteon within 4 weeks before clinical study starts.
Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery

The goal of this randomized, double-blinded, clinical trial is to assess the benefit of administering a Multifidus Cervicis Plane (MCP) block compared to a sham block as a method of postoperative pain control in patients undergoing posterior cervical spine fusion surgery. The main question it aims to answer is if the MCP block group will have reduced maximum pain scores during the first 24 postoperative hours compared to the sham block group.

Participants will receive preoperative bilateral MCP blocks on the back of their neck using the standard of care local anesthetic solution that consists of 30 mLs 0.25% Bupivacaine + 0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 mL Epinephrine (MCP block group). Researchers will compare the MCP block to the preoperative sham block which consists of injecting 3 mL of normal saline into the same area (Sham block group) to compare the postoperative pain scores between the groups as a main objective. The secondary objectives are:

* Postoperative opioid consumption during hospitalization and at 2 weeks after discharge.
* The amount and type of non-opioid analgesics used during hospitalization.
* The occurrence of postoperative nausea and vomiting (PONV) and the use of antiemetics.
* Hospital and Post Anesthesia Care Unit length of stay (LOS).
* Monitor the safety of the study interventions during hospitalization and readmissions within 30 days of discharge.
* Patient satisfaction with pain management and overall satisfaction with the surgery experience.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 40-80 years old, males and females, of any race and any ethnic group.
2. Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study.
3. Ability to speak and read English
4. Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion Criteria:

1. Emergency posterior CSFS.
2. Revision surgery or history of previous cervical spine surgery
3. History of allergy to local anesthetics or steroids.
4. Patients who are coagulopathic at the time of surgery
5. Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks
6. Infection at the site of the block.
7. Weight \< 40 kg to avoid local anesthetic toxicity.
8. Patients on chronic or continuous opioid use of \> 50 MME (morphine milli-equivalent) per day for at least 30 days within 90 days prior to surgery.
9. Patients with a history of chronic inflammatory conditions such as multiple sclerosis
10. Refusal to participate or lack of providing the study consent
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gynecologic malignancy
* No chemotherapy in the last 12 months
* Scheduled to receive Carboplatin (AUC\>=4) and Paclitaxel every three weeks
* ECOG performance status 0 or 1
* English speaking
* Willing and able to provide informed consent
* Laboratory values within protocol-defined parameters
* No vomiting in the 24 hours prior to initiating chemotherapy
* If childbearing potential exists, negative pregnancy test within 7 days prior to registration

Exclusion Criteria:

* Significant cognitive compromise
* History of CNS disease (e.g. brain metastases, seizure disorder, dementia)
* Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)
* Concurrent radiotherapy treatment
* Known hypersensitivity to olanzapine
* Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months
* History of diabetes mellitus on medication (insulin or oral glycemic agent)
* Alcohol abuse / chronic alcoholism
* History of closed angle glaucoma
* Current enrollment in other clinical trials
Emotion Recognition Training in Antisocial Violent Offenders With Psychopathic Traits

Impaired recognition of affective facial expressions has been conclusively linked to antisocial and psychopathy. However, little is known about the modifiability of this deficit. This study aims to investigate whether and under which circumstances the proposed perceptual insensitivity can be addressed with a brief implicit training approach.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed ASPD diagnosis
* PCL-Score available
* arrested for committing violent crimes

Exclusion Criteria:

* Insufficient knowledge of the German language
* Diagnosed with schizophrenia
* Substance abuse
* Neurological disease (e.g. epilepsy)
* Mental retardation
Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (CD).

Many strategies have been suggested to improve post-CD pain management in parturients on buprenorphine. While effective pain relief can be achieved, women maintained on buprenorphine during pregnancy have been shown to require up to 50% more opioids after CD compared to women with opioid use disorder not on a maintenance regimen. The perioperative use of gabapentin has been shown to reduce pain scores and opioid consumption following a variety of surgeries, ranging from cardiac bypass to total abdominal hysterectomy. The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective CD.

Eligibility Criteria:
Inclusion Criteria:

* singleton, term pregnancy
* currently on buprenorphine maintenance therapy
* scheduled for elective CD under spinal anesthesia

Exclusion Criteria:

* use illicit drugs or relapse during the last trimester of pregnancy
* positive drug screen at the time of delivery
* allergies to any medications used in the study
* taking prescribed gabapentin at the time of admission for CD
* contraindications to neuraxial anesthesia or require general anesthesia for CD
* designated ASA physical status 4 or above
Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda

This feasibility study will demonstrate the safety and accuracy of the Neopenda's wireless vital signs monitor, neoGuard, on 30 adult patients in a Ugandan clinical setting. The technology will be tested against a conventional patient monitor. Root mean square deviation (RMSD) and Bland-Altman plots will be used to assess concordance between paired measurements from the two equipment collected over a 1-hour period for each patient.

Continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized in the intensive care units of most low-and-middle income countries. Despite the positive outcomes associated with vital signs monitoring (i.e. increased survival-to-discharge, lower complication rates and shorter length of hospitalization), the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its accessibility in the developing world.

This feasibility study will demonstrate the safety and accuracy of the Neopenda's wireless vital signs monitor, neoGuard, on adult patients in a Ugandan clinical setting. The technology will be tested against a conventional patient monitor. Root mean square deviation (RMSD) and Bland-Altman plots will be used to assess concordance between paired measurements from the two equipment collected over a 1-hour period for each patient.

This technology innovation has large potential to impact health outcomes in low-resource settings, as it is a portable, reusable, long-lasting, cost-efficient monitoring tool designed for settings where patient loads are high and such solutions are direly needed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+ years (legal adult)
* Admitted for suspected or confirmed respiratory illness (excluding COVID-19)
* Stable clinical status (as determined by key physiological parameters pulse rate = 60-100 beats per minute, respiratory rate = 12-18 breaths per minute, oxygen saturation = 90 100% and temperature 36.5°C - 37.5° C)
* Willing and able to provide consent to receive vital sign monitoring

Exclusion Criteria:

* Aged \<18 years
* Unstable clinical status as determined by physiological parameters (pulse rate \<60 bpm, or \>100bpm, respiratory rate \<12 brpm or \>18bpm, oxygen saturation \<90%, temperature \<36.5°C or \>37.5°C)
Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage

This study will provide novel information to the literature base for the pathophysiology of aneurysmal subarachnoid hemorrhage. The association of breakdown products in the serum of aSAH patients were reported in a very small case series of 3 patients, as mentioned above. However, while their results are intriguing and encouraging, our study will provide more definitive information about the GC in aSAH. If there is a positive correlation, the results of this study will guide future investigations into new therapies for this devastating disease such as MMP inhibition with doxycycline.

1. The study will aim to recruit all eligible patients at UTMCK and the University of Virginia hospital over a 12 month period. Our main outcome measure is degradation of the glycocalyx in patients with aSAH. All eligible patients with confirmed aSAH admitted to the neuro-intensive care unit will be enrolled after consent is obtained from the family and/or the patient. Serum samples will be drawn from each patient on admission (day 1) and every other day until day 13 for a total of 7 samples per patient.

   The following serum tests will be performed:
2. Measurement of serum syndecan-1 by ELISA
3. Measurement of serum heparan-sulfate by ELISA
4. Measurement of serum matrix metalloproteinases -9
5. Measurement of serum matrix-metalloproteinase-1
6. Measurement of urinary microalbumin-to-creatinine ratio
7. Measurement of daily TCDs (all patients currently receive daily TCDs as part of the aSAH protocol at UTMCK and UVA Hospital)
8. Outcomes:

   a) Chart review: i) Incidence of DCI as defined by a consensus committee on this subject and published in the journal Stroke \[29\].

   ii) In-hospital mortality will be recorded b) Follow-up performed by phone call or searching the Social Security Death Index \[30\]: i) 30-day mortality ii) 90-day mortality c) Outcomes follow-up: i) The Glasgow Outcome Scale 12 weeks post aSAH \[31\]

Eligibility Criteria:
Inclusion Criteria:

* • Age 18 years of age and older

  * Cerebral aneurysm on CT-angio

Exclusion Criteria:

* • comfort care only orders,

  * the absence of an aneurysm on CT-angiography,
  * onset of aneurysm rupture \> 24 hours,
  * and inability to obtain informed consent from patient or family pregnant women
L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma

The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma

The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor partially due to lack of effective treatment. L-asparaginase was reported to be effective in this setting by several case reports. The investigators aim to evaluate the efficacy and toxicity of L-asparaginase monotherapy in a prospective phase II study.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-75 years old
* Histological confirmed NK/T cell lymphoma with progressive or recurrent disease
* ECOG performance status 0-2
* Life expectancy of more than 3 months
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Presence of Pain Shows Greater Effect Than Tendon Structural Alignment During Landing Dynamics

The goal of this observational study is to investigate the relationship between temporal, kinetic, and kinematic jump variables and patellar tendons' structure in athletes. The main research questions are:

Does the structure of the patellar tendon relate to the temporal, kinetic, and kinematic variables of different jumps?

To answer these questions, participants will undergo a UTC (Ultrasound Tissue Characterization) scan of the patellar tendon and perform two vertical jump: a countermovement jump and tuck jump test.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18-30 years;
* competing in the highest-level Portuguese volleyball league with a minimum of 10 years of volleyball practice.

Exclusion Criteria:

* presence of injuries or discomfort that impeded maximal jumping tests;
* history of surgery within the last 12 months;
* illness during data collection
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.

Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Trauma patients with single-system musculoskeletal injuries.
* Proximal tibia fractures treated with open reduction and internal fixation.
* Unilateral proximal tibial injuries.

Exclusion Criteria:

* Previous ipsilateral knee surgery
* Upper extremity injuries impairing mobilization
* Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
* Associated injuries impairing mobilization
* Suspected or confirmed compartment syndrome
* Open fractures
* Patients previously on narcotics
* Patients with impaired sensorium Concurrent head injury Intoxication
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)


Eligibility Criteria:
Inclusion Criteria:

Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication
* The patient, in the investigator's clinical judgment, has a significant risk of suicide.

Other protocol-defined inclusion and exclusion criteria applied.
Back to Functional Life Following Cardiac Surgery

The investigators will monitor cardiac patients rehabilitation post op upon their pre op status.

In this work we will try to monitor the patients for a longer period, starting from their hospitalization period through their rehabilitation period up to 18 months post their discharge from the hospital.

Many studies tried to evaluate different ways to predict postoperative complications following cardiac surgery, patient's survival, rehabilitation rate and duration. Today, following these studies doctors use different methods to evaluate these parameters. The Society of Thoracic Surgeons mortality risk score (STS) and the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system are the two most frequently used risk profile systems within the United States and Europe. The STS score is comprised of over 40 clinical parameters, whereas the EuroSCORE involves 18 clinical characteristics that comprises three categories, each weighted accordingly. Studies published recently suggest that a combination of a new frailty score and the traditional scoring systems may facilitate a more accurate risk scoring in elderly high-risk patients scheduled for conventional cardiac surgery or trans-catheter aortic valve replacement.

In this study we will try to evaluate the contribution of using a frailty score index in addition to the EuroSCORE evaluation in patients≥50 years of age, in prediction of postoperative complications following cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing cardiothoracic surgery in the Cardiothoracic Surgery Department at Carmel Medical center, Haifa, Israel, between: 1.5.12-28.2.14.
2. Patients ≥ 50 years of age
3. Informed consent from each participant that can understand, read and sign the informed consent form.

Exclusion Criteria:

1. Emergent surgery, defined as a surgery for which there should be no delay due to ongoing refractory cardiac compromise.
2. Clinical instability, defined as active coronary ischemia, decompensated heart failure not yet stabilized, or any acute process causing significant symptoms or abnormal vital signs.
3. Severe neuropsychiatric condition causing inability to cooperate with the study procedures.