cyrilzakka/clinical-trials huggingface dataset:
Interferon ß-1b Treatment by Cyclical Administration

The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. The main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. There is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. This might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. Finally, cyclical administration allows patients to spend actual periods of "therapeutic vacation", with positive psychological effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by remitting Multiple Sclerosis who had at least a relapse in the last year of the disease.
* Satisfying general clinical conditions according to the researcher. Adequate hepatic function. Capacity to use adequate contraceptive techniques during the study.

Exclusion Criteria:

* Any other disease that might better explain signs and symptoms of the patient.
* Any other disability condition that might interfere with the clinical evolution.
* History of hypersensitivity to natural or recombinant interferon or to human albumin.
* Clinically significant heart diseases and not controlled like dysrhythmias, angina pectoris or congestive heart failure.
* Not adequately controlled epilepsy.
* Inability, according to the examining commission, to grant a complete compliance with the protocol requirements for the whole study.
* Previous therapies modifying the disease course in the last six months.
* Steroid therapies in the last 3 months.
* Pregnancy, lactation, serological positivity to the pregnancy test during the screening period.
PDD vs PAD to Treat Initially Diagnosed MM

The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and untreated multiple myeloma patients
* Patients with age between 18 and 70 years
* With a evaluable disease
* ECOG score ≤2
* NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L
* AST, ALT, ALP≤3×ULN, serum BIL≤ULN
* LVEF≥ 50%
* Not in pregnancy
* Written informed consent are acquired

Exclusion Criteria:

* Severe heart failure (NYHA grade II or higher)
* Active and uncontrolled severe infection
* HIV positive
* Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin
* Grade 2 or higher peripheral neuropathy before treatment
* Have suffered any other malignancy in past 5 years
* Females in lactation
* Other situations that investigators consider as contra-indication for this study
Anesthesia for Retinopathy of Prematurity

Premature infants experience more respiratory problems after surgical procedures. The investigators aimed to compare general anesthesia with sedation on the need for post-operative mechanical ventilation in infants undergoing retinopathy of prematurity surgery.

60 patients who underwent laser surgery due to retinopathy of prematurity (ROP) were included in the study. The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance. In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen. Our primary objective was to evaluate the need for post-operative mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP

Exclusion Criteria:

* The exclusion criteria were patients requiring inotropic support,
* the need for mechanical ventilation or intubation in the 3 days prior to the operation,
* known allergy or hypersensitivity reaction to ketamine and propofol,
* age ˃40 weeks.
Statins and ARBs on Rheumatoid Activity

Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients

The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis.

Exclusion Criteria:

* Pregnant or lactating
* Hepatic or renal impairment.
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms

This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of scheduling factors and sleep history on both safety and productivity. The SAFTE model will be used to asses cancer-related fatigue and study potential associations of change in sleep patterns to tumor recurrence in patients with high grade glioma. Data will be collected using the Readiband™ Sleep Tracker (https://www.fatiguescience.com/sleep-science-technology/). The Readiband device captures high-resolution sleep data, validated against the clinical gold standard of polysomnography with 92% accuracy. Sleep data is transmitted to the cloud automatically for SAFTE Fatigue Model analysis. We will correlate clinical progression data obtained from the patient's electronic medical record with SAFTE data.


Eligibility Criteria:
Inclusion Criteria

i. Patients aged between 22 and 70. ii. Patients must have a histologic diagnosis of primary Grade IV glioma. iii. Patients must have received maximal debulking surgery and radiotherapy concomitant with Temozolomide (≥ 75% of their recommended temozolomide dosage is required).

iv. Patients with KPS ≥70. v. Life expectancy at least 3 months. vi. Patients must have signed informed consent for study participation. vii. Patients should be English speakers.

Exclusion Criteria

i. Patients enrolled in active clinical treatment trials for primary Grade IV glioma.

ii. Patients with progressive disease after completion of radiotherapy concomitant with Temozolomide as per RANO criteria. Suspected pseudoprogression should be confirmed by additional imaging studies ordered as part of standard care.

iii. Patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies).

iv. Patients who are pregnant or trying to get pregnant. v. Patients unable to wear the ReadiBand device continuously during study duration.

vi. Patients with infra-tentorial tumors. vii. Patients with known psychiatric concerns. viii. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:

1. Thrombocytopenia (platelet count \< 100 x 103/μL)
2. Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
4. Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
5. Total bilirubin \> upper limit of normal, if clinically significant
6. Significant renal impairment (serum creatinine \> 1.7 mg/dL)
Simultaneous PET/MR Imaging of Human Brain Plasticity

Background: Neuronal plasticity is the brain's ability to continuously adapt to experiences and learning of new skills. Although this affects multiple characteristics of the brain such as structure, function and metabolism, direct interactions between these aspects are largely missing.

Aim: Using recent advancements in neuroimaging we aim to identify novel relationships how neuronal plasticity is related across these characteristics.

Design: 40 healthy subjects will undergo two simultaneous PET/MR measurements at baseline and after 4 weeks. During the measurements a cognitively challenging task will be performed and the training group (20 subjects) will practice during the 4-week period.

Implications: We combine simultaneous PET/MR and novel task-specific PET imaging to study brain metabolism, structure and function in a single measurement session. This provides optimal sensitivity for assessment of multimodal neuroplasticity associations. Knowledge how cognitive training affects multiple characteristics of the brain will also increase our understanding of disorders like depression, dementia and brain injuries, since these are diagnosed with cognitive evaluations. Considering the vast usage of the applied imaging procedures in diagnosis and therapy monitoring, the thorough investigation of multimodal associations offers benefit for the interpretability of neuroimaging in clinical routine.

Methodological details: Each subject will undergo two PET/MR examinations. Imaging will include PET as well as acquisition of structural and functional MRI. Task-specific glucose metabolism will be quantified with the radioligand \[18F\]FDG. Gray matter volume and white matter microstructure will be assessed with T1-weighted and diffusion weighted MRI, respectively. Functional imaging will focus on functional connectivity during rest and task as well as cerebral blood flow as acquired with ASL.

Eligibility Criteria:
Inclusion Criteria:

* Age range 21-30 years
* Right-handedness
* Willingness and competence to sign the informed consent form

Exclusion Criteria:

* History of or current physical, neurological or psychiatric disorder
* History of or current substance abuse or medication including antipsychotic, antidepressant and antianxiety agents
* Pregnancy or current breastfeeding
* Contraindications for MRI-scanning (e.g., metal implants, steel grafts, etc), including dental implants causing signal artifacts
* For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection
* Regular players of the video game Tetris (3 years before scanning).
* Failure to comply with the study protocol or to follow the instructions of the investigating team
Effects of Ladder Training Versus Plyometric

To determine the effects of ladder training versus plyometric training program on agility, speed and power in domestic female cricket players. Plyometric training program and ladder training program consider effective training methods for players for development of speed, agility and power.

Cricket is a well-known, particularly created team sport that is played on an international scale and involves a group of eleven players. Because both baseball and cricket are played on open fields, they are comparable sports. Cricket was first thought to be a game played only by men.1, 2 However, a few years ago, the globe became aware of the female cricket game because it was becoming more and more popular worldwide. It's a game that requires both physical components and a substantial level of technical understanding. Plyometric and ladder training programmes are thought to be efficient ways to help athletes gain strength, speed, and agility. Players will be selected for this randomised clinical study by use of successive sampling. The players will be split into two groups, 1 and 2, with Group 1 receiving ladder training and Group 2 receiving plyometric training. Each group will receive three 60-minute sessions per week for eight weeks. The vertical leap test, the agility t test, and the 30-dash test will be used to examine patients before and after the trial. Software from SPSS 25 version will be used to analyse the data.

Eligibility Criteria:
Inclusion Criteria:

* • Age ranging from 18-25year.

  * Player with minimum 1- year experience of cricket Only female cricket players.

Exclusion Criteria:

* • Any cardiopulmonary problem. Lower extremity injuries of last 6 months(fractures, ligament ruptures)

  * Players who were unable to complete ladder and plyometric training.
Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer

Cancer immunotherapy with immunostimulatory antibodies targeting the CTLA-4 or PD-1/PD-L1 pathways has demonstrated its efficacy in variable proportions of cancer. For metastatic colorectal cancer (mCRC) it appeared that only the small subgroup of patients with MSI-H tumors (microsatellite instability-high phenotype) had a clinically meaningful response to the anti-PD-1- L1 antibodies. In the majority group of non-MSI-H CRC (90-95% of patients), current research expect that additional means would be able to render the tumor "immunogenic" (like MSI-H CRC) and increase the intratumoral immune infiltrate which is the prerequisite to observe a benefit from PD1-PD-L1 inhibitors. Combinations of immune checkpoint inhibitors and procedures that increase intratumoral immune responses, such as targeted therapy, are actively explored.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over, Performance status: ECOG 0-1
* Histologically proven metastatic colorectal adenocarcinoma, refractory to standard chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan) and anti-EGFR treatment (only for RAS WT tumor)
* Measurable disease (RECIST 1.1)
* Metastasis accessible for sequential biopsies
* Patient consent for metastasis biopsies in the study protocol
* BRAF V600E wild-type and MSS tumors
* Adequate normal organ and marrow function (see adequate section of the full protocol for definition)
* Life expectancy of at least 4 months

Exclusion Criteria:

* Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy that are not indicated in the study protocol
* Systemic autoimmune disease,
* Chronic treatment with corticoids or other immunosuppressive treatment
* Clinically significant cardiac, lung or general disease despite optimal treatment
* Non-progressive disease following irinotecan-based treatment.
* For RAS WT, non-progressive disease following anti-EGFR treatment.
A Retrospective Study of Subjects With Thymidine Kinase 2 Deficiency

This is a multicenter, multinational, retrospective chart-review study to evaluate survival in patients with Thymidine Kinase 2 deficiency (TK2d).

This is a retrospective, chart-review study. The primary goal is to use data on survival and other related information to support a comprehensive evaluation of patients with Thymidine Kinase 2 deficiency (TK2d) who have not been treated with pyrimidine nucleos(t)ides including deoxycytidine monophosphate/deoxythymidine monophosphase (dCMP/dTMP), and deoxycytidine/deoxythymidine (dC/dT), and/or MT1621(dC/dT), and those that have received one or more of these treatments. The secondary goals of this study will focus on describing the participant's clinical course and treatment experience.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by the subject or parent(s)/LAR and/or assent by the subject (when applicable), unless the associated IRB or EC provides an appropriate consent waiver that allows review of medical records for this study.
2. Confirmed genetic mutations in the TK2 gene.
3. Availability of medical records or information pertaining to vital status at a minimum.

Exclusion Criteria:

Not applicable as this is a non-interventional study.
Performance Study of the Thermodiag Solution for Body Temperature Measurement

The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core temperature in critical care patients. The main question it aims to answer is to develop non-invasive alternatives to the current methods of measuring core body, to reduce health risks, and overcome various other limitations (as infection, bleeding, thrombosis and local reactions).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years;
* Female or male patients;
* Patients hospitalised in a critical care unit as defined by the Public Health Code of the Republic of France, Article R6123-33: 'The critical care activity consists of the care of patients who present or are likely to present one or more acute failures directly threatening the vital or functional prognosis and which may require recourse to one or more methods of substitution'.
* Patients affiliated to the social security system or beneficiaries of such a system, where applicable, in accordance with local regulations;
* Voluntary patients - or trusted person/family member/relative who have given oral and written consent after being informed by the investigator of the research.

Exclusion Criteria:

* Patients with a corpulence or physical characteristics responsible for a 'tourniquet' effect: arm circumference greater than 47 centimetres;
* Patients with burns on the arm (location for Thermodiag® measurement);
* Patients with particularly sensitive or affected skin in the biceps or armpit (left and right);
* Patients undergoing an MRI examination;
* Patients undergoing extracorporeal circulation;
* Patients with a history of allergy to silicone;
* Patients with active implantable medical devices such as pacemakers, defibrillators, etc. ;
* Patients undergoing dialysis;
* Patients with a tattoo in the area where the investigational device will be worn (arm);
* Patients currently excluded from another protocol or taking part in another interventional research study;
* Pregnant or breast-feeding women.
Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance

The scaphoid is the most common fractured carpal bone in active adults, accounting for up to 80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment. Long periods of cast immobilization may result in wrist stiffness, loss of grip strength, muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent disadvantages of ligament and capsular dissection, blood vessels damage. This study introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire process of drilling and screw insertion and screw fixation for acute scaphoid fractures.


Eligibility Criteria:
Inclusion Criteria:

* acute scaphoid fractures
* Injury to surgery less than 7 days
* Only one injured hand
* Written informed consent to undergo the surgical procedure
* Patients of either sex aged between 18 and 70 years

Exclusion Criteria:

* Patients with vascular injuried requiring revascularization
* Concomitant phalanx fractures or other injuries needing immobilization
* Loss of skin substance requiring grafts or flaps
* Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders
* Smokers
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients

A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status

In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.

Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent document
* Age \>= 18 years at the time of signing the informed consent form
* Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM)

Exclusion Criteria:

* An serious egg allergy or prior serious adverse reaction to an influenza vaccine
* Use of any other influenza vaccine for the 2014 to 2015 flu season
* Women who are pregnant or plan to become pregnant in the study period
Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic

Emergency general surgical care during the COVID-19 pandemic presents a unique set of considerations and challenges. Patients presenting with acute surgical conditions and concomitant COVID-19 infection have higher risk of mortality and morbidity. The investigators present their experience with COVID-19 positive patients presenting with acute surgical conditions and reviewed the implementation of a protocolized pathway to mitigate the impact of COVID-19 infection.

All COVID-19 positive patients who presented to the acute general surgical service over a 2-month period were identified. Patient data including demographics, surgical diagnosis, mortality, morbidity and hospital length of stay was collected. Based on the investigators' early experience from the first patient, the investigators designed a protocolized institutional pathway which incorporated the risk of COVID-19 infection and urgency of operation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with emergency surgical conditions and tested positive for COVID-19 infection

Exclusion Criteria:

* Nil
Essential Oils on Anxiety of Patients Suffering From Cancer

This study evaluates the impact of essential oils massage on anxiety of patients who are suffering from cancer at a metastasis stage. Half of patients will be massaged first by essential oils and then by oil only. The other half will be massaged first by oil and then by essential oils.


Eligibility Criteria:
Inclusion Criteria:

* Adult suffering from cancer at a metastatic stage
* Life expectancy \> 15 days, assessed by investigator
* Hospitalized at the Chevrel unit from Centre Eugène Marquis, palliative unit care, for more than 15 days
* Regular anxiolytic treatment or imperative need to introduce anxiolytic treatment (assessed by investigator) within 48 hours following his hospitalization entry
* \> 18 years

Exclusion Criteria:

* Patient already recruited in a therapeutic trial
* Patient not covered by a social security system
* Pregnant or likely pregnant patient, breastfeeding patient
* Allergy to any component of essential oils mixture and vegetable oils : bitter orange petitgrain, fine lavender, ylang-ylang, macadamia
* Minors, people deprived of their liberty or protected people,
* Impaired cognitive functions making impossible to obtain informed consent