cyrilzakka/clinical-trials huggingface dataset:
HI-CHART:Feasibility of High-Dose Accelerated Conformal Radiotherapy

In this study we try to increase the radiation dose, while reducing or keeping the radiation schedule below 4 weeks.

The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer.

Non-small cell lung cancer is still the most common cancer and the main cause of cancer death. Treatment of choice for these patients is often radiotherapy, which results in an overall 5-year survival rate between 5 and 10%. The addition of chemotherapy improves survival by a few percentages and is therefore considered standard treatment for patients with stage III disease.

However, several factors have been identified that have an impact on the local control but also on survival.

1. There is a dose-effect relationship. A higher dose results in a better survival rate. However, higher radiation doses are currently not delivered with conventional radiation due to the tolerance of normal tissue.
2. The time factor plays an important role in radiotherapy. Prolonging the overall treatment time decreases the outcome of radiotherapy. Radiobiological modelling of data shows that the overall treatmetn time (OTT) should be kept below 4 weeks. Results from studies support this conclusion.

So, probably the best results will be achieved when a very high radiation dose can be delivered within 4 weeks, without severally damaging normal tissue.

In order to achieve this goal, an hyperfractionated accelerated treatment regimen together with a technically very advanced radiation technique to avoid as much normal tissue as possible, will be used in this study.

Eligibility Criteria:
Inclusion Criteria:

histological or cytological diagnosis of non-small cell lung cancer stage I-III disease, except supra-clavicular lymph nodes availability for participating in the detailed follow-up of the protocol able to tolerate a radiation course according to the protocol guidelines in case of previous chemotherapy, radiotherapy can start after a minimum of 3 weeks after the last CT course good performance status: Karnofsky\>=70%, WHO performance status 0-2 adequate lung functions allowing the radiation according to the guidelines protocol no severe recent cardiac disease absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; conditions should be discussed with the patient before registration in the trial -

Exclusion Criteria:

patients who have a peripherally located lower lobe tumor and contralateral upper mediastinal nodes malignant pleural or pericardial effusion concurrent chemotherapy programs history of a prior malignancy excluding non melanoma skin cancer or in-situ cancer history of prior chest irradiation recent myocardial infraction uncontrolled infectious disease distant metastases (stage IV)

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MENTAL PRACTICE IN MOTOR LEARNING OF BRUSHING AND PARKINSON DISEASE

Parkinson's disease (PD) is characterized by dopaminergic neurons degeneration of the substantia nigra, in the midbrain, resulting in the presence of motor disorders, such as tremor, rigidity, bradykinesia, and postural instability. Researches have shown that mental rehearsal in learning motor skills through mental practice (MP), which associates the physical practice to somatosensory imagination to action, causes positive effects in several motor tasks, such as the speed of motion, muscle strength performance and accuracy. Thus, this study aims to report the effects of MP as a tooth brushing training strategy in people with Parkinson's disease. This project was approved by the Ethics Committee in Research with Human beings of UFPE and attempt to compare the presence of bacterial biofilm before and after 8 weeks of brushing through the mental practice training, based on O'Leary's index. The sample consisted of 35 people, divided into two groups: Intervention Group consists of 17 people with Parkinson's, in stages I to III of the disease, who underwent brushing orientation associated with PM, and the control group people without the disease, who received only orientation brushing. Then, the data were evaluated by factorial ANOVA 2x2 and post hoc Tukey test considering p \<0.05. It was observed that after the intervention was a significant improvement of the control dental biofilm.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 80 years;
* Idiopathic PD Clinical Diagnostics according to the Bank of brain London;
* Patients in stages I to III according to Hoehn and Yahr;
* Satisfactory communicative and cognitive level checked by the Mini-Mental State Examination;
* Subject to satisfactory clinical, lying in his home in the care of relatives;
* Patients who possessed a sextant of the dental arch with teeth.

In the control group individuals without neurological disease were included: both sexes at ages similar to the group with PD, satisfactory health, active life, and natural teeth.

Exclusion Criteria:

* Another neurological disease associated with PD;
* Mioarticulares abnormalities in the upper limbs to prevent their use for independent brushing;
* Use of orthotic / prosthetic hand;
* Toothless in both dental arches.

In the control group were excluded individuals with mioarticulares abnormalities of the upper limbs; in use of orthotic / prosthetic hand; presenting any movement disorder in the upper limbs.
Effects of tDCS on High Level and Recreational Athletes

Healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tDCS or sham tDCS.

The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session

Recruitment :

Healthy recreational and high level athletes will be recruited through social media and advertisements.

Each subject came twice to the Liege University Hospitals' isokinetic lab. Each session began with strapping the subjet into the isokinetic machine, making sure that all the settings were adapted to the subject. Then, each subject received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a warmup consisting of stationary bike, and an isokinetic warmup. Then, subjects' endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric contractions at a speed of 180°/s.

Eligibility Criteria:
Inclusion Criteria:

* For the "recreational" group at most 3 hours of sport a week
* For the "athletic" group, at least 10 hours of sport a week
* Right handed and footed

Exclusion Criteria:

* One on the TSST (in high and relatively high risk sections)
* Previous neurological or orthopedic pathologies affecting limbs
Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer

This study is a retrospective real-world study to evaluate the efficacy of Osimertinib for patients with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.

This is a multicenter, retrospective observational real-world study, which evaluates the efficacy of Osimertinib, between 2017 and 2022, in patients with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer. This study serves as the external control for a single arm phase II trial on JMT101 combined with Osimertinib in patients with Non-Small Cell Lung Cancer. The primary outcome measure is objective response rate (ORR).

Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced or metastatic (stage ШB-Ⅳ, 8th AJCC) NSCLC confirmed by histology or cytology;
2. The result of EGFR 20ins is positive detected by tissue, blood, pleural fluid or cerebrospinal fluid;
3. Have received osimertinib treatment after detection of EGFR 20ins;
4. Age of 18 years or above;
5. Information about tumor outcome evaluation is required at least once after osimertinib treatment (such as tumor imaging data, description of efficacy evaluation in medical records, etc.).

Exclusion Criteria:

1. Previously treated with JMT101 (Patients will be included if osimertinib treatment is before JMT101 treatment);
2. Patients harboring EGFR exon20 insertion mutation and also have other EGFR TKI-sensitizing EGFR mutations, such as G719X mutation in exon 18, exon 19 deletion mutation (19 del), exon 20 T790M or S768I mutation, exon 21 L858R mutation, or L861Q mutation.
Outcome of Elderly Patients With Appendicitis

This study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients.

Appendicitis in elderly patients is more challenging due to delayed presentation and higher comorbidities, which is associated with increased postoperative morbidity and mortality. In this study, we aim to investigate the factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients. Records of patients who underwent appendectomy for appendicitis will be extracted. The primary outcome is 30-day postoperative complications. Independent variables examined include demographics, comorbidities, preoperative laboratory values, pathological findings, and surgical features. Both univariate and multivariate regression will be performed to identify factors associated with postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years and older
* Patients undergoing appendectomy for acute appendicitis (pathologically confirmed)
* Patients having complete records of clinical data and postoperative follow-up records

Exclusion Criteria:

* Patients younger than 65 years
* Patients undergoing an appendectomy as part of another major operation or those with appendiceal malignancy
* Patients who are treated nonoperatively for acute appendicitis
A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.


Eligibility Criteria:
Inclusion Criteria:

* Had a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent:

  1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;
  2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA)
* Have a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith
* Have at least 1 British Isles Lupus Assessment Group (BILAG) A and/or 2 BILAG B scores observed during screening
* Have a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score at least 4 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation at screening, Week 0, or both
* Have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to \[\>=\] 6 at screening. Must also have SLEDAI-2K \>= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0

Exclusion Criteria:

* Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded
* Has other inflammatory diseases that might confound the evaluations of efficacy (including but not limited to rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)
* Has urinary protein level of greater than (\>) 4 gram per day (g/day) or protein/creatinine ratio estimating \>4g/day equivalent proteinuria
* Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
* Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location, clinically significant splenomegaly, or history of monoclonal gammopathy of undetermined significance
A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. Subjects must weigh \>50 and \<100 kg
3. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III

Exclusion Criteria:

1. A history of Listeriosis or active tuberculosis (TB)
2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
3. History of prior articular or prosthetic joint infection
4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
5. Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).

The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.

The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.

GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass.

At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years.

Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 40 kg /m2 to ≤ 50 kg/m2
* Eating habit: sweet eater and volume eater
* Signed informed consent
* Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet

Exclusion Criteria:

* History of obesity surgery
* History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
* Patients not eligible to implement silastic ring size 6.5 cm
* History of drug or alcohol abuse
* History of major psychiatric illness conflicting with patient's compliance
* History of recent or chronic steroid medication
* Autoimmune disease
* Inflammatory bowel disease or malabsorptive disease
* Liver cirrhosis (CHILD B + C)
* Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.)
* Pregnant women or women with childbearing potential without efficient contraception
* History of cancer in the last five years
* Need of long-term anticoagulant medication for any reason
* Any medication with ingredient ASA
Community-Based Maintenance Exercise Program for COPD

It is well established that individuals living with chronic obstructive pulmonary disease (COPD) demonstrate significant improvements following a formal rehabilitation program. The problem lies in the fact that these functional improvements diminish over a 12 month period. This decline in function is associated with decreased participation, a decline in health status, and an increased need to access the healthcare system. The objective of this project is to evaluate the effectiveness of a post-rehabilitation community-based exercise program for individuals with COPD and compare the outcomes with those achieved through standard care.

Individuals with COPD who have completed a previous rehabilitation program will be enrolled in the study. Study participants will be assigned randomly to either a year-long community exercise program or usual care. Those assigned to the community program will exercise twice weekly at a local community centre supervised by trained fitness instructors. A case manager will facilitate the transition from the hospital rehabilitation program to the community centre. The case manager will also be available to participants and instructors for consult as needed. Continuing to build on an established partnership with the City of Toronto, the case manager will ensure fitness instructors receive specialized training in order to properly supervise and support the individuals with COPD. Participants assigned to usual care group will receive standard care by their family physician and respiratory specialist. Functional status will be evaluated before the program begins and again at 6-months and 1-year. The outcome of each group will be compared to determine the effectiveness of the community exercise program. It is hypothesized that individuals who participate in the community exercise program will have better function and quality of life versus those individuals who receive standard care.


Eligibility Criteria:
Inclusion Criteria:

* individuals with moderate to severe COPD based on international (GOLD) criteria
* clinically stable
* able to provide their own informed consent
* able to secure independent transportation to the community site

Exclusion Criteria:

* individuals with associated medical conditions that limit their exercise tolerance (cardiovascular, musculo-skeletal, recent surgery, etc.)
* individuals who report a history of significant cardiovascular disease (i.e. congestive cardiac failure, history of cardiac arrest, acute myocardial infarction within the preceding three months, symptomatic ischaemic cardiac disease, uncontrolled systemic hypertension) or report severe non-respiratory symptoms during exercise
* individuals receiving mechanical ventilation
* individuals who are unable to attend the community-based exercise program or follow-up assessment sessions
Hyperekplexia : Adaptative Skills and Neurodevelopmental Trajectory

Hereditary hyperekplexia is a rare neuronal disorder, caused by genetic defects leading to dysfunction of glycinergic neurotransmission.

The clinical presentation is characterized by stiffness and exaggerated startle responses to unexpected stimuli, that appear shortly after birth.

The generalised stiffness can lead to apnea and sudden infant death syndrome.

Several genes are known to be associated with hereditary hyperekplexia. The most frequent are Glycine Receptor Alpha 1 (GLRA1), Glycine Receptor Beta (GLRB) and Solute Carrier Family 6 Member 5 (SLC6A5). They encode for the postsynaptic glycine receptor (GLRA1, GLRB) and the presynaptic glycine transport (SLC6A5). Genetic mutations in these genes lead to dysfunction in the glycinergic inhibitory neurotransmission.

The neurodevelopment was initially described as normal, or as delayed due to the motor difficulties. Global development delay and intellectual disability are reported as well, in the most recent studies.

Nevertheless, the degree of severity of the learning difficulties and the adaptive faculties of the patients is not specified.

Similarly, the efficacy of clonazepam in hyperekplexia is well known, but the evolution of dosage over time and the frequency of complete withdrawal have never been studied.

The primary endpoint of this study is to describe adaptive skills using a standardized questionnaire, Vineland Adaptive Behavior Scale (VABS2).

Secondary endpoints are:

* Neurodevelopmental course study
* Description of the evolution of the clinical manifestations over the years
* Evaluation of the efficacity of the treatment CLONAZEPAM, initially and over time, and evolution of the dosage
* Comparison of clinical and therapeutical characteristics according to the genotype


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnostic criteria for hyperekplexia (see Thomas et al. BRAIN, 2013):

  * The presence of hypertonia (either hypertonia on examination, axial or segmental, or access of stiffness)
  * Exaggerated reflex startles, to auditory, tactile or visual stimuli
  * The presence of reflex bursts on percussion of the midline
* Children \>2 years and adults
* No opposition of one of the two parents (or legal representative) or of the adult patient

Exclusion Criteria:

* The presence of a cause secondary to the hyperekplexia (traumatic, autoimmune, etc.)
* The presence of another cause for a delay in psychomotor development (other neurological pathology, serious head trauma, etc.)
* Pregnant or breastfeeding women
* Person deprived of liberty by judicial or administrative decision
The Nordic Consensus Study

A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.

The primary objective is to evaluate the usability of the Body Assessment Tool for the nurse. The secondary objectives are to explore if the use of Body Assessment Tool has an impact on the leakage associated Quality of Life and leakage incidences for individuals living with ostomies.

Forty to fifty ostomates will be enrolled from each Nordic country (i.e. Denmark, Sweden, Norway and Finland). The users will be recruited from 5-10 clinics in each country. The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit).

The usability of the Body Assessment Tool will be evaluated by the nurses. The user's leakage and QoL will be evaluated by the end-users.

Eligibility Criteria:
Inclusion Criteria:

* Ostomates
* Male or female ≥18years
* Leakage issues

Exclusion Criteria:

* Requires a caretaker or is unable to participate in the study
* Is pregnant or lactating