cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants

The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Must have a body weight in the range of 50 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m\^2), inclusive, at screening and Day -1
* Must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -1
* Must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1
* A woman must not be of childbearing potential
* Must be a non-smoker or tobacco user or 3 months prior to screening

Exclusion Criteria:

* Pregnant or breastfeeding while enrolled in this study or within 20 weeks after the dose of study treatment
* History of or currently has any clinically significant medical illness or medical disorders the investigator considers significant, including, but not limited to immune deficiency state, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
* Active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
* Has had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening and/or plan to receive a BCG vaccine within 12 months after the administration of study treatment
* Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months
* Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) zoster within the past 5 years
* Has received prescription medications within 14 days prior to study treatment
Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy.

The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.


Eligibility Criteria:
Eligibility Criteria

Subjects must:

* be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0) or Stage IIa (T\<3cm, N0, M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).
* be post-surgical patients scheduled to be treated with at least 40 to 50.4 Gy to the whole breast and axilla using either standard or hypofractionated radiation techniques . An additional 10-16 Gy boost to the lumpectomy region may also be delivered. All radiation treatment is to be delivered based on standard CT planning.
* have the ability to understand the informed consent document.
* be able to comply with protocol schedule.
* have a negative serum pregnancy test (within 7 days prior to starting radiation therapy), if a female of child bearing potential.
* consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential.

Exclusion Criteria

Subjects:

* with unhealed surgical wounds or scars in the study treatment area (axilla).
* with underlying active untreated cardiac disease (e.g. arrhythmia).
* with generalized skin disorders that have required treatment within the past 6 months.
* with connective tissue disorders.
* with rashes, ulcerations, or poorly healed scars in the study drug application area (axilla).
* with a known allergy to norepinephrine.
* with known uncontrolled hypertension (repeatedly elevated BP; systolic BP \>139 or diastolic BP \>89).
* with a known clinically significant abnormal ECG within the past 6 months.
* receiving MAO inhibitors or antidepressants (triptyline or imipramine types).
* who are pregnant or breastfeeding.
* with lymphovascular space invasion on pathology.
* with dermal lymphatic invasion on pathology.
* with proximity of the tumor to the overlying skin as evidenced by a distance of less than 5 mm on US or MRI (if performed) and within 2 cm of the anticipated application field
* diagnosis of inflammatory breast cancer.
* receiving chemotherapy other than Herceptin concurrent with the radiation.
* with previous radiation to the breast to be treated.
Addressing Fertility Information Needs and Distress

The purpose of this study is to develop and refine a behavioral intervention to address fertility-related information needs and fertility-related distress among female adult survivors of childhood cancer.

Adult survivors of childhood cancer are a growing population who face a number of long-term and late effects secondary to their cancer treatment, which have the potential to profoundly impact their future health, quality of life, and achievement of life goals. This project will examine the feasibility, acceptability of a novel behavioral intervention aiming to address fertility-related information needs and fertility-related distress among adult survivors of childhood cancer.

Following the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, the proposed study seeks to design and refine a behavioral intervention to address unmet fertility-related information needs and fertility-related distress among female adult survivors of childhood cancer (aged 18-44). The intervention is organized into six remotely delivered sessions integrating patient activation theory and Acceptance and Commitment Therapy (ACT) strategies, and evidence-based reproductive health information and help to empower empower survivors to make informed decisions that align with their personal values. Intervention content will be delivered to a small sample of the target population (N=30). Feasibility and acceptability, as well as examination of pre- to post-intervention patterns of change in intervention targets (primary: fertility health knowledge, fertility-related distress; secondary: psychological flexibility, patient activation, and self-efficacy), will be assessed and utilized to further refine the intervention (e.g., intervention strategies, intervention length, and delivery modality).

Although this project is focused on the late effect of impaired fertility, the intervention developed through this study has the potential to produce significant public health benefits: it could be applied to address other late effects in this population, which if left untreated, may lead to greater health complications in this growing population later in life.

Eligibility Criteria:
Inclusion Criteria:

* Currently aged 18-44
* Diagnosed with cancer at \<18 years old
* Female sex
* Uncertain fertility status

Exclusion Criteria:

* Age \<18
* Currently under the care of a fertility specialist
* Having a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider
* Inability to provide consent.
Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).

* To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
* To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed small cell lung cancer, limited or extensive stage.
* Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist.
* Age 18 or greater

Exclusion Criteria:

* Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
* Pregnancy
Zero Calorie Drink Products

This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke.


Eligibility Criteria:
Inclusion Criteria:

* healthy,
* asymptomatic individuals for diabetes and pre-diabetes,
* especially for people at high risk of developing diabetes,
* such as those with a family history of diabetes,
* those who are overweight,
* and those who are more than 40 to 45 years old

Exclusion Criteria:

* Patients with chronic illnesses, especially diabetes
Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis

This is a randomized controlled study. Baricitinib 4mg in one arm and Baricitinib 2mg in another arm will be used. Methotrexate 10mg per week in both arms will be used.

This open label randomized controlled clinical trial will be conducted in the department of Rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to severe disease activity (DAS 28 ESR/CRP\>3.2) despite treatment with methotrexate or other csDMARDs will be considered as primary entry criteria for this study. Simple random sampling method will be applied. After a washout period of three weeks, Group A will be put on baricitinib 2 mg once daily and Group B will be put on baricitinib 4 mg once daily. Methotrexate 10mg will be used on both groups in addition to barcitinib. NSAIDs and adjuvant analgesics will be used if needed. All the patients will go through baseline evaluation before treatment which include-Disease Activity Score derivative for 28 joints (DAS 28ESR/CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and laboratory tests like CBC, CRP, SGPT, Serum Creatinine, LDH, RF, ACPA, Chest X-ray P/A view and TST or interferon gamma release assay (IGRA). Follow up will be done at 4th, 12th and 24th week. Response to treatment will be evaluated by DAS 28 ESR/CRP. Primary endpoint for efficacy will be assessed at the end of 24th week by DAS 28 CRP response. Secondary endpoints will be determined by SDAI, CDAI and HAQ-DI. Adverse effects will be assessed by history, physical examinations and investigations

Eligibility Criteria:
Inclusion Criteria:

1. age greater than 18 years
2. patients fulfill the ACR/EULAR 2010 classification criteria for RA
3. DAS-28 CRP more than 3.2 despite optimum dose of methotrexate

Exclusion Criteria:

1. Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization
2. Hemoglobin (Hb) \< 8 g/dl
3. White blood cell count \< 4000, Neutrophil count \< 1000, Platelet count \< 100000/mm3
4. Live vaccines within 3 months prior to the first dose
5. Serum creatinine \> upper limit of normal reference range
6. eGFR \< 60 ml/minute/1.73 m2
7. Alanine transaminase (ALT) more than ULN
8. Pregnant or breast feeding females of child-bearing potential
9. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
10. New York Heart Association Class III and IV congestive heart failure
11. Previous history of thromboembolism, deep venous thrombosis, diverticulitis
Objective Characterizatoion of Repetitive Behaviors

Introduction:

Repetitive behaviors (RB) constitute a broad range of symptoms across different psychiatric/neurologic disorders. The most famous are stereotypies (found in autism), compulsions (found in obsessive-compulsive-disorder, OCD) and tics (found in Gilles de la Tourette syndrome, GTS). For some patients, it is sometime difficult to distinguish the nature of the repetitive behaviors presented, however this distinction is crucial in order to chose the appropriate treatment.

Aim:

In our study, the investigators will try to define electrophysiological and accelerometric marker of both OCD and tics to allow objective distinction between both tics and compulsions.

Method:

Subjects: Both OCD and GTS patients will be recruited, 25 patients in each group.

Protocol: our study protocol will involve two step: a step in laboratory, another step at patient home.

* first step: both patients group will be recorded through a high density EEG and a portative EEG while doing a task of symptom provocation. Then they will get an anatomical MRI for source recontruction. Finally, the patients will have to mimic their symptom while wearing an accelerometer (a smartwatch).
* second step: both patient groups will be recorded at home through a portative EEG while tagging their symptom through a smartwatch (also used for accelerometry). After the recording, the patients will keep the smartwatch for 2 weeks, still tagging their sympoms (compulsions or tics).


Eligibility Criteria:
Inclusion Criteria:

* To be more of 15 years old or less than 65 years old
* To suffer from OCD and/or GTS (depressive, anxious and attention deficit hyperactivity disorder (ADHD) comorbidities are accepted)
* To be registered to the french social security (or something equivalent)
* To give written consent to participate to the research
* To have contraception for women participants (or to not have any sexual activity)

Exclusion Criteria:

* Patients with any other psychiatric disorders than those mentioned in the inclusion criteria
* Patients with any other neurological disorder than GTS
* Patients who are not able to take decisions for themselves
* Pregnant women
* Patients not allowed to get MRI due to contraindication
* Patients not speaking french
Optimizing VIM Targeting for Radiosurgery in Severe Tremor

Essential tremor is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. It is in these most severe forms that surgical lesioning of the ventro-intermediate nucleus of the thalamus (VIM) has been proposed. The VIM and its region of interest are almost impossible to identify directly on imaging (especially MRI), as it is part of the thalamus, which has the same intensity. To identify it, teams use average coordinates from stereotactic atlases (imprecise due to the high inter-individual variability of brain anatomy) or retrospective series of implanted patients. The hypothesis of the present trial is that the VIM-RS-LAT-1.0 algorithm developed by RebrAIn for radiosurgery will enable targeting that is at least as effective as conventional targeting. This is a single-center, controlled study, the primary endpoint of which will be assessed at one year, in a blinded, phase 3, comparative, non-inferiority, randomized study in two parallel groups of patients with severe tremor undergoing radiosurgery. In the control group, VIM will be targeted conventionally, and in the experimental group, VIM will be targeted by the RebrAIn algorithm (VIM-RS-LAT-1.0 model) of radiosurgery.


Eligibility Criteria:
Inclusion Criteria:

* Advanced, disabling, drug-resistant essential tremor
* Patient selected as part of the multidisciplinary concertation meeting on abnormal movements
* Patient aged 18 to 85
* Brain MRI showing no anatomical abnormality contraindicating radiosurgical procedure
* MATTIS ≥ 130
* Subject affiliated to or benefiting from a social security scheme
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)
* Pregnant or breast-feeding women
Percutaneous Microelectrolysis (MEP) Versus Ischemic Compression in Miofascial Trigger Points

The Percutaneous Microelectrolysis ® (MEP®) is a technique that employs a galvanic current up to 990 uA, which is applied percutaneously with an acupuncture needle connected to the cathode. Although it is used in tendinopathies, trigger points and muscle injuries, among other conditions, its bases are mostly empirical and there is lack of evidence.

Ischemic compression is a manual therapy that is usually applied in muscle pain.

Myofascial Pain Syndrome (MPS) usually presents painful myofascial trigger points (MTrPs). One methodology used to quantify the pain in MPS is the algometry, which measures the pressure pain threshold (PPT).

The aim of this study was to compare the effects of MEP® with ischemic compression on MTrPs with algometry.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Between 18 to 30 years old.
* Who referred MTrP in the upper trapezious.
* PPT equal or less than 3 KgF/cm2

Exclusion Criteria:

* Being pregnant.
* Taking analgesic medication at least 24 hours before the intervention.
* Being in physical therapy treatment.
* Needle phobia.
VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.

The increasing number of total knee arthroplasty (TKA) procedures is putting a significant burden on healthcare systems, surgeons and their surgical teams. Technology is introduced to improve accuracy, reproducibility and efficiency of TKA surgery, and a significant portion of the patient population is now being treated using Robotic Assisted Surgery. However, robotic surgeries are believed to have a longer procedure time.

The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.

In this multicentre study, measurements will be conducted in 10 hospitals with 10 selected surgeons across selected countries in Europe and the UK. For each surgeon enrolled, a minimum of five VRAS assisted surgical procedures and five conventional surgical procedures will be observed. The OR set-up will be similar for all cases in the same hospital. The same experienced surgeon will conduct all procedures.

Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic surgeons performing conventional and robot-assisted TKA

Exclusion Criteria:

* /
Diet Induced Intestinal Mucosal Adaptation

Human beings are 'omnivores' meaning that all principal components of food (i.e. the macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal tract. When the gut mucosa is exposed to dietary changes it adjusts its functional behaviour. For example, a fatty diet demands certain digestive mechanisms, whereas others are needed to take care of a carbohydrate rich diet. Such dietary induced changes in appearance and functionality of the small intestinal mucosa have been described in animals but only little is known about it in man. The present project aims at elucidating in man if a 2 weeks diet dominated by either fat or carbohydrates, but with similar energy content, is associated with changes in the small intestinal mucosal appearance and metabolic signalling capacity.


Eligibility Criteria:
Inclusion Criteria:

healthy volunteer not taking prescribed medications BMI ≤25 kg/m2

Exclusion Criteria:

BMI ≥26 kg/m2 smoker previous or current gastrointestinal disease significant abdominal surgery pregnancy/breast feeding drug intolerance of importance (particularly opiates and midazolam used during endoscopy) history of drug addiction
Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children

The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.

The objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.

Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.

Background

1% of children present a prenatal alcohol exposure related disorder. Prevalence of consumption increases every year. In a previous study in Barcelona, 45.5% of ethanol positive meconiums were detected, as a biomarker of maternal consumption of alcohol during pregnancy. The most serious clinical picture including facial, mental and cognitive disorders is Foetal Alcohol Syndrome (FAS). Spain is the second country in adoptions from East Europe, where the consumption of alcohol during pregnancy is most important. The only prevention of FAS is avoiding consumption of alcohol during pregnancy and there is no treatment for its deleterious effects on neurodevelopment.

The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.

Objective To determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.

Methodology Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.

Instrumentalization

1. Cognitive and neuropsychologic diagnostic scales of FAS
2. Determination of values of oxidative stress
3. Determination of control biomarkers of the treatment

Eligibility Criteria:
Inclusion Criteria:

1. FAS diagnosed children between 7 and 14 y.o.
2. Included in a previous cohort (ALMAR)
3. Informed consent by parents

Exclusion Criteria:

1. Refuse of parents to participate
2. Unfulfillment of inclusion criteria
3. Any condition in children preventing from FAS diagnostics tests application