cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
* Infants who are entering their first RSV season at the time of screening

Key Exclusion Criteria:

* Meets national or other local criteria to receive commercial palivizumab
* Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to randomization
* Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
* Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis

The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

United States of America (USA) specific inclusion criterion:

* Participant must be 12 to \< 18 years of age at the time of signing the informed consent/assent.
* All participants must be vaccinated against meningococcal infection from serogroups A, B, C, W, and Y within 3 years and at least 2 weeks prior to the first dose of study intervention administration.

Rest of World (ROW) specific inclusion criteria:

* Participant must be 6 to \< 18 years of age at the time of signing the informed consent/assent.
* All participants must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to study intervention on Day 1. If vaccination occurs \< 2 weeks prior to Day 1, the participants will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination for serogroups A,C,W,Y (and B, where available)

Global inclusion criteria:

* Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
* Positive serological test for autoantibodies against AChR

Exclusion Criteria:

* History of thymectomy, or any other thymic surgery within 12 months prior to Screening
* Untreated thymic malignancy, carcinoma, or thymoma
* History of Neisseria meningitidis infection
* Pregnancy, breastfeeding, or intention to conceive during the course of the study
The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients

This triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. The secondary outcome includes serum p53 and cytochrome C levels and functional status.

Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and swallowing difficulties, was shown to be effective in improving the quality of life of head and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies. Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a consecutive month with no serious adverse events. The purpose of this study is to determine safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.

independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome): adverse effects, health-related quality of life score, tumor response, progression-free survival, serum p53 and cytochrome C levels and functional status

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
2. Finished radiotherapy or/and chemotherapy for at least one month
3. Has at least one measurable target lesion
4. Baseline KPS ≥ 40% or ECOG 0-3
5. Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
6. Able to take the intervention (through mouth or NG tube) without aspiration
7. Able to communicate and consent to the study

Exclusion Criteria:

1. Cannot come back for the follow-up visits
2. Receive or had received N-acetylcysteine during the intervention
3. Has systemic diseases that might interfere with the results
4. Chronic kidney disease that requires dialysis
5. Increased risk of aspiration pneumonia
6. Pregnancy or lactation
7. Untreated infectious diseases
Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese

The main purpose of our study is to examine the physiological adaptations in oxygen transport chain for high-intensity exercise and moderate exercise in overweight and obese humans. The main goals are:

1. To investigate the most effective short-and long-interval training in terms of VO2max, pulmonary diffusion, cardiac output, endothelial function and mitochondrial function.
2. How these physiological adaptations affect the aerobic endurance and performance, and how this training can reduce the risk of cardiovascular diseases related to overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25

Exclusion Criteria:

* Exclusion criteria will be cardiovascular disease or another disease that is not consistent with high physical activity. Subjects should not have exercised regularly before the study.
Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome

Iron deficiency is a common problem that is often treated with the administration of oral iron.

Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria.

This influence is usually undesirable and should be kept as small as possible. With lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.

Iron deficiency affects about one in five premenopausal women. The first line treatment for patients with iron deficiency is an oral therapy with iron-supplements, another option is the intravenous iron supplementation.

The oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and many more in a lot of patients. There is a positive correlation between the appearance of gastrointestinal side-effects and the applicated iron dose.

Only a low fraction of orally taken iron is actually absorbed, even in patients with iron-deficiency. Since only a fraction of the orally administered iron is actually absorbed, the toxicity of high concentrations of iron in the gastrointestinal tract and the altered selection advantages of the bacteria presumably leads to microbiome changes.

The unabsorbed iron is potentially changing the microbiome, which leads to undesirable side effects.

With low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a dosage dependent microbiome change would be expected.

The aim of the study is to determine the magnitude of the microbiome response to daily iron substitution with 12mg and 100mg.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Female gender
* Premenopausal
* Age \> 18 years
* Regular menstrual cycle
* BMI in normal range (18-25kg/m2)
* Serum-ferritin ≤30ng/ml
* No anemia (hemoglobin ≥117g/l)
* No intake of dietary supplements for at least 4 weeks

Exclusion Criteria:

* Pregnancy
* Hypermenorrhea (more than 5 unties/tampons per day)
* Chronic inflammatory disease, psychiatric disorders
* Hypersensitivity to iron supplements
* chronic kidney disease (creatinine \>80 µmol/l)
* Liver disease (ALT \>35 U/l)
* Hypo- or Hyperthyroidism (TSH not between 0.16-4.25 mU/l)
* Intake of medicines that interact with oral iron supplementation (e.g. PPI)\*
Nutritional Intervention for Geriatric Hip Fracture Patients

This is a randomized controlled, observer blinded trial to study the beneficial effect of nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D supplementation whereas the intervention group will receive a moderately high dose protein nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the same rehabilitation program and dietary counseling before discharge. They are followed up 4 weeks after discharge or completion of supplementation. The outcome parameters are nutritional parameters and rehabilitation outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment

Exclusion Criteria:

* Patients who require tube feeding
* Patients in unstable medical condition
* Body mass index (BMI) ≧ 25
* Malignancy
* Conditions with contraindication for high protein diet
* Mentally incapacitated and inability to communicate or understand the consent.
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)

The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).

This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In Phase I, a total of 18 participants will be enrolled ie, 6 patients per dose level (0.7, 1.0 and 1.3 mg/m2) to determine the recommended dose of bortezomib. In Phase II, additional 83 participants will be enrolled. Safety evaluations will include assessment of adverse events, clinical laboratory test, specifically hematological toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with symptomatic or nonsecretory multiple myeloma
* Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
* Participants with a measurable lesion
* Life expectancy greater than or equal to 3 months

Exclusion Criteria:

* Previously received treatment for Multiple Myeloma
* Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain
* Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
* Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection
* Active prior malignancy diagnosed within the last 5 years
* Female participant who is pregnant or breast-feeding
* Participant is enrolled in another clinical research study and/or is receiving an investigational agent
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection)

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study


Eligibility Criteria:
Inclusion Criteria:

Healthy Participants SAD:

* Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
* Participants were healthy individuals;
* Participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial;

Participants with Chronic HBV infection, MAD:

* Chronic HBV infection, and HBeAg negative;
* Patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors;

Exclusion Criteria:

* Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease;
* Participants with major trauma or major surgery within 3 months before trial screening;
* Participants with a history of drug allergy;
* Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines;
* Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant;
* Participants who cannot tolerate subcutaneous injection;
* Patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, and other liver diseases;
* Participants with a clinically significant acute infection;
* Women who were pregnant or lactating or had a positive pregnancy test result;
A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.

The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment including a post-approval amendment with follow-up visits at 7 \& 10 years for eligible subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 75 years old and skeletally mature (male or female).
* Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
* At least six (6) weeks of failed, conservative treatment prior to surgery
* Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
* Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
* Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

* Spondylolisthesis Grade II or higher (25% slip or greater).
* Prior surgery at the index lumbar vertebral level.
* Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
* Any metabolic bone disease.
* Subject has insulin-dependent diabetes mellitus.
* Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV).
* Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
* Subject has a known allergy to titanium, polyethylene or polyester materials.
* Any subject that cannot have a baseline MRI taken.
* Subject is pregnant or interested in becoming pregnant in the next three (3) years.
* Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
* Subject is currently involved in another investigational study.
* Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).
Exploration of the Role of Vision on Spatial Cognition

Atypical developpement of spatial cognition has been shown in congenital bindness with some consequences on mathematic learning (Cattaneo et al., 2010) as well as on the mental representation of spatial maps (Thinus-Blanc \& Gaunet, 1997). This raises the issue of the role of vision in spatial abilities underlying mathematics and locomotion. These difficulties could also be found in case of partial visual deficiency, like very low visual acuity or large peripheral shrinkage of the visual field.


Eligibility Criteria:
Inclusion Criteria:

For all :

* Aged 12 to 25
* Participant not opposed to the research and parents do not oppose participation in the protocol for minors

For healthy volunteers (normal sighted):

- with typical visual development with correction if needed

For participant with Visual Deficiencies:

* with congenital blindness
* or low visual acuity (between 1/10 and 3/10)
* or with visual field peripheral shrinkage (angle \<20°).

Exclusion Criteria:

* General knowledge and working memory skills with a standard score of less than 4
* neurological medical history
* Person deprived of liberty by judicial or administrative decision
* Person subject to a legal protection measure (tutorship, curatorship)
Change in Breathing Pattern on Non-invasive Ventilation of COPD Patients Under Home Mechanical Ventilation

Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients. Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that have to be monitored are not well defined.

Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in software which are recording the breathing pattern of patients when used. The aim of this study is to identify ventilation parameters that are modified at the early stage of an AECOPD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed COPD according to GOLD guidelines
* Established on home non invasive ventilation for more than 2 weeks

Exclusion Criteria:

* None
Sensory Morbidity Following Breast Surgery

The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.


Eligibility Criteria:
Inclusion Criteria:

* The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
* Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
* Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
* Patients who have undergone mastectomy alone
* Patients at least 21 years of age
* Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry

Exclusion Criteria:

* Patients who have had any of the following:
* delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
* Patients who have a pre-surgical history of complex regional pain syndrome
* Patients who have had radiation therapy
* Patients who have had a local recurrence
* Patients who do not speak the English language (validated translations of key questionnaires are not available).
Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency

In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use

* Spontaneous mode (S)
* Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the respiratory rate of the patient
* Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue has to our knowledge only been marginally studied without any consensus.

Eligibility: patients under home bi-level pressure support ventilation for obesity hypoventilation in a stable clinical condition, aged over 18

Methods:

Three consecutive sleep studies in a randomised sequence with usual parameters Inspiratory Positive Airway Pressure(IPAP), Expiratory Positive Airway Pressure (EPAP) and change of only back up respiratory rate (RR): one night in a spontaneous mode, one with an intermediate RR, and one with a RR above that of the patient

Endpoints:

Quality of sleep and sleep structure (polysomnography), patient-ventilator synchronisation and respiratory events under NIV, efficacy of ventilation: oxygen saturation measured by pulse oxymetry (SaO2); transcutaneous capnography (PtcCO2), and comfort.

Eligibility Criteria:
Inclusion Criteria:

* Obesity-hypoventilation (OHS) patients, in stable clinical condition, treated with domiciliary nocturnal non invasive ventilation for at least two months

Exclusion Criteria:

* OHS patients: unstable cardio-respiratory status and/or acute cardio-respiratory failure three months before inclusion.