cyrilzakka/clinical-trials huggingface dataset:
Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial

This clinical trial adopts a randomized, double-blind and placebo-controlled design.

A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.

Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.


Eligibility Criteria:
Inclusion Criteria:

* Age range: healthy population aged ≥18;
* Judged by the investigator that the health condition is well after inquiry and physical examination;
* Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
* Be able and willing to complete all prescribed study schedules during the whole study period;
* The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.

Exclusion Criteria:

* Symptomatic and suspected COVID 19 infection positive ;
* Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
* Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
* Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
* Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
* With known immunological impairment or compromised immunological function diagnosed by the hospital;
* Received whole blood, plasma and immunoglobulin therapy within 1 month;
* Known or suspected of suffering from the following diseases: acute or chronic active respiratory diseases, severe cardiovascular diseases \[cardiopulmonary failure, hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg)\], acute infection, active phase of chronic disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be provided)
* Received live attenuated vaccine within one month before vaccination;
* Received inactivated vaccine within 14 days before vaccination;
* Other contraindications related to vaccination that investigators believe.
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals.

Main objective:

To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine.

Secondary objectives:

To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy. To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected adults, age \>= 18 and \<60 years old.
* CD4 \> 200 cells/mm³ within the last 6 months prior to inclusion. Individuals with no CD4 results in the last 6 months which have undetectable HIV viral load and last CD4 count \> 350 can be included.
* Healthy HIV-uninfected individuals (aged \>= 18 and \< 60)
* No history of Yellow Fever vaccination
* Willing to participate and to sign the consent

Exclusion Criteria:

* Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for non-melanoma skin cancer and in situ HIV related carcinoma), use of immunosuppressive agents (including prednisone ≥ 20mg/day, during 7 or more days in the last 30 days before inclusion).
* Pregnant women
* Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
* Administration of immunoglobulins or blood derivates \< 3 months or life attenuated vaccine \<1 month.
* History of thymic dysfunction (including thymoma and thymectomy).
* Use of anti-CCR5
* symptoms of severe acute illnesses or fever (axillary temperature ≥ 38°C)
* HIV positive rapid test for HIV negative subjects.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control

To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second group of subjects will receive VRA with Oculus Rift, and a third group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint-this group will serve as the control group.

Group 1: Oculus Rift This group will receive BTI's per conventional protocols. They will wear the Oculus Rift VRHMD (Figure

1) powered by the laptop pc (Figure 2) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above.

Group 2: Google Cardboard VRHMD This group will receive BTI's per conventional protocols. They will wear the Google cardboard VRHMD (Figure 3) powered by iPod touch/smartphone (Figure 4) during the procedure viewing a VR 360 degree video of their choice. Measurements in pain and anxiety will be taken per the outcome measures listed above.

Group 3. Control This group will receive BTI's per conventional protocols without VRA intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children with spasticity requiring BTI
* Children ages 5 - 18
* Children who have contraindications for sedation for BTI
* Children with intact vision who can attend VR intervention

Exclusion Criteria:

* Children who have uncontrolled seizures \> than 4 per year
* Children who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
* Children on different treatments for spasticity such as baclofen pump, phenol block. For patients who receive phenol block, phenol block will be held during the visits with VR intervention to avoid confounding results
* Children with poor bleeding control
* Children who request general anesthesia/IV sedation.
Tiotropium/Salmeterol Inhalation Powder in COPD

The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations


Eligibility Criteria:
Inclusion criteria:

Main:

Diagnosis of COPD Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted

Exclusion criteria:

Main:

Significant other diseases then COPD Recent MI Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma
Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial

About 60% of children with cerebral palsy (CP) have impaired arm function. Improving arm function requires hundreds of repetitions per day, which is impossible in a single clinical visit. Thus, therapeutic exercises should be sustained in the home environment; however, the compliance in performing home exercise is low due to poor motivation, boredom, and forgetfulness. A better home program is needed. The objective of this project is to examine the effect of our developed "THRIVE" system (Therapeutic Humanoid Robot In Virtual Environment: the combination of robot with virtual reality games), which can provide a motivating and tailored upper-extremity intervention program with instant feedback, to improve arm function in children with CP at their home. The investigators believe the newly developed "THRIVE" system can increase children's engagement and motivation in home exercises as the robot is their playmate to demonstrate and correct their movements. The investigators will also interview parents and children with CP to understand their impression of using technology at home to shape the intervention. The expected outcome is that children with CP receiving "THRIVE" will improve their arm function more and have better engagement than those who receive VR alone immediately after intervention and at follow-up. The long-term goal is to have the "THRIVE" system be the optimal home exercise platform as it can provide challenging but motivating exercises to improve children's arm function while assisting parents in supervising their children with CP to complete home exercises.


Eligibility Criteria:
Inclusion Criteria:

1. Participants are between the ages of 5 and 21 years;
2. diagnosed with spastic CP;
3. have a manual ability classification system (MACs) level I-III;
4. able to sit with trunk supported;
5. are able to reach forward for more than half of their arm length;
6. are able to comprehend and complete a three-steps commands;
7. are able to see a TV screen (with or without corrected vision); and
8. their primary caregiver is willing to follow the desired intervention dosing and all evaluation measurements.

Exclusion Criteria:

1. they have received surgery or botulinum toxin type A injection in the training arm within the preceding 4 months or are scheduled to receive it during the planned intervention period, or
2. if they have a severe attention deficit or uncontrolled epilepsy, which may possibly be triggered by the light or sound of the video games.
A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants

The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration
* A condition of general good health, based upon the results of a medical history, physical exam

Exclusion Criteria:

* Has not participated in another \[14C\] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening.
* Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
* Prior exposure to ABBV-932 or cariprazine within the past 90 days.
Creation of a Pressure Reducing Areas in Socks

Evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing.

Increased pressure in weight bearing areas of the foot, especially in insensate feet may lead to the development of pressure sore. The creation of socks with pressure relieving areas by special weaving technique may prevent the development of these complications.

Three (3) volunteers will be examined walking on a Tekscan pressure mat, barefoot and then wearing socks weaved in a new technique, from cotton, nylon and acrilan.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* foot deformity
Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.

Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. The aim of the present study was to investigate the effects of a medium-chain triglyceride (MCT)/n-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile in preterm neonates. Methods: In this double-blind randomized study, 92 preterm neonates (gestational age \<32 weeks, birth weight \<1500g) were assigned to receive either MCT/n-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Neonates' parents gave their informed written consent for inclusion in the study. Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry.


Eligibility Criteria:
Inclusion Criteria:

Preterm neonates with gestational age \<32 weeks

* birth weight \<1500 g
* admitted to a tertiary neonatal intensive care unit within 12 hours after birth

Exclusion Criteria:

* anticipated needs for parenteral nutrition (PN) at ˃70% of total daily energy for \<10 days evidence of intrauterine infection,
* perinatal asphyxia
* major congenital anomalies
* refusal of parental consent
Exercise as an Adjuvant to Aphasia Therapy

The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity.

The objective of this research project is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities with treatment than patients who do not participate in aerobic activity. As secondary objectives, we will determine if there is a direct relationship between either brain efficiency or increases in Brain Derived Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke aphasia
* at least 6 months post-stroke
* at least minimally intact auditory verbal comprehension
* pre-morbidly right handed
* native English speaker

Exclusion Criteria:

* contraindications for fMRI (metal implants, claustrophobia)
* inability to pass an exercise tolerance test
* significant depression
* uncorrected hearing or vision problems
* severe apraxia of speech
* regularly perform 20 minutes of cardiovascular exercise 3 times per week
China Betaferon Adherence, Coping and Nurse Support Study

Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients
* Having Betaferon treatment, including patients who are

  * First time using; or
  * Re-staring; or
  * Switching from other diseases modifying drugs (DMDs)

Exclusion Criteria:

* Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).
AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

Eligibility Criteria:
Inclusion Criteria:

* de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7
* de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T
* written informed consent

Exclusion Criteria:

* severe comorbidities
* severe uncontrolled complications of the leukemia
* previous therapy of leukemia/MDS
* HIV-Infection
* known relevant allergy against study medication
* pregnancy
* missing written informed consent
Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)

An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8 weeks. Efficacy will be monitored by measuring clinical scores including motor and urination function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid. Safety will be evaluated at the same time.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed as HAM according to the WHO criteria
* Patients who are positive for HTLV-I antibody in the spinal fluid
* Patients, if female, who are not pregnant or breastfeeding, either agreed to take contraceptive measures during and two years after the treatment, or sterile
* Patients, if male, who agreed to take contraceptive measures during and six months after the treatment
* Patients who have been informed and understood the contents of the study and consented to participate in the signed form.

Exclusion Criteria:

* Patients who has a rapid progress in the symptoms defined as an increase of two or more in Osame's Motor Disability Score for HAM patients in the past one year.
* Patients of hyperlipidemia (serum triglyceride higher than 400 mg/dL)
* Patients who were administered new or increased dose of corticosteroid in the past 8 weeks before the intervention
* Patients who received steroid pulse therapy in the past 8 weeks before the intervention
* Patients who were administered new or increased dose of immunosuppressant in the past 8 weeks before the intervention
* Patients with a history of serious drug allergy
* Patients with significant complication such as malignancy, severe heart failure, and other serious diseases.
* Patients who were in the past administered etretinate.
Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations

This study will test if local therapies in addition to erlotinib can improve responses and delay the time until new treatment is required. This study will also collect blood samples for research blood tests.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion):
* all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology
* all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion.
* Each brain metastasis is included as a distinct lesion.
* Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib.
* Lung adenocarcinoma histology confirmed at MSKCC.
* Available archived tissue to perform molecular analysis
* Patients without available archived tissue can have repeat biopsies to determine EGFR status as per standard clinical care guidelines
* Age 18 years or older
* Karnofsky Performance Status ≥ 70%
* Adequate bone marrow, liver and renal function, as specified below:
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
* Hemoglobin ≥ 8 g/dL
* Platelets ≥ 100 x 109/L
* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
* AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
* Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

* Treatment with erlotinib prior to developing metastatic disease
* Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR T790M)
* Malignant pleural effusion or pleural disease
* Leptomeningeal disease
* Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy
* Women who are breastfeeding or pregnant
* Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment.
* Any medical co-morbidities that would preclude surgery or radiation therapy
An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics

The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.


Eligibility Criteria:
Inclusion Criteria

* Insulin-dependent diabetic
* Age 18+
* Shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs
* Use of glucometer for blood sugar monitoring
* Well controlled blood glucose levels
* Hemoglobin A1c less than or equal to 7.5

Exclusion Criteria

* Previous corticosteroid injection within the past 6 months
* Active infection
* Pregnant or plan on becoming pregnant
* Previous adverse event with corticosteroid or lidocaine use