cyrilzakka/clinical-trials huggingface dataset:
HBV Vaccination in HIV-infected Adults

The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.

* A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness
* After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* On combination antiretroviral therapy (cART)
* CD4 ≥ 200 cell/mm3 for ≥ 1 year
* HIV viral load \< 20 copies/ml for ≥ 1 year
* Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening

Exclusion Criteria:

* Pregnancy
* Previous HBV vaccination
* Intolerance to any component of HBV vaccine
* Transaminitis in the past 3 months (≥ 5 UNL)
* Ongoing opportunistic infection (OI)
* Active malignancy, with current chemotherapy or radiotherapy
* Systemic steroid therapy (≥ 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months
* Other immunocompromised disorders (e.g. solid organ transplant)
* Asplenism
* Renal insufficiency (CrCl ≤ 30 mL/min)
* Decompensated cirrhosis (Child-Pugh C)
Prevalence of COPD in Our Lung Cancer Population, Compared to Controls

This study will investigate the prevalence of chronic obstructive pulmonary disease (COPD) in patients who are newly diagnosed with lung cancer and compare it to the prevalence of COPD in controls recruited from a smoking cessation clinic.

Chronic obstructive pulmonary disease (COPD) is a breathing problem that some people develop. Usually it is caused by smoking. Damage to the lungs means that patients are at risk of more chest infections and are unable to exercise like healthy individuals. They may also have a long-standing cough.

COPD is diagnosed by testing lung function, usually using a small device called a spirometer.

COPD is becoming a better understood condition. It is known that the lungs of patients with COPD are sometimes inflamed. This is important because inflammation is associated with some types of cancer, including lung cancer.

The investigators are interested in whether COPD puts people at higher risk of lung cancer. They would like to find out how common COPD is in patients who have lung cancer. The investigators would also like to find out how common COPD is in patients who are not known to have lung cancer (comparison group). This will help them interpret their results better as investigators will be able to compare the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Aged over 18
* Lung cancer group: new diagnosis of lung cancer, with spirometry results available Control group: spirometry result available or obtained

Exclusion Criteria:

* Patient refusal
* Age under 18
* Control group: pre-existing lung cancer
Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Diffuse diabetic macular edema
* Non proliferative diabetic retinopathy
* No VPP previa
* No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria:

* Proliferative diabetic retinopathy
* Previous pars plana vitrectomy
* Previous treatment with diabetic macular edema
* Focal macular edema
* Macular Ischemia
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.

A double-blind (Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must have not smoked in the last 30 days prior to screening for this study. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Subjects where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable. 3. Past history of central serous retinopathy or retinal vein thrombosis,intraocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History or presence of any clinically significant disease or disorder in the opinion of the investigator.
Functional Activity Strength Training

This study is a randomized trial of 100 older adults with mobility disability, who performed a similar brief daily, resistance training program. The investigators set out to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" To answer that question, participants were assigned to an intervention or delayed-treatment control group. Intervention participants were assigned to complete two 30-second lower body exercises and two 30-second upper body exercises. Fitness tests were completed remotely three times during the 12-weeks (i.e., at baseline, week 6, week 12).

This is a 12-week delayed-control randomized trial to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" Participants who screen eligible will be assigned to one of four conditions, an immediate workout group, an immediate workout group with activity monitor, a delayed workout group or a delayed workout group with activity monitor. Participants will complete a daily 2.5-to-3.5-minute exercise routine at home and to record their results using an electronic survey. Other outcome measurements will be conducted remotely at baseline, 6, and 12 weeks.

The investigators hypothesize that participants in the AMRAP condition will report significant reductions in functional physical limitations, increased gait speed, and increased physical performance (i.e., increased exercise repetitions) from baseline to 6 weeks compared to those randomized to the delayed-treatment control.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and older
* Difficulty with walking
* Providers must provide consent for their patient
* Access to the internet
* Must have a camera on computer, tablet, or smartphone
* Fluent in Egnlish

Exclusion Criteria:

* Chest pain or a heart condition on the PAR-Q
* Planning to have surgery in the next 3 months
* Cognitive impairment
* Unable to exercise
* Being currently physically active
Dulce Digital-Project Dulce 2.0 Texting Study

Randomized controlled trial testing the efficacy of a text messaging intervention in a low income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address barriers to participation in health education classes, increasing adherence to treatment and medications and improving diabetes self management behaviors and skills. Two community clinic organizations that provide services to a large proportion of Latino patients with type 2 diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes management care (control) only or text messaging and standard care. Comparisons between groups will evaluate clinical, behavioral and psychosocial outcomes.

Intervention: Standard Care and Text Messaging. All participants will receive standard diabetes care provided by primary care providers at the clinic. Of the 100 that are randomized to the intervention arm will be given instructions on how the text messaging component will be addressed throughout the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75,
* Type 2 DM,
* Enrolled at community health center,
* Latino ethnicity,
* non Project Dulce participant,
* HbA1c\>/= 8%, must be able to read

Exclusion Criteria:

* Have a severe illness precluding frequent visits to the clinic,
* have a severe medical condition, poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study, any history of malignancy, except subjects who have been disease-free for \>10 years, or whose only malignancy has been basal or squamous cell skin carcinoma,
* patients who have a creatinine level greater than 3.5,
* any history of drug or alcohol abuse within 12 months prior to the study,
* those who are not a permanent resident in the area.
* Patients who are not willing to use a cell phone with texting capability.
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction

This study will investigate the efficacy of oral gabapentin in olfactory improvement following Covid-19- associated olfactory dysfunction. This is a randomized, double-blinded, placebo-controlled trial.

The drug will be given over a maximum 14 weeks with up to four weeks titrating up, eight weeks maintaining highest tolerable dose, and up to two weeks tapering down. Change in olfactory function from baseline to completion of 8-week fixed-dose period will be compared between the two study groups. Follow-up assessments will be conducted for both groups 4 weeks after completion of taper down.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 and 65 years
* Residing within the states of Missouri or Illinois
* Clinically diagnosed or subjective olfactory dysfunction (anosmia, hyposmia, or parosmia) of 3 months duration or longer diagnosed within 2 weeks of Covid-19 infection
* UPSIT score consistent with diminished olfactory function (score ≤ 33 in men and ≤ 34 in women).
* Willing to respond daily to study surveys, preferably through smartphone with unlimited texting plan
* In possession of ALL 7 household items: soap, burnt candle, peanut butter, herb, garlic, lemon, and coffee

Exclusion Criteria:

* Clinically diagnosed olfactory dysfunction secondary to genetic abnormalities or congenital dysfunction, trauma, non-Covid-19 viral infection, nasal polyps, neurodegenerative disorders
* Current use of: azelastine, bromperidol, orophenadrine, oxomemazine, kratom, paraldehyde, or thalidomide
* History of addiction to alcohol, cocaine, or opioids
* Impaired renal function, myasthenia gravis, or myoclonus
* Severe allergy to peanuts
* Pregnancy or attempting pregnancy during study participation
* Inability to participate in virtual trial due to lack of access to the internet or unlimited text messaging; inability to comprehend or use English language
* Availability less than 6 months from time of enrollment
* Residency in states other than Missouri or Illinois.
Respiratory Microbiota and Immune Response in CVID

Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary antibody deficiency diagnosed by their treating physician
* Controls will not have a diagnosis of immunodeficiency of any sort
* Male and female patients will be enrolled evenly

Exclusion Criteria:

* Patients who self identify as pregnant
* Patients with asthma or chronic obstructive pulmonary disease (COPD) that are not well controlled clinically
A Study Examining Effects of Apples/ Apple Products on Heart Disease Risk

This study will examine if health benefits of consuming nutrient-rich apples, an apple extract and freeze dried apple product will be similar. 50 volunteers at increased risk of heart disease will consume either a low apple diet (\<1 portion/d), 2 high or low polyphenol apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten participants per group, randomly assigned). Apart from the extract group, all volunteers will consume a placebo. All volunteers will follow a low apple diet (\<1 apple per day) other than what has been provided by the research team. Volunteers will complete food diaries at the start and end of the study and a number of questionnaires. Blood and urine samples collected at 0 and 4 weeks

Many products (such as bioactive extracts) attempt to replicate health benefits of a diet rich in fruit and vegetables, however, it is not known whether similar health benefits can be gained from consuming these processed products. A placebo-controlled intervention study will examine if health benefits are similar between products. Volunteers will have one risk factor for heart disease. Recruitment will be by advertisement from QUB and general public. Apples/apple products will be provided for the 4 weeks, but otherwise volunteers' normal diet and lifestyle will be followed. Blood and urine samples will be collected at week 0 and week 4. 4-day food diaries will be completed at the start and end of the study. A number of questionnaires (physical activity, lifestyle, levels of liking, tolerability to study products, study evaluation) will be completed at the start and end of the study. As this is a pilot study, power calculations were not considered appropriate. Statistical analysis will be carried out in SPSS, each endpoint of interest from the week 0 measure will be compared between the five intervention groups by one way analysis of variance.

Eligibility Criteria:
Inclusion Criteria:

* \> 50 years old or
* Current Smoker or
* Systolic Blood Pressure 120-139mmHg/ Diastolic Blood Pressure 80-89mmHg or
* Total Cholesterol \>5.2mmol/l or HDL cholesterol \<1.03mmol/l or
* BMI \>25 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* An acute coronary syndrome or transient ischaemic attack within the past 3 months
* Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
* Oral anticoagulation therapy
* BMI \>35 kg/m2
* Excessive alcohol consumption (\>28 U/week men or \>21 U/week women)
* Pregnancy/ lactation
* Taking antioxidant supplements
* Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
The Effect of Low Level Laser Therapy (LLLT) in Myofacial Pain Syndrome

Temporomandibular disorders (TMDs) are the major cause of non-dental pain in orofacial area. Laser therapy can be considered as one of the most recent treatment approaches in the field of physiotherapy. The special features of laser light such as coherence, monochromaticity, and collimation can result in the ability of laser light to modify cellular metabolism, increase tissue repair and reduce edema and inflammation. Several studies demonstrated successful results regarding the use of low level lasers in releasing pain of musculoskeletal conditions, but there are also contradictory reports in this field, and the clinical effectiveness of this treatment modality has been debated in some review articles. A few studies evaluated the efficacy of low level laser therapy in the treatment of temporomandibular disorders and the associated myofacial pain. There are remarkable variations in the methodology of these researches and some reported insufficient data regarding the physical properties of the laser used. The aim of this study is to evaluate the effectiveness of low level laser therapy in improving the sign and symptoms of patients suffering from myofacial pain syndrome.

This study will be implemented on 20 patients referring to Department of Prosthetic Dentistry of Mashhad Dental School. The patients are selected according to the RDC/TMD criteria to include those having temporomandibular disorders with muscular origin. The patients will be randomly assigned to two groups: Group 1 (treatment group) will receive low level laser therapy. The laser light will be applied with 890 nm diode laser (Mustang 2000+, Russia) with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the painful muscles.

In Group 2 (placebo) the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects. Laser therapy for both the treatment and placebo groups will be applied on all painful muscles three times a week for four weeks. Patients will be evaluated at the start of the treatment, after the 6th and 12th sessions of laser therapy and also one month after the end of the treatment. At each evaluation, the maximum mouth opening with or without pain and masticatory muscle tenderness will be measured. Pain will be measured through the Visual Analogue Scale (VAS). The range of lateral and protrusive mandibular movements, and the difficulty in chewing food will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The patients are selected according to the RDC/TMD criteria to include those having temporomandibular disorders with muscular origin.

Exclusion Criteria:

1. Patients with disk displacement (with or without reduction)
2. patients with temporomandibular joint arthralgia or osteoarthritis
3. patients with systemic disease affecting temporomandibular joint
4. patients receiving analgesic or antidepressant drugs
A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming

This single-center, split-body, double-blind, randomized, controlled clinical trial was conducted to assess the efficacy and tolerance of a topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.

This single-center, split-body, double-blind, randomized, controlled clinical trial is being conducted to assess the efficacy and tolerance of the topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms.

Efficacy and tolerance will be assessed through clinical grading at baseline and weeks 4, 8, and 12. Efficacy will also be assessed through Corneometer and upper arm circumference measurements at baseline and weeks 4, 8, and 12, and Cutometer and Ultrasound measurements at baseline and weeks 8 and 12. Self-assessment questionnaires will be completed at baseline and week 12. Digital images will be taken at baseline and weeks 4, 8, and 12. Vectra H2 3D images will be taken at baseline and weeks 8 and 12. BMI will be measured at baseline and weeks 8 and 12. Biopsies will be collected from a subgroup of at least 10 subjects at baseline and week 12 (two biopsies on each arm at each time point; total of 8 per biopsy subject).

A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 40 and 60 years
* Mild to moderate skin crepiness upper arm region
* Mild to moderate sagging skin upper arm region
* Mild to moderate overall photodamage upper arm region
* Willing to maintain their body weight within +/- 6.5 pounds

Exclusion Criteria:

* Diagnosed with known allergies to skin care products
* Who have had massive weight loss
* Who have undergone liposuction and/or weight loss surgery in the last 5 years.
* Who are nursing
* Who are pregnant
* History of skin cancer within the past 5 years.
* Having a health condition
* Having a history of immunosuppression/immune deficiency disorders
* Currently using oral or systemic immunosuppressive medications and biologics
* Currently using or having regularly used corticosteroids
* Having a disease such as asthma
* Having started a long-term medication within the last 2 months.
* Who started hormone replacement therapies (HRT)
* Having had brachioplasty (upper arm lift);
* Having liposuction
* Having cryolipolysis
* Having undergone a weight-loss diet or exercise habit change in the last 3 months or planning to start either during the study.
* Having used any of the indicated products or had any of the listed procedures on the upper arms within the indicated time frame prior to the study start date.
Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery)
* Recent chest CT scan (within 14 days)
* No MRI contraindications
* The guardian of the children are willing to undergo the examination after full communication and informed consent

Exclusion Criteria:

* MRI contraindications (including but not limited to: contrast medium allergy; Claustrophobia;Metal implants;chronic kidney disease≥stage 3 (glomerular filtration rate \< 60 mL min-1 (1.73 m2)-1))
* Patients with hepatoblastoma aged 14 years and above
* Children after surgery for hepatoblastoma
* Application of any contrast medium within 24 h before the MRI and/or CT examinations
* There is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.