cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Study of BK1310 in Healthy Infants

The purpose of this study is to:

* (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
* (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

\<Cohort 1\>

* Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
* Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

\<Cohort 2\>

* Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
* Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
* Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

* With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
* Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
* Possibility of anaphylaxis due to food or pharmaceuticals
* With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
* With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
* Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
* Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
* Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
* Participated in other studies within 12 weeks before obtaining consent
* With the gestational age \<37 weeks or weighed less than 2500 grams at birth.
* Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.
Study on the Antibody Level Against SARS-CoV-2 （COVID-19）in Dazhu County in 2023

About 15,000 to 25,000 subjects will be screened. Their information will be collected, venous blood will be sampled, their serum antibody levels will be detected, and the incidence of COVID-19 wil be followed up.

Data of the following will be collected:

1. Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation);
2. Previous disease/surgical history; 3. Previous COVID-19 infections; 4. COVID-19 vaccination history; 5. Infection after this screening; 6. Screening information for COVID-19 antibodies.

Atibody level against SARS-CoV-2 will be test.

Eligibility Criteria:
Inclusion Criteria:

* The age when signing ICF should be ≥3 year, male or female.
* The Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the study.
* Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression.

Exclusion Criteria:

* a history of contraindications for venous blood collection such as thrombocytopenia or other clotting disorders.
* Current severe or uncontrollable cardiovascular disease, endocrine disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic and skeletal system disease, or malignancy.
* If it is not in line with the benefit maximization of the subjects, the investigator determines that it is not suitable to participate in clinical research.
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
* Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg
* Clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria:

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study.
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
* Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.
A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* rheumatoid arthritis \>=6 months;
* lack of response to 1-5 DMARDs or biological agents;
* rheumatoid factor positive.

Exclusion Criteria:

* other chronic inflammatory articular disease or systemic rheumatic disease;
* joint or bone surgery during 8 weeks prior to randomization;
* previous treatment with any cell-depleting therapy.
KEEP Intervention for People Newly Diagnosed With Parkinson's

Parkinson's Disease (PD) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. Research suggests that those detrimental outcomes can be reduced through physical activity (PA) and exercise, especially when those are started early. Educating people with Parkinson's (PwP) on the role of PA and exercise in PD progression can boost PA engagement by increasing enablers such as exercise self-efficacy and removing barriers such as misinformation about exercise and exercise outcomes.

Working closely with PwP and healthcare professionals, a physical health education programme was co-designed to address the needs and preferences of PwP around exercise and PA education. The process was supervised by the patient and Public Involvement group attended by PwP, academics, researchers and clinicians working with PwP.

The study will utilise an assessor blinded randomised controlled design to investigate the acceptability and feasibility of delivering an online physical health education programme for PwP who are newly diagnosed. Thirty PwP, diagnosed in the last 12-months, will be randomly allocated into two groups: 1) the intervention group in which participants will receive online education modules and will be invited to attend virtual group sessions with a specialist neuro-physiotherapist; 2) the control group which will follow the usual care pathway and participants will receive Parkinson's UK booklets.

The aim of the study is to explore an alternative approach to standard care regarding patient education in PD and evaluate the feasibility and acceptability of a co-designed education intervention for newly diagnosed PwP delivered online. Feasibility data will be collected during the study and acceptability data will be assessed via a questionnaire at the end. Outcomes including PA levels, exercise knowledge, exercise efficacy, and participation will be assessed at baseline, post-intervention and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Idiopathic Parkinson's Disease
* Within 12 months since diagnosis
* Stable medication regime for four weeks prior to initiation of trial
* Ability to understand written English

Exclusion Criteria:

* Acute illness
* History of neurological disorder other than Parkinson Disease
* Diagnosis of dementia or significant cognitive impairments
* Participation in NHS structured PD-specific education program with or without exercise classes in the last year
* Unable to understand written English
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by the parents or the legal representatives.
* Patients who completed the FUTURE 1 study.
* Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
* Males or females \>= 2 and \< 12 years of age at enrollment in FUTURE 2 (this study). Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.

Exclusion Criteria:

* Intolerance to bosentan despite dose reductions.
* Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
* Pregnancy or breast-feeding.
* Known hypersensitivity to bosentan or any of the excipients.
* Premature and permanent study drug discontinuation during FUTURE 1.
Effect of Foot Bath on the Severity of Pain, Fatigue and Insomnia in Patients With Acute Renal Failure

One of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath. The aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

Introduction: One of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath.

Objective: The aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

Method: The sample of this study will consist of 54 individuals who meet the inclusion criteria among patients with acute renal failure hospitalized in the internal medicine department of a training and research hospital in Amasya. The research data will be collected using a personal information form, numerical pain scale, fatigue severity scale, and insomnia severity index.

Conclusion: In diseases such as acute renal failure that develop suddenly and require hospitalization, it is important to use and evaluate the effectiveness of simple, applicable non-pharmacological methods in order to quickly control the symptoms of patients and ensure their comfort. The study results will contribute to the literature in this field.

Eligibility Criteria:
Inclusion Criteria:

* Those over the age of 18
* Those hospitalized in the internal medicine clinic with a diagnosis of acute renal failure
* Those who speak and understand Turkish
* Those who consent to participate in the study

Exclusion Criteria:

* Those with cognitive dysfunction
* Those diagnosed with chronic renal failure
* Those with wounds on their feet
* Those whose vital signs are not within normal limits (fever, high blood pressure, bradycardia, tachycardia, etc.)
* Those receiving hemodialysis treatment for acute renal failure
* Those taking medication for insomnia
* Those who did not consent to participate in the study
Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather

Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. \[18F\]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent(\[18F\]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. \[18F\]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram \[ID/g\] at 1 hour post injection\[p.i.\]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of \[18F\]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the \[18F\]AlF-NOTA-Pentixather as a probe for APA.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with primary aldosteronism and willing to undergo surgery
2. Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
3. Postoperative recurrence in patients with primary aldosteronism

Exclusion Criteria:

1. Pregnant and lactating women.
2. Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
3. There are other situations where patients are not suitable for this examination
Ice Versus EMLA for Pain in Laser Hair Removal

The primary objective of this study is to compare the efficacy of ice pack to topical eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary hair removal.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility Criteria:
Inclusion Criteria

1. Subjects are Caucasian or Asian females.
2. Subjects are 18-65 years old.
3. Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair.
4. Subjects are in good health.
5. Subjects can provide informed consent.
6. Subjects have the willingness and the ability to understand and communicate with the investigators.

Exclusion Criteria

1. Subjects who are allergic to lidocaine or prilocaine.
2. History of methemoglobinemia.
3. History of recurrent petechial or purpuric lesions.
4. Bleeding tendency or coagulopathy.
5. History of laser treatment in axilla.
6. History of keloid or hypertrophic scarring.
7. Pregnant or lactating or intends to become pregnant in the next 3 months.
8. Active skin disease or skin infection in the treatment area.
9. Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders.
10. History of cold urticaria.
11. History of current injury or abnormal skin sensation.
12. Unable to understand the protocol or to give informed consent.
13. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to subject.
Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma

Asthma has become increasingly common in the UK, demanding our consideration of the cause. Many patients with asthma are allergic to house dust mites, which thrive in modern housing. Improving ventilation in the home has been shown to reduce dust mite levels, by reducing humidity levels. It is hoped that, by removing the dust mites from homes, asthma may improve. In this study, 140 volunteers will have their carpets steam-cleaned and new allergy bedding provided, before a team of architects installs a ventilation system in the loft. Half of the units will be switched on at the beginning of the study. The other half will be switched on in 12 months time, but only the architects know which units are active. The medical team will compare the asthma, and measures of inflammation in the airways, over that year.

It is due for completion in April 2007.

The prevalence of asthma is rising sharply in the UK. The house dust mite is the most common trigger associated with asthma, thriving in the humid microclimate favoured by modern housing. Could this be redressed by investment in improved ventilation in local housing? In a pilot study in North Lanarkshire Council housing stock, we demonstrated that dust mite avoidance, in combination with installation of domestic mechanical heat recovery ventilation (MHRV), could inhibit the re-colonisation of house dust mites by reduction of indoor air humidity. In this second phase, a double blind randomized placebo- controlled trial will test the resultant effect on asthma. It will be complete in November 2006. 140 patients with asthma and house dust mite allergy are being recruited and all will have new bedding, mattress covers and carpets cleaned. All will have MHRV units installed in their home, but only half will be activated, before 12 months of environmental and clinical monitoring. The primary endpoint is morning peak flow rate. Secondary endpoints include symptom scores, spirometry, rates of exacerbations, quality-of-life, and economic evaluations. Demonstration that well ventilated, energy efficient dwellings improve the respiratory health of patients with allergic asthma could be of considerable importance in helping the NHS cope with the commonest chronic disease in Scotland.

Eligibility Criteria:
Inclusion Criteria:

* House dust mite sensitive
* FEV1 greater than 50%
* Symptomatic asthma or 12% reversibility on spirometry or 15%PEFR lability

Exclusion Criteria:

* Multi-storey flat
Alzheimer's Disease: Therapeutic Potential of Estrogen

This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.

Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.

Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
* Mini Mental State Examination score greater than 15/30

Exclusion Criteria:

* History of cancer of reproductive tissues
* History of deep vein thrombosis or blot clots
* Diabetes
* Heart disease or stroke
* Liver problems including hepatitis
* Severe vision or hearing problems
* Tobacco use
* Lack of an adequate caregiver
* inability to perform psychometric testing
Return to Physical Activities After Total Knee Arthroplasty

The main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels.

There are three purposes of this study. The first purpose is to examine the factors that allow patients that underwent total knee arthroplasty with the Journey II to return to recreational sports and/or work activities, and to achieve recommended physical activity levels (defined by the American Heart Association and the American College of Sports Medicine).

The second purpose is to examine the factors that limit the ability of patients to resume sports, work, and physical fitness training, including comorbidities, general health, complications, and other factors.

The third purpose is to use advanced sports medicine rehabilitation principles that involve staged progressive protocols to safely prepare patients for sports, work, and physical fitness training. Objective measurements of muscle strength, endurance, balance, and neuromuscular control will be used to determine when patients may be cleared to participate in these activities.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 65 years of age or younger.
* Patient indicates before surgery the desire to return to recreational (sports) and/or work activities postoperatively
* Patient provides informed consent.
* Patient complies with postoperative rehabilitation program.

Exclusion Criteria:

* Patient did not desire to return to recreational and/or work activities after TKA
* History of alcohol or drug abuse within 3 years of the operation.
* Disabling or widespread osteoarthritis or other joint disease in any other joint.
* Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
* Any other contraindications that in the opinion of the principal investigator would interfere with the conduct of the study.
Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's effectiveness at motivating smokers to call a Quitline.

Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's impact on: (a) Lung screening participants' motivation to make a quit attempt by calling a Quitline, and (b) the effectiveness of a 45-minute telephone smoking cessation counseling session for motivating an actual quit attempt and abstinence. The RCT will enroll approximately 400 randomly selected participants from lung screening programs at HealthPartners and University of Michigan. Participants will be randomly assigned to one of four conditions: 1) Usual Care + quitline phone number (created specifically for the trial and maintained for the length of the trial); 2) Usual Care + Report (Report will list Quitline number) 3) Usual Care + Counseling, or 4) Usual Care + Report + Counseling. Follow up assessment calls will be conducted with participants at three weeks, three months, and six months following the mailing of the report.

Eligibility Criteria:
Inclusion Criteria:

* 30-pack year smoking history
* currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan

Exclusion Criteria:

* current use of smoking cessation medications
* scan read as a category 3, 4A, 4B or 4X in Lung-RADS
* unstable medical or psychiatric conditions
* current alcohol or drug use disorder
* past-month suicidal ideation
* past-year suicide attempt