cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia.

This clinical trial is a single-blind, randomised study to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccine (Pfizer-BioNTech) as booster dose in adults, who have previously received either Sinopharm (BBIBP-CorV®), AstraZeneca (ChAdOx1-S, or Vaxzevria®) or Sputnik V (Gam-COVID-Vac®) as their primary doses 6 to 9 months earlier. Both standard and fractional doses will be tested.

Participants are healthy adults aged 18 years or older, with no upper age limit. Procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution (\<50 and ≥50 years) in each group. There will be a total of 6 groups (Sinopharm-standard dose Pfizer, Sinopharm-fractional dose Pfizer, AstraZeneca-standard dose Pfizer, AstraZeneca-fractional dose Pfizer, Sputnik - standard dose Pfizer, Sputnik - fractional dose Pfizer), with 200 participants per group for Sinopharm and 100 for AstraZeneca and Sputnik.

As per brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Have completed two doses of Sinopharm, AstraZeneca or Sputnik vaccines with the recommended schedule 6 months prior to the date of enrolment
2. Willing and able to give written informed consent
3. Aged 18 years or above
4. Willing to complete the follow-up requirements of the study

Exclusion Criteria:

1. Received 3 doses of COVID-19 vaccine
2. Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
3. Currently on immunosuppressive medication or anti-cancer chemotherapy
4. HIV infection
5. Congenital immune deficiency syndrome
6. Has received immunoglobulin or other blood products in the 3 months prior to vaccination
7. Study staff and their relatives
8. Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exception to receiving further COVID-19 vaccines
Calcium Intake, Metabolism, and Gestational Blood Pressure

To determine if low dietary calcium intake and disturbances in maternal calcium metabolism were associated with increases in blood pressure in late pregnancy.

BACKGROUND:

The importance of maintaining dietary calcium intake and normal calcium metabolism for optimal regulation of arterial blood pressure has been demonstrated in humans and animals. Recent reports have suggested that low dietary calcium intake and disturbances in maternal calcium metabolism are associated with increases in blood pressure in late gestation. These factors may be associated with an increased risk of developing pregnancy-induced hypertension.

This study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.

DESIGN NARRATIVE:

Blood pressure, nutrient intake, and markers of calcium metabolism were prospectively assessed in normal, pregnant women. Nutrient intakes, including dietary calcium, were assessed during gestation weeks 24, 28, 32, 36, and the postpartum period using 3-day food records and 24-hour dietary recalls. Concomitantly, serum measures of calcium metabolism were assessed including serum total and ionized calcium, parathyroid hormone, calcitonin, vitamin D concentration, serum magnesium, phosphorus, sodium, and potassium concentrations. During weeks 24 and 32, urinary excretion of sodium, calcium, magnesium, potassium, phosphorus, cAMP, and creatinine were measured. Blood pressures were measured at every prenatal visit and postpartum. Measures of infant growth and blood pressure were assessed at 1, 6, and 12 months of age to determine if maternal dietary calcium intake exerted long-term influences on infant development and blood pressure.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Collection of Serum Samples in Studying Emotional Stress in Patients With Prostate Cancer

This pilot research trial studies the collection of serum samples in studying emotional stress in patients with prostate cancer. Studying serum samples from patients with prostate cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol, substances the body makes when stressed, rise or fall with how patients are feeling and/or if those levels are related to clinical information related to prostate cancer.

PRIMARY OBJECTIVES:

I. To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with perceived stress or distress over time in two to five consecutive visits.

SECONDARY OBJECTIVES:

I. To determine the change in serum epinephrine levels in men with prostate cancer over time in two to five consecutive visits.

II. To determine the change in serum cortisol levels in men with prostate cancer over time in two to five consecutive visits.

III. To determine the change in levels of stress in men with prostate cancer over time in two to five consecutive visits IV. To determine the change in levels of distress in men with prostate cancer over time in two to five consecutive visits.

TERTIARY OBJECTIVES:

I. To determine if serum epinephrine or cortisol levels in men with prostate cancer correlate with prostate cancer progression two to five visits.

OUTLINE:

Patients undergo collection of serum samples for epinephrine and cortisol levels at baseline and 4 clinical visits. Patients also receive the Self-Perceived Stress questionnaire and the Distress Thermometer questionnaire to measure perceived stress.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
* Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators
Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.

This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1\<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1\<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).

Eligibility Criteria:
Inclusion Criteria:

* FEV1\<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma

Exclusion Criteria:

* other chronic lung disease, \>15 pack years smoking
Health Equity and Rural Education (HERE!) Clinical Trial

The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools.

The main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health/mental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents/guardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents/guardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.

The HERE pilot study will consist of two phases to strengthen and finalize the HERE school-based community health worker (SB-CHW) intervention. The 6-month Phase I will provide broad stakeholder feedback on the proposed model and rationale, the SB-CHW intervention, the associated domains and measures, and the evaluation. The following 18-month Phase II will align with the school year and provide a feasibility test of the training, intervention, data collection, and analyses.

Eligibility Criteria:
Phase I Stakeholder Interviews (nonintervention):

Inclusion Criteria:

* A member of the program's Community Advisory Board, including community health workers;
* Caregiver of a child ages 12-18 from the Southeast Kansas region; or
* Student at least 12 years in age.

Phase II Feasibility Pilot- SB-CHW Intervention and Enhanced Usual Care Conditions

Inclusion Criteria:

* Children in grades 6-12 (ages 12-18) and their parents/guardians from the Southeast Kansas region
* Student with or at risk for chronic poor attendance (missing 10% or more of the days that school has been in session at any point in the school year)

Exclusion Criteria:

* Parents/guardians or youth with profound intellectual/cognitive disability will be excluded.
Pictorial Representation of Illness and Self Measure

PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. This is an international, multicentre study to evaluate the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges, Montreal and Queensland. The study will recruit 200 patients in total.

In addition to the procedures for the patient's routine clinical visit, the patients will be invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be asked to attend 3 times over 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Written confirmed diagnosed of rheumatoid arthritis

Exclusion Criteria:

* A diagnosis of any of the following:
* Multiple sclerosis
* Motor neurone disease
* Parkinson's disease
* Alzheimer's disease
* Depression or anxiety disorders as identified using the Patient depression screening questions from the patient health questionnaire 9 (PHQ9).
Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.

This study will help the study team determine how the experimental, non-opioid pain control regimen affects opioid-related side effects, participant satisfaction with pain management, PACU length of stay, hospital length of stay, chronic pain level, and chronic pain-related disability in participants, and to determine the safety and tolerability of the non-opioid pain control regimen in head and neck cancer patients undergoing cancer surgery with free flap reconstruction. Ketamine, Lidocaine, Acetaminophen, Gabapentin, and Celecoxib are FDA-approved drugs that have been approved for use individually, and have been used in combination for perioperative pain control. However, the use of these five drugs together in head and neck cancer patients undergoing free flap reconstruction has not been studied, which is why this study is experimental.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing head \& neck free flap reconstruction at the Cleveland Clinic Main Campus
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ketamine, Lidocaine or other agents used in this study
* Subjects receiving any other investigational agents
* Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days
* Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days
* Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and EtOH) within the past 6 months
* Pregnancy
* Contraindication to lidocaine (heart block, heart failure with EF \< 30%) as determined by history of Congestive Heart Failure, or as determined by preoperative evaluation for surgical clearance
* In the opinion of the investigator, subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Clinical Tial of Er:YAG Laser Snoring Treatment

Two modes of laser (Er:YAG) treatment for snoring will be compared with sham treatment in a randomized clinical trial.

The aim of this study is to evaluate the clinical outcome of snoring treatment using non-ablative Er:YAG laser in comparison with sham laser treatment. Furthermore, to different modes of Er:YAG laser will be compared; a long-pulse mode (LP) and proprietary SMOOTH mode (Fotona, Slovenia).

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed consent form
* Diagnosis of snoring/apnea including partner information
* Age greater than 18 years.
* Apnea-Hypopnea index (AHI) less than 30.
* No significant nasal stenosis.
* Bed partner present

Exclusion Criteria:

* People who refuse to participate in the study
* Presence of concomitant disorders and/or diseases
* Infections in the throat
* current use of photosensitive drugs
* pregnancy
* scarring in the throat
* acute pollen allergies
* epilepsy
* People starting with an extreme diet or weight loss plan
* Patients who do not want to follow post treatment recommendation concerning food and drinks intake
* Larynx obstruction (floppy epiglottis)
* Oropharynx obstruction caused by palatine tonsils (\>50%).
Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 80 years at screening;
2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;

4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.

Exclusion Criteria:

1. Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;
2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
3. Neurological signs have improved rapidly and spontaneously at screening;
4. Subjects who have used or are using protocol-prohibited medications after the onset;
5. Subjects with pre-stroke disability;
6. Subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment;
7. Massive infarction on imaging;
8. Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
9. Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg after active antihypertensive therapy;
10. Acute hemorrhage tendency;
11. Blood glucose level \< 50 mg/dL or \> 400 mg/dL;
12. Active visceral hemorrhage;
13. Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results;
14. International normalized ratio \> 1.7 or prothrombin time \> 15 s;
15. Subjects with a history of serious hypersensitivity;
16. Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
17. Subjects who underwent any major surgery before screening;
18. Subjects with a history of active digestive ulcer before screening;
19. Subjects who experienced hemorrhagic disease before screening;
20. Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
21. Serious hepatic impairment or serious renal insufficiency;
22. Subjects who have participated in another investigational study and used investigational product before screening;
23. Other conditions unsuitable for participation in this study determined by the Investigator.
The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises in Cerebral Palsy

The aim of the study; To investigate the effects of Instrument Assisted Soft Tissue Mobilizations and Stretching Exercises on flexibility, spasticity, balance and functional mobility in patients with CP.

Various intervention studies; reported positive results with EDYDM after carpal tunnel syndrome, myofascial trigger point, chronic low back pain, nonspecific thoracic spine pain, ankle instability, mastectomy and total joint arthroplasty. Observational studies have shown positive results in improving posterior shoulder range of motion, hip, knee, and ankle ROM.

There is no study in the literature with EDYDM in patients with CP. Many of the problems in which EDDM is applied for fascia and muscle mobilization in different diseases are also seen in patients with CP. In current rehabilitation methods, Stretching Exercises are applied for muscle and fascia shortening. The advantages of the applications over each other are unknown. Our study is planned as a study with high original value as it is the first study to be conducted using EDYDM in cases with CP. In our study, the effectiveness of EDYDM treatment, which will increase the effectiveness of stretching exercises in CP or can be an alternative treatment approach in cases with CP, will be compared with Stretching Exercises.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Unilateral Spastic Type Cerebral Palsy by the health committee report,
* Level I or II according to GMFCS,
* Being between the ages of 5-18,
* No Botulinum Toxin (Botox) injection in the last 6 months,
* Not using any medication that may affect muscle tone,
* Passive ankle dorsiflexion + 10o and passive plantar flexion -25o,
* Families and children agree to participate voluntarily in the study.

Exclusion Criteria:

* Having undergone any lower extremity surgery,
* Tone in plantar flexors is level IV according to MAS,
* Presence of advanced contracture in the ankle,
* Presence of any diagnosed cardiac or orthopedic disorder that may prevent the application of the treatment,
* Hearing or vision problems,
* Having a history of epileptic attacks,
* Not having the ability to adapt to exercises (cases with the phrase "Mental Retarde" according to the health report).
Research on Translational Outcomes of Alcohol (Project RETRO)

The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.

This is a small (N = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. Participants will be between 21-24 years old from 2- and 4- year colleges in the Seattle Metropolitan area. Interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. Eligible participants will be scheduled to come in for the ad libitum alcohol administration. Participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in 2- or 4-year college program
* Currently living in the Seattle Metropolitan area
* Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days.

Exclusion Criteria:

* Exclusion criteria include:
* past-month severe alcohol or other substance use disorders,
* mood or anxiety disorder
* suicidal ideation
* risk of psychotic disorders
* excessive alcohol use reaching a Blood Alcohol Level greater than .30%
* history of serious medical conditions, regular use of prescription psychotropic or pain medication
* history of negative reactions to alcohol
* history of treatment for alcohol use disorder
* pregnancy or nursing.
* use of non-selective monoamine oxidase inhibitors in the past 2 weeks.
* narrow-angle glaucoma
* undiagnosed skin lesions,
* have a history of melanoma, cardiac issues or peptic ulcer.
* Currently taking or prescribed any form of levodopa or D2 agonists, D2 antagonists, isoniazid, methylphenidate, bupropion, Viagra, or phosphodiesterase inhibitors.