cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children

This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.

A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Wuhan Biological Products Co., LTD. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged ≥ 6 on the day of enrollment;
2. Informed consent should be signed and dated by the participants;
3. The participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures;
4. The participants have received 4 doses of acellular TDap vaccine and have not received any immunization agents related to diphtheria, tetanus, and pertussis in the past 3 years;
5. The participant has no diease history of pertussis, diphtheria or tetanus;
6. ≥ 14 days interval between the last vaccination;
7. Body temperature was ≤37.3℃.

Exclusion Criteria:

1. Being allergic to any component of vaccines ；
2. A history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）；
3. Having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases;
4. Participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to HIV, or having congenital immune disorders in close family members;
5. Injection of non-specific immunoglobulin within 1 month before enrollment;
6. Participants are suffering from acute febrile diseases and infectious diseases;
7. A history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection;
8. Participants with severe chronic diseases or acute episodes of chronic diseases;
9. Participants with infectious, suppurative and allergic skin diseases;
10. Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
Tiotropium Plus Olodaterol vs Inhaled Corticosteroids (ICS) Regimens in the Portuguese Primary Care Setting (TIOLCOR Study)

What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 40 years at the date of COPD diagnosis.
2. Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis (FEV1/forced vital capacity \[FVC\] ratio \<0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records.
3. Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit. The COPD treatment may have been prescribed at primary care sites or at the hospital.
4. Written informed consent prior to participation.

Exclusion Criteria:

1. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date).

2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy for COPD \[with either short- or long-acting bronchodilators or ICS\]) - no data on the GOLD 2019 group at the index date is available in the medical records. Patients may still be included if the determination of the GOLD 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT) at the index date).

2b. For treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. Patients may still be included if this information is obtained based on patient interviews.

3. Participation in a clinical trial within the 3 months prior to the inclusion visit.
Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in early septic shock. However, evidence have associated saline with hyperchloremia and secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney injury (AKI) and mortality. The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

Eligibility Criteria:
Inclusion Criteria:

Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.

Exclusion Criteria:

1. Pregnancy;
2. Likely requirement for immediate hemodialysis or renal replacement therapy;
3. Patients have already received fluids for more than 4 liters;
4. Patient in extremis or death deemed imminent and inevitable.
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants

This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.
* Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG
* BMI of 19 to 27 kg/m2; and a total body weight \>50 kg.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.
* History of allergic or anaphylactic reaction to a therapeutic drug.
* History of recent active infections within 28 days prior to the screening visit.
* Participants with a fever within 48 hours prior to dosing.
* History of TB or active or latent or inadequately treated infection.
* Recent exposure to live vaccines within 28 days of the screening visit.
* A positive pregnancy test.
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes
* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
* Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening.
* No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
* Have had stable body weight (±5%) during the 90 days preceding screening
* Have BMI ≥25 kilogram/square meter (kg/m²)

Exclusion Criteria:

* Have type 1 diabetes
* Have a history of chronic or acute pancreatitis
* Have a history of

  * proliferative diabetic retinopathy, or
  * diabetic maculopathy, or
  * nonproliferative diabetic retinopathy that requires acute treatment.
* Have any of these cardiovascular (CV) conditions within 60 days prior to screening:

  * acute myocardial infarction,
  * cerebrovascular accident (stroke), or
  * hospitalization due to congestive heart failure (CHF).
* Have New York Heart Assocation (NYHA) Functional Classification Class IV CHF
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
* Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies
* Have an estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label)
* Have been treated with insulin prior to screening

  * Exception: use of insulin for gestational diabetes or short-term use (\<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
* Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation
Discretionary Food Sources and Stress Perception

Purpose:

The objective of this study is to determine the effect different sources and forms of discretionary foods have on stress perception in healthy adults in a free living, real world setting.

Rationale:

The rationale for conducting this study is to test the effects of sugar-sweetened beverages and grain-based desserts have on perceived health and stress perception, since the evidence for this topic is limited.


Eligibility Criteria:
Inclusion Criteria:

* Adults who consume sugar sweetened beverages and grain based desserts and candy on a regular basis
* Free from major illnesses or chronic disease
* Willing to consume amount of beverages and food provided to supplement usual dietary habits during each period

Exclusion Criteria:

* Recently lost a significant amount or looking to lose weight
* Recently begun a new diet or exercise regimen
* Pregnant or nursing women
* Report restrained eater or having less than 51% control over food preparation
Exercise Program in Women With Metabolic Syndrome

The purpose of this study is to test whether a supervised mixed aerobic and strength training (MAST) program is effective in improving overall physical fitness and blood flow in the brain and lowering risk factors of coronary artery disease (CAD) in women with metabolic syndrome.

Metabolic syndrome is a cluster of conditions and disorders that increase the risk for coronary artery disease (CAD) and strokes. Sedentary lifestyle is one of the risk factors, which decrease overall physical fitness and together with aging may lead to decrease in physical functioning in everyday life as well as changes in blood flow in the brain and cognitive functions. Regular physical activity is associated with a reduced risk of cardiovascular disease. It may also improve blood flow velocity and cognitive functions. Physical activity should be as effective as possible, but also as safe as possible. Supervised mixed aerobic and strength training (MAST) program for 4 months enables to individualize the intensity of aerobic exercise based on measured maximal exercise capacity. Throughout each training session heart rate will be monitored with a new real time wireless ECG system.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women
* Age 50 or over
* Diagnosed metabolic syndrome

Exclusion Criteria:

* Any unstable or acute medical condition that the study physician deem unsafe for participation
* Positive stress test for CAD or other ischemic conditions
* Myocardial infarction or major surgery within 6 months
* History of a clinically documented stroke
* Clinical dementia (by history) or inability to follow details of the protocol
* Carotid stenosis \> 50% by medical history
* Insulin dependent diabetes mellitus (also type II, if using insulin) or history of severe hypoglycemic episodes within 6 months requiring hospitalization
* Liver or renal failure or transplant
* Severe blood pressure elevation (systolic BP \> 180 and/or diastolic BP \> 110 mm Hg)
* Anemia (Hb \< 10)
* Seizure disorders
* Current recreational drug or alcohol abuse
* BMI \> 45, but body weight under 280 lbs
* Inability to obtain permission for participation from the primary care physician
* Clinically significant and movement limiting hip, knee and/or back disorders or injury, and rheumatoid arthritis
* Transcranial Doppler (TCD) exclusion criteria - poor insonation window and TCD signal
The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients

Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* circumcision,
* inguinal hernia,
* undescended testis,
* hydrocele operation

Exclusion Criteria:

* neurological or spinal anomaly,
* coagulopathy
* allergy to local anesthetics,
* local infection in the area to be intervention,
* with increased intracranial pressure
* children with any ophthalmic pathology
Genetic Mosaicism in Hirschsprung's Disease

Hirschsprung's disease is a complex genetic disorder. The etiology of this disease is not completely understood. It is characterized by the absence of ganglia (nerve cells) in de distal colon. This impairs bowel relaxation which can lead to bowel disfunction, toxic megacolon, ileus and enterocolitis. So far, several genes have been identified that play a role in Hirschsprung's disease. The precise mechanisms however, remain unclear. This study wants to identify new mutations and hopefully clarify more about the etiology of the disease.


Eligibility Criteria:
Inclusion Criteria:

* All children with Hirschsprung's disease that will receive a corrective pull through procedure

Exclusion Criteria:

* None
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
Effectiveness of Decision-aid Video on Colorectal Cancer Screening

Colorectal cancer (CRC) is the second most common cancer in Malaysia. Diagnosing CRC at early stage is crucial to reduce their mortality risk. To achieve this aim, CRC screening promotion intervention is deemed necessary.

High-quality CRC screening interventions and approaches should be delivered to a large proportion of target population.

To our knowledge, there is no interactive video been developed, that can be used as educational tool for CRC screening in Malaysia. By developing an educational video, we hope that it can be used by health professionals to promote CRC screening, favoring their empowerment for prevention and control of disease.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian aged 50 - 74 years old
* No previous history or family history of CRC
* Asymptomatic of CRC
* Never participated in CRC screening

Exclusion Criteria:

* Acute patients
* Patients on aspirin, warfarin or any blood-thinning agent
* Illiterate or having a significant vision or hearing impairment
Sugammadex Reduces Antiemetic Effect of Dexamethasone

Sugammadex is a medication used for reversal of muscle relaxation during procedures under general anesthesia. It works by encapsulating muscle relaxant molecules with a steroid ring in its structure. On the other hand, postoporative nause and vomiting (PONV) is an adverse outcome during anesthesia. PONV can be prevented with pharmacologic agents such as ondansetron and dexamethasone. Dexamethasone is a steroidal agent that can interact with sugammadex. In theory, this interaction could lead to reduced effectiveness of sugammadex. In fact, several studies have explored this interaction. However, the effect of sugammadex on the antiemetic effect of dexamethasone has not been evaluated. This study intends to evaluate this interaction.

The study will use de-identified retrospective data to conduct a cross-sectional study to determine the effect of sugammadex on the antiemetic efficacy of dexamethasone in elective adult surgical patients who underwent surgery in a tertiary care center between January 1 2023 and January 1 2024 . The investigators will conduct univariate and multivariate analysis to assess the effect.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Elective surgery
* ASA 1, 2, 3
* At least one risk factor for PONV

Exclusion Criteria:

* Pregnancy
* Receiving antiemetics prior to arrival to preoperative holding area
* Receiving opioids prior to arrival to preoperative holding area
* Admission to ICU
* Altered mental status
* Rapid sequence induction
* Nausea or vomiting before surgery
MMG vs. EMG for Cortical Breach Detection

The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring hardware. Both MMG and EMG are devices approved by the FDA to detect the location of nerves during surgery so they can be avoided. The results from both tests will be compared to one another to determine if one is better at accurately locating nerves than the other.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation.
* over the age of 18 years old
* unresponsive to conservative care for a minimum of 6 months
* psychosocially, mentally, and physically able to fully consent and comply with this protocol

Exclusion Criteria:

* preexisting medical condition or comorbidity that makes them a poor candidate
* open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis
* requires medications that may interfere with bone or soft tissue healing
* active local or systemic infection
* metal sensitivity/foreign body sensitivity
* implanted pacemaker
* morbidly obese, defined as a body mass index (BMI) greater than 45
* osteoporosis
* involved in or planning to engage in litigation or receiving Workers Compensation related to neck or back pain.
Assessment of Body Composition and Physical Function

Sarcopenia, which is the loss of muscle mass and strength or physical function, naturally occurs in aging. In sarcopenic obesity, growth of muscle mass and increments in strength do not parallel weight gain, and places older adults at increased risk of falls, fractures, physical disability, frailty, and mortality from too low muscle strength relative to body size. The goal of the study is to assess body composition and physical function in older adults with obesity.

This is a cross-sectional study in 40 adults aged 60 to 80 years with obesity. Body composition, physical function, and insulin resistance will be measured. Subjects who satisfy the eligibility criteria and sign the informed consent will be enrolled. Subjects will complete an assessment of body composition by bioelectrical impedance analysis and tests of physical performance. Blood will be drawn for measurement of fasting glucose and insulin.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 30kg/m2
* Age 60 - 80 years

Exclusion Criteria:

* self-reported history of diabetes, or cancer or significant cardiovascular or hepatic or renal disease or dysfunction.
* clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
Testing TRUST Depression Management Intervention

This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.

Half of participants will receive a traditional depression self-management intervention, while the other half will receive the novel depression self-management intervention. In an exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed over 6 months. Data were collected at baseline, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Lives in the Cleveland metro area
* Ages 14-17 years old
* Reports moderate depressive symptoms
* Able to read, speak, and understand the English language

Exclusion Criteria:

* Current suicide risk
* Diagnosis with bipolar disorder, schizophrenia, or a personality disorder
* Severe behavioral problems that preclude group participation (as reported by parent)
* Family plans to move from the region within 6 months
Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.


Eligibility Criteria:
Inclusion Criteria:

* Those who show:

  * Keratoconjunctival disorder confirmed with vital dye staining
  * Abnormal Schirmer score results

Exclusion Criteria:

* Eye disease that needs therapy other than that for dry eye
* Those who need to wear contact lenses during the clinical study