cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults.

This multicenter, randomized, double-blind, placebo-controlled phase II clinical trial aims to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults. Participants with a BMI between 24 and 40 will be include. A total of 180 participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or placebo. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a treatment period will be 12 weeks, followed by an approximate 4-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 65 years of age (inclusive).
* BMI≥28 but \< 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but \< 28 kg/m2 with any of the following:

  1. Hypertension
  2. Impaired fasting glucose or impaired glucose tolerance
  3. Dyslipidemia
  4. Obstructive sleep apnea syndrome
* At least one previous failure to lose weight through lifestyle modification was defined as \< 5% weight loss after ≥3 months of lifestyle modification.

Exclusion Criteria:

* Weight change ≥5% as reported or documented. Previous diagnosis of type 1, type 2, or any other type of diabetes.
* Diagnosis of overweight or obesity due to other diseases or medications.
* History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
* Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
* GLP-1R agonist use within 6 months prior to signing ICF.
* Use of hypoglycemic drugs within 3 months before signing ICF.
Early Mobilization: Evaluation of Feasibility and Security in Pediatric Intensive Care Unit

The purpose of this study is to evaluate the feasibility and the security of early mobilization of infants in pediatric intensive care.


Eligibility Criteria:
Inclusion Criteria:

* cardiorespiratory stability
* between 24 and 48h post admission

Exclusion Criteria:

* Thorax open
* ECLS
* High frequency oscillatory ventilation
Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room

The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation.

A randomization generator will assign each month to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room facemask PPV.

This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR \> 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics.

In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at ≥30 weeks' gestation
* Presence of the resuscitation team prior to delivery
* Need for non-invasive positive pressure ventilation (PPV).

Exclusion Criteria:

* Infants born at \<30 weeks' gestation
* No non-invasive PPV needed in the delivery room
* Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
* Resuscitation team not present prior to delivery/need for PPV
* Infants who have a prenatal plan of comfort care only
Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia

To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD).


Eligibility Criteria:
Inclusion Criteria:

* The subject must have evidence supportive of a PCD diagnosis.
* Subjects with percent predicted FEV1 of ≥40 to \<90 percentage points
* Non-smoker for at least 90 days prior to the Screening Visit and less than a 5 pack-year lifetime history of smoking
* Stable regimen of medications and chest physiotherapy for the 28 days prior to Day 1
* If currently using daily inhaled HS, must be able to discontinue its use for the duration of the study.
* If taking daily chronic or chronic cycling antibiotics, has been on a consistent regimen for at least 4 months prior to the Screening Visit.
* Clinically stable (as deemed by the investigator) for at least 14 days prior to the Screening Visit
* Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening Visit. Subjects of childbearing potential and who are sexually active must meet the contraception requirements.

Exclusion Criteria:

* Diagnosis of CF based on results of sweat chloride or nasal potential difference (NPD) tests or presence of 2 CF-causing mutations in CFTR gene.
* History of any organ transplantation or lung resection or chest wall surgery.
* Significant congenital heart defects, other than a laterality defect, at the discretion of the investigator
* Diagnosis of Cri du chat syndrome (chromosome 5p deletion syndrome).
* Inability to withhold short-acting bronchodilator use for 4 hours prior to clinic visit and long-acting bronchodilator use the night before the first and last clinic visit of each treatment period.
* Use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs
* Symptoms of acute upper or lower respiratory tract infection, acute pulmonary exacerbation, or treatment or was treated with systemic antibiotics for ear or sinus disease within 28 days before Day 1 (topical otic antibiotics allowed).
* History of significant intolerance to inhaled HS
* Pregnant and/or nursing females
* Any clinically significant laboratory abnormalities
* History of chronic B. cepacia complex or M. abscessus or M. avium
* Surgery that required general anesthesia and hospitalization within 3 months of Day 1

Additional Exclusion Criteria for Part B:

* In addition to the exclusion criteria above, subjects who participate in Part B and meet any of the following exclusion criteria will not be eligible to continue into Part B
* Unable to swallow tablets.
* Concomitant use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A, including consumption of certain herbal medications (e.g., St. John's Wort), and grapefruit/grapefruit juice.
* Known hypersensitivity to ivacaftor.
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.

Study 990 is a Phase IIa, proof-of-concept study of BT063 in subjects with SLE. This study is divided into 2 parts. After Part I an interim analysis will be performed. Each Part will enrol 18 subjects. Subjects will be randomly assigned to receive BT063 or Placebo 8 times over 12 weeks and will be followed for 4 months after their last dose.

Eligibility Criteria:
Inclusion Criteria:

* Eligible male and female subjects, Age ≥ 18 and ≤ 75 years with Body mass index ≥ 18 and ≤ 35 kg/m2 at screening visit
* Diagnosed SLE (defined by ≥ 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE) for at least 3 months before screening
* Moderate to severe SLE disease activity demonstrated by SLEDAI-2K total score ≥ 6, including skin and joint involvement
* CLASI Activity score ≥ 5 or at least 5 of 66/68 joints with pain and signs of inflammation
* Positive anti-nuclear antibodies (ANA) test at screening
* No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks)
* Normal electrocardiogram (ECG)

Exclusion Criteria:

* Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis
* Diagnosed psoriasis
* Presence or history of malignancy within the previous 5 years
* Systemic antibiotic treatment within 2 weeks before baseline visit
* A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening
* Clinically significant hematologic abnormalities attributed to SLE: Haemoglobin \< 8 g/dL; Platelets \< 50 E9/L; Leucocytes \< 2.0 E9/L
* Active or history of inflammatory bowel disease (including active or history of colitis)
* Received the following medications: - Rituximab within the last 48 weeks before screening - Belimumab within the last 12 weeks before screening - IV immunoglobulin (Ig) within the last 12 weeks before screening - Intramuscular (IM) or intra-articular glucocorticosteroids within the last 4 weeks before screening - IV cyclophosphamide within the last 6 months before screening - IV glucocorticosteroids (pulse therapy) within the last 6 months before screening
* Pregnant or nursing women or women who intend to become pregnant
* Known intolerance to immunoglobulins or comparable substances (e.g., significant vaccination reaction)
* Known intolerance to proteins of human origin
* History of clinically significant drug or alcohol abuse within the last 12 months
Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3

The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years old
* Roll out secondary renal diseases
* Do not use steroids and immunosuppresive drugs
* ACEI/ARB treated patients should have 7-14 days wash out period，SiDBP\< 110mmHg
* Willing and able to comprehend and give written informed consent
* Willing to follow-up regularly

Exclusion Criteria:

* Use steroids and immunosuppresive drugs
* Secondary renal diseases
* Acute cardio-cerebral diseases within 6 months
* Post renal transplantation
* Pregnant/Nursing women
* History of hypersensitivity to ACEI/ARB
* Refuse to join clinical trial
Predicting the Probability of Return To Work After Injury

To evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury. To derive reliable prediction models for return to work.

Background:

Trauma is a leading cause not only of death worldwide but also of disability, and in Hong Kong it ranks sixth as a cause of death for all age groups. The implementation of trauma systems has improved the survival of injured patients in many settings including Hong Kong. However, the aim of trauma care for the injured person is not only to prolong life but also to restore patients to the best possible health status, and where applicable, to return to work. Survivors of trauma often experience late sequelae that have a major impact on almost all aspects of everyday life, and improvements in functional outcome and health status may continue for at least five years post-injury.

Objectives:

1. to evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury;
2. to derive reliable prediction models for RTW.

Study design:

This is a multi-centre, prospective long-term follow up cohort study of the 1163 trauma patients admitted to the Prince of Wales Hospital (PWH), Queen Elizabeth Hospital (QEH) and Tuen Mun Hospital (TMH) in Hong Kong in 2017-2018. Patients will be recruited within four weeks of ED attendance as soon as the patient is clinically stable and conscious. The follow-up period for return to work status of the 1163 trauma patients will extend from baseline to one year after trauma.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* Eligible for the trauma registry
* Working or seeking employment before injury

Exclusion Criteria:

* Isolated hip or pathological fractures
* Injury severity score (ISS) of 1
* Patients who are unwilling to enter the study
* Patients who have left Hong Kong
Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer

RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast cancer who are undergoing radiation therapy.

PURPOSE: This randomized clinical trial is studying how well healing touch works in treating fatigue in women undergoing radiation therapy for breast cancer.

OBJECTIVES:

* To determine the ability to recruit and retain patients with breast cancer receiving curative radiotherapy in a Complementary and Alternative Medicine trial.
* To determine the acceptability of weekly healing touch therapy to patients with breast cancer who receive curative radiotherapy.
* To examine the effect of healing touch on fatigue and quality of life for patients with breast cancer receiving radiotherapy as a component of therapy.

OUTLINE: Patients are stratified by type of treatment (radiotherapy alone vs chemotherapy completed prior to radiotherapy)

* Arm I:Patients receive healing-touch therapy administered once a week for 45 minutes by a healing-touch therapist for the duration of radiotherapy.
* Arm II: Patients receive sham-therapy administered once a week for 45 minutes by a sham-practitioner (NOT a healing-touch therapist) for the duration of radiotherapy.

Patients complete the Hospital Anxiety and Depression Scale (HAD) and a demographic variables form (age, race/ethnicity, marital status, employment) at baseline. Patient fatigue is measured on a weekly basis throughout radiotherapy with completion of the Brief Fatigue Inventory (BFI). The Functional Assessment of Cancer Therapy-Breast form (FACT-B) is completed at baseline and the end of radiotherapy. Patients undergo a 20-minute interview at the end of study to determine the acceptability of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven breast cancer
* Receiving post lumpectomy or post mastectomy radiation therapy (RT)
* Eastern Cooperative Oncology Group performance status of 0, 1 or 2
* Prescribed a minimum of 5 weeks of RT
* Between the ages of 21 and 75
* Able to speak English.
* Provides written informed consent

Exclusion Criteria:

* Documented active psychiatric illness
* Documented cognitive impairment that would preclude the ability to provide informed consent.
* Stage IV breast cancer
* Receiving concurrent chemotherapy and RT
At Home Brain Stimulation Studies of Memory and Memory Awareness

The main goal of this research is to determine the role of several brain regions in memory processes and cognitive functions. Participants will be remotely supervised via video chat while self-administering tDCS, a form of non-invasive brain stimulation. Before participating in the experiment, participants will be properly trained on use of the remote tDCS device and screened for eligibility. While using the tDCS device, participants will be engaging in tasks that assess different aspects of memory and executive functioning. By using remotely supervised tDCS while participants are completing these cognitive tasks, we will be able to make causal claims about the role of the targeted brain regions in different cognitive processes.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-35
* normal or corrected to normal vision
* fluent in English and speaking English since age 5
* right handed

Exclusion Criteria:

* chronic skin disease or medical skin condition
* unhealed wound or open skin on the scalp, face, neck, or forehead
* metal or electrode implants (e.g., cochlear implants, pacemakers, metal plates, rods, or screws in their head; for complete detail, see the screening form)
* seizures or a family history of seizures, or are taking medications with a lowered seizure threshold
* pregnant or lactating
* any neurologic or psychiatric diseases
* certain hair styles (dreadlocks, cornrows, etc) or hair coverings (e.g., wigs, hajibs, etc that will not be removed; note that a request can be made for an experimenter of a specific gender)
Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus

Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption leading to intracranial hypertension. Assessment of the change in intracranial pressure after ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative management. The optic nerve sheath diameter measured using ultrasonography has been verified as a non-invasive indicator of intracranial hypertension in various clinical studies. The investigators hypothesized that a change in optic nerve sheath diameter detected through ultrasonography could help ascertain a reduction in intracranial pressure following ventriculoperitoneal shunt surgery in adult patients without the risk of serious complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-90 years of age, ASA physical status 3 or less) who are scheduled for elective ventriculoperitoneal shunt surgery with non-communicating hydrocephalus and communicating hydrocephalus except for normal-pressure hydrocephalus
* Non-communicating hydrocephalus is defined as a pattern of ventricular system or at the level of the fourth ventricle's outlets by lesions including tumor, giant aneurysm, or aqueductal stenosis.
* Communicating hydrocephalus is defined as paraventricular enlargement resulting from postoperative complication after cranial surgery, meningitis, subarachnoid or intracerebral hemorrhage.

Exclusion Criteria:

* Patients with previous history of shunt operation, ocular disease and ocular surgery
* Patients with anatomical or functional abnormality of optic nerve
* emergency patient
Actual Use Study of Tamsulosin in Men

An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.


Eligibility Criteria:
Inclusion criteria:

* Men, 18 years of age and older, with bothersome urinary symptoms
* Able to speak, read and understand English
* Subject or anyone in their household is not currently employed by a marketing or marketing research company, advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company, as a certified or licensed healthcare professional or in a healthcare practice
* Has not participated in any clinical trial in the last 12 months
* Willing to sign an informed consent/HIPPA form and willing and able to provide contact information

Exclusion criteria:

* Allergy to tamsulosin hydrochloride or sulpha drugs
* Report current use of a medication listed on the "Do not use" section of the Drug Facts Label (DFL)
* Choose not to purchase the study product
* Do not provide consent or sign HIPPA form
* Do not provide contact information
Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure

Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher doses, while carvedilol is non-selective. We examined whether metoprolol remained beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF) Beta-blocker naïve patients.

METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol. Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50, 100, and 200 mg daily; carvedilol IR at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily). Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose and potassium changes were calculated.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction ≤40%), were \>18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days.

Exclusion Criteria:

* . Patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate \<55; supine blood pressure \<85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine \>2.5 mg/dL), liver disease (transaminase levels \> 3 fold above laboratory normal), or anemia.