cyrilzakka/clinical-trials huggingface dataset:
A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

This pilot clinical trial will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) with antibiotic pre-conditioning and fiber supplementation vs. placebo in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials of MTT as a treatment for PAH. 24 PAH patients will be randomized to receive either MTT with antibiotic preconditioning + fiber supplementation, MTT with antibiotic preconditioning + placebo supplementation, or placebo + placebo supplementation. MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. Fiber supplementation will be 10-14 gm oral fiber supplement. Patients will be followed at week 1, week 2, week 4, week 12, and week 24. Patient will undergo stool sample collection at baseline, week 1, week 4, and week 12, blood sample collection at baseline, week 4, and week,12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated consent form
* Ages 18-75
* Diagnosis of PAH
* On stable treatment for PAH for one month prior to enrollment
* Able to swallow capsules
* Able to provide blood sample and fecal sample
* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.

Exclusion Criteria:

* Dysphagia to pills
* Clinically active inflammatory bowel disease
* Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential at the screening visit or day 1 (prior to the receipt of MTT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTT. Patients will be counseled to avoid pregnancy which is the standard of care for patients with PAH.
* Life expectancy of \< 6 months
* Presence of ileostomy or colostomy
* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
* Patients with neutropenia (an absolute neutrophil count \< 0.5 x 10 9 cells/L) obtained on a complete blood count with differential at screening
* History of solid organ or bone marrow transplant
* Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
* History of severe anaphylactic food allergy
* History of celiac disease
* Patients receiving cancer chemotherapy, immunotherapy, or radiation
Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.

Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18;
2. Low back pain principally below the L5 vertebra;
3. Three out of 6 positive SI joint provocative maneuvers;
4. Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
5. Average pain score \> 3/10 over the past week;
6. Pain duration \> 6 weeks;

Exclusion Criteria:

1. Previous SI joint injection;
2. Leg pain \> back pain or lower leg pain \> upper leg pain
3. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
4. Untreated coagulopathy;
5. Allergy to contrast dye or bupivacaine;
6. Pain \> 20 years in duration;
7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV

The objective of this pilot study is to assess the immunogenicity and reactogenicity of Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare workers.

This is a prospective, randomized controlled, observer blind trial of Fluzone High Dose trivalent inactivated influenza vaccine (HDTIV) versus Fluzone, standard dose TIV (SDTIV) in 100 healthcare workers 18-64 years of age. Participants will receive, in a 1:1 ratio, one dose of either SDTIV or HDTIV containing the strains of influenza virus as recommended by the World Health Organization for the season of recruitment. All adverse events will be collected for 7 days following the injection, serious adverse events will be collected through day 21, and serum for antibody testing will be obtained on day 0 and day 21. The primary outcome will be seroconversion to each strain of vaccine included in the vaccine, as measured by change in hemagglutination inhibition assay (HAI) titer between day 0 to day 21.

Eligibility Criteria:
Inclusion Criteria:

1. 18-64 years old, inclusive, as of October 1st of year of enrolment;
2. Healthcare worker, broadly defined as a person either providing health care, or working in an acute care hospital or long term healthcare facility;
3. Has access to email and the internet for adverse event reporting, or is willing to complete forms on paper and deliver to the site study office;
4. Understand the study, agree to its requirements, and give written consent;

Exclusion Criteria:

1. Receipt of influenza vaccine for the current northern hemisphere season prior to randomization;
2. Serious adverse event to a previous dose of influenza vaccine;
3. Immunoglobulin E mediated allergic reaction to a previous dose of influenza vaccine or to any excipients in the study vaccines
4. Previous episode of Guillain-Barré syndrome with 6 weeks of receiving an influenza vaccine;
5. Receipt of immunoglobulins, blood or blood-derived products in the past 3 months;
6. Receipt of another vaccine, or initiation of new medication, or hospital admission for any reason within the 30 days prior to the study dose of vaccine
7. Plans to receive any vaccine, initiate any medication, or be admitted to hospital before day 21 after vaccination (visit 2);
8. Known or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
9. Any condition, including but not limited to drug and alcohol addiction, which, in the opinion of the investigator might interfere with the ability to comply with trial conduct or completion;
10. Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day the vaccine dose is due (participant may receive dose of vaccine 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.
Correlating Noninvasive Cardiovascular Measures to Left Ventricular End Diastolic Pressure in Heart Failure

HF001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. Subjects will be monitored using CVInsight™ \[CVI\] via a finger and/or forehead sensor, while performing an isometric handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood pressure (BP), patient symptoms, and physical exam findings. The results of this study will be used to develop a powered study to determine if a new configuration of non-invasive monitoring devices can be used to monitor heart failure status more sensitively than current non-invasive techniques.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old
* Signs and symptoms of congestive heart failure including two of the following:
* Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
* Pulmonary edema or pleural effusion as seen on chest X-ray
* Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of normal.
* Willing and able to comply with the study protocol
* Willing and able to give valid Informed Consent

Exclusion Criteria:

* Pregnant patients
* Presence of Left Ventricular Assist Device (LVAD) or heart transplant
* Complex congenital heart disorder or prosthetic valve on right side
* Known mitral stenosis
* Unstable medical condition or impairment other than condition associated with HF
* Unstable hypertension
* Too unstable in the judgment of the investigator to be included in the study
* Active lung infection or acute pulmonary decompensation
* Elevated white blood cell count and signs of infection are evident
* Does not have the cognitive ability to understand and sign the Informed Consent
* Does not have the cognitive capacity to perform handgrip test
* Is not able to perform a handgrip stress test
* Is not able to wear any of the devices
* Patient's life expectancy is less than 3 months
Counterpulsation Reduces Infarct Size Pre-PCI for AMI

Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an ICF
* ≥ 18 and ≤ 90 years of age
* General good health, in the opinion of the investigator
* ST elevation of 2mm in 2 contiguous anterior leads or ≥ 4mm total in anterior leads
* Scheduled for PCI \< 6 hours from onset of symptoms of MI

Exclusion Criteria:

* Known contraindication to MRI
* Prior thrombolytic therapy during the index event
* Known history of MI
* Known severe aortic insufficiency
* Known aortic aneurysm
* Known severe calcific aorta-iliac disease or peripheral vascular disease
* Experiencing cardiac shock
* Known end-stage renal disease
* Weight \>400 lbs. or height \<4 ft.
Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis

Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old (including boundary values), male and female.
2. Female subjects weigh ≥45 kg and male subjects weigh ≥50 kg.
3. HRCT shows bronchiectasis affecting one or more lobes of the lung and is confirmed by the clinician as NCFB.
4. The expected survival is greater than 12 months.
5. Informed consent was signed before the trial.
6. Potentially fertile subjects voluntarily take appropriate contraceptive measures.

Exclusion Criteria:

1. Patients with pulmonary hypertension or chronic obstructive pulmonary disease (COPD) or asthma as determined by the investigators were the primary diagnosis were screened.
2. An active, symptomatic infection caused by respiratory viruses, including COVID-19, influenza viruses, etc.
3. Have psoriasis or lichen planus.
4. Have Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
5. Have chlorine acne, large common warts, or keratodermatitis.
6. Has diabetic foot.
7. Have periodontal disease, oral infection, or loose teeth.
8. History of malignant tumor within 5 years prior to screening.
9. Screening subjects with a history of liver disease or currently receiving treatment for liver disease, including but not limited to acute or chronic hepatitis, cirrhosis, or liver failure.
10. Researchers consider any other unstable clinical disease.
11. Oral or inhaled antibiotics were received 4 weeks prior to first administration.
12. Immunosuppressants were administered 4 weeks before the first dose.
13. Received drugs within 4 weeks prior to screening that may cause hyperkeratosis of the skin.
14. Received live attenuated vaccine within 30 days prior to initial administration.
15. Participated in clinical trials of any medical device within 3 months prior to screening.
16. Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection.
17. Drug abusers.
18. Current smoker or former smoker for less than 3 months.
19. Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure.
20. Pregnant or lactating women.
21. The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
22. The researchers determined that there were other circumstances that were not suitable for participation in this study.
Weightlifting Belts and Wrist Straps for Weightlifters

Objective: This study examined the effects of weightlifting belts and wrist straps on the kinematics of the deadlift exercise, time to complete a deadlift and rating of perceived exertion (RPE) in male recreational weightlifters.

Methods: Twenty participants used various combinations of belt and straps during a conventional deadlift. The hip and knee flexion, cervical lordosis, thoracic kyphosis and lumbar lordosis angles and time to complete a deadlift were measured using video analysis software. RPE was also recorded.


Eligibility Criteria:
Inclusion Criteria:

* men
* aged 18 to 30 years
* more than 3 years of weightlifting experience
* have been training at least 4 hours per week
* engage in recreational weightlifting

Exclusion Criteria:

* musculoskeletal disorders (e.g., leg length discrepancies and severe flat feet)
* neurological disorders (e.g., epilepsy)
* spinal problems (e.g., scoliosis)
* upper limb problems (e.g., history of shoulder dislocation, tennis or golf elbow)
* recent injuries that could affect performance
* train regularly for other sports.
A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily \[TID\]) as compared to placebo on abdominal bloating rating in female IBS patients.


Eligibility Criteria:
Inclusion Criteria:

* Meet Rome III criteria for IBS (any subtype)
* Female aged 18 to 65 years, inclusive
* If of childbearing potential, prepared to use suitable forms of contraception throughout the study and for 30 days after the last dose i.e., hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing, Essure), condoms used with a spermicide, an intrauterine device, or abstinence. Females are not considered to be of childbearing potential if they are naturally postmenopausal (no menses for at least 1 year and, if \< 55 years of age, have a documented follicle-stimulating hormone \[FSH\] level of ≥ 35 mIU/mL) or have documentation of surgical sterility
* Have a BMI between 18 and 30 kg/m2, inclusive
* Have a negative pregnancy urine screening at Visit 1, if of childbearing potential
* Able to provide written consent
* Able to take oral administration of the testing medications
* Have a self-reported average abdominal bloating rating (\>3 daily ratings over the preceding 7 days) equal or greater than 4 on a numerical scale of 0 to 20.

Exclusion Criteria:

* Have a structural or metabolic disease or condition that affects the GI system, excluding asymptomatic gallstones or uncomplicated gastroesophageal reflux disease, or any medical condition that may be a cause of constipation or diarrhea (e.g., hypothyroid status, poorly controlled diabetes, diabetic neuropathy or autonomic neuropathy)
* Be taking any medication that, in the opinion of the Principle Investigator (PI), has potential to alter GI transit. A full list of prohibited medications is provided in the protocol. Have history or presence of any chronic lung disease
* Have presence of hepatic dysfunction, jaundice, or abnormal serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values exceeding 2.5 x upper limit of normal
* Currently pregnant or lactating
* Have a positive urine drug test at screening (subjects who initially test positive will be allowed one retest)
* Be a known substance abuser or be considered to be an alcoholic not in remission
* Have participated in another clinical study in the past 30 days
* Use of supplemental ginger, ginseng, or Zanthoxylum fruit for 2 weeks prior to randomization and throughout the course of the study.
* Have a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit
* Be clinically lactose-intolerant
* Have any other condition that, in the opinion of the PI, causes the subject to be unsuitable to participate
* Have taken antibiotics in the last 3 months
* Have had gastroenteritis ("stomach flu") in the last 3 months
* Have taken probiotics in the last 3 months (over-the-counter \[OTC\] products or supplements only; food products such as yogurts are permitted).
An Observational Study to Develop Algorithms for Identifying Opioid Abuse and Addiction Based on Admin Claims Data

The purpose of this study is to develop and validate a classification model based entirely on medical claims data that can be used to identify patients experiencing prescription opioid abuse/addiction among patients receiving extended-release (ER) and/or long-acting (LA) opioids

The most widely available information about patient care and conditions is that contained in medical claims data. If such data can be used to develop a model for identifying patients experiencing prescription opioid abuse/addiction it could be widely applied to patient populations throughout the United States.

A study recently conducted at Group Health comparing International Classification of Disease, Ninth edition (ICD-9) coding for opioid abuse/addiction to textual mentions in clinical notes describing abuse/addiction found that ICD-9 codes were 64% sensitive and 96% specific in their ability to identify patients experiencing opioid abuse/addiction (compared to evidence from clinical notes). This Group Health study considered codes for abuse (305.x) and addiction (304.x) equivalent because clinicians' usage of these codes did not differentiate well between abuse and addiction.

Needed are methods that can accurately identify patients experiencing opioid abuse/addiction based on widely available claims data.

This study will not evaluate opioid misuse because this will be captured by instruments in a prospective study of pain patients (Study 1A) using a combination of adapted validated instruments, and other new instruments that will be evaluated in post-marketing requirement (PMR) Study 2, plus medical record review to supplement questionnaire-based measurement of misuse, abuse and addiction with aberrant behaviors and physician text entries in the medical records.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Receipt of at least a 60 day's supply of ER/LA opioid analgesics within a 90-day period (including transdermal or oral opioids but excluding buprenorpine)
3. Minimum of at least two years continuous enrollment in Group Health integrated group practice (IGP)

Exclusion Criteria:

1. Residence in a nursing home at any time during the study period
2. Enrollment in a hospice care program at any time during the study period
Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer

Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.

Body mass index (BMI) is strongly associated with the development and progression of breast cancer. Despite the widespread use of cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) in hormone receptor (HR)-positive advanced breast cancer, the effect of BMI on therapeutic outcomes remains poorly understood. Here, we present real-world evidence to substantiate the association between BMI and CDK4/6 inhibitors efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and above;
* Women of any menstrual status;
* Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable;
* Patients with histological pathology that is clearly HR-positive/HER2-negative breast cancer, or if there is metastatic pathology, the histological pathology of the metastatic foci shall prevail. (Those with ER intensity \>1% cellular nuclear staining)
* Patients have at least 3 more fully documented medical records at the enrolled centre, including at least 1 inpatient record.

Exclusion Criteria:

* CDK4/6 inhibitors as neoadjuvant or adjuvant therapy;
* Significantly missing diagnostic and treatment data from patients' medical records;
* Participation in other clinical trials before and during the data collection period.