cyrilzakka/clinical-trials huggingface dataset:
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of study B2601001
* MMSE 12 or greater

Exclusion Criteria:

* Study B2601001 Week 32 MRI with clinically important exclusionary findings.
* Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Comparison of SBRTand Repeat TACE for HCC

Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE

The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.

In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Eastern cooperative oncology group(ECOG) score 0 to 2
* Primary HCC
* HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
* Child-Turgottei-Pugh A or B
* Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
* No evidence of radiologically definable major vascular invasion or extrahepatic disease
* Previously incomplete TACE with radiologically defined residual disease after first TACE
* Informed consent

Exclusion Criteria:

* Prior TACE to the target lesion
* Contraindication to receiving radiotherapy or TACE
* Decompensated liver cirrhosis
* Extrahepatic mets
* Pregnancy
* Patients with other cancers
Guided Imagery & Music in Cancer

This is an RCT pilot study to explore the potential effects of the Guided Imagery \& Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope.

Guided Imagery and Music is a music-assisted psychotherapy method which has been used as a complementary, supportive psychosocial therapy in cancer care. However, its effects have never been explored during the period of active chemotherapy or radiotherapy treatment in various cancer populations, and especially gynecologic and breast cancer. This pilot study is an effort to explore the feasibility of the method to increase quality of life in this population by possibly reducing side-effects of treatment such as fatigue, improving mood, and building resilience as expressed through levels of hope.

Eligibility Criteria:
Inclusion Criteria:

* Speaking Greek
* receiving chemotherapy or radiotherapy treatment for breast or gynecologic cancer
* first occurrence or metastatic
* have an interest in engaging in creative psychotherapies through music

Exclusion Criteria:

* women with active psychosis or PTSD symptomatology
* women receiving other psychological support
* women too ill to participate according to doctors' instructions
Autoantibodies Against Specific Cytokines in Adults With Severe Mycobacterial Infection

In adult, the prevalence of mycobacterial infections is increased with age is largely unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in adult against mycobacteria. Based on this hypothesis, the investigators had applied a functional assay to these pathways in patients with mycobacterial infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mycobacterial infection

Exclusion Criteria:

* Malignancy
* Severe autoimmune
* HIV infection
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)

The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).


Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
* Age between 18-65 years
* Male and female are eligible (although the majority of POTS patients are female).
* Able and willing to provide informed consent

Exclusion Criteria:

* Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
* Pregnancy
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
* Patients who are bedridden or chair-ridden
A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)

To determine the influence of co-ingestion of alcohol on HC-ER.

Determine the influence of co-ingestion of alcohol on the safety, pharmacokinetics, and relative bioavailability of HC-ER 50 mg under fasted conditions

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 21 to 45.
* Female, must be of non-childbearing potential.
* Non-smokers for at least 3 months or light smokers (less than 10 pack-years).
* History of moderate consumption of between 7-21 units of alcohol per week.
* Weighed at least 65 kg with a BMI ≥19 and ≤35 kg/m2.
* Were medically healthy with no clinically significant abnormalities.
* Voluntarily consented to participate in the study.
* Were prepared to be compliant with the study procedures.

Exclusion Criteria:

* Women who were pregnant or breastfeeding.
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* History or presence of alcoholism or drug abuse.
* Hypersensitivity or idiosyncratic reaction to morphine, hydrocodone (Vicodin) or other opioids; naltrexone, naloxone, or other opioid antagonist.
* History of no alcohol intake (alcohol-naive) or less than moderate alcohol intake.
* History of alcohol intake exceeding the equivalence of 21 units/week or exceeding the average of 3 drinks per day.
* Surgery of the gastrointestinal tract which would interfere with absorption of the study drug.
* Taken hepatic enzyme inducing drugs (e.g., Nizoral, Tagamet) within the previous 3 months.
* Taken prescription medications within the previous 14 days or over the counter (OTC) medications within the previous 7 days prior to Day 1 Period 1.
* Sitting blood pressure was less than 110/45 mmHg at screening.
* On a special diet (except for vegetarians who agree to abide by study diet) during the 28 days prior to the first dose and throughout the study.
* Significant blood donation or loss within 56 days prior to first dose of HC-ER.
* Plasma donation within 7 days prior to first dose of HC-ER.
* Hemoglobin value less than 12.0 g/dL.
* Participated in another clinical trial within 28 days prior to first dose of HC-ER.
* Positive urine test for drugs of abuse.
* Positive test for, or had been treated for hepatitis B, hepatitis C or HIV.
Bispectral Index Monitoring To Guide Sedation In The Critical Care Setting

A randomized, control trial to compare the total dose of sedatives use in patients over 65 years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales.

The study will include all patients over 65 years who enter the intensive care unit of the University Hospital of Bellvitge affected with medical or surgical pathology of non neurological etiology who require sedation for more than 24 hours to maintain adaptation to mechanical ventilation.

Patients admitted to the intensive care unit (ICU) usually require use of hypnotics and sedatives to ensure comfort and proper adaptation to mechanical ventilation. An important requirement for an adequate sedation is frequent and proper assessment of its depth. Inadequate sedation can lead to problems of over-sedation, under-sedation and/or delirium in ICU, especially in elderly patients. The main objective od the study is To compare the total dose of sedative use and the rate of over-sedation in patients over 65 years admitted to the ICU, adjusting sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales. METHODS. A randomized, clinical trial including patients over 65 years who were admitted to the ICU affected with medical or surgical pathology of non neurological etiology who required sedation for more than 24 hours to maintain adaptation to mechanical ventilation. Patients were randomized into two groups: the intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60 and; the control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2. The study was approved by the institution's Research Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 yers
* Patients admitted to teintensive care unit of the University Hospital of Bellvitge medical or surgical pathology of neurological etiology
* Patiens requiring sedation for more than 24 hours

Exclusion Criteria:

* Patients less than 65 years
* Patients admitted to the ICU with Neurological condition.
* Postoperative patients admitted and extubation is expected within 24 hours.
Ketorolac vs Oxycodone for Great Toe Arthrodesis

This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75 years.
* Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.
* Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).

Exclusion Criteria:

* Chronic pain syndrome, CRPS or fibromyalgia
* Revision procedures
* Use of allograft bone at the fusion site
* Tobacco use
* Diabetes
* Narcotic abuse or IV drug abuse
* Any CPT codes involving the midfoot, hindfoot, and/or ankle
* Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers
* Weight \< 50 kg
* Does not speak or read English
* If pregnant or planning to become pregnant or breastfeeding
* Non-independent dweller (prisoner)
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty

This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.

This research study will randomly assign subjects post CMC arthroplasty to Intervention A (prefabricated splint) or Intervention B (custom orthosis). The orthosis and splint being used in this study are both considered standard practice. Subjects will be provided the splint or orthosis at the first post-operative appointment. Subjects who are assigned to Intervention A will be provided a pre-fabricated splint by a member of the surgical team. Subjects who are assigned to Invention B will be evaluated by an occupational therapist and a custom orthosis will be fabricated. Outcome measures include: QuickDASH, Pain Visual Analogue Scale, active range of motion measurements, the Applied Dexterity portion of the Arthritis Hand Function Test except for the putty cutting task, edema, Sandy Grading Score and the Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services. Data will be collected at the first, second, and third post-operative appointment.

Eligibility Criteria:
Inclusion Criteria:

* status post CMC arthroplasty
* 18 or older
* able to read and understand English
* capable of independently consenting to health care procedures.

Exclusion Criteria:

* if the surgeon identifies risk factors that would preclude random assignment to the control or experimental group
* if subject requests a prefabricated or custom orthosis.
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

The purpose of the PIINC study is to identify differences in placental inflammatory lesions between women participating in group prenatal care versus standard prenatal care, and additionally, examine whether the frequency of placental inflammatory lesions differ by race and income. The investigators hypothesize that women participating in group prenatal care will have lower pro-inflammatory profiles compared to women in routine prenatal care.

This is a supplementary investigation of placental inflammatory lesions among participants enrolled in a randomized controlled trial comparing biomedical, behavioral and psychosocial outcomes among pregnant women who participate in CenteringPregnancy group prenatal care, to women in the traditional individual prenatal care and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of CenteringPregnancy on outcomes and health disparities. The study will be conducted in a large prenatal care center in South Carolina. Eligible White and Black women will be recruited before 20 weeks of gestational age with low risk pregnancy.

Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
2. Pregnant women aged between 14-45 years
3. Enrolled in prenatal care by 20 6/7 weeks' gestation

Exclusion Criteria:

1. Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care

   * Pregestational diabetes,
   * Severe chronic hypertension requiring medication,
   * Morbid Obesity with BMI \>49.99
   * Renal disease with baseline proteinuria \>1g/24 hours
   * Any disease requiring chronic immunosuppression (SLE, solid organ transplant)
   * Active pulmonary tuberculosis
   * Sickle cell anemia
   * Human Immunodeficiency Virus Infection
   * Other medical conditions that would exclude women from group care at the discretion of the PI
2. Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care

   * Multiple gestation
   * Lethal fetal anomalies
   * Other pregnancy complications that would exclude women from group care at the discretion of the PI
3. Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care

   * Current incarceration
   * Severe psychiatric illness
PRISM-GENOMICS-Smoking Cessation for Patients With Coronary Artery Disease Undergoing Cardiac Catheterization or Having a Heart Attack at Barnes Hospital in St. Louis Mo

It has previously been shown that patients with coronary artery disease may have a harder time quitting smoking if they have a specific genetic profile and that these individuals have a better chance at quitting if they receive nicotine replacement therapy. The investigators hypothesize that determining which individuals with coronary artery disease should receive nicotine replacement therapy based on their genotype may improve the number of individuals who are able to quit smoking.This study randomizes treatment to that determined by the patient's genotype compared to standard, non-genotype-guided, treatment.

In this study, the investigators propose to show the feasibility of incorporating genotype-guided therapy into post-MI smoking cessation therapy and/or smoking cessation therapy in patients with coronary artery disease (CAD) using the CHRNA5 rs16969968 variant as the pilot case. The investigators propose to genotype ½ of PRISM-GENOMICs patients who are active smokers within 48 hours of admission and to guide their smoking cessation therapy based on CHRNA5 rs16969968 genotype (A allele carriers will be given pharmacologic therapy and GG homozygotes will be given counseling). The investigators will use the other ½ as controls. The participants will be followed and the investigators will test whether the genotype-guided group has better rates of smoking cessation compared to the control group. This pilot study will lay the foundation for personalized, genotype-guided, post-MI therapy and/or therapy in patients with CAD.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* presenting to Barnes hospital cardiac catheterization laboratory with coronary artery disease or admitted to Barnes hospital within 24 hours of a type 1 myocardial infarction (heart attack)
* active smoker at time of presentation to Barnes Hospital
* participating in PRISM-GENOMICS observational study

Exclusion Criteria:

* Unable to provide informed consent
* Unable to answer questions (e.g. intubated)
* Incarcerated
* Complications of myocardial infarction (such as shock, hemodynamic instability, life- threatening infection, etc)
* Women of child-bearing age with positive pregnancy test or who is breast feeding
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation


Eligibility Criteria:
Cohort A\* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.

* Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received \<4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity
* Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50%
* Presence of measurable disease per RECIST v1.1

Exclusion Criteria:

* All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
* Cohorts A \& E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was \>1 year prior to first dose of study treatment)
* Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
* Radiation to the lung \> 30 Gy within 6 months prior to first dose of study treatment
* Active brain metastases
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects

This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) meeting one of the following requirements:

  1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
  2. Between ≥ 27.0 kg/m2 and \< 30.0 kg/m2 (overweight) with at least 1 of the following: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome
* Have a stable body weight (\<5% self-reported change during the previous 8 weeks) before screening
* Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.

Exclusion Criteria:

* Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
* Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
* Have received drugs that have an impact on body weight within 12 weeks before screening.
* Surgical treatment for obesity.
* Known type I/II diabetes.
* History of acute or chronic pancreatitis or pancreatic injury.
* History of drug abuse or alcoholism at screening.
Reliability and Validity of iOS in IPF

Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities.

Lung function tests are breathing tests that measure how well the lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately.

Impulse oscillometry (iOS) is a new type of breathing test. It uses sound waves to measure the stiffness of the lung. The test is very quick (30 seconds), does not require any effort from the patient, and only requires a patient to breathe in their usual way. iOS has been used successfully in children who are unable to perform normal lung function tests.

The investigators will assess whether people with IPF can perform iOS tests accurately and to compare their experiences of having iOS tests with their experience of performing current lung function tests. The investigators will also compare whether there is a relationship between iOS tests and the information gathered from the tests currently used by doctors to measure the impact of IPF (lung function tests, exercise tests, lung scans and questionnaires that measure quality of life).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards
2. Able to provide written informed consent

Exclusion Criteria:

1. Contraindication to performing conventional lung function tests, e.g untreated TB, haemoptysis, pneumothorax, unstable cardiovascular status, recent eye, thoracic or abdominal surgery, thoracic, abdominal or cerebral aneurysm, acute illness (including diarrhoea and vomiting)
2. Unable to create seal on mouthpiece