cyrilzakka/clinical-trials huggingface dataset:
Point of Care Ultrasonography

This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is to evaluate the benefit of adding POC US to the management of inpatients admitted to the internal ward with respiratory, cardiovascular or hemodynamic abnormalities.

This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is to evaluate the benefit of adding POC US to the management of inpatients admitted to the internal ward with respiratory, cardiovascular or hemodynamic abnormalities.

This is a stage 1 pilot trial aimed to provide better understanding on the study population and study groups. This trial will comprise a total of 60 patients, 30 subjects on the intervention group and an equal number on the control group. The results of this pilot trial will be to design a larger trial and calculate a required sample size.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to internal ward
2. Age ≥ 18
3. No previous internal ward admission within the last 6 months
4. At least one symptom or sign of the following on admission:

   * Respiratory abnormalities: Dyspnea, RR\>20, O2 SAT\<90% requirement of oxygen or non-invasive ventilation or mechanical ventilation
   * Cardiovascular abnormalities: Chest pain, HR\>100, new/worsening peripheral edema, newly diagnosed ECG changes
   * Hemodynamic instability: SBP\<90 mmHg or on vasopressor infusion or pre-renal azotemia

Exclusion Criteria:

1. Patients with cognitive impairment or cannot sign informed consent.
2. Subject enrolled in a different study
3. Patients with end stage disease receiving Palliative/end of life treatments.
4. Pregnant patients.
5. Patients that were given a consult by one of the research members pre enrollment
6. Patient under responsibility of one of the study team members
Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases.

Primary end point is local progression free survival.

Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the colon or rectum
* Liver metastases
* Inoperable (technical or medical)
* 1-4 metastases
* Maximum 40 mm in diameter
* Suitable for both therapies, RFA and SBRT

Exclusion Criteria:

* Uncontrolled extrahepatic disease and uncontrolled primary cancer
* Liver cirrhosis
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)
* Two rising PSA levels greater than or equal to (\>/=) 2 ng/mL measured \>/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
* Adequate hematologic and organ function
* Documented willingness to use an effective means of contraception
* Safety cohort only: agreement to use CGM for first cycle of treatment

Exclusion Criteria:

* History of Type I or Type II diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible
* New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction \< 50% or ventricular arrhythmia requiring medication
* Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
* Clinically significant history of liver disease
* History of adrenal insufficiency or hyperaldosteronism
* Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
* Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
* Need for chronic corticosteroid therapy of \>/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
Cardiotoxicity of Radiation Therapy (CTRT)

The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy.
* Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose.
* Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed.
* Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy.
* Ability to read and comprehend English.

Exclusion Criteria:

* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Patients receiving stereotactic body radiotherapy
* Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study.
* Life expectancy less than 12 months
* Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners)
* Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study.
* Non-diagnostic echocardiography windows
Psychopharmacological Treatment of Emotional Distress

This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C
* Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study.
* Patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the C-SSRS (Columbia Suicide Rating Scale).
* Admitted to an inpatient unit in the last 36 hrs.
* Able to understand the nature and the substance of the consent form.
* Currently domiciled.
* Able and willing to provide verifiable contact information for follow-up.

Exclusion Criteria:

* Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.
* Past adverse reactions to clonazepam, olanzapine, or buprenorphine
* Past history of opiate or benzodiazepine use d/o in the last 2 years
* On agonist therapy for opiate addiction
* Ongoing treatment with clonazepam or olanzapine.
* Significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent.
* Receiving involuntary treatment in psychiatric unit
* Clinical suspicion of malingering by a CP.
* Undomiciled.
Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Demodex blepharitis is a prevalent cause of comorbid infection among individuals undergoing cataract surgery. Several complications may arise in the postsurgical period from Staphylococcus or Streptococcus co-infections, as Demodex is a vector for these pathogens. Hence, prophylactic treatments before cataract surgery may lead to a reduction in complication rates. Since Demodex infestation and cataract surgery are two prevalent coexisting conditions in the general population, this study aims to test the effect of four combined treatments to eradicate or improve the Demodex infestation index before surgery. The investigators are conducting a single-blinded randomized trial of four therapies in participants undergoing cataract surgery. All participants will or are receiving daily eyelid cleansing bid and topical 0.3% ciprofloxacin q4h for three days added to the allocated treatment arm. Our four intervention groups are: \[1\] Blephaclean eye scrubs; \[2\] 50% dilution baby shampoo; \[3\] tea tree oil shampoo; \[4\]: topical 0.3% ciprofloxacin alone. To assess treatment efficacy, the investigators will perform eyelash hair epilation pre and postoperatively. The primary outcome is a change in the mean Demodex spp. infestation index. Also, a change in the crude number of Demodex (egg, larvae, nymph, or adult-form) spp. in eyelashes after one-week of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent after explanation of the nature and possible consequences of the study.
* Clinical diagnosis of cataracts staged with Lens Opacity Classification System III based on the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery guidelines.
* No topical antibiotic ointment therapy or eyelid cleansing in the past six months.
* No systemic antibiotic or antiparasite treatment in the past six months.
* No ocular comorbidities (other than cataracts)
* No systemic comorbidities.

Exclusion Criteria:

* Withdrawal from the study.
* Minimal changes based on the Lens Opacity Classification System III.
Bleeding of Unknown Cause: a Swiss Case-control Study

The goal of this prospective cohort is to identified specific biological patterns in patients with a bleeding of unknown cause and to study the specific mechanisms of the bleeding disorder for each subset of patients.

Patients with bleeding of unknown cause are included. At baseline, blood will be drawn to evaluate the hemostatic profile. Findings are compared to a control group of healthy individuals. Patients and controls are followed for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Man with ISTH BAT\>3. If the calculated score includes a surgical bleeding, then two other items of the score should be \>0
* Woman with ISTH BAT \>5 points. If the calculated score includes a surgical or a postpartum bleeding, then two other items of the score should be \>0

Exclusion Criteria:

* Ongoing pregnancy
* Intake of antithrombotic treatment or non-steroidal anti-inflammatory drugs for least 10 days at time of blood collection
* Intake of antifibrinolytic or blood product administration (factor concentrate, frozen fresh plasma, prothrombin complex concentrate) for least 14 days before blood collection
* Active cancer (defined as cancer diagnosis within the last five years or treatment within the two last years before study inclusion)
* Active autoimmune disease
* Active chronic inflammatory disease
* Severe liver disease (cirrhosis \> Child A)
* Renal insufficiency stage 3
* Active or recent infection (within the last 30 days)
* Recent hospitalization (\<3 months)
* Recent surgery (\<3 months)
* Recent trauma requiring medical intervention (\<3 months)
Factors That Impact the Relationship Between Pulmonary Status and Susceptibility to Electronic Cigarette Use

The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use

In this study self-report questionnaires will be distributed and it should take between 20-25 minutes. Participants will be be asked questions related to smoking history, e-cigarette use, psychosocial factors, behavioral factors, environmental factors, and cognitive factors.

There is also an option of taking a web-based survey, Qualtrics® (Qualtrics, Provo, UT), if they do not have enough time to complete the surveys at this time. The online version of the questionnaires will be sent to the one week from now.

There is also a follow-up 5 minutes call with 6 months after today to follow-up with any change regarding to e-cigarette use.

Eligibility Criteria:
Inclusion Criteria:

Pulmonary Are 18 years of age or older. Attend outpatient Pulmonary clinic at UAB Diagnosed with a pulmonary disease Speak English as primary language Are medically stable and without psychiatric disorders. Signed Informed consent Healthy Are 18 years of age or older. Free from any pulmonary disease Report good to excellent general health Speak English as primary language Signed Informed consent

Exclusion Criteria:

Pulmonary Are younger than 18 years of age Do not attend the outpatient pulmonary clinic at UAB (pulmonary group) Report current e-cigarette use Are non-English speakers Have unstable medical or psychiatric disorders as determined by the assigned medical doctor (pulmonary group) Refuse to sign the informed consent

Healthy Are younger than 18 years of age Report any pulmonary diseases (control group) Report fair to poor general health (control group) Report current e-cigarette use Are non-English speakers Refuse to sign the informed consent
The Impact of Protein Intake on Protein Metabolism During Intensified Training

Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 30% higher than the recommended protein intake.

The present study will investigate the impact of protein sufficiency on protein metabolism and performance during intensified training periods as a means to further our understanding of the nutritional requirements for the endurance athlete.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male, endurance-trained participants who have run regularly more than 45 km or 4.5 hours/week
* Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold \[40\], in which peak rate of oxygen consumption(VO2 Peak) is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y), ≥47 ml/kg/min (40-44 y), ≥44 ml/kg/min (45-50 y) according to his age,
* Participants who can cover 10 km in less than 60 min after the VO2peak test and 5 km Time trial on session 2.
* Participants will be 18-50 years old.
* Participants are willing to abide by the compliance rules of this study

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the The Physical Activity Readiness Questionnaire for everyone.
* Female
* Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor
* Regular tobacco use
* Illicit drug use (e.g. growth hormone, testosterone, etc.)
A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients with Vitiligo

The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1
* Stable or active vitiligo
* Aged 12 or more
* Fitzpatrick skin types III-VI

Exclusion Criteria:

* Fitzpatrick skin types I-II
* Extensive leukotrichia
* Treatment with NB-UVB phototherapy in the last three months prior to study start
* Allergy to afamelanotide or the polymer contained in the implant
* Any other treatment for vitiligo within 30 days prior to the Screening Visit
* History of melanoma or lentigo maligna
* History of dysplastic nevus syndrome
* Any malignant skin lesions
* Presence of severe hepatic disease or hepatic impairment
* Female who is pregnant or lactating
* Female of child-bearing potential not using adequate contraceptive measures
* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures
* Use of any prior and concomitant therapy which may interfere with the objective of the study
* Extensive tattoos
Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* ASA I-II
* Undergoing elective hip arthroscopy

Exclusion Criteria:

* Known allergies to study drugs
* Opioid use 1 month prior to surgery
* BMI \>30
* Unable to comprehend visual analog scale
A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)

CAR-T therapy was therefore proposed and has been recently used for cancer treatment. It has been hailed for its promising remission rates after early stage clinical trials for acute lymphoblastic leukemia. However, CAR-T therapy is seldom used for autoimmune diseases. Researchers only use it for the treatment of multiple sclerosis (MS, an autoimmune disease of the central nervous system). SLE is a kind of autoimmune diseases which involving multiple systems, organs and with the present of a variety of autoantibodies. In the conventional treatment options, SLE could be treated with chemotherapy drugs or hormone drugs. But chemotherapy and hormone drugs could barely cured SLE. And now, chimeric antigen receptor modified T cell infusion maybe an effective treatment to solve these problems. The investigators use a 2nd CAR- T with the optimized hinge and transmembrane domain to treat patients with SLE. The purpose of this study is to assess the safety and efficacy of this 2nd CAR-T cells in the treatment of SLE.

This study is being conducted to assess anti-CD19-CAR-T cells safety and efficacy in treating patients with systemic lupus erythematosus（SLE）.The investigators constructed a 2nd CAR, using CD19 as target, using 4-1BB as co-stimulator, and optimized the spatial conformation by a suitable hinge and transmembrane domain sequences. The infusion dose is (1-10)E6 CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of systemic lupus erythematosus (SLE) patients
* Patients with CD19+ B-cell SLE as confirmed by Flow Cytometry
* Age: 18-69 years old
* Creatinine \< 1.5 mg/dl
* cardiac ejection fraction\>55%
* hemoglobin\>9g/dL
* Bilirubin \<2.0 mg/dl
* Successful test expansion of T-cells
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given

Exclusion Criteria:

* Pregnant or lactating women
* Uncontrolled active infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* Feasibility assessment during screening demonstrates\<5% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
* Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia)
TD-1607 SAD Study in Healthy Subjects

TD-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at Screening. Females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (FSH) level \>20 IU/L.
* Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg

Exclusion Criteria:

* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), penicillin, or cephalosporin antibiotics.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
The Effect of Rectus Sheath Block on the Postoperative Analgesia in the Patients Undergoing Robotic Single Port Cholecystectomy

The primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy.

The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.


Eligibility Criteria:
Inclusion Criteria:

* robotic single Port cholecystectomy for gallbladder disease

Exclusion Criteria:

* Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30