cyrilzakka/clinical-trials huggingface dataset:
Escitalopram in Asthma Patients with Frequent Exacerbation

Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), such as escitalopram are widely used for mood and anxiety disorders. However, they have also been explored, with promising findings, for a variety of disorders outside of psychiatry. Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. In this study, the number of asthma exacerbations will be assessed as the primary outcome measure, in patients using escitalopram vs. placebo.

A 24-week, randomized, double-blind, placebo-controlled trial of escitalopram will be conducted in 105 people with moderate to severe persistent asthma who, despite treatment with medium to high dose inhaled corticosteroids and long-acting beta-agonist therapy, had ≥ 3 asthma exacerbations in the past year. The primary outcome measure will be the number of times systemic corticosteroids are given for an asthma exacerbation with the Asthma Control Questionnaire as a secondary outcome measure. Mood and anxiety symptoms and functioning will be assessed as will the role of psychological asthma triggers on asthma symptom exacerbation. Serum IL-6 and peripheral eosinophil levels as well as fractional exhaled nitric oxide (FeNO) will be assessed. Thus, psychological/psychiatric and biological or immune mechanisms for the effect of escitalopram on asthma will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe persistent asthma
* Treatment with medium to high dose ICS and LABA therapy
* Three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year
* Age 18-65 years old, male or female sex, English or Spanish speaking
* Participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry
* Biologic therapy for asthma (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) will be allowed if started at least 6 months prior to randomization

Exclusion Criteria:

* Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
* Psychiatric illnesses other than MDD or anxiety disorders, including bipolar disorder, schizophrenia, schizoaffective disorder
* Vulnerable populations including intellectual disability or other severe cognitive impairment, inmates, pregnant or nursing women or women of childbearing age who will not use UT Southwestern IRB-approved methods of birth control or abstinence during the study
* Currently taking an antidepressant
* High risk for suicide defined as \> 1 past suicide attempts or any attempt within the past 12 months
* Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline
Schistosoma Mansoni in Mwanza Region, Tanzania

The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni. Despite the increasing focus on the use of praziquantel against schistosomiasis infections for the last three decades many areas in Sub-Saharan Africa still have high prevalences and intensities of schistosomiasis especially among school-age children. This is true for the area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12 years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are included, diagnosed and treated with praziquantel using strategies composing of a mixture of community wide treatment (CWT), school-based treatment (SBT) and years without treatment (-T). The 100 school children provided stool specimens on three consecutive days, while the 100 first year students and 50 adults with few exceptions only provided one specimen. The treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT, CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT; Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.

Eligibility Criteria:
Inclusion Criteria:

-All school children and adults who consent to participate can be included

Exclusion Criteria:

-Those not consenting or with any chronic disease not related to schistosomiasis will be excluded
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors

This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering Lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.

PRIMARY OBJECTIVE:

I. To evaluate the sensitivity and specificity of CEUS for the evaluation of TACE treatment response in a variety of solid liver tumors (years 1-4).

SECONDARY OBJECTIVES:

I. To determine the ability of CEUS to identify residual tumor vascularity intraoperatively, thereby enabling immediate retreatment when necessary (years 1-4).

II. To explore a variety of advanced imaging approaches to improve on the suboptimal specificity of CEUS for identifying residual viable tumor following TACE (years 1-5).

III. To investigate the ability of CEUS obtained prior to TACE to quantitatively assess tumor vascular morphology and predict response to therapy (years 2-5).

EXPLORATORY OBJECTIVE:

I. Use acquired B-mode in-phase and quadrature (IQ) data for H-scan imaging.

OUTLINE:

Patients receive sulfur hexafluoride lipid microspheres (Lumason) intravenously (IV) and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.

After completion of study treatment, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for TACE therapy of a liver tumor
* Be at least 18 years of age
* Be medically stable
* If a female of child-bearing age, must have a negative pregnancy test
* Have signed informed consent to participate in the study

Exclusion Criteria:

* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
* Patients with known sensitivities to the components of lumason
DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 18 years of age in sinus rhythm
2. Able to communicate effectively with trial personnel
3. Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
4. Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -

Exclusion Criteria:

1. Female subjects who are pregnant or lactating. All women of child bearing potential \[WOCBP\] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
2. Women of child-bearing potential are excluded unless they:

   1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
   2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
   3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
4. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
5. Unstable cardiovascular status defined as:

   1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
   2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
   3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
   4. clinically significant congenital heart defects
   5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
   6. acute pulmonary embolus or pulmonary infarction
   7. acute myocarditis or pericarditis
   8. acute aortic dissection
   9. atrial fibrillation
6. any major surgery within 4 weeks prior to screening
7. known contraindications to undergoing CMR or claustrophobia
8. participation in any investigational drug, device, or placebo study within 30 days prior to screening
9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -
Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

PRIMARY OBJECTIVES:

To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).

OUTLINE:

Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Received a regimen containing one or more immuno-oncology therapeutics
* Must have experienced one or more of the following:

  * One or more serious (Grade 3-4) AEs that are likely immune-related
  * One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
  * Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment

    \*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
  * Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
  * Has not previously been registered to this study
Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder

Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a plant native to India, recommended in the treatment of infertility, low libido and impotence. Its main active ingredient is the protodioscin, which has been attributed to an increase in testosterone levels and improved sexual function. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.


Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycle
* with no use of hormonal contraception within the last 3 months
* without any medication, drugs or alcohol.
* Healthy patients without systemic or psychiatric disease

Exclusion Criteria:

* Patients with amenorrhea and/or pregnant.

  * Patients who underwent bilateral oophorectomy.
  * Patient smoker (10 cigarettes per day).
  * Patients with blood pressure \> 160/90 mm Hg.
  * Patient with breast or endometrial carcinoma.
  * Patients with a history of myocardial infarction.
  * Patient with Diabetes.
  * Patient with vaginal bleeding from any source.
  * Patients with hepatic injury.
  * Patients with active thrombophlebitis or thromboembolic disorders recent
  * Patients with interpersonal relationship problems with your relationship or partner
  * Patients with sexual problems from your partner
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. In this study the investigators will investigate wether desmopressin reduces postoperative microvascular bleeding. The investigators will investigate wether desmopressin reduces platelet activation as measured by plasma concentration of neutrophil activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total postoperative bleeding and need for transfusions of blood components after surgery. The need for transfusions will be registered during the whole hospital stay. Patient with excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours during the first four hours) will be randomized into two groups and given either desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma concentration measurements will be drawn before infusion of desmopressin/placebo, immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years of age scheduled for cardiac surgery
* Excessive postoperative bleeding, more than 250 ml for one hour, or more than 150ml for two hours during the first four hours

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients with a medical condition known to influence the hemostatic system
* Patients treated with clopidogrel or systemic steroids during the last week before surgery
* Patients with INR above 1.5
* Patients who are not able to give written informed concent
* Unstable patients who need other transfusion limits than in this study
EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years,
2. Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
3. Patient who has signed an informed consent form,
4. Patient covered by a social security system,

Non-inclusion Criteria:

1. Patient with contraindication to general anaesthesia,
2. Patient undergoing a procedure without appropriate breathing control,
3. Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
4. Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
5. Pregnant or breast-feeding women,
6. Patient under legal protection (tutorship, guardianship, ...),
7. Patient already participating in another interventional clinical study.
Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)

The purpose of this study is to improve the investigators ability to diagnose von Willebrand Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening blood test used to determine if a person has VWD. This new screening blood test can determine a diagnosis more rapidly than current blood tests. Also this test could be available at local hospital labs rather than require samples to be sent to bigger more specialized labs.

This investigation will be a prospective, multicenter trial to validate the clinical utility of a novel screening assay as a diagnostic screening assay for VWD variants: Type 1C, 2A, 2B, 2M and 2N. Once the subject is enrolled into the study, a minimum of 0.5ml of citrated plasma will be collected and analyzed at the Bleeding and Clotting Disorders Institute Laboratory in Peoria Illinois. Results will be collected: phenotype function profiles will be determined, statistically analyzed and compared to the qualitative data from Blood Center of Wisconsin. Data is expected to correlate as previously shown in prior studies and will confirm the utility of this assay.

Eligibility Criteria:
Inclusion Criteria:

* New subjects undergoing evaluation for the diagnosis of VWD determined to have a VWF:Ag or VWF: RCo \< 50 IU/dl and or a VWF:RCo/VWF:Ag of \<0.7. Also subjects will be included if Type 2 N VWD is clinically suspected

Exclusion Criteria:

* Those subjects whose lab results do not meet the inclusion criteria
Study of Dotatate Imaging in Breast Cancer

This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.

Subjects with metastatic breast cancer are planned to be enrolled to undergo Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT imaging at one time point. SSTR uptake in metastatic lesions will be evaluated by independent central review (ICR). FDG PET and bone scans will also be performed within +/- 3 weeks of DOTATATE imaging.

The primary objective of this study is to evaluate uptake of Gallium-68 DOTATATE or Copper-64 DOTATATE in metastatic ER+ breast cancer lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years at the time of signing the informed consent.
* Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.
* For women of childbearing potential (WOCBP):

  a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea \[no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.\] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).
* Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.

Exclusion Criteria:

* Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE
* Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.
* Unable to perform PET/CT scans according to technical specifications and local guidelines.
* Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.
* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
* Unable or unwilling to comply with the requirements of the study protocol.
* Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent prior to any study-specific activities/procedures
* Ambulatory postmenopausal women.
* Age 55 years or older
* Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria:

* Administration of osteoporosis treatments or bone active treatments within specific timeframes
* Vitamin D deficiency
* Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
* Contraindications to denosumab therapy (e.g., hypocalcemia)
Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey

The goal of this surgeon survey is to find out if orthopedic and trauma surgeons can predict outcomes in older adults with distal radius fractures. The main questions it aims to answer are:

* Can orthopedic and trauma surgeons effectively predict which treatment would benefit a patient the most in terms of good outcome versus poor outcome (based on Δ PRWE) following casting or surgical treatment for displaced intra-articular distal radius fractures?
* What are the perspectives of trauma surgeons and orthopedic surgeons on current literature?
* What factors direct trauma surgeons and orthopedic surgeons to surgery?


Eligibility Criteria:
Inclusion Criteria:

* Dutch orthopedic and trauma surgeons
* Residents
* Experience with at least five surgeries of distal radius fractures in the past 3 years

Exclusion Criteria:

* No experience with distal radius fractures