cyrilzakka/clinical-trials huggingface dataset:
Prehab Prior to Undergoing Tricuspid Intervention

This study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.

Prior to screening activities, each subject will be given an opportunity to ask questions and to understand the details of study participation. Subjects who meet the inclusion and exclusion criteria and have signed an informed consent form will be considered enrolled into the study. After a subject is consented and enrolled in the study, data will be collected prior to any intervention or surgery at the following time points: a) Screening/Baseline b) Day 1 of Prehab c) Day 2 of Prehab d) Day 3 of Prehab e) Day 4 of Prehab, f) and any data collected immediately prior to an intervention or incision (in the case of a surgical patient)

Subjects meeting eligibility criteria with planned tricuspid intervention will receive in-hospital optimization with THHBP's Prehab Protocol.

Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. If there are clinical and functional signs of improvement before Day 4, and the subject is ready for TV surgery or any other intervention, they will have Day 4 procedures performed. After the tests and evaluations are completed, the Principal Investigator or Sub-Investigators will decide if the patient is a candidate for TV surgery or another intervention

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Moderate-Severe or Severe TR
3. Undergoing tricuspid valve surgical or catheter-based intervention

Exclusion Criteria:

1. Clinical instability according to the judgement of the Investigator
Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.

OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this regimen.

OUTLINE: This is a dose-finding study. Patients receive a test dose of borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined. Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study, provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as needed.

PROJECTED ACCRUAL: Approximately 15 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Biopsy-proven melanoma that is clinical stage III Estimated clinical tumor depth 1.0-6.0 cm from the epidermis Tumor surface diameter no greater than 10 cm Grossly evident cutaneous or subcutaneous tumor nodules are eligible for irradiation

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of phenylketonuria Negative serum pregnancy test required of fertile women Adequate contraception required of fertile women during and for 6 months after the study

PRIOR CONCURRENT THERAPY: No prior radiotherapy to the target area
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age and older with histologically confirmed disease.
* Active disease as defined by at least one of the following (IWCLL consensus criteria):

  * Weight loss ≥10% within the previous 6 months
  * Extreme fatigue
  * Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection
  * Night sweats for more than one month without evidence of infection
  * Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
  * Massive or progressive splenomegaly
  * Massive nodes or clusters or progressive lymphadenopathy
  * Progressive lymphocytosis with an increase of \>50% over a 2 month period, or an anticipated doubling time of less than 6 months
  * Compensated autoimmune hemolysis
* Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation
* Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children.
* Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies.
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

Exclusion Criteria:

* Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks.
* Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. Impaired hepatic function
Fluoxetine for Anxious Children

The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD).

Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children.

Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks.

A child is eligible for this study if he/she:

Is 8 to 17 years old and has anxiety disorder.

A child will not be eligible for this study if he/she:

Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.

To evaluate the safety and efficacy of fluoxetine as a treatment for children and adolescents with Generalized Anxiety Disorder (GAD).

Anxiety disorders are among the most common childhood and adolescent psychiatric disorders and are often associated with academic, social, and family morbidity. These disorders frequently increase the risk for developing other psychiatric disorders (e.g., depression, substance abuse), aggregate in families, and appear to continue into adulthood. Except for Obsessive-Compulsive Disorder, there are very few pharmacological treatment studies for childhood anxiety disorders. Given the sparsity and methodological problems of previous anxiety pharmacological studies, it is clear that further investigation of the use of pharmacological treatment of children and adolescents with these disorders is needed.

Patients are randomized to receive either fixed-dose fluoxetine or placebo for 12 weeks. Patients are assessed for psychiatric symptomatology, functional status, and side effects. In addition, to assess attainment of steady state and compliance with treatment, plasma levels of fluoxetine and norfluoxetine are measured at 4, 8, and 12 weeks. To standardize the treatment protocol and to assure that both groups (fluoxetine and placebo) receive equivalent nonpharmacological treatment, a manual is used. Potential predictors of clinical response (such as age, sex, duration and severity of anxiety, school absenteeism, sub-syndromal depressive symptoms, family history of anxiety or mood disorders) are explored.

Eligibility Criteria:
Inclusion Criteria:

-

Patients must have:

Generalized anxiety disorder.

Exclusion Criteria:

-

Excluded:

Patients with current major depression, as well as patients with panic and obsessive-compulsive disorder.

-

Excluded:

Current substance abuse.
Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome

Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life. Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating it can be hard. Recent research has shown that certain nerve blocks are good for treating shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve) and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will use ultrasound guidance to accurately inject these nerves. These injections have never been described for SHS patients however, so investigators want to make sure people with SHS can go through with the injections without too much pain or discomfort. That is, the investigators want to test the tolerance of these injections for people with SHS. Investigators are also hoping to better understand how consistent a set of diagnostic criteria, called the Budapest criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are required to be 18 years of age or older and have a presumptive diagnosis of SHS post-stroke with a minimum visual analog scale of 40mm (greater than 40mm is considered moderate pain).

Exclusion Criteria:

* Subjects will be excluded from the study if they have significant cognitive impairment (mini-mental state examination \<23) and language deficits (difficulty cooperating due to aphasia) as this may affect their response to the outcome measures. Subjects with uncontrolled hypertension (\>180/110), septicemia, and brachial plexus injuries will be excluded. Patients who are blind and deaf will also be excluded, as they will be unable to adequately complete the post-procedure survey and VAS. Patients on anticoagulation medications will also be excluded on a case-by-case basis and medications will be held prior to injection if required for safety. Patients with INR \>1.5 will be excluded.
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers older than 45

Exclusion Criteria:

* impaired renal function
* congestive heart failure ascites known electrolyte abnormalities
Angelman Natural History Study - FAST Spain

The goal of this study is to conduct a prospective, longitudinal study to observe the natural clinical progression and disease outcome of AS patients receiving no disease-modified intervention, with the purpose of obtaining data that will be useful for future clinical trials.

The overall goal is to increase our understanding of the long-term natural history of Angelman syndrome and to identify and validate objective and sensitive outcome measures, which could serve as endpoints for outcome measures that can be used in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 3 months and 99 years of age.
2. Clinical diagnosis of Angelman Syndrome and molecular confirmation of the diagnosis.
3. The participant has an acceptable guardian capable of giving consent on behalf of the participant,
4. Willingness and ability of their guardians to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Patients with any comorbidity that, in the clinical judgment of the principal investigator, may affect the results of the study. Any confirmed chronic or acute condition or illness affecting any system(s) that could interfere with study results and/or compliance with study procedures is included.
2. Patients who are participating in parallel studies with investigational drugs.
3. Unwillingness or inability of their guardians to follow the procedures outlined in the protocol.
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Secondary objectives include:

* To compare response rate of patients in both treatment arms
* To compare overall survival of patients in both treatment arms
* To compare toxicity in both treatment arms
* To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of non-small cell lung cancer
* Documented disease progression after first-line chemotherapy for non-small cell lung cancer
* Stable and treated CNS metastasis is allowed
* Radiation must be completed at least 2 weeks prior to starting protocol treatment
* Major surgery must be completed at least 4 weeks prior to starting protocol treatment
* ECOG performance status 0-2
* Sexually active patients must use adequate contraception
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function

Exclusion Criteria:

* Severe hypersensitivity reaction to docetaxel
* Pre-existing grade 3 or 4 neuropathy
* Women who are pregnant or breastfeeding
* Uncontrolled intercurrent illness
* Receipt of 3 or more prior chemotherapy regimens
Utility of Syringe Based Suction Versus Channel Suction in Bronchoalveolar Lavage

Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a bronchus, instilling saline, and removing the saline via suction. Two techniques are currently used for suctioning: syringe based and channel suction.

The investigators concern is that channel suction creates too much force and there is collapsing of the airways which results in decreased fluid removal as well as cell sampling. The investigators propose that syringe based suctioning will not only return more of the instilled fluid but also more cells from the alveoli.

The pulmonary segment with the most disease on imaging will be the segment sampled. The scope will be wedged in the airway leading to that segment and 100mL of saline will be instilled into the selected segment and collected via the syringe based or channel based suction. Prior to unwedging, another 100mL of saline will be instilled into the same segment and will be collected using the alternative method. There will not be randomization, but the investigators will alternate which method is used first to eliminate confounding variables. All patients will receive both modalities of suctioning. The wall suction used for the channel suction will be set at 80 mm Hg. Syringe based suctioning will be performed with 20mL syringe. Total amount of fluid collected will be recorded and samples will be sent for cell count and differential as well as Gram stain and culture. Results of the two techniques will then be compared to determine which is the superior suctioning modality for BAL.

Eligibility Criteria:
Inclusion Criteria:

* Bronchoscopy scheduled

Exclusion Criteria:

* None
Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask.

Southmedic, Inc. has received approval to distribute a newly designed oxygen mask. The current design has been studied and the FiO2 delivered reported to be inconsistent. The purpose of this study is to determine if the performance is the same, better, or worse than current mask. We can evaluate performance by determining Liter flow required to maintain oxygen saturations that are within limits described in NM CDH oxygen protocol. We will measure the flow rate necessary to maintain the same saturation in adult patients using both the OxyMask and Oxy2Mask. The Oxymask has a flow device inside the mask that has been revised since implementation. The mask itself is otherwise unchanged. We intend to determine if the same amount of flow results in the same outcome.

This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same.

Eligibility Criteria:
Inclusion Criteria:

* Participants have oxygen device and are being titrated per NM CDH oxygen protocol (maintained between 90%-96%; or 88% - 92% if CO2 retainer)
* Participants to have period of stability; 2 hours at same liter flow on open design mask, 5-15 lpm 02.
* All adult patients (\> 18 years old) in med surge units (bed tower)
* Post-op patients requiring oxygen on Post-op Day 2.
* Patients currently on \>5 LPM via nasal cannula, clinician can recommend the change to OxyMask. If remains on \>5 LPM via OxyMask, patient can be included.
* Oxygen protocol will be followed per standards of care.

Exclusion Criteria:

* Patients receiving home oxygen therapy who do not require additional oxygen during hospital stay.
* Patients with a history of Bleomycin therapy.
* Patients with a history of Paraquat poisoning
* Patients that are pregnant
An Analgesic Study to of V117957 for the Treatment of Postsurgical Pain Due to Third Molar Extraction

The primary objective of this study is to assess the analgesic properties of an oral dose of V117957 4.5 mg aqueous suspension in the third molar extraction model


Eligibility Criteria:
Inclusion Criteria include:

* Males aged 18 to 45 years;
* Females aged 18 to 45 years of nonchildbearing potential;
* A body mass index of 18 to 30.0 kg/m2, inclusive;
* Scheduled to undergo outpatient surgical extraction of 2 or more third molars (with at least 1 partial bony mandibular extraction);
* Experience moderate to severe pain;
* Use only topical benzocaine, 2% lidocaine with epinephrine, and nitrous oxide as preoperative medication;
* Are deemed by the investigator to be appropriate candidates for the protocol-specified therapeutic regimen.

Exclusion Criteria include:

* Are female who are pregnant, lactating or of child-bearing potential, or who have a positive pregnancy test result at screening or check-in;
* A history or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion;
* A history of frequent nausea or emesis regardless of etiology;
* A history of seizures or head trauma with sequelae;
* A cardiovascular disorder, including hypertension, unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure or active myocardial ischemia;
* A history of alcohol or substance abuse or addiction;
* A history of opioid abuse or addiction;
* A positive urine drug or alcohol test at screening or check-in;
* A positive urine cotinine test result at screening or check-in, smokes frequently (\>1 time per week) or have used tobacco or nicotine substitutes within 1 month before the loading dose of study drug, and/or have an inability to refrain from use of nicotine between check-in and the follow-up visit;
* Ingest xanthine- or caffeine-containing foods or beverages (eg, coffee, tea, chocolate, and colas) within 24 hours before the loading dose of study drug and for the duration of confinement to the clinical site;
* Have the presence or history (within 2 years of screening) of bleeding disorder(s) or peptic ulcer disease;
* Have donated or lost ≥ 500 mL of blood in the 60 days before screening;
* Use of any medication, other than those that are standard for dental surgery;
* Have used acetaminophen, ibuprofen, aspirin, or other nonsteroidal anti-inflammatory drugs or any other analgesics (OTC or prescription) within 3 days before surgery; or have used long-acting anesthetics (eg, bupivacaine) or any other medications that may result in prolonged anesthesia, analgesia, or sedation;
* Have presence of a chronic or acute painful condition, other than the study indication, which could interfere with the assessment of efficacy of the study drug or any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures;
* Are unsuitable to participate in this study for any other reason, in the opinion of the investigator.
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy

Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index (BMI) between 18.0 and 40.0
2. Stable (\>4 weeks prior to the Screening Visit) dose of statin therapy with or without ezetimibe
3. Fasting low-density lipoprotein cholesterol (LDL-C): ≥100 mg/dL for those without cardiovascular disease, or ≥70 mg/dL for those with cardiovascular disease.
4. Fasting triglycerides (TGs) \<400 mg/dL

Key Exclusion Criteria:

1. Women who are pregnant, nursing or breast feeding
2. Currently prescribed a lipid lowering agent other than a statin or ezetimibe.
3. Clinically significant disorder or laboratory abnormality that could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results