cyrilzakka/clinical-trials huggingface dataset:
EXPAREL Post-tonsillectomy Clinical Trial

Tonsillectomy is one of the most commonly performed surgical procedures in the United States. The primary indications for tonsillectomy in the adult population include recurrent pharyngitis, chronic tonsillitis, and obstructive pathology. Tonsillectomy is often associated with severe postoperative pain, which can result in prolonged poor oral intake, dehydration, and the need for high dose narcotics. In severely dehydrated patients, epithelial shedding and necrosis of soft tissues at the surgical site can lead to postoperative complications such as bleeding, delayed healing, and severe pain. The goal for this study is to explore the use of a long acting local anesthetic bupivacaine liposome injectable suspension (Exparel) to manage pain experienced by adult patients after tonsillectomy

The proposed investigation will examine whether Exparel (bupivacaine liposome injectable suspension 1.3%-13.3 mg/mL) when used as a post-excision adjunct to the standard of care bupivacaine HCl 0.25% (2.5 mg/mL) with Epinephrine (5mcg/mL), will decrease the patient's post-tonsillectomy experience of pain intensity, especially for the first three days after surgery, and correspondingly reduce the requirement for pain medications and improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo bilateral palatine tonsillectomy as the only procedure
2. Adults age 18 years and older.

Exclusion Criteria:

1. Severe systemic disease that is clinically significant in the judgement of the investigator.
2. Coagulation disorder that is clinically significant in the judgement of the investigator.
3. Current or previous history of analgesic dependence
4. Allergy to any of the drugs used in the study (bupivacaine)
5. Women known to be pregnant, planning to become pregnant, or lactating
6. Hearing impairment that is clinically significant in the judgement of the investigator.
7. Cardiovascular disease that is clinically significant in the judgement of the investigator.
8. Impaired liver function that is clinically significant in the judgement of the investigator.
9. Impaired renal function that is clinically significant in the judgement of the investigator.
10. Unable to provide consent.
11. Additional surgical procedures planned concurrently with palatine tonsillectomy.
12. Planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.
Effect of Accelerated RTH in Squamous Cell Carcinoma in Head and Neck

Evaluation of the efficacy of the accelerated radiotherapy in squamous cell carcinoma of head and neck

* HNSCC is the sixth most common cancer worldwide, with 890.000 new cases and 450.000 deaths in 2018.
* The incidence of HNSCC continues to rise and is anticipated to increase by 30% (that is, 1.08 million new cases annually) by 2030.
* Squamous cell carcinoma constitutes 90% of all head and neck cancers and it predominates in males.
* Risk factors such as cigarette consumption and alcohol consumption, are well established.
* Treatment decisions are guided by clinic-pathologic factors such as age and stage.
* Treatment of the majority of patients with HNSCC requires multimodality approaches.
* Radiotherapy or surgery alone can be considered as the standard treatment modality for patients having early head and neck squamous cell carcinoma.
* When conventionally fractionated radiotherapy is used, long-term tumor control can be achieved in less than 30% of patients with advanced head and neck carcinomas.

Eligibility Criteria:
Inclusion Criteria:

* Patients of (18 up to 75 years of age)
* Performance status of 0-2 according to ECOG scale.
* Patients with no prior chemotherapy, radiotherapy or surgery except for biopsy.

Exclusion Criteria:

* Patients with previous irradiation to head and neck.
* Pregnant or lactating women.
* Patients with impaired heart or lung diseases.
Steam Inhalations in COVID-19 Patients

The new coronavirus (SARS-CoV-2) causing COVID-19 is an RNA virus coated with a capsid and a peri-capsid crossed by glycoprotein structures. The external proteic structure, which attacks human cells, is a potential target to therapeutic interventions against virus replication in airways.

Since high temperature can cause irreversible denaturation of proteins and loss of SARS CoV and SARS CoV-2 infectivity was obtained after heating at 56 ◦C for 15 and 30 min in liquid environments respectively, we designed a protocol aimed at damaging SARS-CoV-2 capsid through steam inhalation cycles. Although the ominous consequences of COVID 19 infections has directed medical attention toward solidly established medical approaches, the European Pharmacopoeia VI edition also quotes steam inhalations as a procedure to treat of respiratory diseases.

Based on these suggestions we established a quasi-randomized clinical trial enrolling 200 asymptomatic or paucisymptomatic patients in whom rhino-pharyngeal-swab revealed a SARS-CoV-2 infection. The study protocol consisted of exposure of airway mucosae to humidified steam (pH 8 per NaHCO3 and hypertonic 15 g/L NaCl) through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days.

The objective of the study is to reduce the viral shedding using steam inhalations.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a SARS-CoV-2 positive molecular swab carried out in the previous 48 hours before the enrollement
* Adults with mild infection
* Adults with symptoms such as fever above 37 ° C, feeling bad, cold symptoms (cough, pharyngodynia, nasal congestion), headache, myalgia, diarrhea, anosmia, dysgeusia
* Adults without the above symptoms

Exclusion Criteria:

* Adults with dyspnea and/or dehydration and/or alterations in consciousness and/or sepsis.
* Subjects with severe asthma
* Subjects and with contraindications to treatment with steam inhalations
* Multi-allergic subjects
* Subjects unable to complete the protocol
The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention

The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.

Pas er randomized to a 6 months training group or none training. At baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).

Eligibility Criteria:
Inclusion Criteria:

* Successful PCI with stent implantation,
* Able to participate in the training program,
* No planned further revascularisation

Exclusion Criteria:

* CAGB,
* Inflammatory diseases other than CAD,
* Heart failure,
* Severe kidney failure,
* Inability to participate in the training program
Pharmacologic Treatment of PTSD in Sexually Abused Children

This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Eligibility Criteria:
Inclusion:

1. Ages 10-17 years, inclusive
2. Confirmed sexual abuse
3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
4. Parent/primary caregiver available to participate in treatment
5. Assent with parental consent to participate

Exclusion:

1. Non-English speaking
2. schizophrenia or other severe psychotic disorder
3. MR (IQ\<60) or PDD preventing CBT treatment
4. taking current psychotropic medication
5. documented substance dependence (substance abuse allowed)
Quality of Life Assessed With the PAH SYMPACT Questionnaire

Researchers are evaluating quality of life in pulmonary hypertension subjects using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire and assessing the questionnaires' performance with regard to relationship to other markers of disease severity, response to treatment, and outcome in a clinical practice setting.

Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic. The PAH-SYMPACT questionnaire will be administered either in written form or by telephone interview.

On the second 100 patients implement a standardized palliative care referral program for patients with Group 1 and 3 PH and high SYMPACT scores\> 1.0.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Consents to participate
* Documented group I PAH based upon these hemodynamic criteria: (mPAP \> 20, PCW 18 or less, PVR \> 3 Wood units
* Mean PAP \> 20, PCW ≤ 18, PVR \> 3 Wood units
* Parenchymal lung disease that in the opinion of the investigator qualifies patient as group III PH
* Documented chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease with intent to treat with surgery, balloon pulmonary angioplasty, and/or PH medication

Exclusion Criteria:

* Left sided heart disease (LVEF\<50%, PAWP\>18)
* Any other known concomitant life-threatening disease with a life expectancy \<12 months
* Any other clinically relevant and/or serious chronic medical condition that would affect study participation in the opinion of the investigator
* Non English speaking
Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees

The purpose of this graduate research study is to explore the therapeutic benefits of Myofascial Release massage on lower limb amputees with pain levels, range of motion, and muscle strength.

There are no other studies that address the effects of massage therapy as a treatment option for lower limb amputees suffering from lower back pain or the effects this has on muscle performance and/or range of motion. In addressing the physical, psychological, and social needs of a person living with limb loss, there should be a consideration for a multidisciplinary approach that could potentially include massage therapy as a fundamental standard of care. Therefore, the purpose of this graduate student research study is to test whether myofascial release massage can improve lower back pain levels in lower limb amputees and consequently improve quality of life and other measurable variables such as range of motion and muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* Pain in the lower back region
* Trans-tibial, trans-femoral, knee disarticulation, or Symes amputees
* Unilateral lower limb amputation
* Subject willing to receive massage once a week over a 4 week span
* Subject must be willing to abstain from over-the-counter and prescription pain medication 24 hours before each treatment

Exclusion Criteria:

* Open wounds within the treatment area
* Bilateral lower limb amputees
* Pregnant subjects (self-reported)
* Lymphedema
* Amputation distal to ankle
* Subjects who currently receive regular massage treatments
* Subjects taking anticoagulant medication
* Subjects with allergies to coconut oil
Modified Post-Transplant Cyclophosphamide Regimen for Children With Juvenile Myelomonocytic Leukemia

Hematopoietic stem cell transplantation (HSCT) is the only curative option for most of juvenile myelomonocytic leukemia (JMML). However, relapse after HSCT severely influence the long-term overall survival (OS). Researches demonstrate that these malignant myeloid disorders is a particular responsiveness to epigenetic therapy with the DNA-hypomethylating agents decitabine. However, hypomethylating therapy does not eradicate the malignant clone in JMML and an emerging concept with intriguing potential is the combination of hypomethylating therapy and HSCT. Graft-versus-host disease (GVHD) is major complication after HSCT as a threshold of the quality of patient life. Many data indicate that post -transplant cyclophosphamide (PT/Cy) is an effective method to control the occurrence of GVHD.

Hematopoietic stem cell transplantation (HSCT) is the only curative option for most of juvenile myelomonocytic leukemia (JMML). However, persistent disease statute and relapse after HSCT severely influence the long-term overall survival (OS). Researches demonstrate that JMML is an aggressive myeloproliferative neoplasm occurring in young children. The common denominator of these malignant myeloid disorders is a particular responsiveness to epigenetic therapy with the DNA-hypomethylating agents 5-azacytidine (azacitidine) or decitabine. However, hypomethylating therapy does not eradicate the malignant clone in JMML and an emerging concept with intriguing potential is the combination of hypomethylating therapy and HSCT. Graft-versus-host disease (GVHD) is severe complication after HSCT. Post -transplant cyclophosphamide (PT/Cy) is an effective method to control the occurrence of GVHD. Based on these encouraging results, investigators launched a noval method for patients diagnosed as JMML and treated in our institution. They modified PT/Cy conditioning regimens. Patients all subsequently received modified DCAG regimen as the induction chemotherapy including decitabine of 20 mg/m2 intravenously over 4 h for five consecutive days (Day -15 to -11) followed by cytarabine of 10 mg/m2 q12 h for 7 days (Day -15 to -9), aclarubicin of 10 mg/day for 4 days (Day -12 to -9), and G-CSF 5µg/kg per day for priming until white blood count was \>20 x109/L and immediately followed by myeloablative conditioning regimen (MAC) consisted with thymoglobulin (2.5mg/kg/day) which was administered for 3 days （Day -8 to -6), iv Bu (4 mg/kg in divided doses daily for 4 days) on days -5, -4, -3, and -2, iv Flu (30 mg/m2 once daily for 4 days, total dose 120 mg/m2) on days -5, -4, -3, and -2 and iv Melphlan (70 mg/m2 once daily for 3 days, total dose210 mg/m2) was performed on days -4 and -2.

Eligibility Criteria:
Inclusion Criteria:

* JMML patients diagnosed in our center and with the indications of transplant without the suitable donor.

Exclusion Criteria:

* JMML patients do not need to transplant.
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy

The investigate will conduct a cohort study to compare the growth and development, metabolism, lifestyle behavior, and health-related quality of life among three groups: children with transfusion-dependent β-thalassemia (TDT) who have received gene therapy, TDT children with lifelong supportive therapy and healthy children.


Eligibility Criteria:
Inclusion Criteria:

Gene therapy group-inclusion

* Male or female age of 3-14 years
* TDT Children who have received gene therapy.
* Subjects who are willing and able to provide written informed consent.

Supportive therapy group-inclusion

* Gender same as the matched case
* Age similar to the matched case
* Children with β-TDT
* No history of gene therapy or allogeneic hematopoietic stem cell transplantation
* Subjects who are willing and able to provide written informed consent.

Healthy children group-inclusion

* Gender same as the matched case
* Age similar to the matched case
* Subjects who are willing and able to provide written informed consent.

Exclusion Criteria:

* Diagnosis of compound α-thalassemia
* Uncontrolled systemic fungal, bacterial, or viral infection
* History of malignant solid tumors, myeloproliferative or immunodeficiency diseases
* Diagnosed with mental illness
* Patients considered to be ineligible for the study by the investigator for reasons other than the above

Discontinuation of Study :

* Subjects who are unwilling or unable to continue participating in the study (withdrawal of informed consent) may withdraw from the study
* Subjects who received gene therapy or allogeneic hematopoietic stem cell transplantation during the study
* The subject is seriously non-compliant with the study requirements, such as missing 2 consecutive visits
* Subject lost to follow-up
Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer

The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of lung cancer and brain cancer consistent with metastatic lung cancer.


Eligibility Criteria:
Inclusion Criteria

Patients will be eligible for the study if they:

* Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
* Have an ECOG performance status of Zero or One
* Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer
* (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment
* (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain.
* Have signed an informed consent form

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
* Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
* Are taking or have taken part in any investigational study within 30 days of start of study
* Have received an indium agent within 30 days of start of study
* Are not able to remain immobile during scanning time
* Have taken drugs that may damage the kidneys within 2 weeks of start of study
* Have abnormal laboratory test results: hemoglobin\<9.5 gms/dl, serum creatinine\>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal
* Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration
* Have undergone a PET scan within 7 days prior to study drug administration
* Have any active or previously treated second malignancy except carcinoma in situ of the uterine cervix or non-melanoma skin cancer
Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy

Single sequence clinical study designed to evaluate the effectiveness of B. Braun PA on improved clinical outcomes, indwell time and first stick success of PIVC using B. Braun Peripheral Advantage (PA) by Registered Nurses (RNs).

The study will be conducted in the Emergency Department (ED) and/or Medical Surgical (MS) floor(s)/unit(s) in multiple hospitals.


Eligibility Criteria:
Inclusion Criteria:

* RNs must complete all of the required B. Braun trainings in Stage 2 in order to participate in Stages 3 and 4.

Subjects must meet all of the following Inclusion Criteria:

1. Male or female aged ≥18 years;
2. The subject or the subject's LAR voluntarily agrees that the subject will participate in this study and is able to understand and sign the Informed Consent Form (ICF);
3. Have a medical condition that requires a PIVC anticipated to last for at least 48 hours;
4. Have intact skin at the site of insertion;
5. If the patient has an existing IV in one arm he/she must have a viable contralateral arm for additional PIVC insertion.

Exclusion Criteria:

Subjects must not meet any of the following Exclusion Criteria:

1. Are currently participating in another medical device or pharmaceutical study;
2. In the opinion of the Investigator, would not be suitable candidates for this study;
3. The subject or his/her LAR is an employee of the Investigator or study center, or the sponsor, or have direct involvement in the study or other studies under the direction of that Investigator or study center, or are a family member of the employees or the Investigator;
4. Have a laboratory confirmed bloodstream infection within 48 hours prior to participation in the study. The assessment is based on clinical observations and not routine for all subjects;
5. Patient has an existing non study related IV;
6. Was removed from any Stage of the study due to an AE associated with the PIVC.
Bizelesin in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have advanced cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of bizelesin in patients with advanced cancer. II. Determine the qualitative and quantitative toxic effects of this therapy in these patients. III. Determine the pharmacokinetics of this therapy in these patients. IV. Determine the recommended dose of this drug for phase II trials. V. Determine the antitumor effects of this therapy in these patients.

OUTLINE: This is a dose-escalation study. Patients receive bizelesin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor for which there are no therapeutic options that are potentially curative or have been demonstrated to increase survival No primary or metastatic CNS malignancy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No atrial or ventricular arrhythmia requiring medication No ischemic event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No other serious concurrent medical illness No history of seizure disorder requiring active therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 10% of bone marrow No prior electron-beam radiotherapy At least 4 weeks since other prior radiotherapy Surgery: Prior surgery allowed Other: Recovered from prior therapy