cyrilzakka/clinical-trials huggingface dataset:
Respiratory Rate Validation Study - ChroniSense Polso

20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso

20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso.

A range of stable respiratory rates were elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.

Each subject was instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as the Accuracy Reference Device (Reference) in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent
* Subject is adult over 18 years of age
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker, or a smoker who has refrained from smoking for 1 day.
* Male or female of any race

Exclusion Criteria:

Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)

* Subjects with known respiratory conditions such as:

  * uncontrolled / severe asthma,
  * flu,
  * pneumonia / bronchitis,
  * shortness of breath / respiratory distress,
  * respiratory or lung surgery,
  * emphysema, COPD, lung disease
* Subjects with self-reported heart or cardiovascular conditions such as:

  * high blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg
  * have had cardiovascular surgery
  * chest pain (angina)
  * heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
  * previous heart attack
  * blocked artery
  * unexplained shortness of breath
  * congestive heart failure (CHF)
  * history of stroke
  * transient ischemic attack
  * carotid artery disease
  * myocardial ischemia
  * myocardial infarction
  * cardiomyopathy
* Self-reported health conditions as identified in the Health Assessment Form

  * diabetes,
  * uncontrolled thyroid disease, kidney disease / chronic renal impairment,
  * history of seizures (except childhood febrile seizures),
  * epilepsy,
  * history of unexplained syncope,
  * recent history of frequent migraine headaches,
  * recent head injury within the last 2 months,
  * Cancer / chemotherapy
* Other known health condition, should be considered upon disclosure in health assessment form
WHODAS-II for Patients With Nonspecific Low Back Pain

The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with low back pain (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).


Eligibility Criteria:
Inclusion Criteria:

* Patients seen for nonspecific low back pain, with or without referred pain
* Able to read and write
* Have signed the informed consent form

Exclusion Criteria:

* Central nervous system pathology (with or without treatment)
* Diagnosis of rheumatic inflammatory disease or fibromyalgia
* Red flags for underlying systemic disease
* Criteria for diagnosis of symptomatic herniated disc or symptomatic spinal stenosis
Patient-driven Compression in Urography

Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.

Evaluation of radiation dose, image quality and patients' experiences

Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.

Two compression devices are investigated in each patient, in randomized order.

Aims of the study:

1. Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.
2. Evaluate image quality with the two devices.
3. Describe patients' experiences from using the two devices.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a request for a urographic study

Exclusion Criteria:

* Emergency studies,
* cannot participate actively with compression,
* contraindications to compression of the abdomen,
* pregnancy,
* inability to understand the language of the questionnaire
Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer

RATIONALE: New diagnostic procedures, such as laparoscopic ultrasound, may improve the ability to detect pancreatic cancer and determine the extent of disease.

PURPOSE: Phase II trial to study the effectiveness of laparoscopic ultrasound in diagnosing patients with stage I or stage II pancreatic cancer.

OBJECTIVES: I. Determine whether a comprehensive laparoscopic examination of the abdomen with laparoscopic ultrasonography improves staging of pancreatic cancer with respect to (a) better assessment (compared to CT) of the extent of localized extra pancreatic disease, (b) vascular invasion, (c) regional lymph node involvement, and (d) metastatic deposits in liver parenchyma. II. Assess whether one of the newer minimally invasive imaging techniques, laparoscopic ultrasonography, predicts vascular invasion in pancreatic cancer. III. Develop an optimal cost effective strategy for assessing resectability in pancreatic cancer.

OUTLINE: Patients who have undergone routine clinical staging (CT scan, angiogram, etc.) and who have been classified as potentially resectable undergo laparoscopy and laparoscopic ultrasound (L+LUS). At the end of the L+LUS, based on the new findings patients are reclassified as either potentially resectable or potentially unresectable. All patient then undergo definitive staging: those who have metastasis to the liver that can be pathologically confirmed by biopsy at the time of the laparoscopy are classified as unresectable and do not undergo laparotomy; all others undergo laparotomy and then are classified as resectable or unresectable. If 8 or more patients are misclassified at the time of the L+LUS, then this study is terminated.

PROJECTED ACCRUAL: There will be 50 patients accrued into this study with 25 patients in each stage. In order to accrue 50 patients, approximately 70 patients will undergo the initial routine clinical staging (CT scan, angiogram, etc.).

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histological or radiological evidence of stage I or II pancreatic cancer No evidence of metastatic disease on CT scan

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prohibitive anesthetic risk due to cardiac disease Pulmonary: No prohibitive anesthetic risk due to respiratory disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No adhesions from previous surgery that preclude laparoscopy
Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible

Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated in two groups randomly : In group1, 10 patients underwent debridement and primary closer of the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.

All patients undergo surgical necrotic bone debridement in combination with antibiotic therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients were evaluated after 1(time1) ,6(time2) and 12(time 3) months.

The size of bone lesion was measured by using come beam computer tomography (CBCT).

Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a time span of 3 months without clinical symptoms were documented in each group.

Eligibility Criteria:
Inclusion Criteria:

* Criteria of bisphosphonate-related Osteonecrosis in stage II
* need debridement and surgical intervention

Exclusion Criteria:

* Malignancy in the area
* History of chemotherapy ,
* diabetic mellitus
* HIV
* odontogenic infection or undergo dialysis
UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization

The purpose of this study is to compare the accuracy, set-up time, and amount of image-guided radiotherapy (IGRT - a system that helps line up the radiation beam with the tumor for treatment) needed when mixed-reality guided radiotherapy is used for treatment set-up.


Eligibility Criteria:
Inclusion Criteria:

* Targets adult patients who are planning to undergo photon or proton radiation therapy at UFHPTI for treatment of the breast or chest wall. As this type of treatment is rare in men, the study will focus on female patients only.

Exclusion Criteria:

* Male subjects
Liraglutide Use in Prader-Willi Syndrome

Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See attached Citation). In this case report, the subject showed improvements in hemoglobin A1c and body weight over 14 weeks.

The investigators plan to examine the use of liraglutide in a single subject with Prader Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid control.


Eligibility Criteria:
Inclusion Criteria:

* Prader Willi Syndrome, Diabetes Type 2

Exclusion Criteria:

* Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome.
* Subjects with acute or chronic Pancreatitis
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection

This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult or adolescent patients greater than (\>)16 years of age
* HIV-1 infection
* CD4 count less than (\<)350/cubic millimeters (mm\^3)
* HIV RNA viral load \>10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
* Documented resistance, treatment-limiting toxicity, and/or \>=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.

Exclusion Criteria:

* Women who are pregnant or breastfeeding;
* Patients unable to self-inject;
* Active, untreated opportunistic infection.
A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas

A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.

In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2 arms of metastatic cancer pancreas patients in the first line , the first arm will receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm will receive 4 months of FOLFRINOX then kept under follow-up:

•Primary end point: PFS.

•Secondary end points: OS, QOL and Toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive adenocarcinoma of pancreas.
* Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th Edition) 2017.
* Measurable metastases according to RECIST 1.1.
* Patients underwent surgical resection and postoperative evaluation revealed distant metastasis.
* Patients with age ranging from 18 to 69.
* WHO performance status 0-1.
* An adequate bone marrow reserve and adequate liver and renal function as follow: Neutrophils ≥ 1500 cell/dl, Platelets ≥ 100,000 cell/dl, Hemoglobin ≥ 9.0 g/dl, Total bilirubin \< 1.5 × upper normal level (UNL), SGOT and SGPT \< 3 × UNL, Creatinine \< 1.5 × UNL or estimated GFR \> 30 ml/min.
* Adjuvant and neoadjuvant chemotherapies will be permitted if administered more than 6 months before inclusion.
* Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemotherapy.
* All patients must have signed and dated informed consent form.

Exclusion Criteria:

* Endocrine or acinar pancreatic carcinoma.
* Patients who progressed during FOLFRINOX regimen.
* Pregnancy or breast feeding.
* Patients with complicated systemic diseases such as diabetes, HTN or decompensated liver disease.
* Patients with any serious uncontrolled medical conditions that might compromise study participation: Central nervous system disorders, gastrointestinal tract disorders that interfere with oral medication.
* Patients with history of previous other carcinoma except basal cell carcinoma of the skin, insitu cervical carcinoma or non-metastatic prostate cancer.
* More than grade 1 peripheral neuropathy.
* Brain metastasis.
Dysbiosis in Bipolar Disorder

The gut microbiota is a complex community comprising around 10\^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. However, clinical evidence of the relationship between microbiota and mood disorders is lacking. The aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.

A prospective longitudinal study will be carried out with three groups of patients: a group of euthymic bipolar I or II patients without cognitive impairment (n=50), a second group of euthymic bipolar I or II patients with cognitive impairment (n=50) and a control group of healthy volunteers (n=50). Cognitive impairment will be defined as performance in any test of a domain below 2 standard deviations or more from the mean of normative data of each test assessed in the control group. Subjects will be recruited in the Hospital Clinic of Barcelona. At baseline clinical variables and diet patterns (ROME III) will be collected and neuropsychological performance (WCST, FAS, Stroop Colour-Word Interference test, TMT, WAIS-III, CVLT-II) and functionality (FAST) will be assessed. All subjects will be reassessed at 12 months follow-up. The mood state and possible affective relapses will be evaluated and treatments will be registered. All patients will receive standard psychiatric care according to international guidelines on bipolar disorders. Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C until assayed. Sequencing will be performed on an Illumina MiSeqTM platform. Statistical analysis will be performed with the latest existing version of the SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Diagnosis of bipolar disorder type I or II according to DSM-IV criteria (SCID);
  * Age between 18-55 years;
  * Euthymia (YMRS\<6 and HMDRS\<8) for at least 3 months;
  * Signed informed consent.
* Healthy controls:

  * No psychiatric diagnosis (SCID);
  * Age between 18-55 years; euthymia (YMRS\<6 and HMDRS\<8);
  * Signed informed consent.

Exclusion Criteria:

* Use of any type of antibiotics, antifungals or pro/prebiotics within at least one month prior to recruitment;
* IQ\<85;
* Neurological illness;
* Stomach/gut problems;
* Current diagnosis of substance abuse or dependence according to DSM-IV criteria (SCID);
* Electroconvulsive therapy in the last year.
Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study

This study will evaluate the rate of radiation necrosis following treatment with immune checkpoint inhibitor (ICI) treatment and radiation therapy in subjects with metastatic brain cancer. Subjects will be treated with the standard of care immunotherapy followed by radiation therapy via stereotactic radiosurgery at a reduced dose.

This is a prospective, single arm, pilot study to determine the symptomatic radiation necrosis rate at 6 months utilizing dose-reduced stereotactic radiosurgery with immunotherapy for subjects with a diagnosis of 1-10 brain metastases from MRI and tissue diagnosis of primary malignancy.

Primary end-point is 6 month symptomatic radiation necrosis, defined as a 6-month rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. Follow-up MRIs will be fused with the planning scan for this assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Brain MRI-confirmed 1-10 solid tumor brain metastases
2. Biopsy-confirmed primary malignancy
3. ds-GPA estimated median survival of at least 6 months, for histologies not included in the ds-GPA, publications or noted online at brainmetgpa.com, the PI will use either published or validated data or their best clinical judgment to determine the patient's expected survival
4. Stereotactic radiosurgery candidate per treating Radiation Oncologist
5. ≥ 18 years old at the time of informed consent
6. Ability to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization.
7. ALC \> 800/ul (Ku et al., 2010)
8. Patients currently on cytotoxic chemotherapy are eligible
9. Patients receiving ICI up to 30 days prior to delivery of SRS are eligible
10. Patients having undergone operative resection for metastatic brain disease within 30 days of immune checkpoint inhibitor (ICI) administration are eligible.

Exclusion Criteria:

1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up
2. Patients unable to receive MRI Brain
3. Patients with more than 10 brain metastases on MRI Brain imaging
4. Any lesion \> 4 centimeter maximum diameter
5. Total volume of metastatic disease more than 30 cubic centimeters
6. Previous whole brain radiation therapy
7. For Cohort 1: Previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
8. For Cohort 2: Patients whose treatment will have a dose overlap within the target from prior treatments of 20% or greater
9. Already receiving chronic dexamethasone (chronic = \> 2 weeks) prior to SRS
10. Not a radiosurgical candidate per Radiation Oncology discretion
11. Existing autoimmune disease
12. Patients who have an unknown primary cancer
13. Histology not amenable for SRS (i.e. lymphoma). (Small Cell Lung Cancer IS amenable.)
Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lymphoma (excluding lymphoblastic lymphoma)
* Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy
* Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2
* Life expectancy of at least 3 months

Exclusion Criteria:

* Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
* Ongoing treatment with chronic immune-suppressants
* Overt CNS lymphoma
* Inadequate hepatic, bone marrow, or renal function
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
* Venous thromboembolic event requiring anticoagulation
* Presence of active systemic infection within 72 hours of treatment
* Human immunodeficiency virus (HIV) infection
* Pregnant or lactating women
Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease

The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score\>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.


Eligibility Criteria:
Inclusion Criteria:

* Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent
* Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI
* Experienced ischaemic pain at rest
* Lasting 10 minutes and occurring within 7 days before enrollment
* As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (\< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference -
* High-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score \> 26 and chronic total occlusion disease.

Exclusion Criteria:

* Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
* Recent (\<1 month) trauma or major surgery (including bypass surgery);
* Active bleeding
* Unexplained clinically significant bleeding, thrombocytopenia (platelet count \< 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy
* Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure \> 180 mm Hg despite treatment)
* Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, - Thrombolytic therapy within preceding 24 hours
* Receiving antiIIb/IIIa therapy
* Creatinine clearance of \<30 mL/min