cyrilzakka/clinical-trials huggingface dataset:
The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur

The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study

The objective of this study was to evaluate the effect of high-intensity laser therapy (HILT) and exercise in patients with calcaneal spur. The patients were randomly assigned to receive either HILT + exercise (n=21) or placebo HILT + exercise (n=21). Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS) ), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement (with pedobarographic assesment), and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline, at 4 weeks, and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients aged 30-75 years old with pain in the plantar region lasting for at least one month, who were sensitive to palpation and who were diagnosed with a calcaneal spur in the subcalcaneal region as shown in a lateral x-ray of the foot were included in the study.

Exclusion Criteria:

* Patients with any sign of pathology in the blood count, with an increased sedimentation rate, having undergone any physical therapy for calcaneal spur within the past six months and/or local anesthesia and/or steroid injection in the region of pain, with the presence of a pathology on the x-ray apart from calcaneal spur, pregnancy, with the presence of systemic inflammatory disease, and with a history of local trauma or a history previous HILT therapy were excluded from the study
Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)

The purpose of this study is to test the safety of sorafenib and vorinostat when given together to see what effects (good and bad) it has on the patient and their acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the highest dose of sorafenib and vorinostat that can be given together without causing severe side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of AML (\> 20% myeloid blasts in the peripheral blood or bone marrow) or MDS with \> 10% myeloid blasts in the bone marrow. Patients with Acute Promyelocytic Leukemia (APL) must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide.
* The patients must have one of the following criteria:

  * Age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
  * Age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
  * Age of 70 years or older with relapsed or refractory disease
* The patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
* Patients must have an ECOG (Zubrod) performance status of 0-2
* Patients must be able to take and tolerate oral medications
* Patients must have adequate organ function as specified in the protocol.
* Patients not on anti-coagulation must have an INR \< 1.5 and a PTT within normal limits.

Exclusion Criteria:

* Pregnant women or nursing mothers are not eligible for this trial.
* Patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
* Patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. See protocol for listing.
* Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging
* Patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation

The purpose of this study is to test the accuracy of a new noninvasive way to measure how much blood our heart pumps per minute. This new way measures the heart's pumping activity from outside the body, instead of breaking the skin and measuring it from the inside.

Subjects will breathe normally through a mask while we record how fast and how much air they are breathing. We will have them "re-breathe" some of the air they breathed out by adjusting the ventilator. During this time, we will use the air breathed out to calculate how much blood per minute the subject's heart is pumping. We will also measure how much blood the heart is pumping at this time by injecting fluid into the catheter in the neck and then drawing about 1 teaspoon of blood from the catheters in the neck and arm. We will compare the calculated and measured values of the amount of blood pumped out of the heart for accuracy.

After we complete this procedure, we will remove the mask and allow you to rest for 10-30min. Following the rest period, we will repeat the process and collect a second set of measurements. We will draw a total of 4 teaspoons of blood for the study.

If you cannot comfortably breathe along with the ventilator, we will withdraw you from the study. If you want to stop taking part in the study at any time, let the study doctor know that you wish to withdraw. We will take off the mask, and your time in the study will end. This decision will not affect your regular medical care.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is already monitored with a pulmonary artery catheter and arterial line (not for the purpose of this study);
2. Hemodynamic stability.

Exclusion Criteria:

1. Patients with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
2. Patients who have central nervous system disorders that might be adversely affected by CO2 rebreathing, such as head trauma patients with increased intracranial pressure;
3. Patients with severe tricuspid regurgitation;
4. Patients with intra-cardiac shunts;
5. Patients who cannot cooperate and synchronize with the ventilator;
6. Patients with unstable respiratory conditions, such as acute respiratory failure;
7. Patients who have claustrophobia and cannot wear the mask.
8. Patients with aortic stenosis.
9. Patients with left main coronary artery disease.
10. Pregnancy.
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia


Eligibility Criteria:
Inclusion Criteria:

* Male and female 50 years or older
* Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night

Exclusion Criteria:

* CHF
* Diabetis Insipidus
* Renal insufficiency
* Hepatic insufficiency
* Incontinence
* Illnesses requiring systemic steroids
* Malignancy within the past 5 years
* Sleep apnea
* Nephrotic syndrome
* Unexplained pelvic mass
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Pregnant or breast feeding
Fluid Balance in Children Undergoing Fontan Surgery

This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.

The study hypothesis are

1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
3. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.


Eligibility Criteria:
Inclusion Criteria: Diagnosis of Congenital heart defect in need of Fontan procedure -

Exclusion Criteria: No parental consent

-
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)

To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy

The enrolled patients are randomized to Treatment Group with setting to provide Antitachycardiac Pacing (ATP) multiple times at an early timing or Control Group with Long Detection setting for the conventional ATP, at latest 10 days after the implantation of the Implantable Cardioverter Defibrillator(ICD) system in the domestic centers to confirm the safety and efficacy of the setting for the early timing multiple ATP treatment in Japanese patients.

The follow-up is not pre-defined and the data (including the home monitoring data) is collected according to the site's standard outpatient schedule, but the data will be collected at the hospital visit for the initial appropriate or inappropriate shock therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient has an indication for ICD according to the The Japanese Circulation Society (JCS )/ Japanese Heart Rhythm Society (JHRS) 2021 Guideline Focused Update on Non-Pharmacotherapy of Cardiac Arrhythmias
* Patient is either planned for de novo ICD implantation or is already implanted with an investigational ICD for 10 days or less.
* Patient can be treated with ATP therapy for both VT and VF zone
* Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept
* Patient is willing to visit the hospital in accordance with physician's instruction
* Patient is able to understand the nature of the study and to provide written informed consent

Exclusion Criteria:

* Patient planned for implantation with or already implanted with Cardiac Resynchronization Therapy Defibrillator (CRT-D) device
* A patient who is confirmed to have received ICD therapy
* A patient who is diagnosed as Idiopathic VF (e.g. Brugada syndrome, Long QT Syndrome, other IVF)
* Age \< 18 years
* A patient who has impaired mental status
* Life expectancy less than 18 months
* Participation in another interventional clinical investigation
* Pregnant or breastfeeding
Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures

Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. To the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.

The investigators current standard has been to use liposomal bupivacaine routinely for surgical infiltration which was a change from the historical practice of infiltration with lidocaine/bupivacaine, plain bupivacaine or no local anesthetic at all. The change was made due to the perceived benefits in analgesia past the 12-24 hours that plain bupivacaine was effective. It is not clear, however, that there are statistically significant benefits in terms of reduced narcotic use and length of hospital stay and improved pain control and return of function post-operatively.

Primary outcomes: The investigators will then measure narcotic use post-operatively as calculated by combining measures of patient-controlled analgesia (PCA) use for first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR)) as well as out-patient oral narcotic use as reported by patients. Subjective pain levels and pain interference scale and physical functioning scale will be evaluated pre-operatively and post-operatively with use of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) developed by the Defense and Veterans Center for Integrative Pain Management (DVCIPM) as a measure of perioperative pain and function.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* American Society of Anesthesiologists (ASA) status 1, 2 or 3
* Having an elective, minimally invasive, general surgery procedure at Naval Medical Center San Diego (NMCSD)

Exclusion Criteria:

* Age: Younger than 18 years old
* Pregnant women - safety of liposomal bupivacaine has not been studied in pregnant women
* ASA status greater than or equal to 4
* Conversion to open procedure/laparotomy
* History of reaction to local anesthetics
* History of hepatic disease - local anesthetics are metabolized in the liver
* History of pre-operative/concurrent condition requiring narcotic use
* Patient not able to adhere to post-operative pain control regimen outlined in methods section
Anesthesia and Lymphocytes Apoptosis

Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.


Eligibility Criteria:
Inclusion Criteria:

* male adults
* aged 18-80 yr
* undergoing elective OPCAB surgery containing left anterior descending artery bypass

Exclusion Criteria:

* a previous unusual response to any of the experimental anesthetics
* severe cardiac dysrhythmias or ejection fraction below 30%
* hemodynamic instability
* previous surgical coronary artery repair
* anemia, abnormal leukocytes or coagulopathy
* severe hypertension
* severe hepatic (albumin\<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
* concomitant surgical procedures and psychiatric disorders
* Insulin-dependent diabetics
Efficiency of Kinesio Taping in Chronic Lateral Epicondylitis

Lateral epicondylitis is a degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow. This randomized, double-blinded, controlled study aimed to evaluate the short term and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life, and functionality.

Fifty patients diagnosed with chronic unilateral lateral epicondylitis with a symptom duration of at least 12 weeks. The study group received a true inhibitor Kinesio taping while the control group received sham taping for the first four weeks. In both groups, progressive stretching and strengthening exercises were given as a home program for 6 weeks. Patients were assessed with the numerical rating scale (NRS), Cyriax resistive muscle test evaluation, maximal grip strength, PRTEE (Patient- Rated Tennis Elbow Evaluation), and SF-36 (Short Form-36) by the first assessor who was blinded to taping types.

Eligibility Criteria:
Inclusion Criteria:

* Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
* Unilateral elbow pain at least 12 weeks,
* Not received injection therapy to the elbow in the last six weeks,
* Not received a physical therapy program in the last three months,
* Presence of normal elbow radiographic findings,
* Normal elbow joint range of motion,
* Having no neurological deficits

Exclusion Criteria:

* Patients with degenerative joint disease,
* Radial tunnel syndrome,
* Cervical nerve root compression,
* Pain reflected from the neck, shoulders,
* Wrist, radiohumeral joint osteochondritis dissecans,
* Tendon rupture,
* Osteoporosis, Infection,
* Malignancy,
* Inflammatory disease,
* Pregnant women
Effects of Reflexology and Generalized Stretching in Postmenopausal Females.

To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females


Eligibility Criteria:
Inclusion Criteria:

* BMI less than 30 kg/m2
* Residents of rural areas
* Stable vital signs
* Participants with natural cessation of menstrual periods for at least 12 months
* Moderate and severe hot flash

Exclusion Criteria:

* Participants with history of hysterectomy surgical menopause females
* Participants with orthopedic disorder
* Participants taking sleeping pills
* Women suffer from pathological conditions for example cardiac disease, cancer impaired skin integrity
* Participants with history of recent bone fracture
* Severe pathology(eczema) of feet
Clinical Validation of the M5L Lung CAD

To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.

The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed extra-thoracic neoplasm

Exclusion Criteria:

* More than 10 nodules
* Severe pulmonary fibrosis
* Diffuse bronchiectasis
* Extensive inflammatory consolidation
* Massive pleural effusion
* Pregnancy
Interpersonal Psychotherapy for Severely Depressed Inpatients

We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower rates of relapse for patients initially treated with combination therapy.

A randomized controlled trial was conducted in 124 hospitalized patients with a DSM IV diagnosis of Major Depressive Disorder comparing 5 weeks of Interpersonal Psychotherapy modified for depressed inpatients (IPT-S) plus pharmacotherapy versus medication plus intensive Clinical Management (CM). The study included a prospective, naturalistic follow-up 3- and 12 months after acute treatment in 97 of 105 treatment completers. The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

Major Depression (single episode, recurrent or bipolar II) according to the Structured Clinical Interview for DSM IV (SCID)and a score of ≥ 16 on the 17-item version of the Hamilton Rating Scale for Depression (HAMD)

Exclusion Criteria:

(1) concurrent diagnosis of bipolar I disorder, primary substance abuse or dependency, mental disorder due to organic factors, and borderline or antisocial personality disorder, (2) psychotic symptoms, (3) severe cognitive impairment, (4) contraindications to the study medication, and (5) being actively suicidal
Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate

Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. The response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. This study tested the hypothesis that echocardiography to assess acute resynchronization of the left ventricle during device implantation may improve the response rate to the therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with SR or AF, indicated for CRT procedures (NYHA Class III or ambulatory Class IV despite optimal medical therapy, QRSd≥120ms and LVEF≤35%)
2. Patients with ischaemic or non-ischaemic cardiomyopathy can be recruited

Exclusion Criteria:

1. Patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement
2. Patients who aged less than 18 or over 80.
3. Patients who are pregnant.
4. Patients who cannot give informed consent.
5. Patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up.
6. Patients who have comorbid congenital heart disease.
7. Patients who have severe valvular heart disease, apart from severe mitral regurgitation.
8. Patients who have unstable angina or who are within 1 month of myocardial infarction.
9. Patients who have severe lung disease and accurate clinical assessment for heart failure symptoms cannot be performed.
10. Patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment, CRT procedures or follow-up.
Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease.

PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.

OBJECTIVES:

* Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer.

OUTLINE: This is a multicenter study.

Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (\^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.

Blood samples are collected at baseline and periodically after \^131I-TF2 infusion for pharmacokinetic studies and \^131I-TF2 biodistribution by ELISA and radioactivity measurements.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal cancer

  * Radiological documentation of disease is preferred, but not required

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Life expectancy ≥ 3 months
* WBC ≥ 3,000/mm³
* Neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Serum creatinine normal
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST/ALT \< 2 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 1 month after completion of study therapy
* No medical conditions that might prevent full participation in protocol-required testing or follow-up
* No institutionalized patients (e.g., in prisons or mental health institutions)

PRIOR CONCURRENT THERAPY:

* No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments