cyrilzakka/clinical-trials huggingface dataset:
Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence.

General anesthesia and one lung ventilation is the standard type of anesthesia employed for VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating patients is being increasingly employed to perform several cardio-thoracic surgery procedures in an attempt of minimize operative risks and facilitate resumption of daily-life activity.

The investigators have reasoned that for a simple and palliative procedure such as talc pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might be considered a potential cause of morbidity and delayed recovery. The investigators have also hypothesized TEA could be considered an optimal type of anesthesia in this setting leading to a fast recovery a reduced overall workload in medical care.

In this single-center randomized study, the investigators have comparatively assessed the impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive results of VATS talc pleurodesis.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.
* Karnofsky performance status ≥ 50
* ASA score II-III
* Acceptance of the randomly assigned anesthesia protocol
* Radiologic evidence of lung re-expansion after previous drainage/thoracentesis
* Absence of blood clotting disorders (INR \< 1.5)
* No contraindications to TEA
* No neurological or psychiatric disturbance contraindicating awake surgery

Exclusion Criteria:

* Patients refusal of random assignment to treatment arm
* Patients refusal or noncompliance to TEA
* Patients refusal or noncompliance to general anesthesia and one-lung ventilation
* Unfavourable anatomy for TEA
* Previous surgery of the thoracic spine
* Coagulation disorders (thromboplastin time \< 80%, prothrombin time \> 40 sec, platelet count \< 200/nL or bleeding disorders
Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach

This study aims to determine the minimum effective dose of bupivacaine 0.5% in 90% of patients undergoing lower limb surgery with ultrasound-guided spinal anesthesia using Taylor's approach. A biased coin design up-and-down sequential method is applied. The initial dose is 15 mg of bupivacaine 0.5%. After 45 successful spinal anesthesia, the ED90 of bupivacaine 0.5% will be calculated.

The minimum effective dose of local anesthetics for spinal anesthesia using Taylor's approach is not known. This study aims to determine the minimum effective dose of bupivacaine 0.5% using a biased coin design up-and-down sequential method. Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. The initial dose is chosen as 15 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the bupivacaine dose is increased by 2 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 2 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks will be accomplished. MED90 will be calculated by isotonic regression.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical statusⅠ- Ⅲ
* Lower limb surgery, expected operation time within 2 hours

Exclusion Criteria:

* Patient refusal
* American Society of Anesthesiologists physical status IV/V
* Peripheral neuropathy
* skin infection at the site of injection
* allergy to bupivacaine or lidocaine
* BMI \> 35 kg/m2
* coagulation disorders
High- vs Low-Frequency Exercise for Depression in Adolescents

This research project aims to examine the antidepressant effects of different exercise routines on adolescent depression, which has risen significantly in recent years. Depression, particularly prevalent among adolescents at a global rate of around 12%, is associated with reduced positive emotional responses and difficulties in managing negative emotions. Prior studies indicate that physical activity can boost positive moods, like feelings of excitement and calm, potentially leading to overall mood stabilization with regular exercise. However, results on how exercise influences negative moods remain inconsistent. This study will compare two exercise routines-a single 60-minute weekly session versus four 15-minute weekly sessions of moderate-intensity running-over three weeks to determine which approach has a stronger effect on reducing depressive symptoms in adolescents.

Depression is a mental disorder that affects millions of people globally every year. This mental health issue is particularly prominent in adolescents populations, where depression has been found to increase at a greater rate than in adults over the last decade. In concrete terms, the global current prevalence of depressive disorders (major depressive disorder and dysthymia) is about 7-8% in adults worldwide, whereas it is around 12% among adolescents.

Depression is characterized by a limited capacity to inhibit negative emotions and a dampening of positive affective and emotional reactions.

There is strong evidence that physical activity increases pleasant-activated states like excitement and vigor both immediately following a bout of exercise and more accumulatively, and some studies show that physical activity enhances pleasant-deactivated affective states like calmness or relaxation. Over time, these acute affective responses to physical activity may accumulate to chronically regulate core affect. One logical implication of all this is that shorter but more frequent exercise sessions throughout the week will offer repeated doses of mood improvement, leading to a more stable mood over time, which should predict greater reductions in depressive symptoms.

Previous studies have reported inconsistent and inconclusive findings for the influence of physical activity on unpleasant core affects, and the general pattern in previous research is that physical activity has a more pronounced effect on positive affect than negative affect. Although, recent findings suggest that daily moderate to vigorous physical activity can decrease the level of depressed and angry affects in adolescents.

Therefore, the current randomized controlled study aims to compare the antidepressant effects of a 3-week exercise program with either one weekly 60-minute session or four weekly 15-minute sessions of moderate-intensity running among adolescents (in which findings have been mixed to date).

Eligibility Criteria:
Inclusion Criteria:

* baseline PHQ-9 score \> 9 (i.e., "moderate depression")

Exclusion Criteria:

* unability to read and understand French language
* specific medical contraindications for physical activity
Instrument Development of Screening Prediabetes Patients

It will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection.

During the past years, many efforts were put on the diagnosis and treatment of DM and its complications. It will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection. As a first public health step, it is worthwhile to identify prediabetes people in community by screening program. Three thousand persons will be randomly selected from residents of Taichung city. All the participants will fulfill a structured questionnaire and 'Diabetes risk factor screening tool' which American Diabetes Association suggested in 2003. This project will estimate the prevalence of prediabetes in conventional hospital-base population as well as the validity of a screening questionnaire for prediabetes.

Eligibility Criteria:
Inclusion Criteria:

Residents aged 40 and over of Taichung city, Taiwan in October, 2004.

Exclusion Criteria:

-
Diagnostic and Interventional Therapy in Acute Pancreatitis

The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Laboratory values were assessed as well.

For laboratory values different inflammation markers were measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Acute pancreatitis
* Written formal consent

Exclusion Criteria:

* Pregnancy
* Missing formal consent
* Individual contraindications for CT-scan
* MRI or endoscopic ultrasound
Clinical and Basic Investigations Into Congenital Disorders of Glycosylation

The purpose of this research is to study the natural history of congenital disorders of glycosylation and its causes and treatments.

The investigators are conducting a natural history study of patients with congenital disorders of glycosylation (CDG). The study will look into the progression of the disease amongst the participants and also look at the clinical symptoms and how they vary amongst different diseased population groups. The participants will be asked to fill out questionnaires either on their own or with a provider that will grade the severity of disease and document symptoms and diet. Participants will have an opportunity to submit blood, urine, and stool samples that will be tested for biomarkers for CDG.

Participants will also complete dietary food records, physical exams, CDG scores, and the PROMIS questionnaires to assess disease progression and severity.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a genetically, enzymatically, or molecularly confirmed diagnosis of CDG or NGLY1 deficiency

Exclusion Criteria:

* None
Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France

Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age.

The delay in diagnosis is a factor of poor visual acuity. Will justify the implementation of information programs with health and education professionals in order to improve the functional prognosis of patients with congenital glaucoma.

Prospective multicentre prospective cohort Enabling the identification and follow-up of an almost exhaustive population of incidents of congenital glaucoma in 23 ophthalmology centers in France Inclusion over 4 years Epidemiological data, all reports of consultation, medical and surgical procedures collected in an E-CRF.

Database for gene research related to congenital glaucoma to provide screening, genetic counseling and personalized care

Eligibility Criteria:
Inclusion Criteria:

* Boys or girls under the age of 4, without antecedent, French or resident in France, Suspected Glaucoma

Exclusion Criteria:

* Antecedent of surgery for glaucoma
Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women

RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels.

PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on blood estrogen levels in postmenopausal women.

OBJECTIVES:

* To measure the change in levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates in postmenopausal women after 6 weeks of daily ingestion of 94 grams of freeze-dried table grape powder.
* To conduct bioavailability research on the freeze-dried table grape powder in humans through the analysis of participants' blood and urine samples.

OUTLINE: Participants receive oral freeze-dried table grape powder once daily on days 1-42 in addition to their usual diet. Treatment continues in the absence of toxicity.

Participants undergo blood sample collection at baseline, periodically after the first dose, and on the last day of the study for pharmacokinetic and bioavailability analysis. Samples are examined by mass spectrometry to measure plasma levels of estrone (E1), estradiol, E1-conjugates, E1-sulfates, testosterone, and androstenedione. Participants also undergo spot urine collection and weight and height measurement periodically during study.

Participants complete food diaries on days 1-3, 21-23, and 40-42 to assess their intake of grapes, grape juice, and red wine and to examine the constancy of their caloric intake over the course of the study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Participant in the Mayo Mammography Health Study

  * Has consented to provide baseline mammogram for digitization

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Female
* Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months)
* Able to give informed consent and complete food records alone or with assistance
* Willing to provide research blood and urine samples
* Must be a non-smoker
* Willing to maintain current weight
* No history of breast ductal carcinoma in situ or any other cancer, except basal cell or squamous cell skin cancer or lobular carcinoma in situ
* No history of allergic or other adverse reaction to grapes
* No history of diabetes or glucose intolerance

PRIOR CONCURRENT THERAPY:

* No concurrent hormone therapy, including estradiol, estrone, or progestins
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
* If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
* Patients must voluntarily sign and date Subject Information Form and Informed Consent Form prior to inclusion into the study.
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
* Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.

Exclusion Criteria:

• None
Tenoxicam for Intrapartum Analgesia

The aim of this study is to assess whether tenoxicam is as effective as pethidine for analgesia during the first stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* Primiparity
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus

Exclusion Criteria:

* Clinical evidence of cephalopelvic disproportion
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy
* Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family
Integrated Care for Pediatric Obesity Using Telehealth

Obesity is perhaps the most urgent public health crisis in pediatrics. Thus, managing childhood obesity is a top priority among pediatricians in primary care settings. However, effective treatment typically is multidisciplinary, and most practices currently do not have the infrastructure for coordinating integrated care. With the advent of the Affordable Care Act (ACA), innovative systems for building multidisciplinary teams to provide integrated care through a patient-centered medical home will be at a strategic advantage. The use of electronic technologies for delivering health-related information or services, known as telehealth, is an innovation with the potential to streamline integrated care and transform interventions for chronic diseases. We propose a pilot study to evaluate telehealth for treating pediatric obesity in collaboration with a community practice (Wareham Pediatrics).

Patients aged 10 to 17 years who participate in the telehealth intervention study (N=40) will be randomly assigned to an "immediate" intervention group or a "wait list" control group. Subjects in the "immediate" intervention group will begin the 6-month telehealth intervention at the time of enrollment in the study and then receive general patient/family counseling from their primary care providers (PCPs) at routine office visits during a 6-month follow-up period. Those in the "wait list" control group will receive general patient/family counseling from their PCPs for 6 months followed by the telehealth intervention for 6 months. Thus, the total duration of participation in the study for each subject will be 12 months. The telehealth intervention will include dietary, physical activity, and behavioral management counseling provided by videoconferencing from the OWL clinical providers at Boston Children's Hospital to children in their homes, or at a telehealth station at Wareham Pediatrics.


Eligibility Criteria:
Inclusion Criteria:

* Aged 10 to 17 years
* BMI ≥95th percentile for age and sex
* No known significant obesity comorbidity or cause requiring urgent medical evaluation or treatment in a subspecialty program other than an obesity program
* No known physical limitations to changes in diet or activity level (i.e., concern for cardiac disease, primary gastrointestinal disease, or orthopedic concerns)
* Patient at Wareham Pediatrics practice

Exclusion Criteria:

* Unstable home environment (homeless, temporary living situation, lack of working phone or electricity)
* Inability to actively participate in treatment (developmental delay, nonverbal, severe psychiatric illness).
* Physician diagnosis of a major medical illness or eating disorder.
* Chronic use of any medication or supplement that may affect study outcomes.
* Another member of the family (i.e., first degree relative) or household participating in the study.
* Planning to relocate from current area of residence during the proposed timeframe for study participation
Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis

N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) are two drug metabolizing enzymes. Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite. Slow acetylator genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater toxicity of ATT drug. Therefore this study has been designed to analyze the genetic polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced hepatitis upon administration of antituberculosis drug.Polymorphism study of NAT2 and CYP2E1 gene may help in predicting the high risk group of ATT induced hepatitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary tuberculosis
* Patients receiving conventional antituberculosis drugs
* Patients who directly presented with antituberculosis drug induced hepatitis

Exclusion Criteria:

* Habitual alcohol drinkers
* Patients with evidence of viral hepatitis
Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients

This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.

The objective is to understand the effect of PEMF on skin thickness and toxicity after radiotherapy on breast cancer.

The study included 50 adult female breast cancer undergoing whole-breast irradiation.

This is a randomized, controlled clinical trial was conducted at the outpatient clinic of the Faculty of Physical Therapy, Ahram Canadian University, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.
* Unilateral breast cancer
* Age from 35-55 years.

Exclusion Criteria:

* Patients had previous irradiation to the same breast.
* Patients had bilateral breast cancer.
* Patients had metastatic disease.
* when the use of bolus material was required to deliver RT.
* Patients had a pre-existing skin condition or open wound in the treatment area.
Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

To check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney

To check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney.

Ten patients scheduled to perform ultrasound guided biopsy of transplanted kidney will be enrolled. The patients who have previous medical history of cardiac problem or who do not recover renal function over three days after graft surgery will be excluded.

Before ultrasound guided biopsy of transplanted kidney, we will perform conventional, Sonoelastography and real-time contrast-enhanced ultrasound using Sonovue for acquisition of parameters and data, respectively. We will check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images using analyzing program (VueBox, Bracco, Swiss). And we will verify the correlation of acquired data and parameters with pathologic results from ultrasound guided biopsy of transplanted kidney.

From perfusion images, several regions of interest (ROIs) will be marked including main renal artery, segmental artery and renal medulla. A number of time-intensity curves (TICs) are acquired from ROIs using VueBox.

The parameters acquired from time intensity curve (TIC) (i.e. arrival time, mean transit time, time to peak, basal intensity, peak intensity, area under curve, slope rate of ascending and descending curves), the date acquired from spectral Doppler ultrasound (i.e. restive index, pulsatility index) and Values of shear wave velocities of the several regions of interest acquired from Sonoelastography will be analyzed to find statistical significance in assessment of allograft nephropathy such as acute rejection or chronic allograft nephropathy.

Pathologic conditions such as acute rejection may show the decrease in arrival time, peak intensity, area under curve suggesting total blood flow and accelerating slope rate, compared with non-pathologic condition.

Eligibility Criteria:
Inclusion Criteria:

* 1)Patients to perform ultrasound guided biopsy of transplanted kidney

Exclusion Criteria:

* 1)Patients to have the medical histories of heart such as acute failure, arrhythmia, ischemia, infarction and angioplasty 2)Patients to show poor graft function which does not recovery within three days after transplantation