cyrilzakka/clinical-trials huggingface dataset:
Improving the Outcomes of Community-based Management of Acute Malnutrition

Severe acute malnutrition (SAM) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. The current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. The purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment programs and thus improve child health outcomes.

A prospective observational study in inpatient care within community-based management of acute malnutrition(CMAM) program run by the nongovernmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria

The objectives of the study are to validate the BedsidePEWS scores as a measure of severity of illness in children who are treated as inpatients for severe acute malnutrition and to compare the BedsidePEWS scores with other risk factors associated for mortality and relapse of children with severe acute malnutrition. The design is a prospective observational study of 1000 children admitted as inpatients in a CMAM program in Maidaguri Teaching Hospital in Maidaguri, Nigeria. Data collection (estimated duration 4-5 months) involves vital signs, and risk factor assessment every 12 hours for duration of hospitalization. Blood test for hemoglobin and malaria will be done once upon admission. Outcomes will be measured every 12 hours and include mortality and/or escalation and de-escalation of care. Logistic regression with significance testing will be used to compare BedsidePEWS scores and risk factors between patients and among individual patients within the outcome categories. Exploratory sensitivity analyses will repeat the main logistic regression analyses to evaluate the performance of partial BedsidePEWS score in patients with missing data of 1-3 of the 7 components, by randomly removing 1-3 data elements from the score calculation from patients, and by removing systolic blood pressure from scoring.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1 to 59 months
* Diagnosed with severe acute malnutrition (criteria for severe acute malnutrition is \<3Z Weight for Height Z score, and/or MUAC \<115mm, and/or bilateral pitting oedema)
* Meet the criteria for admission into inpatient care (failed appetite test, and/or medical conditions).

Study amendment for inclusion: children with and without severe acute malnutrition admitted to emergency pediatric unit (EPU)

Exclusion Criteria:

- Children with congenital anomalies that interfere with feeding (ie. cleft lip and/or palate); previous enrolment in this study.
Binaural Sound for Remimazolam Maintenance

It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for general anesthesia
2. Patients aged 20-60
3. Patients with American Society of Anesthesiologist physical status classification 1-2
4. Patients with ideal body weight 50-80 kg

Exclusion Criteria:

1. Patients with hearing disability
2. Patients using opioids or sedatives in 1 week
3. Patients who are dependent for alcoholics or drugs
4. Patients with hypersensitivities to remimazolam or remifentanil
5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
6. Patients with liver failure
Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.

It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \> 18 years
2. Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)
3. Patients who undergo ERCP for confirmation of CBD clearance
4. Dilated common bile duct (\> 10 mm)
5. Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation

Exclusion Criteria:

1. Presence of biliary tract cancer
2. Presence of distal CBD stricture
3. Bleeding tendency (INR\>1.5 or platelets \<50000 mm3)
4. Contraindications of ERCP
Efficacy of Alkalinized Lidocaine Compared to Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

This study is designed to compare the effects of alkalinized lidocaine in the endotracheal tube cuff to a bolus dose of remifentanil given prior to the emergence of anesthesia:

* on the incidence of perioperative coughing
* on the time needed for the emergence of a desflurane-based anesthesia
* on the incidence of sore throat after extubation.

The investigators hypothesis is that the use of alkalinized lidocaine in the endotracheal tube cuff will reduce the incidence of perioperative coughing after a desflurane-based anesthesia.

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.

Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. The use of intracuff alkalinized lidocaine has been proven effective to reduce the incidence of coughing during emergence of anesthesia.

Furthermore, there is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and hemodynamic stimulation. However, depending on the type of opioids given, this may delay the emergence from anesthesia. The effect of a remifentanil infusion given in combination with isoflurane as the volatile agent has been shown to reduce the incidence of perioperative coughing without delaying the emergence of anesthesia. Bolus doses of remifentanil have also been proven effective to reduce the hemodynamic response to extubation.

The effect of these two modalities (alkalinized lidocaine and remifentanil) have never been compared. This study will assess their efficacy to prevent perioperative coughing after a desflurane-based anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* Physical status 1-3
* Patients undergoing elective surgery under general anesthesia requiring oral endotracheal intubation (excluding head and neck surgery)
* Expected duration of surgery of at least 1.5 hour.

Exclusion Criteria:

* Current use of ACE inhibitor
* Chronic cough
* Asthma or severe pulmonary disease
* Pulmonary tract infection
* Anticipated difficult intubation
* Current use of opioids
* Current use of cough medicine
* Contraindication to remifentanil, lidocaine
* Pregnancy
* Symptomatic cardiac, renal or hepatic disease
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection

The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.

Dissection of the aorta is a medical emergency requiring immediate surgery. Type B dissections are typically treated with surgery or endoluminal therapy when complications such as uncontrollable pain, organ ischemia, or aortic rupture are present. However, the treatment of patients with uncomplicated, acute type B dissections is controversial. Best medical therapy (BMT) is the standard of care in these cases since surgical repair offers no additional survival advantage. However, Endoluminal stent graft therapy with the GORE TAG Thoracic Endoprosthesis (GORE TAG device) may offer distinct advantages as an adjunct to medical therapy for uncomplicated acute type B dissection. The goal of endoluminal stent grafting is to cover the primary entry tear of the dissection to isolate the false lumen from blood flow and induce aortic remodeling.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of acute uncomplicated type B aortic dissection
2. Able to tolerate endotracheal intubation and general anesthesia
3. Maximum transverse diameter of the descending thoracic aorta \< 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology.
4. Arterial anatomy is appropriate for stent graft therapy

Exclusion Criteria:

1. ASA classification = V
2. Severe renal insufficiency defined as SVS risk renal status = 3
3. Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
4. Presence of connective tissue disease
5. Active infection or active vasculitides
6. Positive pregnancy test
7. Participation in another medical research study within 3 months of study enrollment
8. Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
9. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass), or major surgery within 30 days of study enrollment
10. History of drug abuse
BREATHING EXERCISES FOR LABOR PAIN AND DURATION

This study aimed to assess the efficacy of breathing exercises (BE) during the second stage of labor for maternal pain, duration of labor and first-minute APGAR score. This is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding BE with a control group (CG) that received standard care service. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum. One session of BE training were given to pregnant in intervention group (IG). Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR scores were recorded. Significance was set at p\<0.05.

In this trial, it is aimed to assess the effectiveness of breathing exercises (BE) for management of labor pain during the second stage of labor. Nulliparous pregnant were randomized two arms. Intervention group received breathing exercise at the first stage of labor. Control group received routine care services. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum, Turkey. Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of labor. Time of the second stage was recorded as second (sec), and first minute APGAR scores of newborn were recorded. All analysis was carried out using SPSS 20. Significance was set at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Nullipar females
* Gestational age 37-42 week

Exclusion Criteria:

* Analgesic and anestezice use
* Clinical instability
* Psychiatric disorders
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are considered by the investigator eligible for the present study with no significant safety concerns
* Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion Criteria:

* Patients who are planning pregnancy for the expected duration of the study
* Patients who are otherwise considered ineligible for the study by the investigator
Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.

This clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant.

Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").

PRIMARY OBJECTIVES:

I. To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.

OUTLINE:

Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion (PBSCT) over 1-3 hours.

After completion of study treatment, patients are followed up for 100 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received a prior hematopoietic progenitor cell transplantation, including matched sibling and unrelated donor transplants, mismatched sibling and unrelated donor transplants and haploidentical transplants from related donors
* Patients with a presence of secondary engraftment failure defined as decrease in donor chimerism by ≥ 50% (i.e. 40% to 20%) in two measurements done at least 30 days apart
* OR a presence of incomplete graft function manifested by presence of persistent or new cytopenias 60 or more days after transplantation:

  * Anemia; hemoglobin less than 8g/dL, or red blood cell transfusion requirements over the preceding 4 weeks
  * Neutropenia, with absolute neutrophil count less than 1,000 neutrophils per microliter or requirement of growth factor support over the preceding 4 weeks
  * Thrombocytopenia, with platelet counts below 20,000 platelets per microliter or platelet transfusion requirements over the preceding 4 weeks

Exclusion Criteria:

* Patients for whom hematopoietic progenitor cells from the original donor are not available
* Presence of reversible causes of engraftment failure or incomplete graft function, including

  * Active viral infection
  * Medications
  * Acute or chronic graft versus host disease (GVHD) that is not controlled to less or equal than stage II with immunosuppressants
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer

The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).

The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.

Patients are stratified according to their disease classification and randomized to one course of IL-2 \[600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)\] or observation.

Eligibility Criteria:
Inclusion Criteria

* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
* Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
* No history or evidence of cardiac disease on ECG
* No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
* No prior history of invasive malignancy in the past 5 years
* Human immunodeficiency virus (HIV) negative
* Female patients must not be pregnant or planning to become pregnant

Exclusion criteria

• Age younger than 16
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial

Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.

This study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the LIVE Catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
* Able to undergo general anaesthesia (sedation, intubation and mechanical ventilation)
* Susceptible indication for atrial septal defect closure

Exclusion Criteria:

* Subject has an EF of \< 30%
* Subject has a co-morbid illness or life expectancy \< 2 years
* Subject has experienced an AMI within 72 hours prior to this procedure
* Subject is contraindicated for or unwilling to take aspirin or anticoagulants
* Subject is in cardiogenic shock
* Subject has other cardiovascular disease requiring open heart surgery
* Subject is known to have a demonstrated intra cardiac thrombus on echocardiography
* Subject has been treated with paralytic medications within 72 hours prior to procedure
* Subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult
* Inability to cannulate the left subclavian vein (post-consent exclusion)
* Subject has a known or suspected phrenic nerve paralysis
* Subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator
* Subject has an active systemic infection or local infection at or around the insertion site
* Subject is known or suspected to be pregnant or is lactating
* Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol
* Subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
Turkish Adaptation of Heart Health Self-efficacy and Self-Management Scale

The importance of lifestyle changes to control risk factors in the prevention, treatment and management of coronary heart disease (CHD), a major health problem, has been emphasised. In addition, physical, social, psychological and occupational limitations arising from the disease negatively affect the quality of life and self-efficacy perceptions of individuals, making it difficult to comply with treatment and disease management. There are general self-efficacy and self-management scales for which Turkish validity and reliability studies have been conducted previously. However, these scales are not specific to coronary heart disease patients and evaluate either only self-efficacy or only self-management. The aim of this study was to adapt the Heart Health Self-efficacy and Self-Management Scale (HH-SESM) into Turkish and to investigate its validity and reliability in patients with coronary heart disease. The study is conducted in Cardiology outpatient clinics of Karaman Training and Research Hospital. Before the study, the purpose and content of the study will be explained to the participants and an informed consent form will be obtained from the participants. Since the sample size in validity and reliability studies should be at least 10 times the total number of scale items, at least 120 individuals will be included in the study as the number of items x number of options (12 x 10 = 120). Detailed medical history and sociodemographic information (age, gender, height, weight, body mass index, disease duration (months), occupation, daily working hours, educational status, sports/exercise habits) will be recorded. In order to measure self-management and self-efficacy levels, patients will be administered the HH-SESM, Self-care management in chronic diseases scale- Self-care subgroup questions and General self-efficacy scales.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with coronary heart disease for at least 6 months
* Speaking Turkish
* to be able to read and write
* Being over 18 years old
* volunteering to participate in the study

Exclusion Criteria:

* Having a serious psychiatric illness such as panic disorder or major depression