cyrilzakka/clinical-trials huggingface dataset:
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female between the ages of 18 and 70
* Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of bipolar disorder (type I, II, or NOS)
* Currently depressed as confirmed by the MINI-Plus at the screening visit
* Currently receiving treatment with an anti-manic drug
* Meets criteria for metabolic syndrome or insulin resistance

Exclusion Criteria:

* Pregnancy or breast feeding
* Unstable or inadequately treated medical illness as judged by the investigator
* Severe personality disorder
* Serious suicidal risk
* Known history of intolerance or hypersensitivity to pioglitazone
* Treatment with pioglitazone in the 3 months prior to randomization
* Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry
* Currently taking an antidiabetic/glucose-lowering agent.
* Diagnosed with dementia
* Acute Mania as defined by a Young Mania Rating Scale (YMRS) score \> 15
* Diagnosed with heart failure
* Transaminase elevation \>2.5 times the upper limit of normal
* Presence of renal impairment (eg. creatinine \> 1.5)
* Fasting blood glucose \>150 mg/dL
* Hb A1c \> 7.5%
Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?

Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia. Percutaneous central venous catheter placement is essential to ensure adequate caloric intake and intravenous administration of treatments, but this procedure can cause major body temperature variations, responsible for complications in these neonates, as convection incubator function is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours) depending on the technical difficulties encountered during catheter placement.

In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal transport is now clearly defined and ensures stability or even a considerable temperature gain during transfer immediately after birth. In the light of several clinical cases, the use of a polyethylene bag during central venous catheter placement appears to be effective to prevent body temperature loss in preterm neonates. No data are currently available concerning the value of this method of prevention of hypothermia during this type of procedure.

Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet could be useful during this procedure by significantly reducing heat loss caused by convection and evaporation. However, compensation phenomena such as generalized vasoconstriction to cold in preterm infants are very poorly described, but can induce a functional conflict between mechanisms ensuring maintenance of homeostasis and those involved in maintenance of blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* premature Newborn child = 32 weeks of gestational age
* 7 days of life
* Normothermic (core temperature between 36.5 and 37.5 ° C)
* Stable on a hemodynamically manner
* Need the installation of a central catheter KTEC

Exclusion Criteria:

* Parental Refusal
* hypothermia (temperature \< 36.5 ° C)
* Hyperthermia (temperature \> 37.5 ° C)
* heart disease and malformation syndromes life-threatening
* Hemodynamic instability ( catecholamine vasoconstrictor and vasodilator )
* Breakdown by oscillation
A Study of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) in People With Thymic Cancer That Has Spread to the Lining of the Lungs and Chest

The researchers are doing this study to find out whether hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) is a safe treatment that causes few or mild side effects in people with pleural metastases from thymic malignancies. The researchers will also look at whether hemithoracic IMPRINT is effective against participants' cancer.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate on the study
* Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.
* Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected.
* No evidence of extrathoracic metastatic disease or contralateral pleural/pericardial disease.
* Patient age ≥ 18 years but ≤ 80 years at the time of consent
* Karnofsky performance status ≥ 80%
* Preoperative or Postoperative Pulmonary Function Tests: DLCO \> 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb)
* Glomerular filtration rate (GFR): ≥50 mL/min/1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL/min) = \[140 - age (years)\] x weight (kg) \[x 0.85 for female patients\] 72 x serum creatinine (mg / dL) ° In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.

Exclusion Criteria:

* Continuous oxygen use
* Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months
* Prior nephrectomy on the contralateral side of the pleural metastases
* Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed.
* Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P/D, debulking/metastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed.
* Acute congestive heart failure requiring hospitalization within the past 30 days.
* COPD requiring chronic oral steroid therapy of \> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed
* Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months
* History of interstitial lung disease
* Pregnant or lactating women
* Men or women not using effective contraception
Motion Analysis and Assessment of Cardiac Function for Cardiac Images

The study develops software for motion analysis and assessment of cardiac function for cardiac images. Cardiac catheterization ventriculography of several randomly selected patients were taken from our hospital's PACS system. The investigators remove the patient information on the images, and use the image for motion analysis and assessment.

The study develops software for motion analysis and assessment of cardiac function for cardiac images. Twenty patients who have both cardiac catheterization ventriculography and cardiac echo studies will be randomly selected. Cardiac catheterization ventriculography of the selected patients were taken from our hospital's PACS system. The investigators remove the patient information on the images, and use the image for motion analysis and assessment. The results will be compared and correlated with their cardiac echo, which could validate the clinical usefulness of the software.

Eligibility Criteria:
Inclusion Criteria:

* patients who already have cardiac catheterization ventriculography and cardiac echo studies.

Exclusion Criteria:

* patients who do not have either cardiac catheterization ventriculography or cardiac echo studies.
Evidence Based Management of Acute Biliary Pancreatitis

This study aims to assess the outcome of standardized evidence-based care to all patients with acute biliary pancreatitis treated at surgery department, Zagazig University hospitals during the period from may, 2017 to may 2019.

Acute pancreatitis (AP) is one of the most important gastrointestinal disorders causing emotional and physical human burden . The annual incidence worldwide for AP is 4.9-73.4 cases per 100,000 people and the overall mortality rate is 4 to 8%, which increases to 33% in patients with infected necrosis. AP is diagnosed when two of three criteria are fulfilled: typical abdominal pain of AP, more than three times elevated serum amylase/lipase level and signs of AP on imaging.

It is necessary to clarify the etiology of AP promptly. The diagnosis of gallstones, as the leading cause for AP, should have the top priority as that will direct the treatment policy. Long standing alcohol consumption and gallstones disease incriminated in the majority of cases with AP. Small common bile duct stones, in particular, are the cause of AP in approximately 32 to 40% of cases. In 10-30% of cases, the cause is unknown, so studies have suggested that up to 70% of cases of idiopathic pancreatitis are secondary to biliary microlithiasis.

The pathogenesis of biliary AP has been intensively investigated. Many theories explain how gallstones can trigger AP. The predominant theories include common pathway theory and gallstone migration theory. In general, AP occurs when intracellular protective mechanisms fail to prevent trypsinogen activation or reduce trypsin activity.

It is important that management of such potentially life threatening condition to be guided by an evidence-based approach. After comparing the Japanese (JPN) Guidelines 2015 and its former edition 2010 with the other two guidelines, International Association of Pancreatology/American Pancreas Association guidelines (IAP/APA), 2013 and American College of Gastroenterology (ACG), 2013, the JPN Guidelines, 2015 proved to be the highest quality regarding its systematic literature review prepared by the meta-analysis team, including the grading of recommendations and providing pancreatitis bundles.

Eligibility Criteria:
Inclusion Criteria:

* all cases with acute biliary pancreatitis

Exclusion Criteria:

* all cases with non biliary pancreatitis
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.

The goal of this clinical trial is to compare in Oligozoospermia Patient. The main questions it aims to answer are: 1. Electroacupuncture therapy and standard therapy can affect oligozoospermia. 2. Electroacupuncture therapy and standard therapy can affect semen and spermatozoa plasma SOD levels.

Researchers will compare patient with standard therapy with patient with standard therapy with electroacupuncture.

1. Male subjects aged more than 25 years and less than 45 years.
2. Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (\<5 million spermatozoa/mL).
3. Willing to take part in research and sign informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Male 25 to 45 years old.
* Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (\<5 million spermatozoa/mL).
* Willing to participate in research and sign informed consent.

Exclusion Criteria:

* Emergency case patient / bleeding disorders
* Have a tumor, scar tissue or infected wound in the area where the acupuncture needle will be inserted.
* Alcoholic
* Using a pacemaker (heart pacemaker).
* Azoospermia
* Varicocele
Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity

There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ranging in age between 18 and 30.

Exclusion Criteria:

* Ginseng group: exclude those that regularly consume caffeine or Panax Ginseng, or those that are diabetic, have hormone sensitive conditions, autoimmune diseases, bleeding conditions, heart conditions or take medications that are known to interact with Panax Ginseng. These include anticoagulants, Warfarin, Ibuprofen, MAOIs, medications that are changed by the liver, and stimulant drugs (e.g. pseudoephedrine, epinephrine).
* Ginkgo Biloba group: exclude those that regularly consume caffeine or Ginkgo Biloba, or those that are diabetic, have experienced seizures in the past, have bleeding disorders, or take medications that are known to interact with Ginkgo Biloba. These include Ibuprofen, anticoagulants, Warfarin, Buspirone, Fluoxetine, Trazodone
Survivor-Sleep Health Information Program

The purpose of the study is to learn if an educational program delivered to parents/guardians can help improve the sleep of children experiencing sleep problems after completing cancer treatment. The name of the intervention is Survivor-SHIP (Sleep Health Information Program).

This study will evaluate Survivor-SHIP in a single-arm trial of 20 off-treatment childhood cancer survivors (ages 5-12). The intervention is an adapted version of the family-centered Sleep Health Program designed at Seattle Children's Hospital. The program offers parents information about how to utilize evidence-based strategies for their child's sleep, and has demonstrated success in a community-based sample of children with behavioral sleep problems. Sessions will focus on providing parents with education about healthy sleep and setting targets for modifiable behaviors that can improve their child's sleep health.

The study will include 3 education sessions taking place over videoconference. Families will be asked to track their child's sleep using sleep diaries during the course of the program. Prior to, and following the program, families will be asked to complete study questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 5-12 years, with a history of a cancer diagnosis (except non-melanoma skin cancer).
* No cancer therapy (excluding chemoprevention) in the past 6 months, and no further therapy planned.
* Child meets diagnostic criteria for insomnia disorder as determined by insomnia screening criteria (see Appendix A)
* Parent/guardian is able to read and write in English.
* Regular access to a computer/smartphone with internet access at home.

Exclusion Criteria:

* Reports child has been diagnosed with a Seizure Disorder or has experienced a seizure in the past 12 months.
* Reports child has been diagnosed with a developmental disorder such as Autism Spectrum Disorder, Cerebral Palsy, Fragile X Syndrome, or Moderate to Profound Intellectual Disability.
* Reports child has been diagnosed with sleep apnea, and are not receiving recommended medical treatment for their sleep apnea.
* Intention to adjust (decrease or increase) child's use of any prescribed or over-the-counter sleep medications during the study period.
* Any impairment (e.g., hearing, visual, cognitive) that interferes with the parent/guardian's ability to complete all study procedures independently.
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery

Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.

Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.

Our study hypothesis is that different types of anesthetics reduce PONV further.

Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).

The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.

See above

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.

Exclusion Criteria:

* Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.
Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).


Eligibility Criteria:
Inclusion criteria:

* male and female
* 18 years or older
* written informed consent
* The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC

Exclusion criteria:

* Pregnant patients
* The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an open thoracotomy for lung resection
* Has at least one or more intraoperative visible air leak \>= 2 mm following the lung resection surgery

Exclusion Criteria:

* Pregnant or breast feeding
* History of an allergic reaction to Human Serum Albumin
* Has a significant clinical disease or condition
* Had previous open thoracotomy procedures
* Unable to participate in all necessary study activities due to physical or mental limitations
Development of a Practical, Minimally Invasive Seizure Gauge

The researchers are trying to assess changes in physiological signals before and during seizures.

Subjects that are undergoing video EEG monitoring in the hospital for their epilepsy at Mayo Clinic will be consented to participate in this study for a minimum of two days and/or the duration of their hospital stay for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys.

In the second year of the study patients who have implanted devices capable of recording or detecting seizures will be recruited to wear a noninvasive biosensor for multiple months. This data will be used to develop algorithms capable of detecting and/or forecasting seizures.

When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.

Eligibility Criteria:
Inclusion Criteria:

* Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g. NeuroPace RNS, Medtronic PC+S, Medtronic RC+S)
* Pediatric subjects 7 years of age or older.

Exclusion Criteria:

* Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
* Presence of open or healing wounds near monitoring sites (infection risk).
The Efficacy of Traditional Chinese Herbal Medicine for Dementia

The Clinical trial is a pilot study for treatment of Alzheimer dementia by traditional Chinese herbal medicine(TCM).

Dementia is a chronic, progressive neurodegenerative syndrome, characterized by an abroad category of non-reversible impairment in cerebral function, making a long-term and gradually decrease in the ability to mental cognitive tasks and performance of daily activities.

The World Health Organization says that 47.5 million people around the world are living with dementia. Alzheimer's disease is the most common type of dementia. Alzheimer's disease is often getting worse with time, affecting memory, language, and thought.

According to the record from Ministry of Health and welfare in Taiwan. The population over 65 year-old is more than 3.36 million. It is estimated that there are more than 250,000 people with mental disabilities, and nearly 600,000 people with mild cognitive impairment (MCI). Alzheimer's disease is accounting for 60-70%, the most common type of dementia. With the aging of population, experts predict that the number of patients suffering from Alzheimer's disease will be up to 800,000.

In 2016, a study based on the health insurance database in Taiwan showed that 78.2% of patients will take Chinese medical treatment, such as herbal medicine, acupuncture or traumatology medical therapy like massage after diagnosed as Alzheimer's disease during 1997-2008.

The clinical trial is a pilot study. The main purpose of this study is to evaluate the efficacy of traditional Chinese herbal medicine(TCM) of Alzheimer's dementia. The participants diagnosed as Alzheimer's dementia will be given Traditional Chinese herbal medicine powder, each pack included of Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks. The participants will be assessed by the MMSE, IADL, NPI-Q, GDS, QOL-AD, CCMQ, which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks). To see if the traditional Chinese herbal medicine can improve the symptoms of Alzheimer's dementia or its related symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of mild to moderate Alzheimer dementia;
2. aged over 65 years old in both gender;
3. MMSE score between 14 and 26;
4. adequate vision and hearing ability to complete all study tests;
5. with a stable caregiver.

Exclusion Criteria:

1. a medical history of other dementia types, like Frontotemporal dementia, Dementia with Lewy Bodies, Vascular Dementia, and mixed type, et al;
2. known of other neurological diseases, cranial nervous system cancer
3. severe liver or kidney dysfunction (alanine aminotransferase\>200 IU/L, aspartate transaminase\>200 IU/L or serum creatinine \>2.5 mg/dl);
4. severe cardiovascular disease (heart failure, coronary heart disease)