cyrilzakka/clinical-trials huggingface dataset:
Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania

The aim of this study is to show the physiological changes during manic episode in bipolar mania how much they differentiate from remission and healthy control. Relation of audio-visual features as physiological changes and cognitive functions and clinical variables will be searched. The aim is to find biologic markers for predictors of treatment response via machine learning techniques to be able to reduce treatment resistance and give an idea for personalized treatment of bipolar patients.

The objective of this research protocol is to find audio-visual features which differentiates bipolar mani/ remission/ health/ simulation and predicts treatment response earlier and detect neurocognitive changes during mania/ remission and difference from the healthy control. During hospitalization in every follow up day (0th- 3rd- 7th- 14th- 28th day) and after discharge on the 3rd month, presence of depressive and manic features for patients was evaluated using Young Mania Rating Scale(YMRS) and Montgamery- Asberg Depresyon Scale (MADRS). Audiovisual recording is done by a video camera in every follow up day for patients and for healthy controls which includes also depression and mania simulation. Cambridge Neurophysiological Assessment Battery (CANTAB) were administered to both groups( for patients both in the manic phase and in the remission) to assess neurocognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of BD type I, manic episode according to DSM-5 \[10\] given by the following doctor,
* being informed of the purpose of the study and having given signed consent before enrollment.

Exclusion Criteria:

* being younger than 18 years or older than 60 years,
* showing low mental capacity during the interview
* expression of hallucinations and disruptive behaviors during the interview,
* presence of severe organic disease,
* presence of any organic disease that may affect cognition
* having less than five years of public education
* diagnosis of substance or alcohol abuse in the last three months (except nicotine and caffeine)
* presence of cerebrovascular disorder, head trauma with longer duration of loss of consciousness, severe hemorrhage and dementia,
* having electroconvulsive therapy in the last one year.

For the healthy control group, the following additional criteria were considered for exclusion

* presence of family history of mood or psychotic disorder,
* presence of psychiatric disorder during interview or in the past.
Glucose Regulation in Acute Stroke Patients (GRASP) Study

The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.

Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated glucose levels upon admission to the hospital, and hyperglycemia is associated with poor outcome for post-stroke patients. It is unclear if treatment of hyperglycemia or glucose lowering improves outcome, however, in animal stroke models and other human conditions, aggressive glucose lowering is beneficial.

The goal of this multicenter trial is to determine if tight control of blood glucose is beneficial in hyperglycemic patients with acute ischemic stroke. In the trial, researchers will compare intravenous (IV) glucose insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 stroke patients.

Participants will be randomly assigned to one of three groups-(1) the control group with a target glucose level of \<300mg/dL; (2) the tight control GIK plus meal insulin group with a target of \<110mg/dL; or (3) the loose control GIK plus meal insulin group with a target of \<200mg/dL-with all groups avoiding glucose levels of \<70mg/dL.

The specific aims of this study are to collect preliminary data on the safety and feasibility of GIK for treatment of hyperglycemia in acute stroke patients, and to collect preliminary data comparing tight GIK therapy with loose GIK therapy and control therapy. Information learned in this study will compliment ongoing work and allow for maximum efficiency in the design of future treatment trials.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels.
* Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time.
* Admission plasma glucose of \> 110 mg/dL.

Exclusion Criteria:

* Renal dysfunction as defined by a serum creatinine of \>/=2.5 mg/dL at enrollment.
* Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment.
* Patients who have received experimental therapy for the enrollment stroke.
* Pregnant females.
* Patients with other severe life threatening conditions that makes them unlikely to survive 90 days.
* Patients who are unable to follow the protocol or come back for 90-day followup.
* Patient has condition for which insulin infusion is the usual practice or the treating physician feels that there is an indication for insulin infusion.
Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects

Investigators suggest that in lean subjects cortisol increases in response to overfeeding and that this increase is blunted in obese subjects. A group of 18 male healthy lean subjects and another group of 18 male healthy obese subjects will undergo a high-calorie meal test. Prior to the meal intake, an indirect calorimetry, bioelectrical impedance, heart rate variability, a fasting blood sample and a perceived stress questionnaire will be assessed. After intake of the study meal, blood tests will be performed in order to measure the secretion of cortisol, glucose and lipid metabolism and inflammatory markers. Indirect calorimetry will be assessed again 60 and 180 minutes after the meal intake.

Obesity is one of the most serious health problems in the 21st century. High energy food and a sedentary lifestyle are driving the current obesity pandemic. These factors activate the hypothalamic-pituitary-adrenal (HPA) axis, the key regulatory pathway of energy homeostasis. Activation of the HPA-axis leads to secretion of glucocorticoids from the adrenal glands, which control energy homeostasis by mobilizing and redistributing energy substrates.

Animal models of obesity have shown that glucocorticoids play a key role in the development of the metabolic syndrome. However, studies in humans yielded conflicting results. These studies have a major limitation in common. They do not consider glucocorticoid rhythmicity but rather investigate a snapshot of glucocorticoid secretion. Rhythmicity, however, is crucial because already minor glucocorticoid phase disturbances cause disease and could contribute to obesity.

Interestingly, excessive food intake may increase cortisol levels in healthy subjects . The consequence of this food-induced cortisol peak is not understood, but it may be key to restoring energy homeostasis after a meal. Whether the food-induced cortisol peak in obese subjects is disturbed is not known

With this study, investigators aim to better understand the role played by glucocorticoids in the origin of overweight and obesity. Researchers will investigate, in lean and obese subjects, whether the pulsatile release of cortisol increases after intake of a high-calorie meal. 36 subjects will take part in the study: a group of 18 male lean subjects and a second group of 18 male obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>18,5 and \<25 kg/m2
* BMI \>30 kg/m2

Exclusion Criteria:

* Any clinically significant concomitant diseases in lean subjects
* Any clinically significant concomitant diseases in obese subjects apart from features of the metabolic syndrome (dyslipidemia, arterial hypertension and insulin resistance)
* Lactose intolerance
* Severe food allergy
* Regular alcohol consumption (\>30 g/d)
* Regular fitness training (\>4 hours/week)
* Previous enrolment in a clinical trial within the last 3 months
* Inability or contradictions to undergo the investigated intervention
* Inability to follow the procedures of the study
Women's Mammography Study To Improve Comfort During Mammography

The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Must have signed the informed consent.
* Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain

Exclusion Criteria:

* May not have taken ibuprofen or other pain medication within the last 12 hours.
* Must not have a contraindication for taking ibuprofen e.g:
* No history of allergic reactions to ibuprofen or aspirin
* No recent history with the last year of bleeding from GI tract
* Not pregnant or suspected of being pregnant
Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus

We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital

Exclusion Criteria:

* Patients with prior history of diabetes mellitus
* Elevated admission HbA1c (≥6.5%)
* Age \>80 years
* Metastatic disease with expected life expectancy of less than 12 months
* Pregnancy or a woman who plans to become pregnant
Multimodal Ultrasound in Peripheral Neuropathy

This study will enforce the role of ultrasound in early diagnosis and screening on peripheral neuropathy in comparison with other modalities.

Each case will undergo informed Written consent and will be told the aim of the study including benefits, no harm from this procedure to the participants.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinical symptoms of peripheral neuropathy

Exclusion Criteria:

* patients with unhealthy tissue texture to put on probe
The Effectiveness of ACB-IP 1.0 Convalescent Plasma in COVID-19 Infection

Pathogen-free, concentrated, pooled convalescent plasma has higher SARS-CoV2 antibody titers and neutralizing antibody activities, without requiring blood group compatibility that allows patient accessibility in a shorter time and has safe plasma characteristic.

The efficacy of SARS-CoV2 standard single donor convalescent plasma varied according to the application time and most importantly the amount of antibody that is administered. Single donor plasma has some drawbacks; such as the insufficient levels of neutralizing antibody activities, the requirements of blood group compatibility, and the risk of infection transmission. In this study, the efficacy and safety of pathogen inactivated, isohemagglutinin-depleted (concentrated) and pooled convalescent plasma was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Are over the age of 60 or-
* Between the ages of 18-60, serious comorbidities (cancer, COPD, cardiovascular illness, hypertension, DM)
* Clinically diagnose COVID-19 or radiological diagnosed COVID-19 pnemonia

Exclusion Criteria:

* Multiple Organ Failure
A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma

The purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.

Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of severe, persistent asthma.This study will assess the safety and effectiveness of subcutaneously (under the skin) administered golimumab and determine if there is a reduction of signs and symptoms in patients with active severe, persistent asthma. The effect of subcutaneously (SC) administered golimumab on the quality of life in patients with severe, persistent asthma will also be assessed. About 200 patients will take part in the study at approximately 60 centers worldwide. Participation in the study will last for about 42 weeks. The study consists of 3 phases: the screening phase (lasting between 1 and 4 weeks), the treatment phase (20 weeks), and the follow-up phase (20 weeks). Visits are scheduled to occur once every 4 weeks during the treatment and follow-up phases of the study. Patients eligible to take part in this study will be randomly placed into one of the following study groups: Group 1: Placebo (an inactive or dummy treatment that looks the same as the study drug, golimumab, but does not contain any active medication) from Week 0 through Week 20. Group 2: Golimumab 100 mg from Week 0 through Week 20. This study is "blinded." This means that neither patient nor study doctor will know in which group a patient is placed. However, if needed for safety or health reasons, the study doctor can find out a patient's study group at any time.

Patients will receive an injection (under the skin) of placebo (Group 1) or golimumab 100 mg (Group 2) every 4 weeks from Week 0 through Week 20.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma for \>= 3 years and a diagnosis of severe, persistent asthma for \>= 1 year prior to screening
* Reversible airway obstruction
* Continuous treatment with high dose inhaled corticosteroids and long-acting Beta2-agonist for at least 3 months prior to screening
* At least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral)
* Score of \>= 2 points on the Asthma Control Questionnaire (ACQ) at screening

Exclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder
* Life-threatening asthma attack requiring intubation in the 6-month period prior to screening
* Steroid use at a dose \> 20 mg of prednisone at the screening visit
* Known malignancy or history of malignancy
* Previous exposure to anti-TNF therapies
Triple Combination DAAs for Treating HCV GT1b Subjects

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. HCV RNA positive \>2000 IU/ml or NAT POC positive
2. Genotype 1b
3. CP score ≤6

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner
2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements
3. Active or recent history (≤ 1 year) of drug or alcohol abuse
4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
5. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates

Hypothesis: a special solution for improving human embryo implantation, when added to the solution during embryo transfer, will improve implantation rates in embryo transfers using previously frozen embryos.

EmbryoGlue (TM) is added to embryo transfer solutions immediately prior to the transfer of frozen-thawed human embryos before placement of embryos into the patient uterus.

Eligibility Criteria:
Inclusion Criteria:

* Frozen embryo transfer patients, men over the age of 18 and women between the ages of 18 and 42 completed years (if using their own eggs and with embryos frozen before 39 completed years) or 18 to 50 completed years if using donated eggs.

Exclusion Criteria:

* Prior participation in this study, blastocyst transfers, single embryo transfer for medical reasons, prior embryo transfer with large amount of blood on the outside of the catheter, \> or = 3 consecutive failed embryo transfers at Mayo Clinic (fresh or frozen-thawed cycles).
Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.

Sample size: around 150 patients based on the availability of tumor size

Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

Eligibility Criteria:
Inclusion Criteria:

* MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
* Patients will be selected based on the availability of tumor tissue

Exclusion Criteria:

* NA
Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination.

This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination. This study uses a randomized single-blind trial design to compare the proportion of posturodynamic UTI in the group receiving preurodynamic single-dose levofloxacin with the group receiving three days - once daily of Levofloxacin posturodynamic. The target population is patients who undergo urodynamic examination at the RSUPN dr. Cipto Mangunkusumo, Siloam ASRI Hospital, and Persahabatan Hospital during the given time.

of the study. The total sample size in this study was determined based on a two-proportion analytical sample calculation formula with type 1 error of 5% and type 2 error of 80%. On the fourth posturodynamic day, urinalysis and urine culture were performed to determine the diagnosis of UTI. To analyze the association between UTI and the treatment group, the chi-square test was used. Results were considered statistically significant if p \< 0.05.

The expected results are data on the comparison of the incidence of UTI after urodynamic examination in the group given a single dose of levofloxacin and levofloxacin for three days post-examination.

The incidence of UTI in the group receiving a single preurodynamic dose of levofloxacin compared to the group receiving levofloxacin for three days posturodynamics.

Eligibility Criteria:
Inclusion Criteria:

* Male/female patients \> 18 years who have indications for urodynamics
* Willing to participate in research

Exclusion Criteria:

* Allergy to levofloxacin
* History of taking antibiotics in 1 month • Pregnant
* Uncontrolled DM
* Use a urinary catheter
* Having a UTI before urodynamics, based on clinical symptoms and urine examination results
* Refuse to participate in research
Evaluation of Pain Measurement Device

This longitudinal observational study will attempt to objectively measure pain with an experimental, non-invasive device. Patients and volunteers will receive a baseline screening with psychophysical tests and questionnaires. Investigators will apply the device to measure pain during routine clinical care and correlate patients pain ratings and analgesia requirements to that measured by the device. A more standardized approach with experimental pain stimuli will be pursued in human volunteer studies.


Eligibility Criteria:
Inclusion Criteria:

* age 18-100 years

Exclusion Criteria:

* inability to sign consent