cyrilzakka/clinical-trials huggingface dataset:
Invasive Decoding and Stimulation of Altered Reward Computations in Depression

Novel invasive neurostimulation stimulation strategies through neurosurgical interventions are emerging as a promising therapeutical strategy for major depressive disorder. These have been applied mostly to the anterior cingulate cortex, but other limbic brain regions have shown promise as anatomical targets for new neurostimulation strategies. The researchers seek to study neural activity in limbic brain areas implicated in decision behavior and mood regulation to identify novel targets for treatment through electrical stimulation. To do this, the study team will record local field potentials (LFPs) from the orbitofrontal cortex, hippocampus and amygdala of epilepsy participants undergoing invasive monitoring (intracranial encephalography, iEEG) during choice behavior. Leveraging the high co-morbidity of depression and intractable epilepsy (33-50%), neural responses will be compared to reward across depression status to identify abnormal responses in depression. Finally, the researchers will use these as biomarkers to guide development of neurostimulation strategies for the treatment of depression.

Participants (n=24) will complete a decision-making task in which participants will make decisions under uncertainty and seek to maximize rewards. The researchers will assess behavioral (risk attitudes) and neural (LFP) responses using a combination of intracranial recordings and computational modeling. A subset of patients will complete the game a second time under electrical stimulation of pre-identified anatomical targets in orbitofrontal cortex, hippocampus or amygdala. In addition, patients' depression status will be assessed through questionnaires (BDI-II and HDSA). Finally, the researchers will examine whether electrical stimulation results in behavioral or mood modulation.

Eligibility Criteria:
Inclusion Criteria:

- The study will follow clinical criteria for epilepsy patient recruitment for invasive monitoring. As a results, individuals of adults of all ages are expected to be included in this study.

Exclusion Criteria:

* Adults over 80 years of age will be excluded as per concerns of cognitive decline.
* Children under 18 will be excluded from the study since the maturation of frontal lobes continues through adolescence and significant differences in frontal lobe functioning between children younger than 18 and adults are often observed.
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A

The purpose of the study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of this study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria:

* Prior bariatric surgical procedures
Topiramate-Phentermine Combinations for Cocaine Dependence

This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.


Eligibility Criteria:
Inclusion Criteria:

* Recent cocaine use by the intranasal or intravenous route

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine, topiramate or phentermine
Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination

The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination

Contaminated feeding tubes can occur in the neonatal intensive care unit (NICU) and have been associated with significant morbidity. Due to an immature immunologic systems, premature infants are at significant risk of complications related to contaminated feeding tubes. Feeding tube dwell time may affect the level of contamination. This study will determine if a maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* be born to a mother who is at least 18 years of age and English or Spanish speaking
* born at \< or equal to 30 weeks
* have a birthweight \< or equal to 1500 grams
* be born to a mother who is COVID Negative
* have a feeding tube placed within 24 hours of birth
* be expected to require a feeding tube for 4 weeks following birth.

Exclusion Criteria:

* infant with known congenital GI anomalies
* infants which are not expected to live
* infants will be withdrawn from the study if they require abdominal surgery for GI morbidities
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)

The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.


Eligibility Criteria:
Inclusion Criteria:

* The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment.
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation.

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection.
A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.

The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed;
* The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and
* The subject is male or non-pregnant, non-lactating female

Exclusion Criteria

* Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
* Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or
* In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated.
* For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.
Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

In this randomized controlled trial, we aim to investigate whether the avoidance of mechanical ventilation by application of nonintubated thoracoscopic surgery improves intraoperative cerebral oxygenation and postoperative cognition recovery for patients undergoing thoracic surgery.

Postoperative neurocognitive impairment is not uncommon for patients undergoing thoracic surgery. Based on the literature, this is associated with reduced cerebral oxygenation during one-lung ventilation which may be because of reduced cardiac output, impeded cerebral venous return due to mechanical ventilation. In our hospital, nonintubated thoracoscopic surgery is commonly conducted and achieves noninferior outcomes than intubated thoracoscopic surgery. Particularly, the application of nasal high flow oxygen may maintain intraoperative oxygenation despite the absence of controlled ventilation. Therefore, the nonintubated technique may be beneficial to maintain an improved intraoperative cerebral oxygenation and hopefully improves postoperative cognition recovery. In this randomized controlled study, we aim to investigate the differences in intraoperative cerebral oxygenation and postoperative cognitive recovery bewteen nonintubated and intubated thoracoscopic surgery. Patient will be randomly assigned to receive nonintubated or intubated thoracoscopic surgery. During surgery, bifrontal cerebral oxygenation will be monitored. Cognitive test will be arranged before and after surgery.

Eligibility Criteria:
Inclusion criteria:

Adult patients receive elective thoracoscopic surgery

Exclusion criteria:

1. pregnancy
2. preexisting cerebral dysfunction such as cerebral vascular incidence, Alzheimer's Disease. Parkinsonism.
3. Cardiopulmonary dysfunction such as heart failure \> New York Heart Association score III; chronic obstructive pulmonary disease with a forced expiratory volume in one second/forced vital capacity \< 70 % and FEV1 \< 50% predicted.
Efficacy of Social Cognition Training in Schizophrenia

The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy.

Objectives:

This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia.

Research Design and Methodology:

Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder
* Age between 18 and 65
* minimum of 30 days since discharge from last hospitalization
* minimum of 30 days since last change in psychiatric medications
* no housing changes in the past 30 days

Exclusion Criteria:

* current diagnosis of alcohol or substance abuse/dependence
* history of brain trauma or neurological disease
* mental retardation or developmental disability
* auditory or visual impairment that would interfere with study procedures
Carvedilol vs. Propranolol in Second Prophylaxis of Variceal Bleeding

This randomized controlled trial was conducted to evaluate the efficacy and safety of carvedilol versus propranolol, combined with routine endoscopic treatment, in the secondary prophylaxis of variceal bleeding in patients with cirrhosis.

Non-selective beta blockers combined with endoscopic variceal band ligation (EVL) is the most effective methods for the prevention of variceal bleeding. Carvedilol has emerged as the preferred NSBB for treating portal hypertension in compensated cirrhosis due to strong evidence demonstrating that it has a more pronounced effect than propranolol to reduce the hepatic vein pressure gradient (HVPG), together with good patient acceptability and safety profile. However, No data from prospectively designed trials are available on the efficacy of carvedilol in the secondary prophylaxis of variceal bleeding. The aim of this randomized controlled trial was to evaluate the effectiveness and safety of carvedilol compared to propranolol as secondary prophylaxis of variceal bleeding in patients with cirrhosis. All cirrhotic patients with at least one episode of variceal bleeding were included and randomized to the carvedilol or propranolol groups. EVL protocol was routinely performed in both groups. Variceal rebleeding, further decompensation, liver-related death, and overall survival was the outcomes of this trial.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 80 years old;
* With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image;
* At least 5 days after index variceal bleeding;
* Informed consent.

Exclusion Criteria:

* Refusal to participate in the study;
* Portal hypertension resulting from other causes than liver cirrhosis;
* More than 42 days after index variceal bleeding;
* Bleeding from cardiofundal gastric varices;
* Portal venous thrombosis \>50% of the portal vein trunk;
* Contraindications to beta-blockers (asthma, chronic obstructive pulmonary disease, atrioventricular block, heart failure, bradycardia with HR ≤40 bpm, arteria hypotension with systolic blood pressure \<90 mm Hg, peripheral arterial disease, uncontrolled diabetes);
* Prior NSBB+EVL combined treatment, TIPS implantation or surgical shunt as secondary prophylaxis of variceal bledding;
* Chronic kidney disease;
* Pregnancy or lactation;
* Neoplastic disease.
Oropharyngeal Space in Videolaryngoscopy

In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.

Intubation using indirect videolaryngoscopy has many advantages over classic direct laryngoscopy using the Macintosh laryngoscope. There are many different videolaryngoscopes available, and the blade differs largely between videolaryngoscopes. Different size and angles of blades may have an impact on the space available for insertion of the endotracheal tube. The space between the blade and the palatopharyngeal wall may be reduced significantly, so that there is less room in the mouth to insert an endotracheal tube. Positioning and manoeuvring of the endotracheal tube may consequently be more difficult and may traumatize the pharynx as was described in a few case reports, especially when an endotracheal tube with a rigid stylet inserted was used.

Eligibility Criteria:
Inclusion Criteria:

* Informed patient consent
* ASA I - III
* Age \> 18 years
* Elective surgery, other than head and/or neck surgery
* Pre-operative Mallampati I - III
* BMI \< 35 kg/m2
* Fasted (≥6 hours)

Exclusion Criteria:

* No informed patient consent
* ASA ≥ IV
* Age \< 18 year
* Emergency surgery, surgery of head and/of neck
* Locoregional anaesthesia
* Pre-operative Mallampati IV
* BMI \> 35 kg/m2
* Fasted \< 6 hours
* Pre-operative expected difficult airway (restrict neck movement, thyromental distance \< 65mm, retrognathia)
* Bad, fragile dentition
* Dental crowns and/or fixed partial denture
Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

Acceptability and tolerance of a new food product in adults and children.

Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. The participants will record amount of daily intake, and will be given an entry and exit surveys. These surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. Acceptability will be measured as the number of servings and portion of serving completed each day over the trial period.

In adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.

Eligibility Criteria:
° Inclusion Criteria:

* Male, 40-60 years old
* Male or Female 9-13 years old
* Subject is willing and able to comply with the study protocols
* Subject is willing to consume the test products

Exclusion Criteria:

* Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
* Under current medical supervision
* Non-English speaking
* Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
* Currently taking prescription drugs or supplements
* Daily use of aspirin and or non-steroidal anti-inflammatory medicines.
* Indications of substance or alcohol abuse within the last 3 years
* Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
* Self-reported malabsorption
* Current enrollee in a clinical research study.
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

This prospective, randomized control study aims to compare the analgesic effect, satisfaction with anesthesia and analgesia between single-injection QLB (quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic adrenalectomy
* Informed consent

Exclusion Criteria:

* a known allergy to the medications being used for anesthesia
* coagulopathy or on anticoagulants
* chronic opioid therapy or history of substance abuse
* participating in another RCT
* inability to properly describe postoperative pain to investigators (e.g., language barrier, neuropsychiatric disorder).
Prognostic Value of the SGA and NUTRIC in the ICU

There are two nutrition assessment tools that are commonly used in the ICU, namely the Subjective Global Assessment (SGA) and Modified Nutrition Risk in Critically Ill Score (mNUTRIC). It has been proposed that both assessments should be performed in the ICU but their combined prognostic ability has not been adequately assessed.

This study aimed to: 1) determine the agreement between SGA and mNUTRIC scores, and 2) quantify their utility in discriminating and quantifying hospital mortality risk both independently and in combination.

This prospective observational study will be conducted in a 35-bed mixed ICU in Ng Teng Fong General Hospital, and all the intensivists and nurses will be blinded to the objectives of the study. All patients admitted to the ICU will be consecutively included in the study. For patients readmitted to the ICU during the same hospitalisation, only data from the first admission will be collected.

As per routine care, all patients will have their nutritional status assessed by the dietitian within 48 hours of ICU admission. Information required for the nutritional assessment (SGA) will be obtained from the patients or their main care givers, and nutritional status will be dichotomized into well-nourished and malnourished.

The electronic medical records automatically and prospectively collects all data required to calculate the mNUTRIC. At the end of the study, the mNUTRIC will be retrospectively calculated. Patients with values of "0-4" will be classified as low-mNUTRIC and "5-9" as high-mNUTRIC.

The primary outcome will be hospital mortality and all patients will be followed until discharge or death, for up to one year after admission to the ICU.

Agreement and mortality discriminative value (i.e. discrimination) of the 2-category classification of mNUTRIC (Low- and high-mNUTRIC) and SGA (SGA-A and SGA-B/C) will be assessed by Kappa statistics and C-statistics respectively.

A multivariate logistic regression will be used to generate the adjusted odds ratios that quantify the association between high-mNUTRIC, malnutrition, and their combination (mNUTRIC ≥ 5 and SGA-B/C) with hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old who had ≥ 24 hours length of stay in the ICU
* received a nutrition assessment (SGA) from a dietitian within 48 hours of admission to the ICU

Exclusion Criteria:

* Nil
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults \>/= 60 to \</=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
2. Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
3. Female subjects who are not of childbearing potential.

Exclusion Criteria:

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
2. History of microbiologically proven invasive disease caused by S pneumoniae.
3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.