cyrilzakka/clinical-trials huggingface dataset:
Memory Rehabilitation by Means of Working Memory Training in Combination With a Recollection Training

Memory deficits after brain damage are common and there is still a need for evaluated therapy methods. In this study we compare two therapeutic interventions and investigate whether therapy effects can be found on neuropsychological tests and on a test measuring memory in everyday life.

In the interventiongroup a computerbased working memory training is combined with a recollection training (repitition-lag procedure). The patients in the active control group undergo the standard memory therapy that is normally provided in the rehabilitation centre (with a focus on the acquisition and execution of different memory strategies, e.g. the spaced retrieval method). The patients in both groups are tested on different neuropsychological tests before and after nine hours of therapy. Additionally, a test is conducted that assesses memory in everyday life.

Eligibility Criteria:
Inclusion Criteria:

* brain injury
* memory deficits (performance below average in the California Verbal Learning Test in learning trial 1 or 5, sfr or lfr)

Exclusion Criteria:

* severe amnesia (less than 2 words in sfr of the CVLT), dementia, sensory or motor aphasia, impaired vision, insufficient German language skills, lack of patient's consent
Elemental Diets vs. Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation

Study 1: A randomized, crossover trial using elemental or semi-solid diets containing contrast medium as a tracer given to bedridden PEG patients. The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.

Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to estimate gastric emptying.

Study 1: A mix of elemental or semi-solid diet (300 kcal/300 mL ) and contrast medium (5ml) is administered using PEG, respectively. Using a plain CT, the distribution of the administered diet is assessed at the distal esophagus, proximal and distal stomach before and 1 hour after the administration. The volume of the residual diet at the distal esophagus, proximal and distal stomach is compared between an elemental and semi-solid diet.

Study 2: Either the elemental diet or semi-solid diet (200 kcal/200 mL) is labeled with 100 mg \[13C\]sodium acetate (Cambridge Isotope Laboratories Inc, Cambridge, MA) and is administered in the first 15 min of the examination at the same speed using the PEG.

Eligibility Criteria:
Inclusion Criteria:

* Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital.

Exclusion Criteria:

* Regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.
Vitamin D Supplementation of Lactating Mothers

The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.

The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.

Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem

Exclusion Criteria:

* Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
* Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.

This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat \[ITT\] population).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits \>=6 swollen joints and \>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints \[DIPs\] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \[DMARDs\] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)
* Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).
* If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
* Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
* Both rheumatoid factor positivity and a C-reactive protein value \>=1 mg/dL, or at least one joint erosion on X-ray.

Exclusion Criteria:

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
* Female subject who was pregnant or breast-feeding or considering becoming pregnant.
* Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
* Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
* Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
* Subject was wheelchair bound or bedridden.
High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition

The purpose of this study is to determine the separate and combined effects of high-intensity interval exercise and chocolate milk on glycemic response, cognitive function, subjective appetite, and salivary cortisol among children aged 9-13 year old children.

Twenty children 9-13 years of age will be recruited for this study. On four separate mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a 2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20 min, followed by a treatment drink of chocolate milk or water (control) consumption in 10 min. During high-intensity interval exercise treatment, children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Blood glucose will be measured via finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be measured using a battery of cognitive tests which assess verbal declarative memory, working memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min. Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS) at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples collected using the passive drool method, and will be collected at baseline, 10 and 30 min.

Eligibility Criteria:
Inclusion Criteria:

* be between 9 and 13 years of age
* be healthy, and have been born at term
* not be taking any medications
* not have allergies to dairy or gluten.

Exclusion Criteria:

* Food sensitivities, allergies, or dietary restrictions
* Health, learning, emotional, or behavioural problems
* Receiving any medications
* Non-habitual breakfast eater (\<5 days/week)
A Study of JNJ-63733657 in Healthy Japanese Participants

The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI; weight \[kilogram {kg}\]/height \[meter square {m\^2}\]) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive, and a body weight greater than 50 kg but less than 110 kg at screening and Day -1. For participants to be enrolled in the highest dose cohort (Cohort 3), additional weight limitations will apply in order not to exceed the total dose of 5 gram (g) JNJ-63733657; the participant weight in the highest dose cohort will be limited
* Women must not be of childbearing potential

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening and Day -1 in the opinion of the investigator
* Clinically significant abnormal physical or neurologic examination (including fundoscopy), vital signs, or 12-lead electrocardiogram (ECG) at screening and Day -1 in the opinion of the investigator
* Positive result on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody (antiHCV) positive, or any other clinically active liver disease at screening (per screening evaluations)
* History of human immunodeficiency virus (HIV) antibody positive, tests positive for HIV or tests positive for syphilis at screening
* Mini-Mental State Examination (MMSE) score less than or equal to (\<=) 27 at screening
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction \& Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form
Heart Rate Variability and Nocturnal Blood Oxygen Saturation in Patients With Idiopathic Pulmonary Fibrosis

The goal of this observational study is to compare the overnight heart rate variability (HRV) and nocturnal oxygen saturation (SpO2) in patients with idiopathic pulmonary fibrosis (IPF). The main questions it aims to answer are: (1). if there are correlations between pulmonary function test and HRV and overnight SpO2; (2). if HRV and SpO2 can predict the occurrence of acute exacerbation in patients with IPF. Participants will be asked to examine pulmonary function test (including lung volumes and six-minute walk test) and wear pulse oxygenation recorder and "LARGAN" ECG Holter" ("LARGAN HEALTH TECHNOLOGY" Sleep Apnea And Sleep Quality Examination System) during sleep.


Eligibility Criteria:
Inclusion Criteria:

* individuals meet the diagnosis of idiopathic pulmonary fibrosis
* individuals agree to participate this study and sign the informed consent
* individuals have cognitive and behavioral abilities

Exclusion Criteria:

* age less than 50 years old
* individuals refuse to participate this study and sign the informed consent
* individuals of unclear consciousness
Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours

The goal of this prospective observational study is to generate new personalised 3D preclinical models of pancreatic neuroendocrine tumors. The models will be exploited for studying the mechanisms underlying disease development and progression, as well as for performing drug testing. For the development of the newly proposed models, patients' surgical specimens will be evaluated by the Pathological Unit. If the presence of pathological material in excess, not required for the routine diagnostic procedure, is confirmed, such material will be employed for the generation of the proposed personalised models.

Pancreatic neuroendocrine tumors (PanNETs) are characterized by highly heterogeneous biological behavior. Another distinctive feature of these neoplasms is the presence of a dense vascular network, reminiscent of their physiological counterpart. Indeed, the tumor microenvironment plays a critical role in these neoplasms and influence their therapeutic management. Although they are typically indolent in nature, approximately 40% of PanNET patients are metastatic at diagnosis, requiring non-surgical treatments such as somatostatin therapy, chemotherapy, targeted therapy, and peptide receptor radionuclide therapy (PRRT). Furthermore, 1 out of 5 patients experience disease recurrence after surgical resection, necessitating pharmacological therapies. Currently, no specific recommendations exist on the most effective therapeutic sequence to follow in presence of metastatic disease/disease relapse. One of the main reasons behind this unmet clinical need is the scarcity of available preclinical models of these neoplasms able to accurately reproduce the biology and physiology of the primary tumor and that can be used as valid platforms for drug testing.

The study aims to generate a new 3D in vitro model of PanNET, replicating the complex primary tumor in vitro, including also the tumor microenvironment (e.g., vascular network and stroma, essential elements of these neoplasms), personalised for each patient. Indeed, for the development of the newly proposed models, patients' surgical specimens will be initially evaluated by the Pathological Unit and, in the presence of pathological material in excess not required for the routine diagnostic procedure, it will be employed for the generation of the proposed personalised models. 3D culture techniques (e.g., 3D bioprinting) will be used for the development of the models. Moreover, in order to further mimic in vitro the in vivo environment, the models will be maintained under dynamic conditions.

These newly proposed models will be exploited for studying the mechanisms underlying disease development and progression, as well as for performing drug testing.

Eligibility Criteria:
Inclusion criteria:

* patients who undergo pancreatic surgical resection for non-functioning pancreatic neuroendocrine tumor
* age ≥ 18 years
* informed consent

Exclusion criteria:

* non-pancreatic neuroendocrine tumor histological diagnosis
* age \< 18 years
Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection

This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. After a tourniquet made from NIBP cuff were inflated, subjects were given either Ondansetron 8 mg or Lidocain 20 mg intravenously, then the tourniquet was set off. Hemodynamic data was recorded. Propofol 1 mg/kg of body weight (BW) injection was given. Verbal rating scale was used to measure pain at 0 s, 5 s and 30 s. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numeric data using uni-variate analysis and bi-variate analysis. Significant value is p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-65 years old
* Subjects were planned to undergo general anesthesia with propofol
* Subjects with Body Mass Index (BMI) 18-35 kg/m2
* Subjects with American Society of Anesthesiologists (ASA) physical status of I-II
* Subjects with signed informed consent.

Exclusion Criteria:

* Subjects with allergies to propofol, lidocain, ondansetron
* Subjects with massive cardiac disorder
* Subjects with cardiac rhythm disorder with or without treatment
* Subjects with unstable hemodynamic
* Subjects with contraindication to propofol, lidocain, ondansetron
* Subjects with intubation and ventilation difficulty
* Subjects with decreased consciousness, seizure history or head injury
* Subjects with analgesic treatment history
* Subjects with pregnancy.

Drop out criteria:

* Subjects with allergic reactions induced by propofol, lidocain, ondansetron
* Uncooperative subjects
* Subjects in emergency
* Subjects with difficult vein access in the dorsum manus
* Subjects with infection and/or inflammation in the planned intravenous cannulation location.
RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding

INTRODUCTION Acute variceal bleeding (AVB) is a severe complication of portal hypertension in patients with liver cirrhosis. The primary therapy includes the administration of vasoactive drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (EBL) and/or cyanoacrylate injection when bleeding occurs from gastric varices.

In this context, the idea is to assess "Hemospray" (Cook Medical, Winston-Salem, NC) as an initial therapy in patients with massive bleeding as a temporary "bridge" until definitive treatment could be instituted.

The data generated from the pilot study performed between Erasme hospital, ULB and TBRI , Cairo showed that adding Hemospray as early as possible in the management steps could increase the bleeding control rate up to 95 % at 24 hours.

OBJECTIVE The primary efficacy objective of this study is to assess the efficacy of Hemospray in combination with standard of care (SOC) medical treatment compared to the efficacy of SOC in the Control Arm in patient with acute variceal bleeding in cirrhotic patient.

The primary safety objective of this study is to evaluate the safety of Hemospray when used in combination with SOC compared to SOC in the Control Arm.

1.1. Secondary:

* To evaluate the effect of timing of Hemospray treatment on the outcomes of bleeding patients
* To evaluate the adverse effects on both therapeutic regimens (SAEs and clinically significant AEs).

STUDY ENDPOINTS :

1.1. Primary endpoint: Hemostasis is the primary end point: which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours.

1.2. Secondary endpoints:

* Need for rescue endoscopy (Before 12h)
* Safety
* Interaction with coagulation profile
* Rebleeding at 5 days.
* Survival at 5 days
* Survival at 30 days

Eligibility Criteria:
Inclusion Criteria:

* Subject must be over 18 years of age.
* Suspected or proven acute variceal bleeding , Gastric lavage will be done for all patients at admission (Acute bleeding is confirmed on the presence of blood in stomach)
* Subjects must be willing to give written informed consent for the trial
* Known or suspected cirrhosis

Exclusion Criteria:

* Patient is: \< 18 years of age
* Unable to consent
* Contraindicated to undergo endoscopy,
* Already hospitalized for another illness
* Pregnant or lactating
* Patients with altered post-surgical anatomy of the stomach
* Previously placed intrahepatic portosystemic shunt
* Patient treated by other endoscopic or surgical modalities within 30 days prior to the intended application of Hemospray
Phenobarbital for Acute Alcohol Withdrawal

Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

* allergy to phenobarbital, lorazepam, age\<18 or \>65