cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager

Development and feasibility test of an Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity.

Aim of the current project is to develop and test Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity. EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. The EMI developed and tested here is based on theoretical and empirical findings and consists of several items and a repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.

This study tests the feasibility and effects of the EMI on a change in (i) reward sensitivity, (ii) mental imagery, and (iii) indices of perceived stress. One hundred twenty healthy student participants, aged 18-29 will be included in the study. Participants will be screened first and included if they score 5 points or more on the Reward Sensitivity Subscale of Behavioral Avoidance/Inhibition (BIS/BAS) scales. This is necessary in order to avoid a ceiling effect. Then, participants will be randomly assigned to an experimental (reward sensitivity EMI) or two of the control conditions (control EMA or waitlist). The reward sensitivity EMI group will be taught about experiencing rewards in daily life and will be asked to apply the specific techniques to personal situations repeatedly. The control EMA group will use the same app consisting of Ecological Momentary Assessment only, and the waitlist group will not receive any mobile app.

The training will last seven consecutive days and the app will send (i) 10 prompts per day to ask about the current mood of the user in control EMA and experimental groups and (ii) three prompts per day resulting in a total of 21 reward training sessions only in the experimental group. Participants will be able to use a special button triggering the intervention or EMA by themselves too. After one week, participants will return to the lab, fill in questionnaires and participate in behavioral tasks.

Eligibility Criteria:
Inclusion Criteria:

* being a student
* having sufficient knowledge of the German language
* being a smartphone user
* score of 5 points or more in Reward Sensitivity Subscale of Behavioral Avoidance/Inhibition (BIS/BAS) scales

Exclusion Criteria:

* having a mental illness or attending the psychotherapy
Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury

The goal of this observational study is to screening for clinical, pathological and HLA features in patients with recurrent drug-induced liver injury. The main question it aims to answer is: Which patients with drug-induced liver injury need to be more cautious when re-dosing?

Research Objectives:

1. To summarise the clinicopathological characteristics of patients with recurrent drug-induced liver injury (DILI) in the Liver Disease Centre of Beijing Friendship Hospital in the past 10 years.
2. Compare the differences in clinicopathological characteristics between patients with only one episode of different drug use and those with recurrent DILI, and predict the risk/protective factors in patients with recurrent DILI.
3. Explore the susceptibility genes in patients with recurrent DILI.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for recurrent drug induced liver injury:

  1. Liver enzymes returns to normal or has a tendency to remission after the first drug liver injury;
  2. Signs and symptoms of liver injury after the patient takes the different drugs for liver injury again, and the liver enzymes returns to normal through follow-up.

Inclusion criteria for drug induced liver injury:

1. RUCAM ≥6 and met one of the following biochemical conditions: (1)ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
3. Onset to enrollment ≤3 months.

Exclusion Criteria:

* 1. Hepatotropic viral infection: hepatitis A, B, C, D and E. 2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.

  3. Hypoxic ischemic hepatitis and congestive liver disease. 4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.

  6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG)simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.

  7. Parasitic infection. 8. Sepsis. 9. Previous liver transplantation or bone marrow transplantation. 10. Pregnancy or lactation. 11. Genetic and metabolic liver diseases.
Which Balance Test is More Effective When Evaluating Stroke Patients With a Tele-assessment?

The aim of this study is to compare the feasibility levels and advantages of balance tests applied with tele-assessment methods to clinical application methods in stroke patients and to reveal their effectiveness.

The aim of this study is to compare the feasibility levels and advantages of balance tests applied with tele-assessment methods to clinical application methods in stroke patients and to reveal their effectiveness. Stroke patients who are referred to İstinye University Bahçeşehir Liv Hospital Physiotherapy and Rehabilitation Unit at March-September for physiotherapy and meet the inclusion criteria will be included in the study. The Patient Assessment Form which were prepared by the researcher and the Standardized Mini Mental Test, The Rankin Scale, Timed Get Up and Go Test, Berg Balance Scale, Tinetti Balance and Gait Test in order to evaluate the balance and walking of the participants due to stroke and to compare the applicability level of the tests applied with the tele- assessment method and tests will be completed by individuals who agreed to participate in the study and / or the researchers who carried out the study.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient cognitive function for communication (Standardized Mini-Mental Test score\> 24)
* Not dependent on bed or wheelchair. (1 ≤ Modified Rankin Scale score \<5)
* Balance problem (Timed Get Up and Go Test score\> 12 sec)
* Providing the necessary technological competence for remote video communication at home
* Near a relative who can accompany you during the assessment
* Age 20-80 years
* Speaking Turkish

Exclusion Criteria:

* Individuals with a neurological and orthopedic disease other than stroke, whose vision and auditory function are affected by stroke, and those with aphasia will not be included in the study.
Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

Intranasal dexmedetomidine has been studied and used in children for premedication before anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal Atomization Device (MAD®).

Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and bioavailability would be better compares to simple dripping method. To date no pharmacokinetic information of intranasal dexmedetomidine delivered by either method is available. This investigation is designed to compare the bioavailablity of intranasal dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy adults.

This is a three-period crossover double-blinded study. 8 subjects will be recruited and they will attend 3 study sessions after informed written and verbal consent. They would have dexmedetomidine administered via different rout each time, intravenous, intranasal via dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability of each mode of drug delivery.

Eligibility Criteria:
Inclusion Criteria:

healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit -

Exclusion Criteria:

-
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock

Background Cardiogenic shock is a life-threatening state of acute heart failure with severely depressed blood pressure and organ perfusion. The 30-day mortality is reported as high as 50%. To date, no randomized trial has documented a survival benefit of any medical treatment in this patient group. In a first-in-man study the investigators have recently discovered that treatment with ketone bodies increases cardiac output by 2 liters per minute.

Objective The present study aims to examine the direct effects of ketone body supplements on the heart function in patients hospitalized with cardiogenic shock. Also, the aim is to determine the relative need for medical circulatory support following ketone body supplement.

Design A randomized double-blind cross-over study of the hemodynamic effect of enteral ketone ester versus placebo in 12 patients with cardiogenic shock

Methods Right heart catheterization will be installed to monitor cardiac pressures and output. The investigators will observe heart function with transthoracic echocardiography. Blood- and urine samples will be analyzed for electrolytes, energy substrates and vasoactive substances. Organ perfusion is to be examined by renal ultrasonography and near-infrared spectroscopy for measuring cerebral and peripheral circulation.

Perspectives This investigation may grant essential knowledge on ketosis in cardiogenic shock. This may lead to larger clinical trials, and hopefully a new and better treatment for patients with cardiogenic shock.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing treatment with inotropes and/or vasopressors because of cardiogenic shock as judged by the clinicians
* Patients are required at some point in time to have had \> 1 of the following: systolic blood pressure \< 90 mmHg; arterial blood lactate ≥ 2.5mmol/l; organ hypoperfusion (e.g. urinary output \< 0.5 ml/kg/hour or SvO2 \<55% with normal PaO2 and Hgb)
* LVEF \< 40%
* Age ≥ 18 years

Exclusion Criteria:

* Other primary causes of shock (hypovolemia, hemorrhage, severe infection or sepsis, pulmonary embolism or anaphylaxis),
* Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall)
* INTERMACS level 1 or 2 \[18\] with unstable or sliding hemodynamics on inotropes/vasopressors
* Use of or probable need for mechanic circulatory support (e.g. left ventricular assistant device, IMPELLA, extracorporeal membrane oxygenation)
* Recent post-cardiotomy cardiogenic shock (defined as thoracic surgery with the last 3 days)
* Inability to position a nasogastric tube
* Severe gastroparesis or abdominal distension
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with asthma
* Aged 18 or above
* Patients using inhaled corticosteroid (with or without long acting beta agonist)
* Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

* Asthma exacerbations in previous 6 months
* COPD or other pulmonary disease
* Excessive use of short acting beta agonists
Non-operative Management of Pediatric Appendicitis With an Appendicoltih

To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Eligibility Criteria:
Inclusion Criteria:

* Age : 7-17 years
* Abdominal pain \</= 48hours prior to receiving antibiotics
* White Blood Cell Count \>5 but \< 18
* US or CT confirmed early appendicitis plus:

  * US: \</=1.1 cm in diameter, presence of appendicolith
  * CT: \</= 1.1cm in diameter, presence of appendicolith

Exclusion Criteria:

* Positive urine pregnancy test
* Pain \> 48 hours prior to first antibiotic dose
* Diffuse peritonitis
* History of chronic intermittent abdominal pain
* White Blood Cell count ≤ 5 or ≥ 18
* Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.

In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.

Eligibility Criteria:
Inclusion Criteria:

* More than 20 years old
* Chronic hepatitis B patients under anti-viral therapy

  1. In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months
  2. In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart

Exclusion Criteria:

* Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia
* Patients who suffered from other chronic medical condition
RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa

Currently enrolling a total of 12 patients for Phase 2a of the study: 6 patients must have VA of no-better-than hand motion in the study eye, and 6 patients must have VA in the study eye to range from no-worse-than count fingers to 20/200 vision.


Eligibility Criteria:
Inclusion criteria:

Participants must meet all of the following criteria.

1. Age \>= 18 years
2. Signed and dated written informed consent obtained from the patient.
3. Ability to comply with testing and all protocol tests.

Exclusion criteria:

Any one of the following will exclude patients from being enrolled into the study:

1. Unable or unwilling to meet requirements of the study;
2. Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy in the past six months
Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application

At least 50 patients with intracranial infection receiving anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime and avibactam were included in each group for pharmacokinetic study, and the outcomes and adverse events of intracranial infection treatment were observed.

This study intends to establish a high performance liquid phase method to determine the concentration of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime abvibactam and other anti-infective drugs in cerebrospinal fluid, determine the concentration of cerebrospinal fluid in patients with central infection, and simultaneously determine the concentration of blood drugs at the same time point, optimize the clinical treatment plan by combining the concentration of cerebrospinal fluid and blood drugs, and explore the optimal concentration range of cerebrospinal fluid. At the same time, it can improve the cure rate of central infection, shorten the course of treatment and reduce the occurrence of adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. clinically diagnosed as central infection (cerebrospinal fluid culture is positive with clinical infection symptoms) or suspected as central infection (abnormal cerebrospinal fluid examination, such as hypoglycemia, \&amp;lt; 50%; High protein, \&amp;gt; 50 mg/dl; The number of cells increased with clinical infection symptoms, but no cerebrospinal fluid culture was positive)
3. receiving anti-infection treatment such as vancomycin or meropenem or linezolid or cefoperazone sulbactam;
4. Sign the informed consent form.

Exclusion Criteria:

1. There is no cerebrospinal fluid to determine the concentration;
2. allergic to drugs;
3. Other factors that researchers think are not suitable for inclusion.
The Correlations Between Clinical Effect and Emotional State

To analyze the correlations between preoperative emotional state and postoperative clinical effect among patients undergoing lumbar surgery

Preoperative emotional state and postoperative clinical effect of patients undergoing lumbar surgery will be evaluated and compared. Then the relations of anxiety and depression on quality of life will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. patients with relevant symptoms of lumbar degenerative diseases;
2. patients with bad emotional state,such as anxiety or depression.

Exclusion Criteria:

1. spinal tumor;
2. spinal trauma;
3. congenital spinal disease;
4. patients diagnosed psychosis;
5. patients with incomplete clinical informations.
Post-Fatigue Vibration: Impact on Grip and Reaction Time

This study aims to investigate the acute effects of local vibration applied after induced fatigue of the wrist flexor muscles on grip strength and upper extremity reaction time.

This randomized controlled study will be conducted with a minimum of 42 participants who meet the inclusion and exclusion criteria. Participants will be randomly assigned to one of three groups: control, 50 Hz local vibration, or 100 Hz local vibration.

Eligibility Criteria:
Inclusion Criteria:

1. Being between 18 and 25 years of age

Exclusion Criteria:

1. Having an open wound in the area where local vibration is applied
2. A history of previous or current upper extremity injury
3. Use of anti-inflammatory drugs
4. Having a diagnosis of epilepsy
A 75 Year Old With Dyspnea a Case Report.Observational Study

Clinical Case report Of spontaneous esophageal perforation in a 75 year old man. He prsented with breathlessness and on investigation found to have esophageal perforation

Boerhaave's syndrome represents a diagnostic dilemma for the physician. Boerhaave's syndrome is an uncommon condition where there is oesophageal rupture following forceful vomiting. We report a case of spontaneous rupture of the esophagus in 75-year-old male with chronic obstructive pulmonary disease who was referred to our hospital with acute onset of breathlessness. The absence of vomiting prior to presentation is the distinguishing feature of this particular case.

Eligibility Criteria:
Inclusion Criteria:

* male with esophageal perforation man with COPD

Exclusion Criteria:

* Iatrogenic perforation
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.

SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.


Eligibility Criteria:
Inclusion Criteria:

1. primary gastric cancer, Phase III
2. D2 radical gastrectomy(R0)
3. 18 year old or above
4. KPS≥70%；
5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
7. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .

9. the authorized ICF must be signed

Exclusion Criteria:

1. non-initial gastric cancer；
2. having the other uncontrolled diseases.
3. obvious loss of weight ( more than 10% within 6 weeks )
4. the female in pregnancy or feeding.
5. contraindication to study drug
6. participating in other clinical trial and at the time of treatment period.
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program

This trial is a mixed-methods, non-randomized design guided by the Consolidated Framework for Implementation Research (CFIR) to develop, implement, and evaluate Coverage and Cost-of-Care Links (CC Links) -a novel financial navigation intervention for hematologic cancer survivors and their caregivers.

The CC Links intervention included an oncology financial navigator who worked in the Hematology-Oncology Clinic. The navigator's functions included: screening for financial hardship to identify unmet financial needs (using the Comprehensive Score for Financial Toxicity (COST) and National Comprehensive Cancer Network's Distress Thermometer; initiating cost of care conversations; providing cost of care estimates; ensuring adequate health insurance coverage and assisting with applying for additional coverage; assisting with internal financial assistance program applications; connecting survivors/caregivers with disease specific resources and other external assistance programs; coordinating discharge planning; referring survivors to social workers and other staff/resources as needed; and, coordinating financial assistance services as survivors/caregivers transition between outpatient and inpatient settings.

Eligibility Criteria:
Inclusion Criteria:

* hematological cancer patients from the Division of Hematology and Bone Marrow Transplantation at the University of Kentucky
* caregivers of cancer patients
* positive screening for financial hardship

Exclusion Criteria:

- unable to provide consent