cyrilzakka/clinical-trials huggingface dataset:
Enhancing Coping and Communication in Children With Cancer and Their Parents

Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.

Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. This online program includes modules to teach parenting, communication and coping skills to parents of children with cancer, and coping skills to their children who have been recently diagnosed with cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.

Eligibility Criteria:
Inclusion Criteria:

* Child from ages 10 to 17 years old who has been diagnosed with cancer

Exclusion Criteria:

* Significant intellectual disability that would interfere with completing the online program
First-in-Human Exploratory Single Ascending Dose of GLPG0974

The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.

Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis a Multi-center, Prospective Study

Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
2. Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc

Exclusion Criteria:

Exclusion Criteria Subjects who meet one of the following criteria will not be enrolled: 1. Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy 2. Patients with trauma, hepatosplenic rupture and other organ hemorrhage 3. Patients with severe disease such as shock, sepsis, and multiple organ failure 4. Patients with DIC 5. Patients with long-term anemia 6. Patients with acute promyelocytic leukemia 7. Patients with idiopathic deafness 8. Patients who have taken hormones/immunosuppressants 72 hours before admission 9. Hereditary fibrinogen deficiency
A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder

The purpose of this study is to determine whether methylphenidate is effective in the treatment of binge eating disorder, in a randomized controlled trial extended release methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight or obese adult females.

Fifty-six adult female outpatients with binge eating disorder will receive 12 weeks of methylphenidate (dosage 18-72 mg) or 12 sessions of manualized cognitive behavioral therapy. Participants will complete interviewer-rated and self-report measures of eating, mood, attention, and personality features before treatment, after 6 weeks of treatment, immediately after treatment is completed, and 3 months after treatment is completed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Binge-Eating Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* Body Mass Index ≥ 25
* Must be fluent in English
* Must be capable to give informed consent

Exclusion Criteria:

* Current pregnancy or lactation
* Psychotherapy or behavioural treatment for eating or weight initiated during the past month
* Psychotropic or investigational medications initiated / changed during the past three months
* Concomitant use of another psychostimulant
* Current mental disorders that are acute/unstable, that require alternate treatment, and/or that preclude ability to complete research protocol including mania, psychosis, substance use (alcohol or drugs), dementia, organic brain disorders, mental retardation
* Current severe suicidality or homicidality
* Current uncontrolled medical conditions that affect weight or BED symptoms or that are contraindicated for methylphenidate including metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine diseases
* Other serious medical illness or event such as acute myocardial infarction or stroke during the past six months
* History of seizures or tics in the past year
* Diagnosis or family history of Tourette's
* Clinically relevant laboratory results, including: Tachycardia as indicated by heart rate \> 110; Hypertension as indicated by blood pressure parameters \> 140 (systolic) and 90 (diastolic); Arrhythmias or conduction abnormalities as indicated by ECG parameters QTC\> 460msec, QRS\>120 msec, and PR\>200 msec; Abnormal laboratory results (e.g., hypokalemia) as indicated by values \> 20% above the upper range of the laboratory standard of a basic metabolic screen
* Current medications that affect weight
* Current medications that are contraindicated for methylphenidate
Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia

Coronavirus-2019 disease (COVID-19) and community-acquired pneumonia are significant problems of modern medicine. Pneumonia is the most common severe complication of COVID-19. But at the same time, COVID-19 is not the only cause of community-acquired pneumonia. Moreover, pneumonia is only one of the numerous possible severe complications of COVID-19. Medical centers specialized for the hospital treatment of patients with severe COVID-19 and community-acquired pneumonia were organized in different regions of Russia during coronavirus pandemic-2020. The indications for hospitalization to one of these centers based in the National Medical and Surgical Center (NMSC) are: confirmed or suspected severe COVID-19 or community-acquired pneumonia.

A prospective medical registry of such patients hospitalized to NMSC, is intended to analyze and compare their clinical and instrumental data, co-morbidity, treatment, short-term and long-term outcomes in real clinical practice.

Stage 1. Hospital treatment in NMSC

Duration of this stage: from the date of admission to the hospital up to the date of discharge from the hospital / or up to the date of death during the reference hospitalization. The date of admission to the hospital will be the date of enrollment to the study.

Evaluation of electronic health record data using the Medical Information System (MIS). Assessment of the outcomes of the hospital phase (discharge from the hospital, death) and significant events (acute respiratory and pulmonary failure, requiring mechanical ventilation; cardiovascular events - myocardial infarction, cerebral stroke, acute heart failure, paroxysmal heart rhythm disturbances, bleedings, thrombosis of large vessels and thromboembolic complications). A survey of patients to clarify data on risk factors, somatic diseases, and drug therapy before hospitalization.

COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was confirmed by Polymerase chain reaction (PCR). Pneumonia was confirmed according to computerized tomography (CT) data.

Stage 2. Prospective outpatient follow-up for 24 months

Duration of this stage: 24 months after discharge from the hospital This work will be delivered by investigators from the National Medical Research Center for Therapy and Preventive Medicine.

Evaluation of long-term outcomes and events among residents of Moscow and the Moscow Region according to a patient survey (contact by phone for 30-60 days, 6 months, 12 and 24 months after discharge from the hospital) and medical records.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized to the National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russia (NMSC) with suspected or confirmed COVID-19 or community-acquired pneumonia.
2. Age 18 years and older.
3. Permanent residency in Russia.

Exclusion Criteria:

1. Permanent residency outside of Russia.
2. The patient's refusal to participate in the study.
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older and skeletally mature
* Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
* Noninflammatory degenerative joint disease including:
* Osteoarthritis
* Avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other -techniques
* High risk of dislocation due to:
* History of prior dislocation
* Bone loss
* Joint or soft tissue laxity
* Neuromuscular disease
* Intraoperative instability
* Revision procedures where other treatment or devices have failed

Exclusion Criteria:

* Off-label use
* Infection and/or distant foci of infections which may spread to the implant site
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease
* Patient is known to be pregnant or nursing
* Patient is a prisoner
* Patient is a known alcohol or drug abuser
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
* Patient is unwilling to sign an informed consent
Comparison of Two Different Optical Biometric Systems

Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).

This is a prospective study including patients visiting the outpatient Ophthalmology clinic of the University General Hospital of Alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. The patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. They will then undergo an ocular biometry examination using two optical biometric systems, Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG). IOL Master 500 (Carl Zeiss Meditec AG) is a non-invasive optical biometer that uses partial coherence interferometry (PCI) with a wavelength of 780 nm to measure the AL of the eye. Argos (Alcon Laboratories, Inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (SS-OCT) with a wavelength of 1050 nm. The measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (ACD), the horizontal corneal diameter (white to white \[WTW\]) and the lens power in diopters (D).

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.

Exclusion Criteria:

* Dense cataract that does not allow measurements to be taken with an optical biometrics system.
Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, the investigators plan a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, the investigators plan to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. The investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. The investigators hypothesize subjects in the mDOT arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. The investigators also hypothesize that adherence in the mDOT arm will be higher than in the TAU arm. Lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mDOT on adherence.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smoke 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation stage of change)
* Enrolled in Einstein/Montefiore methadone program for 12 weeks or more
* Receiving methadone in clinic three, four, five or six times per week
* No more than 2 methadone clinic misses in prior 14 days
* Agree to use contraception for the duration of the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance \<30 mL/min
Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders

Investigation is designed to determine whether the gold standard for treating anxious youth is enhanced by teaching parents to become their anxious child's CBT coach. Children (7-17 years old) with either Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety Disorder are treated with a combination of the Coping Cat Program and a parent-training intervention that is designed to teach the child's parents the same cognitive and behavioral skills that the child is learning and how to help their child to complete exposure activities. The research methods are parallel to those used in the CAMS study so that this data can be merged with that data set to evaluate the relative efficacy of the enhanced intervention.

Children between the ages of 7 and 17 years old who are primarily experiencing either Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia and are not experiencing a cognitive or learning disability that would prevent them from validly completing the measures are eligible for participation in the study. Children who are experiencing another psychological disorder as their primary disorder would be excluded from the current investigation. Outcome measures include the ADIS for Diagnostic and Statistical Manual (fourth edition)(DSM-IV( Child or Parent, Children's Global Improvement Scale (CGI-I), Children's Global Assessment Scale (CGAS), Pediatric Anxiety Rating Scale (PARS), Negative Affect Self-Statements Questionnaire (NASSQ), Coping Questionnaire (CQ), Goal Attainment Scale (GAS), Mood and Feelings Questionnaire (MFQ), Multi-dimensional Anxiety Scale for Children (MASC), Screen for Child Anxiety and Related Emotional Disorders (SCARED),Family Assessment Measure (third editions) (FAM-III Dyadic), Perception of Therapeutic Relationship (PTR), Satisfaction Questionnaire (SQ), Child Behavior Check List (CBCL), Family Burden Assessment Scale (BAS), Brief Symptom Index (BSI), State Trait Anxiety Inventory (STAI), Brief Family Assessment Measure (third editions (Brief FAM-III).

Eligibility Criteria:
Inclusion Criteria:

* Child is between 7-17 years old
* Primary diagnosis of Generalized Anxiety Disorder
* Separation Anxiety Disorder, or Social Phobia.

Exclusion Criteria:

* Presence of Major Depression, suicidal risk, presence of a learning disability or cognitive deficit that would prevent the child from validly completing the measures
* Presence of another psychological disorder that is of primary significance
Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.

the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy

All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.

Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.

VAS scores and total analgesic requirement is going to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Artroscopic surgery
* ASA I-II

Exclusion Criteria:

* Long time NSAID use
* Travmatic knee injury
* Long ter analgesic use
* Intraartiular catheter insertion at the end of surgery