cyrilzakka/clinical-trials huggingface dataset:
Social Skills Training in Refractory Schizophrenia

Objective Primary:

To evaluate the efficacy of social skills training in reducing negative symptoms in patients with refractory schizophrenia, in comparison with control (befriending group).

Secondary:

To evaluate changes in social functioning.

To evaluate the effect of SST in other dimensions of psychopathology: positive symptoms, depression and general psychopathology.

To evaluate the impact of SST in cognition.

Hypothesis Social skills training is more effective than control group (Befriending) in reducing negative symptoms in patients with refractory schizophrenia.

In schizophrenia positive symptoms can be improved with an antipsychotic treatment. However there is a subgroup of patients who have a predominance of persistent negative symptoms that do not respond to antipsychotic treatment, such as blunted affect , emotional and social withdrawal, and there is evidence that such symptoms can improve with psychosocial interventions.

The objective of this study is to evaluate the efficacy of Social Skills Training on negative symptoms in patients with refractory schizophrenia by means of a randomized, single-blind controlled trial with the duration of a year, including, follow up.

This study will be conducted in two groups: one group will receive social skills training (N=46) and a control group (N=46) will attend the same number of sessions, but without intervention of the therapists (befriending).

Psychiatric, psychological and neuropsychological aspects will be evaluated at baseline, after 20 weeks and 6 months after the end of the intervention.

The scales that will be used for the psychiatric assessments are: PANSS (reduction of 20% in the negative subscale), CGI, CALGARY, SDS, and PSP, As well as the Social Skills Inventory IHS. The neuropsychological assessment will have groups of scales to measure: Attention, Memory, Executive Functions, Estimated Intellectual Efficiency and a ToM. For statistical , the repeated measure ANOVA will be used, as well as the effect size and number needed to treat.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia can´t not be over 10 years old.
* Age between 18 and 55 years old.
* A minimum of 16 in negative subscale of PANSS.
* A score 4 in at least 3 of the following symptoms:

  * blunted affect
  * social withdrawal
  * rapport
  * passive social withdrawal
  * lack of spontaneity
  * motor retardation
  * active social avoidance
* Stable disease, in use of clozapine, without recent hospitalization.

Exclusion Criteria:

* Comorbid substance use.
* Axis I comorbidity.
* History of head trauma or neurological disease.
* Clinical problems which can affect central nervous system.
* Mental retardation.
* Patients treated with other antipsychotic than clozapine.
* Patients who underwent other psychosocial treatments.
Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.

Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Referred for Cardiovascular Magnetic Resonance Imaging

Exclusion Criteria:

* Non-compatible Devices
Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty

This study will be conducted to evaluate the effect of pericapsular nerve group and erector spinae plane block as adjuvants to general anesthesia in geriatrics undergoing total hip arthroplasty.

Total hip arthroplasty is one of the most common major orthopedic procedures to improve a patient's functional status and quality of life. Total hip arthroplasty is one of the most cost-effective and consistently successful surgeries performed in orthopedics and can be associated with significant postoperative pain.

General anesthesia may be considered more versatile and suitable for patients with complex medical histories or those who cannot tolerate spinal anesthesia. However, older patients undergoing hip fracture surgery under general anesthesia may experience a higher risk of postoperative delirium, prolonged sedation, and respiratory complications. Moreover, delayed mobilization is possible, leading to a higher incidence of complications such as deep vein thrombosis and pressure sores.

The target nerves of the hip joint arise from the lumbar plexus (L1-L4), the lumbosacral trunk of the sacral plexus (L4-L5), and the sacral spinal nerves (S1-S4) (7). The femoral nerve, obturator nerve, and the accessory obturator nerve supply the anterior capsule of the hip; the sciatic nerve and the nerve to the quadratus femoris mostly supply the articular branches to the posterior capsule of the hip joint The erector spinae plane block is a novel inter-fascial plane block targets the dorsal and ventral rami of the spinal nerves, is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. This block can potentially provide analgesia to the posterior pelvis potentially safer alternative to epidural or paravertebral techniques, areas often involved in hip fracture pain.

The pericapsular nerve group block targets the articular branches of the femoral and obturator nerves near the hip joint capsule. By blocking these nerves, the pericapsular nerve group block effectively provides analgesia to the hip joint, particular tissues, and proximal femur.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>75 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) classification I-III.
* Undergoing total hip arthroplasty under general anesthesia.

Exclusion Criteria:

* Patient refusal.
* Body mass index (BMI) \> 30 kg/m2.
* Allergy to local anesthesia drugs.
* Infection at the site of intervention.
* Coagulopathies.
* Preexisting advanced diseases of the kidney or liver.
Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position

The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery. Hemodynamic instability is frequently encountered problem associated with BCP. In addition, high rates of cerebral desaturation events have been reported during surgery in BCP. Although fluid loading could alleviate hypotension associated with BCP, it may lead to volume overload. As an alternative to static indices, dynamic preload indices such as pulse pressure variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of fluid responsivness in several surgical condition. The investigators will examine the abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery in BCP. Using transesophageal echocardiography (TEE), the investigators will directly estimate the change of cardiac output during BCP.


Eligibility Criteria:
Inclusion Criteria:

1. Above 20 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. shoulder arthroscopy under Beach-chair position

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. cerebrovascular disease 4. Pregnancy
Home-based Transcranial Electrical Stimulation (TES) in Patients With Chronic Tinnitus

The investigators applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus.

For treatment of motor and psychiatric disorders, transcranial electrical stimulation including transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS), or transcranial random noise stimulation (tRNS) are in use worldwidely. The investigators applied these neuromodulation techniques into patients with intractable chronic tinnitus for symptom relief. Experimental groups with 60 subjective tinnitus subjects will be consisted of three different treatment groups which are: TES group, TES with sham stimulation group, and control group. Subjects will be given 1.0 milliampere (mA) TES on bifrontal areas for neuromodulation.

Eligibility Criteria:
Inclusion Criteria:

* Research volunteers with intractable chronic tinnitus who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital

Exclusion Criteria:

* psychoactive drug user
* implanted material
* pacemaker user
Trial of PCIT-ED in School for Preschoolers in Poverty

A shorted form of the previously tested, Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral problems as rated by teacher. Children aged 3-7 will be randomized to a 12-week PCIT-ED delivered by trained therapists in the school setting or an on-line parent training called "Parenting Wisely (PW)". Children will have a 60% chance of being randomized to PCIT-ED and 40% to PW. The treatment will be provided to eligible children in the Jennings School District at the school site. In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes, and to investigate mediators and moderators of treatment response, participants will complete comprehensive pre- and post-assessments at Washington University School of Medicine Early Emotional Development Program.

Preschoolers over age 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED or PW.

Compared to those randomized to PW, we expect preschoolers who undergo PCIT-ED will show significantly increased rates of remission of behavioral problems, greater reductions in symptoms, and decreases in impairment. We hypothesize that they will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the PW, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.


Eligibility Criteria:
Inclusion Criteria:

* Over the clinical threshold on the Teacher Report Form

Exclusion Criteria:

* Autism
* Major neurological disorder
* Participating in active weekly individual or family therapy
Transient Elastography in Hepatectomy for Hepatocellular Carcinoma

The purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
What is the Experience of the Professional Nurse Advocates (PNAs) Application of the A-EQUIP Model Into Practice

The study will utilise focus groups with trained PNAs from different Trusts spread over the Midlands region within England. This approach will help explore the experiences and views of trained PNAs in the application of the role and the foundations on which it is supported. It will also supply valuable feedback regarding the preparation, implementation, and outcome of adopting the PNA position with health care organisations, as there is a suggestion that the role could expand from England to the United Kingdom and possibly the United States of America.


Eligibility Criteria:
Inclusion Criteria:

• Qualified Professional Nurse Advocate (PNAs) all of whom would have successfully completed a PNA level 7 module provided by a Higher Education Institution within England

Exclusion Criteria:

• Any qualified nurse who has not successfully completed a PNA module.
ACRODAT Prospective Evaluation Study

ACRODAT® is a new software medical device developed by a group of acromegaly experts to help practising endocrinologists assess disease activity in patients with acromegaly. It uses 5 key parameters (IGF-I level, tumour status, comorbidities, symptoms and Quality of life) to evaluate the patient's health status. The purpose of this post marketing surveillance study is to prospectively evaluate whether patients monitored by ACRODAT® with appropriate clinical decisions based on disease activity status will benefit from improved treatment outcomes both in the short and in the long term.

This is an international, multicentre, randomised, non-interventional, collaborative post marketing surveillance study to assess the clinical use of the newly developed software medical device named ACRODAT®. Patients newly enrolled will be followed-up over a 2 year period. Patients will be assigned to the ACRODAT® group or the Standard Practice group according to a central randomisation. Patients assigned to the ACRODAT® arm will be followed up with the treating physician using ACRODAT® at every visit. The frequency of visits will be according to standard practice in the clinic. Patients not followed up with ACRODAT® will be followed-up in accordance with the standard medical practice of the hospital where they have been recruited, until study completion (Standard Practice arm).

Eligibility Criteria:
Inclusion Criteria:

1. All patients with a confirmed diagnosis of acromegaly, aged 18 years or over, pre-treated and treatment naïve;
2. A follow-up visit is scheduled or anticipated for the patient at least once every year;
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of and consented to all pertinent aspects of the study.

Exclusion Criteria:

1. Patients who are surgically cured and remain controlled for at least 3 years;
2. Patients who are unable to understand the nature of the study and/or unwilling to sign an informed consent;
3. Patients who are unwilling to abide by the guidelines of the study;
4. Patients participating in any clinical trial on an investigational medicine or software medical device/evaluation tool for acromegaly.
Phase 1 Study of ANAVEX3-71

A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female between 18 and 55 years of age, inclusive.
* Body mass index (BMI) between 19-28 kg/m2 and within a body weight of ≥ 60 kg and ≤ 120 kg.
* Female subjects must be of non-childbearing potential (defined as postmenopausal for at least 2 years or surgically sterile at least 6 months prior to dosing) or must be using adequate contraception.
* Subject is judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12-lead electrocardiogram (ECG).
* Non-smoker (no tobacco use within past 3 months).
* Subject is willing to comply with the study protocol, in the investigator's judgement.

Exclusion Criteria:

* Subject has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological (including myelosuppression and bleeding disorders) or immunological/autoimmune disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
* Positive test result on Hepatitis B surface antigen (HBsAg) or is Hepatitis C virus antibody (HCV-Ab) positive or positive HIV-1 and/or -2 serology.
* Subject has a history of chronic alcohol abuse within the last 2 years, or has a positive alcohol test or is known to have excessive alcohol intake.
* History of substance abuse, known drug addiction, or positive test for drugs of abuse.
* Subject has participated in another clinical trial of an investigational drug (or a medical device) within the last 3 months or is currently participating in another trial of an investigational drug (or a medical device).
* Female subject who is pregnant or lactating or planning a pregnancy.
* A history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study (psychosis is to be disqualified).
* Subject has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns

The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid ceramic on pink and white esthetics in comparison with lithium disilicate.

The research hypothesis is that there will be comparable clinical performance results between polymer-infiltrated-ceramic-network and lithium disilicate hybrid abutment crowns.


Eligibility Criteria:
Inclusion Criteria:

* Literate, capable of reading and signing the informed consent document
* Healthy, free from or with controlled systemic disease
* With acceptable oral health to support implant restorations
* With good bone quality and quantity
* Cooperative, accepting follow up and maintenance sessions
* Having single missing tooth in esthetic zone

Exclusion Criteria:

* Under 18 years old
* Illiterate, unable of comprehending or signing the informed consent document
* Unhealthy with uncontrolled systemic disease
* Pregnancy
* With unfavorable oral state that might affect implant procedure and restoration
* Uncooperative, not willing to return for follow up visits
Evaluation of a Web-based Platform for Osteoarthritis Treatment

This study will compare the effects of a novel web-based program (Joint Academy) to regular face-to-face treatment (the BOA program) for people with osteoarthritis of the knee. Half of the participants will be randomized to the web-based program whilst the other half will receive regular face-to-face care.

According to national and international guidelines, osteoarthritis (OA) treatment consists of exercise and information. The face-to-face BOA program is a model to deliver this treatment at primary care facilities in Sweden. Presently less than 20% of people with OA receive adequate treatment. This may be due to lack of healthcare resources or people having trouble to fit their schedule to primary care opening hours. To facilitate a better OA care, alternative methods are therefore required.

A two-armed randomized clinical superiority trial will be performed to compare OA treatment by a web-based program, Joint Academy, with the traditional face-to-face BOA program in 270 adults with clinically verified OA. Using intention-to-treat analysis and per-protocol, evaluations will be performed at baseline, after 6 weeks and after 3, 6 and 12 months. The primary outcome is physical function. Secondary outcomes are joint pain, health-related quality of life, self-reported function, amount of time of physical activity/exercise and overall satisfaction. A health-economic analysis will also be performed. The primary endpoint will be at 12 months. Data will be monitored using web-based questionnaires in Joint Academy, and regular paper questionnaires for the face-to-face treatment.

Should the trial show superiority in favor of Joint Academy, an implementation of the web-based treatment would benefit both patient and society at large, since Joint Academy entails a more flexible treatment in regards to time and location, and is not as costly per-patient as regular face-to-face treatment.

Eligibility Criteria:
Inclusion criteria:

I: A clinical diagnosis of knee OA according to American College of Rheumatology (ACR) diagnostic criteria as well as national and international guidelines: knee pain and 3 of the following: \> 50 years of age, morning stiffness \>30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth; II: Reported knee pain ≥4 and ≤8 on the NRS, and ≥6 to ≤16 in number of repetitions of the 30 second chair stand test, at pre-randomization screening.

II: Able to handle a software program via phone, tablet or computer. III: Able to read and write the Swedish language.

Exclusion criteria:

I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient
The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer

In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide.\[1\] Rectal cancer accounts for 30% to 35% of CRCs\[2\], Between 5% and 10% of patients with rectal cancer present with locally advanced rectal cancer (LARC),\[3\] Useful and practical prognostic biomarkers obtained before treatment are anticipated to predict the outcome after main treatment. Such biomarkers will help in planning strategies for adjustment of postoperative adjuvant therapy.\[4\]

Inflammation-induced markers play an important role in tumorigenesis and tumor progression. More evidences had reported systemic inflammation-based biomarkers could be used to predict tumor behavior.\[4\] Two convenient and economic measures of systemic inflammation, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), that reflect the interaction between inflammation and host immune status, making them potential prognostic factors for various types of cancers. Increased NLR has been advocated to be an independent prognostic factor for poor survival outcomes in pancreatic cancer, CRC, and gastric cancer \[5-6\].

In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function.

5- Performance status 0-1 according to ECOG PS

Exclusion Criteria:

* 1- metastatic disease 2- Younger than 18 year old 3-Any other malignancy 4-There is contraindication for CCRT