cyrilzakka/clinical-trials huggingface dataset:
Linear and Non-linear Analysis of EEG Changes in Schizophrenia After Atypical Antipsychotics Medication

The purpose of this study is to evaluate clinical meaning of EEG changes in antipsychotic-treated patients with schizophrenia.

Electroencephalographic (EEG) changes are abundant in patients receiving antipsychotic treatment. However, studies on the meaning of these changes are rare. The results of traditional analyses based on linear methodologies were inconsistent and hard to interpret. Therefore, non-linear analyses of EEG may provide additional information in evaluating antipsychotic-induced changes in EEG.

In this study, we hypothesized that linear and non-linear EEG changes in patients with schizophrenia may be valuable in predicting treatment outcome. We also hypothesized that the assessment of other psychotic symptoms and side effects of antipsychotics may provide additional information in interpreting the results of EEG analyses.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 15-65 years of age.
* Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* Patients who are drug-naive or drug-free for more than 4 weeks.
* Patients who are scheduled to receive atypical antipsychotics.
* Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
* Subjects who are fluent in Korean.

Exclusion Criteria:

* DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
* Mental retardation (IQ \< 70).
* Neurological disorders including epilepsy, stroke, or severe head trauma.
* Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
* Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline.
* History of electroconvulsive therapy or transcranial magnetic stimulation within the past 3 months.
* Subjects who are not fluent in Korean.
Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

The Precision-Panc Master Protocol is a "portal" protocol for patients with known or suspected pancreatic cancer to be accrued through multiple centres in the UK, with the option of being subsequently enrolled into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Studies) examining different treatment regimens and/or biomarker development. Eligible patients will undergo tumour biopsy and blood collection prospectively for molecular profiling at a central laboratory and the results may be used to inform enrolment to PRIMUS studies.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>16 years).
* Either:

  * Presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a Pancreatic Multi-Disciplinary Team (MDT).

Or

o Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants.

* Patient is willing and able to undergo additional tumour biopsy (from the primary or a metastatic site) aimed at obtaining sufficient tissue for molecular profiling if this is required.
* Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation.
* Patient is deemed potentially eligible for a currently open PRIMUS study
* Patient has signed informed consent for screening research tumour biopsy (Consent 1).
* Patient has signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2).
Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Efficacy and Safety

The aim of our study is to estimate the efficacy, safety and postoperative complications of the thulium fiber laser enucleation of the prostate (ThuFLEP) with Urolase system (NTO IRE-POLUS, Russia).

In all patients, IPSS, Qmax, QoL, prostate volume, and IIEF-5 are measured prior to surgery.

For ThuFLEP, we use the Urolase system (NTO IRE-POLUS, Russia) and a 600 mcm fiber. The thulium fiber laser is set with a mean output power of 60 W and energy of 1.5 J. Tissue morcellation is completed with the Piranha Morcellator (Richard Wolf, Germany).

At the end of the procedure a 22 French three-way Foley catheter is placed. IPSS, Qmax, QoL, prostate volume are recorded at 1, 3 and 6 months after surgery. IIEF-5 are recorded at 3 and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 or older
* Infravesical obstruction due to prostatic hyperplasia (IPSS \> 20 or Qmax \<10)

Exclusion Criteria:

* Participation in another clinical study
* Prostate cancer (pathology confirmed)
* Urinary tract infection
* Neurogenic bladder
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)

Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL


Eligibility Criteria:
The main inclusion criteria include but are not limited to:

* Adult participants must be age 18 or older
* Pediatric participants must be at least 2 years old and less than 18 years old.
* Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment
* Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:

  * Failure to achieve complete remission after initial induction therapy;
  * Failure to achieve complete remission after salvage treatment;
  * Relapse with first remission duration ≤12 months
  * Second or later relapse
  * Relapse after allogeneic HSCT
* Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above or, those with the T315I mutation

The main exclusion criteria include but are not limited to:

* History of Burkitt's leukemia.
* Received anti-CD19 therapy within 3 months prior to entering the study
* Received allogeneic HSCT within 12 weeks prior to entering the study
* Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
* History or presence of clinically relevant central nervous system (CNS) pathology
* History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges
* History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.
* History of serious cardiovascular and cerebrovascular disease
* Has active autoimmune diseases that may relapse
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures

Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using such cells to treat patients suffering from distal tibial shaft fractures. The cells will be isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the fracture site.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 and 65. males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation.

Exclusion Criteria:

* active systemic or local infection. history of malignancy radiotherapy or chemotherapy. active autoimmune disease. any past or present immunosuppressive treatment. fracture treated by open reduction. fracture grade gustillo grade IIIB, IIC. use of steroids in past 6 months. chronic renal insufficiency. administration of marrow suppressive drugs. history of metabolic bone disease. administration of drugs that may interfere with bone metabolism.
Hepatitis B Virus Prevalence and Risk Factors in Belgium

The aim of this study was to evaluate the current prevalence and risk factors of hepatitis B virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.

Although the HBV prevalence is generally low in Western countries, such as Belgium, pockets of higher HBV prevalence exist in areas with large immigrant populations. Therefore national prevalence figures can underestimate the burden of HBV infection. The prevalence of chronic HBV in the population-based study in 2003 is believed to be an underestimate due to under-representation of the non-Belgian population. Moreover, by this time there are no data regarding the risk factors for HBV infection in the general population of Belgium.

Even in low-prevalence areas such as Belgium, HBV prevention and control is a public health priority, particularly since safe and effective vaccines are available. The aim of this study was to evaluate the current prevalence and risk factors of HBV infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70
* Males and females

Exclusion Criteria:

/
Statin for Immunomudulation in Sepsis

The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of several sepsis or shock septic
* no more than twenty four hours than diagnosis

Exclusion Criteria:

* use of statins in the last thirty days
* unequivocal indication for statin treatment
* active treatment with imunosuppressors drugs
* High risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase \> three times upper limit of normal
* diagnosis of AIDS
* unable to receive enteral medications
* pregnancy
* expected survival of less than 48 hours
Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation

The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is :

• If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.

The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 316 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=158) or the ECMO group (n=158). The primary end point was the 30-day rate of weaning from VA-ECMO.

Eligibility Criteria:
Inclusion Criteria:

1. Age of ≥18
2. Cardiogenic shock
3. Successful implantation of VA-ECMO
4. Informed consent

Exclusion Criteria:

1. Presence of moderate to severe aortic insufficiency
2. Severe peripheral vascular disease
3. Post-cardiotomy cardiogenic shock or bridging to cardiac procedure.
4. VA-ECMO for definite non-cardiac causes
5. Extracorporeal cardiopulmonary resuscitation
6. Implantation of IABP or IMPELLA before VA-ECMO
7. Severe bleeding
8. Terminal malignancy
9. Irreversible neurologic injury
10. Pregnancy or lactation
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury

The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline \[within 6 weeks of injury\], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.

Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.

For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage.

The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab

For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements \[CDEs\], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 \[PHQ9\] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction

Eligibility Criteria:
Inclusion Criteria:

1. 18-85 years of age
2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
3. classification of A, B, C (motor complete, incomplete).

Exclusion Criteria:

1. Women who are pregnant prior to consent
2. neurological impairment other than SCI
3. self-reported history of Crohn's disease or diverticulitis
4. irritable bowel syndrome
5. gastric blockage/obstruction or swallowing disorder
6. prior GI surgery
7. intrathecal pump
8. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).
9. able to ambulate
Impact of Individual Cognitive Remediation for Parkinson's Disease

This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers.

The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic and enroll the eligible candidates based on the inclusion and exclusion criteria. Subjects will have 11 study visits over the 11-week period. Subjects cognition will be assessed using a paper-based Test of Memory and Learning (TOMAL) tool. The same tool will be used to asses and compare the cognition at baseline, and end study visits. The weekly 30-mins of cognitive remediation exercises will be done using the Brain. HQ cognitive remediation software.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.
2. Subjects must have a diagnosis of Parkinson's Disease by a physician.
3. Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
4. Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.
5. Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1
6. Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.

Exclusion Criteria:

1. Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.
2. Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
3. Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator
4. Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions
All-On-4® Treatment Concept

Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla.


Eligibility Criteria:
The subject is at least 18 years of age (or age of consent) and has passed secession of growth

Obtained informed consent from the subject

Edentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM Implant bridge on four (4) implants is regarded as an appropriate treatment solution

The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed sites implants with a length of at least 8 mm

The implant site is free from infection and extraction remnants Implants will be placed in healed sites.

Good gingival / periodontal / peri-apical status of opposing teeth/implants

The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based

The subjects as well as the implant site(s) fulfill the criteria for immediate loading.

The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation

Exclusion Criteria:

The subject is not able to give her/his informed consent of participating

Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure

Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area

Alcohol or drug abuse as noted in subject records or in subject history Smoking of \>10 cigarettes/day

Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake

Pathologic occlusion, e.g. severe bruxism or other destructive habits

Lack of opposing dentition or unstable occlusion

Ongoing infections, endodontic or periodontal problems in opposing teeth or implants

Subject shows an unacceptable oral hygiene

Subject has allergic or adverse reactions to the restorative material.

Bone augmentation of more than 3mm vertical height performed less than 6 months prior to planned implant placement.

Bis-phosphonate therapy

Implant insertion torque is \<35 Ncm or \>70 Ncm
Fixed Inclination Humeral Cut

The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.


Eligibility Criteria:
Inclusion Criteria:

1. patients 18 years or older
2. primary glenohumeral osteoarthritis
3. intact rotator cuff
4. primary anatomic shoulder arthroplasty

Exclusion Criteria:

1. revision arthroplasty
2. reverse shoulder arthroplasty candidates
3. cognitive or behavioral problems which would preclude informed consent
Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing

The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing.

In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome.

Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support.

By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.


Eligibility Criteria:
Inclusion Criteria:

* patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face

Exclusion Criteria:

* patients not seen within 24 hours postburn
* patients with mental or cognitive deficits that may interfere with providing informed consent
* patients with poor Dutch proficiency
* patients with chemical burns
Obstetric Anesthesia and Analgesia Month Attributes in Czech Republic

A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic.

A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic.

Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Eligibility Criteria:
Inclusion Criteria:

Women in labor undergoing anesthesia care