cyrilzakka/clinical-trials huggingface dataset:
The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy

Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Remote ischemic preconditioning is a novel and simple therapeutic method to lessen the harmful effects of ischemia-reperfusion injury, however, the majority of remote ischemic preconditioning studies on hepatic ischemia-reperfusion injury have been animal studies. Therefore, our aim was to assess the effects of remote ischemic preconditioning on postoperative liver function in living donor hepatectomy.

Liver transplantation(LT) is the gold standard treatment for patients with end-stage liver disease. In light of advancements in surgical techniques, immunosuppressive agents, and perioperative critical care, the overall 3-year survival of patients undergoing LT has exceeded 80%. Despite its outstanding success, LT still entails certain complications including ischemia-reperfusion injury (IRI).

IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.

Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.

Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Donors who plan to have living right hepatectomy for liver transplantation.
* age : between 18 to 60 years.

Exclusion Criteria:

* donors who plan to donate left lobe
* donors who plan to have laparoscopic right hepatectomy
* donors who cannot proceed remote ischemic preconditioning
Virtual Ileostomy Versus Diverting Ileostomy

This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with virtual ileostomy versus conventional divertingileostomy after total mesorectal excision for rectal cancer.

Diverting ileostomy (DI) is a common procedure performed in patients undergoing total mesorectal excision for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI remains one of the most common methods used in clinical practice to prevent anastomotic leakage, there is still considerable debate in clinical practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly increased the risk of non-elective readmissions and reinterventions as well as higher total costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula, etc.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rectal cancer confirmed by pathology
* Age ≥ 18 years
* Lap/robot total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis#1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
* Ability to understand the nature and risks of participating in the trial

Exclusion Criteria:

* Emergency surgery, open surgery
* ASA score \>3points
* Patients with combined complete intestinal obstruction
* Long-term history of using immunosuppressants or glucocorticoids
* Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2. Patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure
* Chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/ min)
* Intraoperative combined multi-organ resection
* Combined cirrhosis of the liver
* Intraoperative findings of incomplete anastomosis and positive insufflation test
* missing information
PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab

Investigational Drugs:

Ofatumumab (Azerra) + bendamustine (Trenda)

Route of Administration:

Intravenous (IV)

Hypothesis:

This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.

Participation:

Approximately 37 relapsed/refractory CLL subjects will participate in this study over two years.

Treatment Plan:

A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.

Follow-up:

Patients will be followed monthly for six months, then every three months for five years then annually thereafter.


Eligibility Criteria:
Inclusion Criteria:

* Must be \>/= 18 years old and able to provide consent
* Must have diagnosis of CLL as defined by NCI criteria
* Must require chemotherapy
* Must be previously treated with a minimum of one course of prior chemo or other treatment
* Serum creatinine \<1.8 mg/dl
* Bilirubin must be \</= 2 mg/d, unless secondary to tumor
* Must have adequate liver function (as defined as \<2x ULN, unless related to CLL)
* AST/ALT \<2x ULN
* Performance status 0-2
* Women of child bearing age must be willing to use accepted/effective method of birth control.

Exclusion Criteria:

* Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.
* Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia
* Not have history of corticosteroid treatment for CLL
* Not have CNS disease
* Not have clinically significant infections
* Patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible.
* Not have positive serology for Hepatitis B or Hepatitis C
* Not have be known to be HIV positive
* Not have New York Classification III or IV hear disease

Other protocol specific criteria may apply
The Interactive Physical and Cognitive Exercise System

This study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a videogame on a portable tablet), or combining these activities together (as in the iPACES™ exergame).


Eligibility Criteria:
Inclusion Criteria:

* co-residing older adults (e.g., spouses, partners, roommates, relatives)
* both at least 50 years of age
* normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease
* adequate vision and dexterity for on-screen assessments
* able to pedal an under-table elliptical
* permission of primary care provider and cardiologist (if applicable)

Exclusion Criteria:

* history of seizure
* Parkinson's disease
* significant dementia/memory loss
Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder

This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention.

According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD.

Positive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention.

The primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary).

The secondary objectives are:

To test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD.

Eligibility Criteria:
Inclusion criteria:

Primary caregivers

* (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD;
* (ii) who are over 18 years old;
* (iii) who have the ability to communicate and read in Chinese;
* (iv) who have at least one mobile phone with an internet connection.

Exclusion criteria:

Primary caregivers

* (i) who participate in a similar psychological intervention within one year;
* (ii) currently on regular psychotropic medications.
Molecularly Aided Stratification for Tumor Eradication Research

NCT/DKFZ/DKTK MASTER is a prospective, continuously recruiting, multicenter observational study for biology-guided stratification of adults with rare cancers, including rare subtypes of common entities, using comprehensive molecular profiling, and clinical decision-making in a multidisciplinary molecular tumor board.


Eligibility Criteria:
Inclusion Criteria:

Rare cancer (Incidence \<6/100,000 persons/year) or Rare subtype of a more common entity (case-by-case decision; example: pancreatic ductal adenocarcinoma without KRAS mutation)

Metastatic and/or locally advanced cancer with no curative therapy option and indication for systemic therapy

Exclusion Criteria:

Severe neurological or psychiatric disorder interfering with the ability to give oral and written informed consent
tDCS and Spasticity in Stroke Patients

Multiple research has worked on tDCS and its impact on stroke. But none have studied the effects of tDCS on stroke in relation to the different stages of stroke like mild, moderate, moderate to severe and severe stroke as per national institute of health (NIH) scale.

Additionally, this study will be conducted to address the few drawbacks in previous studies such as short follow up period by employing evidence based standardized protocols. It can potentially instigate the efficacy of tDCS on spasticity, motor recovery and Quality of life in relation to the different severity levels of stroke.

Multiple noninvasive brain stimulation is also introduced over the few years regarding their impact on spasticity, tDCS being the most common due to its effects on spasticity. There are multiple structural and functional changes in motor cortex post stroke, tDCS causes improvement in motor control by reorganizing the motor cortex. Anodal and cathodal tDCS are based on the current direction with cathodal decreasing excitability of the cortex area and anodal increasing it. Anodal tDCS is more effective in reducing spasticity as compared to cathodal. The change in cortical excitation alters the reflex arc i.e. altering the neurons and reducing their excitability which causes a decrease in tone and facilitates neuroplasticity.

Spasticity is often found along with weakness in stroke and is one of the reasons for impaired motor function, increased resistance to stretch and is due to increased excitability and abnormal regulation of spindle and reflex arc. With chronicity and reduced motor control spasticity also increases by 97 %. Spasticity and paresis lead to impaired motor control. Spasticity will not change recovery in function in early stages but is going to affect motor recovery in all stages. Spasticity disrupts motor function and the daily tasks which creates different levels of dependence in the patients hence effecting the QOL. Spasticity is found in almost 40% of individuals suffering from stroke. It affects joints and extremities in a way that impedes function and ADLs. Painful, restricted joints resulting from prolonged spasticity badly impacts the QOL leading to high burden on caregivers

Eligibility Criteria:
Inclusion Criteria:

* Stroke for more than 6 months.
* Both genders.
* Spasticity score ≥1 at modified ashworth scale.
* National Institutes of Health Stroke Scale (NIHSS) for severity level; Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion Criteria:

* Have any metallic implant including intracranial electrode, pacemaker, surgical clip.
* Any symptoms effecting understanding of instructions.
* Any neurological disorder
Inspiratory Muscle Training in Individuals With Cystic Fibrosis

Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis, confirmed by the sweat test;
* 14 - 25 years;
* Clinical stability;
* Absence of bacterial colonization for 4 weeks;
* Both sexes;

Exclusion Criteria:

* Inability to perform the protocol established by the study;
* Present any intercurrence during data collection;
* Being unable to understand and / or perform procedures.
* Colonization during study participation;
* Patient hospitalization due to worsening of the clinical picture.
Effect of "breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study

Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. These are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes.

The aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.

The "breath of fresh air" flash strategy is to offer the patient the possibility to go out of the medical unity and walking outdoor.

When the caregiver identify a level of agitation greater or equal to two on the gravity score and greater or equal to two on the impact score with the NPI test (The Neuropsychiatric Inventory Test), the caregiver let the patient wandering in the outside lanes of the hospital and encourage him to us his senses. For example, the sight could be stimulated by looking at a bird.

This variation of sensory stimulations enable a temporo-sensory break on the crisis, allowing the patient to turn his attention from the crisis context to another stimulation.

Eligibility Criteria:
Inclusion Criteria:

* New patients admitted in the unit to the management of the Psychological and Behavioural Symptoms of Dementia
* Dementia regardless of etiology and severity
* Score greater than 2 than NPI established on entry into service
* Free, informed and written consent signed by the person trust and/or family member and/or legal representative
* Health insurance membership

Exclusion Criteria:

* Absence of agitation
* Juveniles
* Pregnant women
* Patient who has previously participated in the study
* Persons under protection of justice
Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment

This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.


Eligibility Criteria:
Inclusion Criteria:

* women
* between19-45 years of age
* singleton pregnancy
* no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization
* normal fetal anatomic survey (fas) ultrasound
* fluent in English

Exclusion Criteria:

* additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound
NuVasive® ACP System Study

The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of the NuVasive ACP System in patients who undergo anterior cervical spine surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with pathologic conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo anterior cervical spine surgery using the NuVasive ACP System based on the surgeon's standard of care. At least 75 subjects will be enrolled and will be followed for 24 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are ≥18 years of age at the time of consent
2. Have planned anterior cervical (C2 to C7) spine surgery using the NuVasive ACP System in conjunction with a NuVasive interbody implant or vertebral body replacement device (VBR), or a structural bone allograft spacer, for treatment of any of the following conditions:

   1. degenerative disc disease, as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
   2. trauma (including fractures)
   3. tumors involving the cervical spine
   4. cervical spinal deformity (kyphosis, lordosis, or scoliosis)
   5. failed previous cervical fusion(s) (e.g., pseudoarthrosis)
   6. cervical spondylolisthesis
   7. cervical spinal stenosis
3. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
4. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Procedures performed with interbody implants with integrated vertebral body screw(s)
2. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
3. Use of bone growth stimulators postoperatively
4. Active smoking within 6 weeks of surgery
5. Patient has known sensitivity to materials implanted
6. Systemic or local infection (latent or active) or signs of local inflammation
7. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
8. Pregnant, or plans to become pregnant
9. Patient is a prisoner
10. Patient is participating in another clinical study that would confound study data
Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers

The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.

The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.

Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.

Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.

In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.

During the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation).

The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age
* Have a pacemaker implanted
* Understand and be able to properly perform self-monitoring at home

Exclusion Criteria:

* Be participating in another study
* Refuse to participate in the study
* Have implanted a different cardiac device to the pacemaker