cyrilzakka/clinical-trials huggingface dataset:
Assessment of Spinal Stability

The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in humans, and develop non-invasive techniques to measure intervertebral kinematics of the lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a foundation for clinical trials on low back pain patients using this methodology.


Eligibility Criteria:
Inclusion Criteria:

* 21-45 years of age - typical working age in physically demanding jobs
* no history of low back injury or musculoskeletal disorder in the past one year
* any activity history: sedentary, active, or non-athletic, and 4) any ethnic background or race
* body mass index score less than 30

Exclusion Criteria:

* Younger than 21 or older than 45 years old (range not relevant to majority of physical labor force)
* previous injury, disorder, or illness related to the low back
* professional athletes
* professional workers engaged in physical labor (e.g., roofers, loaders/unloaders in warehouses, tile/concrete layers, etc.)
* pregnancy
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of 2 years.

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA, CLL-1, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
2. ECOG score≤2;
3. To be aged 1 to 70 years;
4. More than a month lifetime from the consent signing date.

Exclusion Criteria:

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Pregnancy or lactation women;
12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life

Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life.

Patients and Methods: 60 discharged patients suffering from nutritional (MUST\>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.


Eligibility Criteria:
Inclusion Criteria:

* MUST =\>2
* Region of living Bney-Brak or Petah-tikwa
* Fine cognitive state

Exclusion Criteria:

* Progressive cancer
* Dementia
* Fiddling by PEG or Enteral nutrient via Naso gastric tube
* Psychiatrics disorder
Psychological Intervention for Misophonia

The investigators are proposing to test Acceptance and Commitment Therapy (ACT)+ traditional audiological behavioral intervention as an integrated, multi-disciplinary approach for the assessment and treatment of misophonia. Participants will be 60 adults with misophonia and will be randomly assigned to receive 12 sessions of ACT+behavioral intervention or receive 12 weeks of progressive relaxation training+psychoeducation (PRT; a commonly used active control condition) after undergoing a comprehensive psychological and audiological evaluation.

Acceptance and commitment therapy (ACT) is a promising psychotherapy for supporting traditional behavioral methods for treating misophonia, but has not been previously tested. ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes.

This study will help determine if ACT+behavioral intervention is a feasible and acceptable treatment for misophonia, help clarify active psychological mechanisms of misophonia, and determine whether or not this combination of services can effectively help individuals diagnosed with misophonia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals seeking treatment for misophonia.
* Meet clinical cut-off for misphonia (minimum score of five on the Misophonia Questionnaire).
* Stable on psychotropic medication for at least 30 days.
* English speaking.

Exclusion Criteria:

* Presence of psychological and/or neurological impairments that would preclude someone from participating in the study or exceed misophonia as the primary presenting problem (e.g. active self-harm or need for treatment for psychosis).
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule

The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Glucose, Activity, Diet, & Sleep Assessment Study

GLADS is a cross-sectional, observational study assessing free-living diet, physical activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.

Monitoring free-living lifestyle behaviors can provide important information on behavioral determinants of health. New technologies have improved accessibility of ambulatory assessment of diet, biomarkers, physical activity, and sleep. The study will assess the effects of free-living diet assessed by questionnaire and sleep and physical activity measured by actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult men and women over a 2-week period.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 y old
* In possession of a smartphone
* English speaking
* Live in New York City metro area

Exclusion Criteria:

* Active food intake disorder
Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients

This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.

This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The treatment portion of the study requires patients to visit the BIDMC daily, Monday through Friday, for 6 weeks. All participants will receive real cognitive training, but half of our participants will receive active TMS treatment and half will receive a placebo TMS treatment. However, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. This study goes up to approximately 4.5 months.

TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. The investigators are examining if this combination of TMS and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 55-90
* Diagnosed with mild to moderate AD according to DSM-IV criteria
* Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA
* Normal or corrected normal ability to see and hear
* Primary language is English

Exclusion Criteria:

* IQ below 85
* Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)
* Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
* Any functional psychiatric disorder (eg. Schizophrenia)
* Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)
* History of seizures, diagnosis of epilepsy
* Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
* Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate
Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease

This study will test G:DATA, a simple computer game designed to diagnose Alzheimer's Disease, in three different groups of people, some of whom have Alzheimer's Disease. It will look at whether the results of G:DATA match the results of tests that are used to diagnose people with Alzheimer's Disease now. The Investigators will also ask patients and healthcare staff for participant views on the G:DATA game.

Alzheimer's Disease is a type of dementia that causes progressive deterioration to memory, thinking and behaviour. It is currently thought to affect 50 million people globally, although 75% of those affected are thought to be undiagnosed, with no access to treatment.\[2\] Diagnosis requires extensive clinical evaluation, involving a range of techniques that are resource-intensive and can only be performed in clinical settings. Research has demonstrated a direct link between carefully designed spatial learning within computer games and the detection of deterioration in specific brain cells first affected by Alzheimer's Disease, overlooked by existing assessment techniques. This research will look at the feasibility of using a computer game diagnostic tool, called G:DATA, in the diagnosis of Alzheimer's Disease. It will do this by providing a clinical benchmark, consolidating the results of gameplay performance against current clinical gold-standard assessments, during a clinical study conducted with two patient groups (patients with Mild Cognitive Impairment (MCI), patients with mild AD-related dementia) and a healthy controls group. Outcomes will include validity data of the game's output in diagnosing Alzheimer's Disease, together with data on the tool's usability, and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 55-79 years
* Willing and able to provide informed consen-

Exclusion Criteria:

* A concurrent diagnosis of epilepsy
* A history of severe visual impairment, e.g. macular degeneration, diabetic reti-nopathy, as determined by the clinical team
* A history of head trauma
* Presence of Sleep Apnoea
* History of alcohol dependence
* History of illicit drug use
* Severe upper limb arthropathy
* The use of cognitive enhancing drugs e.g. cholinesterase inhibitors-
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma

This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average.

Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.

The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age.
2. Patient must be able to give own signed informed consent.
3. Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin.
4. Patients that are planned to receive either:

   * Adjuvant treatment
   * 1st line treatment for metastatic disease
   * 2nd line treatment for metastatic disease
5. Patients with prior adjuvant treatment are allowed.
6. Patients receiving planned standard treatment of one or more of the following:

   * Chemotherapy regimens containing DTIC, TMZ and/or cisplatin
   * Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies)
   * BRAF and/or MEK inhibitors
7. Patients were FFPE and fresh frozen tissue is available (both mandatory).

Exclusion Criteria:

-
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth

This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years.

The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.


Eligibility Criteria:
Inclusion Criteria:

* informed consent signed and understood by the subject
* partial or full denture with SR Phonares II teeth
* dentures delivered in the internal clinic between August 2010 and August 2012
* to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.)

Exclusion Criteria:

* patient does not wear the dentures regularly
* health status (physical and mental) does not allow participation.
The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics

Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in patients with schizophrenia switched from other antipsychotics which were suboptimal due to insufficient efficacy or insufficient tolerability.

Methods:

This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerability of the patients.


Eligibility Criteria:
Inclusion Criteria:

* The participants who were aged from 20 to 65 years and met the diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) were eligible for the recruitment to the clinical trial.
* They also fulfilled the criteria including having a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics due to insufficient efficacy or insufficient tolerability.

Exclusion Criteria:

* Any DSM-IV-TR Axis I disorder other than schizophrenia, except comorbid obsessive-compulsive disorder, anxiety disorder, eating disorders or impulse control disorders if they had been stable and had not been primary focus of treatment over the previous 6 months
* An imminent risk of suicide or a danger to self or others
* Pregnancy or lactation
* Intolerance or lack of response to quetiapine IR
* Use of cytochrome P450 3A4 inhibitors or inducers in the 14 days preceding enrolment
* Administration of a depot antipsychotic injection within one dosing interval before recruitment
* Unstable or inadequately treated medical illness as judged by the investigator.
Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases

The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.

All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.

Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject.

Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).

Eligibility Criteria:
Inclusion Criteria:

* Patients who elect to undergo fetoscopic neural tube defect repair

Exclusion Criteria:

* Patients who do not elect to undergo fetoscopic neural tube defect repair
MIStreatment Screening in Elders Before Discharge

The purpose of this study is to demonstrate the feasibility of introducing, implementing, and integrating a brief, existent elder mistreatment screening tool (the National Collaboratory to Address Elder Mistreatment (NCAEM)'s Elder Mistreatment - Screening And Response Tool (EM-SART) Pre-Screen) in the Memorial Herman Hospital (MHH)-Texas Medical Center (TMC)Acute Care of Elders(ACE) (MHH-TMC ACE) unit and to identify older adults who may already be suffering from abuse, neglect, and/or financial exploitation, as well as connecting the study participants to the primary Geriatric Medicine team on the ACE unit such that additional care, evaluation (including additional in-depth mistreatment screening), and intervention can be taken to prevent and minimize further harm prior to discharge. The investigators hope to reduce missed opportunities for mistreatment detection to lead to safer health outcomes and hospital discharges.


Eligibility Criteria:
Inclusion Criteria:

* current admission to the MHH-TMC ACE unit
* ability to independently hear, understand, and verbally answer the 3 participant questions on the NCAEM's EM-SART Pre-Screen screening tool when it is read to them

Exclusion Criteria:

* unwillingness to participate in the research study.
Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain

This study aims to measure the effects of spinal manipulation on Chronic Spinal Pain by assessing Muscle Mechanical Properties (MMPs) using MyotonPRO®, Mechanical Perception Threshold (MPT) using Von Frey monofilaments, and Pressure Pain Threshold (PPT) using an algometer. Participants will be randomly assigned to either spinal manipulation or placebo groups to compare effects on MMPs, MPT, and PPT. Assessments will occur at three time points: baseline, immediately post-intervention (real or simulated), and 24 hours post-intervention. This research targets individuals with chronic spinal pain, providing insights into the potential benefits of spinal manipulation in managing this condition.


Eligibility Criteria:
Inclusion Criteria:

* Subject with chronic low back pain

Exclusion Criteria:

* Spinal trauma or surgery history.
* Spinal congenital deformities.
* Inflammatory or autoimmune disease
* Herniated disc in the segment L5.
* Pregnant women.
* Body Mass Index \&gt; 30kg/m2
* Subjects that have received treatment for low back pain in the seven days prior to the study.