cyrilzakka/clinical-trials huggingface dataset:
Pilot Study for Automated Deep Brain Stimulation Programming

The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Implanted deep brain stimulation system awaiting initial programming session

Exclusion Criteria:

* Subjects with significant psychiatric illness or dementia
* Significant cognitive impairment
Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors

This study is a pilot clinical trial to assess the feasibility of implementing a group-psychotherapy intervention to modify emotional stress (e.g., anxiety, depression, post-traumatic stress) following ICU hospitalization

Psychological symptoms and emotional distress, including anxiety, depression, and posttraumatic stress, are common problems among patients discharged from the intensive care unit (ICU). The presence of psychological distress is associated with poor medical adherence, slower recovery, and reduced quality of life in this patient population. There is a lack of research on evidence-based interventions to address mental health symptoms in ICU patients post-hospitalization. Researchers have recently highlighted the potential utility of peer support/group interventions in the post-ICU recovery process; however, they have yet to be widely tested in interventional trials, and their feasibility and acceptability in the post-ICU population have yet to be demonstrated in a research study. Thus, the purpose of this study is to adapt and deliver a 6-session group-based psychological intervention for post-ICU patients in a single-arm, non-randomized interventional study. Patients' symptoms will be assessed at baseline, post-intervention, and 3-month follow-up. The primary aim of the study is to assess the feasibility and acceptability of the group intervention in the post-ICU patient population. Secondarily, changes in patients' emotional distress will be examined to assess for the impact of the intervention on patients' symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years
* ICU stay of at least 3 days
* Access to a smartphone, laptop, or computer and able to participate in a meeting via a virtual platform
* Montreal Cognitive Assessment (MoCA)-BLIND score of at least 18
* English fluency
* Screening questionnaires consistent with clinically significant depression OR anxiety (Hospital Anxiety and Depression Scale-Depression \[HADS-D\] OR HADS-Anxiety \[HADS- A\] score of \>7) OR Post-traumatic Stress (PTSD Checklist-Civilian Version \[PCL-C\] score of ≥ 30)
* Resides in the state of Massachusetts.

Exclusion Criteria:

* Unable or unwilling to participate in 6 weekly sessions of group therapy
* Permanent or severe cognitive impairment severe enough to impede participation (as assessed via the MMSE).
"Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries."

The goal of this clinical trial is to compare the use of antibiotics with no use in people undergoing soft tissue hand surgery in developing countries.

The main question it aims to answer is:

• Is an antibiotic necessary for this type of surgery in this population? Researchers will compare a group of patients who receives antibiotics during the surgical procedure with a group who receives no antibiotics to see if infection rates are the same.


Eligibility Criteria:
Inclusion Criteria:

* individuals with clean soft tissue conditions of the upper limb requiring surgery

Exclusion Criteria:

* abandonment of treatment
* ASA \> 3
Oral Glutathione Supplementation in Older Healthy Adults and Its Effect on the Number of Healthy Days Experienced During Four Months of Supplementation Compared to Placebo

A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. The primary end point is the number of healthy days experienced during the duration of the study. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.

The long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. The goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. The central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants.

After obtaining informed consent, human participants will receive 500 mg/day of Setria® Glutathione or placebo for 120 days. Peripheral blood mononuclear cells (PBMC), neutrophils and serum will be obtained from blood draws before and after the 120 days. A daily diary of illness will be kept by each participant and will record any incidence of illness, the number of symptoms per incidence, and the number of days in which symptoms are present. This study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. The analysis indicated 60 people per group.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* must have had at least one cold during the previous year
* age 50-75
* must discontinue other dietary supplement use

Exclusion Criteria:

* on arthritis medication
* on hypertension medication
* severe allergies
* compromised immune system
* high cholesterol, heart failure, angina, etc.
* diagnoses of diabetes or metabolic syndrome
Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.

Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient.

In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects.

In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital.

The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration.

The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for lumbar fusion surgery on account of vertebral fractures or degenerative spondylolisthesis.
* Patients consent.

Exclusion Criteria:

* Opioid tolerance;
* Documented sleep apnoea or home oxygen therapy;
* History of alcohol or drug abuse;
* Patients with an allergy or hypersensitivity to opioids.
Flexible Tip Bougie Catheter Intubation

We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.


Eligibility Criteria:
Inclusion Criteria:

* physicians
* give voluntary consent to participate in the study
* none experience in videolaryngoscopy
* less than 1 year experience in medicine

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease

Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.

Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and about half of them also exhibit supine hypertension. In current clinical practice both are undertreated. The common co-occurrence of OH and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. Head-up tilt sleeping (HUTS) is the only intervention known that could improve both. The concept of HUTS is based on several small-scale observational studies and expert opinion. Although HUTS has been proposed as an effective and even first choice non-pharmacological treatment for OH for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. The Heads-Up trial is a multicenter home-based double-blind phase II RCT. The study aims to investigate the efficacy and tolerability of HUTS, leading to optimal implementation strategies of HUTS to treat orthostatic hypotension and supine hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Orthostatic hypotension defined as a systolic BP decrease of ≥20 mmHg, or a diastolic decrease of ≥10 mmHg, within 3 min after changing from a supine to standing position OR mean standing BP of ≤75 mmHg (marker for symptomatic orthostatic hypotension). In patients with supine hypertension, a decrease in systolic BP of ≥ 30 mmHg is required;
* Orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/or indirect signs (falls or freezing episodes that relate to postural challenge);
* Supine hypertension defined as a systolic BP of ≥140 mmHg, and/or diastolic of ≥90 mmHg, after 5 min of supine rest;
* Idiopathic PD or parkinsonism (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, vascular parkinsonism and Lewy body dementia);
* Ability to walk (with or without a walking aid), as subjectively determined by the researcher;
* Stable medication regimens for orthostatic hypotension and supine hypertension during the trial;

Exclusion Criteria:

* Inability to follow instructions and complete questionnaires, as assessed by the researcher;
Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma

Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous system lymphoma (PCNSL).

In a pilot study of primary central nervous system(CNS) lymphoma patients, ketogenic diet was given in adjunction with standard HD-MTX chemotherapy as interventional group; standard HD-MTX is given with routine diet as control group. The primary endpoint is the safety of ketogenic diet in PCNSL patients receiving chemotherapy, secondary endpoints include rate of complete remission, remission time, rate of tumor relapse and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70
2. Histopathologically confirmed PCNSL
3. No systemic involvement
4. Ability and willingness to sign informed consent
5. Normal liver and kidney function
6. Karnofsky Performance Score of 60 or more

Exclusion Criteria:

1. Any systemic involvement of the tumor
2. Systemic illness or medical condition may pose additional risk, including cardiac, metabolic or endocrine disorders; incompensated renal or liver disfunction; history of renal calculi, hyperuricemia, hyper calcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
3. Uncontrolled hyperlipidemia or hyperglycemia
4. Human immunodeficiency virus positive, or hepatitis C positive
5. Pregnancy of breastfeeding
6. Inability or unwillingness to give written informed consent.
A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency

This trial includes dose-escalating part (phase 1) and dose confirming part, to prove the safety and efficacy of VGN-R09b to treat patients with severe AADC deficiency

Aromatic L-amino acid decarboxylase (AADC) is an enzyme responsible for the final step in the synthesis of neurotransmitters dopamine and serotonin. AADC deficiency is a rare genetic disorder. VGN-R09b is a kind of Gene therapy with adeno-associated virus (AAV) serotype 9 (AAV9) driven human AADC (hAADC) being injected directly into putamen.

This is an open, dose-escalating and dose confirming study. The sponsor plans to explore two dose levels (6.0×1011vg and 1.28×1012vg) in dose-escalating phase (three subjects each cohort), then plans to have 10 subjects enrolled for dose confirmation phase.

This study is to give evidence for the safety and efficacy of VGN-R09b treatment for patients with severe Aromatic L-amino acid decarboxylase (AADC) deficiency.

Eligibility Criteria:
Inclusion Criteria:

1. The child patient has to be ≥18 months old and \< 8 years old, and a head circumference big enough for surgery as judged by investigator.
2. Historical diagnosis of AADC deficiency with clinical symptoms consistency, AND with Molecular genetic confirmation of homozygous or compound heterozygous mutation point of IVS6+4A\>T in DDC gene.
3. With Plasma AADC activity less than or equal to 12 pmol/min/mL.
4. Motor development at baseline \<3 months (head fully uncontrollable at baseline）, and Failed to benefit from standard medical therapy (dopamine agonists, monoamine oxidase inhibitor or related form of Vitamin B6) at discretion of investigators.
5. Parent(s)/legal guardian(s) with custody of subject must give their consent for subject to enroll in the study.
6. Parent(s)/legal guardian(s) of the subject must agree to comply with the requirements of the study, including providing disease information and support disease assessment of symptoms.

Exclusion Criteria:

1. Intracranial neoplasm or any structural brain abnormality or lesion (e.g., severe brain atrophy, white matter degenerative changes), which, in the opinion of the study investigators, would confer excessive risk and/or inadequate potential for benefit.
2. Presence of other significant medical or neurological conditions that would create an unacceptable operative or anesthetic risk (including congenital heart disease, respiratory disease with home oxygen requirement, history of serious anesthesia complications during previous elective procedures, history of cardiorespiratory arrest), liver or renal failure, malignancy, or HIV positive.
3. Severe coagulopathy, or need for ongoing anticoagulant therapy.
4. clinically active infection or with severe infection within 12 weeks before screening (e.g. adenovirus or herpes virus, pneumonia, sepsis, central nervous system infection).
5. Previous stereotactic neurosurgery, or any gene/cell therapy.
6. Received live vaccination within 4 weeks.
7. Contraindication to sedation during surgery or imaging studies (PET or MRI).
TMS Treatment for Depression in the National Health Service

This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of depressive disorder (DSM-IV)
* Diagnosis of treatment resistance (at least stage 1 as defined by Thase \& Rush, 1997 for depression)
* Female or male between 18 and 70 years

Exclusion Criteria:

* History of Bipolar disorder
* Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
* Metal objects in and around body that cannot be removed
* Pregnancy
* Cardiac pacemaker or implanted medication pump
* Major unstable medical illness
* Change in prescribed medication in the 2 weeks preceding the start of TMS trial
* Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment

Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies
* Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT).
* Number of previous lines of therapy \>2
* Karnofsky index ≥60%
* availability of signed informed consent -

Exclusion Criteria:

* Number of previous lines of therapy ≤ 2
* Karnofsky index \< 60
* Intolerance to drugs used in the study
* Presence of a second tumor
* Pregnancy or lactation
* Participation in another study within six months
* Presence of concomitant severe disease
* Presence of HIV and/or viral hepatitis (B or C)
Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery were prospectively enrolled.

Exclusion Criteria:

* History of End Stage Renal Disease or on Dialysis;
* prior kidney transplantation;
* patients with a DNR order;
* patients without written informed consent;
* pregnancy;
* moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

The main purpose of this study is to determine the distribution of 18F Fluorocholine (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient and/or guardian is able to provide written informed consent prior to study registration
* Age ≥ 21 years old
* Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology)

Exclusion Criteria:

* Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
* Pregnant or nursing female
* Unable to cooperate for PET/CT
The Relationship Between Health Literacy, Physical Activity, Back Pain and Posture Habits in University Students

This study aims to investigate the relationship between health literacy, physical activity, back pain, and posture habits among university students. The Health Literacy Scale, the International Physical Activity Questionnaire, and the Posture Habits Questionnaire for Back Health in Daily Activities will be used to collect data from participants. Health literacy will be assessed in terms of individuals' ability to access, understand, and apply health-related information, while physical activity levels and posture habits will be examined for their influence on back pain. The findings are expected to shed light on the role of health literacy in promoting healthier physical activity and posture habits, providing insights for strategies to improve back health in this population.


Eligibility Criteria:
Inclusion Criteria:

* Being a university student

Exclusion Criteria:

* Having any diagnosed physical or psychological illness