cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads

The purpose of this study is to provide proof-of-concept that directional stimulation, in an intraoperative setting, is perceivable in a subject and is different from omnidirectional stimulation. The tests will be performed using a dedicated DBS lead connected to external neurostimulator.


Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site
* For Parkinson Disease:

  * Person is between 18 and 75 years of age
  * Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years.
  * Person has a history of at least 30% improvement on the Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa)
  * Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on)
* For Essential Tremor:

  * Person is between 18 and 80 years of age
  * Established diagnosis of Essential Tremor for a minimum of 2 years
  * Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant.
* Person has given his/her written consent

Exclusion Criteria:

* Person suffering from an active major psychiatric disorder
* Mattis Dementia Rating Scale score \<130 or otherwise not capable of discernment
* Presence of major co-morbidity or medical condition that may affect participation to the study
* Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker)
* Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor
* Person with a previous brain ablation procedure
* Person who suffers from epilepsy
* Person who is pregnant: a pregnancy test will be performed in women of childbearing age
* Person with coagulopathies
* Abuse of drugs or alcohol
Evaluating Therapeutic Boundaries Among Bedside Nurses At A Pediatric Hematology/Oncology Research Hospital

Professional therapeutic boundaries are defined as the limits that protect the space between a professional's power and patient's vulnerability. It is important to develop therapeutic alliances while maintaining boundaries, thus ensuring nurses develop safe connections with patients and their families based on therapeutic needs. Due to the professional nature of nursing, boundary violations are common. For example, closeness and familiarity develops between the healthcare provider, patient, and caregiver that encompass the physical, emotional, and spiritual realms. This provides an opportunity for intense bonds with patients and families. Furthermore in oncology healthcare, providers deliver compassionate care and empathize with patients and families while sharing in the patient's illness journey. As a result of these bonds and relationships the nurse may over disclose personal information, provide excessive patient attention, meeting their own personal needs instead of the patient and family. In addition, continuity of care contributes to boundary crossings because there is frequent repeated contact with the same patients and families which allows blurring of boundary lines. When staff spend weeks, months, or even years with the same patient the opportunity to connect and talk about personal life details exist. At the national level, the National Council of State Boards of Nursing (NCSBN) has created materials for educating nurses in maintenance of therapeutic boundaries. Adherence to therapeutic boundaries has now become an education objective, with the development of educational interventions within many health care settings. Likewise, St. Jude nurses are at an increased risk of crossing therapeutic boundaries due to long term care relationships and vulnerable family members. However, nursing administration has not formally assessed the attributes or behaviors of the nursing staff. This proposal will describe the attributes and behaviors of the St. Jude staff nurse towards nurse-patient/family boundaries, providing knowledge to nursing leadership that will facilitate therapeutic boundaries focus groups with direct care nurses.

Participants will take a onetime researcher generated therapeutic boundaries questionnaire which will describe behaviors and attitudes regarding therapeutic boundaries.

The main objective of the study is to :

To describe behaviors and attitudes towards nurse-patient/family boundaries of direct patient care Registered Nurses (RNs) at St. Jude Children's Research Hospital

Eligibility Criteria:
Inclusion Criteria:

* Registered Nurse (RN)
* Employed at St. Jude Children's Research Hospital at least one year
* Employed full-time (at least 90% full-time equivalent - works at least 72 hours every two weeks).
* provides direct patient care

Exclusion Criteria:

Declines survey participation
Registry Study for Radiation Therapy Outcomes

The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Planned treatment with radiation therapy
* Ability to understand and sign IRB approved consent
A Comparative Study of High and Low Tidal Volume in Preventing Hypoxemia in Patients With Mechanical Ventilation After Cervical Spinal Cord Injury

This study in order to best tidal volume mechanical ventilation in patients with cervical spinal cord injury (sci) as the research point, through higher low volume Settings to find the difference of two groups of patients to prevent the incidence of hypoxemia, to find suitable Settings, tidal volume in patients with lower mechanical ventilation in patients with cervical spinal cord injury (sci) the incidence of pulmonary complications, live less intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* All critically ill adult patients with cervical spinal cord injury who require mechanical ventilation and informed consent to be admitted to the Department of Critical Care Medicine of Peking University Third Hospital were selected by the subjects or their close relatives to enter the clinical study.

Exclusion Criteria:

* previous chronic obstructive pulmonary disease, diagnosis of acute respiratory distress syndrome at admission, presence of pneumothorax at admission, subjects or close relatives who refused to participate in the study, and non-signed informed consent."
Ultrasonographic Diameter of Optic Nerve Sheath in Fluid Assessment in Severe Preeclamptic Patients

Changes in the optic nerve sheath diameter detected by ultrasound are considered an important manifestation of increased intracranial pressure . The normal optic nerve sheath diameter measures up to 5.0 mm and an average optic nerve sheath diameter more than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.Cerebral edema have been demonstrated in 71% to 100% of magnetic resonance imaging in preeclamptic patients and an increase in optic nerve sheath diameter has been described in preeclamptic females compared to healthy pregnant females Therefore, Increased optic nerve sheath diameter can indirectly reflect the state of intracranial edema that could be a part of generalized edema of preeclampsia and it could be a possible marker of generalized tissue edema and fluid overload in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure of 160mm Hg or higher, or diastolic blood pressure of 110mm Hg or higher on 2 occasions at least 6 hours apart on bed rest.
* Proteinuria ≥5g in a 24 hour urine specimen or ≥3+ on 2 random urine samples collected at least 4 hours apart.
* patient acceptance
* Accepted mental state of the patients

Exclusion Criteria:

* patient refusal to participate in the study
* chronic kidney disease
* chronic pulmonary disease
* chronic cardiac disease
* chronic hypertension
* previous ocular operation and diseases
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype

The aim of this interventional study is to investigate the correlation between Magnetic Resonance Phenotype and levels of FKBP51s protein pre and post surgery in adult patients affected by Glioblastoma


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of Glioblastoma with surgery criteria
* Brain MRI with contrast both pre and post surgery

Exclusion Criteria:

* No availability of radiological documentation
* Glioblastoma diagnosis not confirmed by Histological examination
* Withdrawal of ICF
The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants

This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm neonates. Each experimental and control groups consists of at least 30 participants, and only the experimental group uses cerebral NIRS and a treatment guideline.

There are still high number of preterm mortality and morbidity in Indonesia. Preterm infants are susceptible to get brain injury due to hemodynamic changes and loss of cerebral autoregulation. Some studies showed that fluctuated changes of brain blood flow caused intraventricular hemorrhage (IVH), and the decreasing of brain blood flow lead to a hypoxic- ischemic state which had role for periventricular leucomalacia (PVL) formation. These result a long term neurologic deficit outcome such as cerebral palsy and cognitive impairment. The standard measures that mainly performed in the NICU were systemic arterial oxygenation and mean arterial blood pressure. There is not yet routine procedure to measure the brain perfusion and oxygenation in Indonesia.

Cerebral Near Infrared Spectroscopy (NIRS) is an invasive tool that continuously measures brain tissue hemoglobin oxygen saturation (rStO2) and determines cerebral circulation. The mechanism of NIRS is based on the light absorption by the hemoglobin, which the value reflects the ratio of oxygenated hemoglobin concentration to total hemoglobin in the penetrated tissue.

To prevent the permanent neurological damage from hypoxia or hyperoxia events, we use cerebral NIRS combined with SafeboosC (Safeguarding the brain of our smallest children) treatment guidelines. The research programme SafeboosC phase II trial hypothesizes that the burden of hypoxia and hyperoxia can be reduced among preterm. We recruit eligible neonates who are admitted in our neonatal intensive care unit and randomly assign them into 2 groups after a written informed consent was approved by the parents. One group uses cerebral NIRS as a monitoring device and performed a treatment guideline to maintain a normal value of rStO2. The other group receives standard treatment without placement of cerebral NIRS. A routine brain ultrasonography is done in both groups to evaluate brain injury (PVL or IVH).

Significance testing is done by Chi-square or Fisher's exact test as needed.

Eligibility Criteria:
* Inclusion Criteria:

  * Neonates born in dr. Cipto Mangunkusumo Hospital and admitted in the neonatal intensive care unit
  * Gestational age ≤ 32 weeks and/or birth weight ≤ 1500grams
* Exclusion Criteria:

  * Parents refuse to participate
  * Participants who are not able to use cerebral NIRS in the first 3 hours of life
  * Participants with congenital malformation and cerebral complications during delivery
  * Participants who are diagnosed with IVH/PVL in the first 3 hours of life (confirmed with brain ultrasonography examination and assessed by radiology pediatric specialist)
The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy

To explore the effects of wheat sprouts supplements on the key health indicators of the patients with breast cancer after chemotherapy, Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy and nutritional status, immune function, quality of life were measured and evaluated. Through data analysis, we found that Maiji tablets may improve the symptoms of appetite loss, nausea and vomiting, and fatigue in patients with breast cancer during chemotherapy. Meanwhile it may help patients maintain weight, keep appetite and improve the food intake.


Eligibility Criteria:
Inclusion Criteria:

- patients diagnosed with breast cancer, receiving chemotherapy for the first time

Exclusion Criteria:

- Patients with severe liver or kidney disease or other infectious diseases
Effect of Game Activity and Stress Ball on Anxiety and Vital Signs

This randomized controlled trial aims to determine the effect of game activity and stress ball use on preoperative anxiety and vital signs in patients undergoing total knee arthroplasty. The primary purpose of the study is to evaluate the effect of these methods (game activity, stress ball use) on patients' anxiety and vital signs. The research involves three groups: one group will engage in a game activity, another group will use a stress ball, and the control group will receive no intervention. Patients over 18 years of age who pass the Mini-Cog test, demonstrate cognitive competence and meet other sampling criteria will be included in the study. Data will be collected using the State Anxiety Scale, a vital signs and pain level form, and a descriptive characteristics form.

Preoperative anxiety causes various physiological and psychological reactions. In addition, it is known that preoperative anxiety negatively affects the patient's satisfaction with the surgery, the surgical success rate, and the development of postoperative complications. Total knee arthroplasty (TKA) is a surgical procedure frequently performed today to relieve pain and restore knee joint function. Approximately 30% of patients undergoing TKA experience psychological distress before surgery. Anxiety is a problem that needs to be managed in TKA patients because it negatively affects them in the postoperative period.

Interventions such as music, funny videos, massage, meditation, hypnosis, VR glasses, and motivational interviewing have been used to reduce preoperative anxiety in adults. These methods can be applied by nurses, are low cost, and have few side effects. Gaming activities are also one of the methods used to distract patients and reduce their anxiety levels in the preoperative period. The literature shows that game-based approaches in the management of preoperative anxiety are frequently used with pediatric patients. A stress ball is a method used to draw a person's attention in a different direction by squeezing and loosening the ball held in the palm. Although the use of stress balls has not been widely studied in preoperative anxiety management, research shows that stress balls may be useful in anxiety management. Game activity and stress ball use are methods that are easy to implement and will not burden patients in terms of cost.

Eligibility Criteria:
Inclusion Criteria:

Being over 18 years old Undergoing total knee arthroplasty Having passed the Mini-Cog test Ability to understand, read, and write Turkish No hearing or speech problems Having a person accompanying the patient

Exclusion Criteria:

Not wanting to participate in the research Unstable general condition Sudden change in vital signs Having a psychological disorder and using antidepressant medication Having any psychiatric or cognitive/mental disease (e.g., dementia) Use of psychiatric medication for any reason
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.


Eligibility Criteria:
Key Inclusion Criteria:

1. Greater than or equal to 18 years of age
2. HPV associated carcinomas
3. Patients must have at least one measurable lesion defined by RECIST 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Key Exclusion Criteria:

1. Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.
2. Patients with active autoimmune diseases.
3. Patient has a known active Hepatitis B or Hepatitis C.
4. Other severe medical conditions that may limit subject\&#39;s participation in this trial.
Enteral Nutrition in Cancer Patient

CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Eligibility Criteria:
Inclusion Criteria:

* Were chemotherapy, age above one year and malnutrition. A z-score of weight for height (zW/H) \< -1.0 to -2.0 in children26 and ≥ 5th to \< 15th of body mass index (BMI) in adolescents27 were considered as mild malnutrition; and a zW/H \< -2.0 in children and \< 5th of BMI in adolescents as severe, respectively.28 In adults, the World Health Organization (WHO)29 cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition.

Exclusion Criteria:

* Were corticosteroid or hormonal therapy, swallowing abnormalities, parenteral or tube feeding therapy, palliative care and presence of non cancer-related diseases.
COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study

Fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. Growth restricted fetuses do not reach their potential due to multiple factors. Although early (\<32 weeks' gestation) FGR is associated with the highest risk of adverse outcomes, late FGR (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. Despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR (COSMOS) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset FGR observation.

All women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial. Patients will be randomly divided into two groups: CTG - a group that will receive electronic device for cCTG home assessment, and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria. Further management will depend on the arm of the study. Pregnancy and neonatal outcomes will be collected and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 years or older,
* singleton pregnancy,
* ≥32+0 and ≤36+6 weeks' of gestation,
* fluent in Polish or English,
* diagnosed with late-onset FGR based of the Delphi criteria,
* with positive EDF in UA,
* with macroscopically normal fetus on ultrasound assessment.

Exclusion Criteria:

* multiple pregnancy,
* fetal malformations,
* abnormal genetic testing results (if available),
* uncertain pregnancy dating,
* indication for immediate delivery within 48 hours after enrollment,
* preterm prelabour rupture of membranes.
Overcoming Treatment Barriers

This study aims to assess whether negative or rather the lack of positive treatment expectations could be positively influenced by online short interventions and increase intention so seek treatment and actual help-seeking behavior when compared to a no-treatment control group. Further, the study investigators like to explore if specifically focusing on intensifying positive treatment expectations vs. a reduction of expectations about negative treatment effects will influence the pattern of results differently.

The investigators expect that participants receiving an intervention e.g., amplifying positive (performance) expectancies vs. reducing negative (performance) expectancies of psychotherapeutic treatment, will show an increase in intentions to seek treatment and are more likely to report actual treatment-seeking behavior after the intervention when compared with participants who will describe their treatment expectations via a writing task.

Further, the investigators want to explore if the expectancy-modulating interventions will differently affect the intention to seek treatment within socially anxious individuals.

If participants agree, the investigators plan to assess changes in expectations, attitudes as well as actual treatment seeking behavior at a Follow-Up assessment one week later (data from Follow-Up will be analyzed exploratively and is not part of the main hypotheses).

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* fluent in German (C Level)
* access to a computer device with internet access

Exclusion Criteria:

* non correctable hearing or visual impairment
* current in psychotherapeutic treatment or on a waiting list
* no neurological impairment or psychotic disorders
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).

Eligibility Criteria:
Inclusion Criteria:

* squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
* Stage III - IV (T1-T4, N0-N2)(UICC 2002)
* Not resected
* Indication of radiotherapy to bilateral cervical nodes at dose\>= 50 Gy
* Delineation of target volumes done before randomization
* Scintigraphy of parotid gland done before radiotherapy start
* Quality of life questionnaires (EORTC-C30 and EORTC-H\&N35) filled in by the patient
* Informed consent signed

Exclusion Criteria:

* N3 (UICC 2002)
* Distant metastasis
* Contra-indication to concomitant cisplatin
* History of cancer within the last 5 years
* History of head and neck radiotherapy
* Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)