cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

This multicentre proof-of-concept study, involving 4 centers, aims to establish the value of fractionated neoadjuvant stereotactic radiotherapy (NaSRT) as a new treatment paradigm for brain metastases (BM) in the frame of the Czech neurooncology network. Most relevant studies published to date used single-fraction radiotherapy and dealt with the inherent bias related to their retrospective nature. The researchers aim to increase the level of evidence for this treatment paradigm together with other similar ongoing studies.

The prospective study will evaluate the efficacy and toxicity of neoadjuvant stereotactic radiotherapy (NaSRT) in patients with brain metastases (BM). Clinical data gathered will include local control (LC), the incidence of leptomeningeal disease (LMD), radiological and clinical signs of radiation necrosis (RN), overall survival, and incidence of metachronous brain metastases. The magnetic resonance imaging (MRI) characteristics of irradiated and subsequently resected BM will be obtained according to the usual protocol and specified time intervals. Clinical monitoring will comprise neurological findings, Karnofsky performance status, and quality of life (FACT-Br/EORTC QLQ-C30 questionnaire and EORTC QLQ-BN20 questionnaire. These questionnaires are designed to measure cancer patients' physical, psychological, and social functions. The questionnaires are composed of multi-item scales and single items). The data obtained from the retrospective control group (estimated for 160 patients) will include the same parameters monitored in the consecutive group of patients who underwent surgery at centers included in our study, with or without adjuvant radiotherapy (RT). Formation of this control group corresponding to the NaSRT group will enable the efficacy and risks of NaSRT to be determined in comparison with established treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Karnofsky Performance Status ≥ 60
* Histologically verified primary cancer disease
* MRI findings indicating BM
* Target BM indicated for surgical resection and any other metastases suitable for radical SRT.
* Target BM between 1 cm and 7 cm at the longest diameter on T1 post-contrast MR imaging

Exclusion Criteria:

* Confirmed hematological malignity
* Small-cell (lung) carcinoma
* Peracute condition requiring immediate neurosurgical intervention
* History of whole-brain radiotherapy (WBRT)
* History of stereotactic radiotherapy to a target brain metastasis
* Pregnancy
* Inability to perform surgical resection of the target BM within 7 days after NaSRT
Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes.

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes. Pregnant women undergoing specialized fetal anatomic ultrasound surveys at Women and Infants' maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate. Volunteers will be randomized to receive either standard education about prenatal genetic testing or standard education plus additional education about federal genetic privacy protections. Next, the participants view the educational materials to which they were randomized. Finally, all volunteers will take the same survey, which will assess baseline demographic variables as well as their knowledge of and attitudes toward broad sharing of data obtained from prenatal genetic testing. Once finished with the survey, volunteers will have completed their participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients undergoing a scheduled L2 ultrasound at the Women and Infants Prenatal Diagnosis Center (PDC)
* Singleton pregnancies
* English speaking
* Results available from cell-free DNA screening for this pregnancy

Exclusion Criteria:

* Prior L2 ultrasound at the PDC during the current pregnancy (to avoid test-retest or multiple approach)
* Prior participation in this study
* Gestational age \<17'0 weeks or \>23'6 weeks
* Suboptimally dated pregnancies (i.e. dated by ultrasound after 22 weeks gestation)
* Unscheduled / add-on L2 ultrasounds
Alpha-s1 Casein Hydrolysate on Sleep

This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysomnography (PSG) recordings.

During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.

Eligibility Criteria:
Inclusion Criteria:

1. age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
2. PSQI score greater than 5;
3. participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.

Exclusion Criteria:

1. currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
2. patients with a history of significant head trauma;
3. individuals with alcohol abuse within the past year;
4. those with other severe medical conditions (e.g., hepatic or renal dysfunction);
5. Pregnant women or breastfeeding mothers;
6. participants unable to comply with the trial schedule;
7. individuals on a vegetarian diet;
8. those with allergies to dairy products.
Evaluation of an Online Mindfulness-based Course for New Mothers

This research study is aiming to explore whether an online mindfulness programme is accessible and supportive for first time mothers who has a child who is less than 12 months old.

This study is a randomised controlled trial (RCT) comparing an online mindfulness based course (10ofZen) with a treatment as usual group (delayed 10ofZen course materials). Participants will be informed about the study and asked to undertake a screening questionnaire to ensure the eligibility criteria is met. Following this, participants will be invited to give online consent. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 10) and at follow-up (week 14). A sleep measure will also be undertaken and used as a co-variate during data analysis. At the end of participation in the research study, all participants will gain access to the course materials, including audio recordings of meditations and any written materials used within the course.

Eligibility Criteria:
Inclusion Criteria:

* Women who identify as a mother (Biological, adoptive, foster-carer or step-mum)
* Have an infant under the age of 12 months at baseline measures
* Sufficient English reading and listening abilities
* Access to the internet via an electronic device (phone, tablet, laptop or computer)
* Access to a mobile phone
* No prior experience of parenting a baby (under 12 months of age)

Exclusion Criteria:

* Previous completion of a formal 8-week mindfulness course or current mindfulness/meditation practice
* Currently pregnant
* Severe levels of depression and/or anxiety as measured by 15+ point on the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9 (NICE, 2011).
* Suicidal ideation or thoughts of self-harm in the last two weeks
* Currently experiencing symptoms of psychosis
* Diagnosis of Post Traumatic Stress Disorder (PTSD)
* Bereavement within the last six months which they still feel affected by.
Postoperative Pain After the Use of Different Root Canal Sealers

This study evaluated the postoperative pain after the endodontic treatment using AH Plus, Endoseal MTA and EndoSequence BC sealers in root canal obturation.


Eligibility Criteria:
Inclusion Criteria:

* Participants between 18 - 60 years of age,
* Good oral hygiene,
* Have not taken any analgesics in the last day,
* Have not taken antibiotics in the last week,
* Patients diagnosed with asymptomatic irreversible pulpitis caused by deep carious lesion on the mandibular first or second molar teeth.
* A prolonged positive response to cold vitality tests,
* The presence of pulp, which is exposed during caries removing and bleeding with a dense and thick consistency.
* The periapical region was healthy in radiographic diagnosis.

Exclusion Criteria:

* Devital teeth that have no response to pulp test,
* The presence of advanced periodontal disease,
* Having a systemic disease that requires antibiotic prophylaxis,
* Radiographically more than 30° root inclination, presence of clear apex, presence of calcification, presence of root resorption,
* The need for root canal treatment which is mesial and/or distal neighbour of the tooth to be treated,
* The presence of a sinus tract in the relevant tooth region,
* Having systemic diseases that reduce immune system resistance,
* Participants with allergic sensitivity to materials and agents that should be used during the root canal treatment,
* Allergic sensitivity to local anesthetics,
* Pregnant participants or participants in the lactation period,
* Over preparation or over filling during treatment,
* Teeth which cannot be applied a rubber-dam,
* Teeth which was damaged enough to require coronal fiber post application,
* Sensitive to Ibuprofen based analgesics.
An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies

This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Adult 18 to 75 years old at screening
2. Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology

   Part A (Dose Escalation)
   1. that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved
   2. or for which standard or curative therapy is not available

   Part B (Dose Expansion)
   1. metastatic cutaneous melanoma
   2. PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma)
   3. metastatic renal cell carcinoma
3. Protocol-defined measurable disease
4. Available tumor biopsy representative of current disease
5. ECOG performance status grade 0-2
6. Life expectancy of ≥ 3 months
7. Recovery to ≤ Grade 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of ALPN-202 (except alopecia, hearing loss, ≤ Grade 2 neuropathy or endocrinopathy managed with replacement therapy)
8. Adequate baseline hematologic, renal, and hepatic function

Key Exclusion Criteria:

1. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
2. Active or prior pneumonitis or interstitial lung disease
3. Presence of any active central nervous system metastases
4. Prior organ allograft or allogeneic hematopoietic stem cell transplantation
5. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
6. Receipt of any protocol-restricted therapy within the timeframes indicated:

   1. PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days)
   2. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks
   3. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks
7. Any active, known, or suspected autoimmune disease
8. Systemic treatment with corticosteroids (\> 10 mg/day prednisone) or other immunosuppressive medication
9. Any second malignancy active within the previous 3 years
10. Active infection requiring therapy at the time of the first dose of ALPN-202.
11. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.
12. Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.
13. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.
Collecting Real-life Data for the Updated TENA SmartCare Change Indicator.

This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.

The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the updated TENA SmartCare Change Indicator. The collected data will be used to assess and develop the device related algorithms. These algorithms have been tested in a laboratory setting but real-life measurement data are to be collected to the aid in further product development.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide informed consent to participate or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the resident.
* Be 18 years of age of older.
* Be cared for at the investigation site.
* Suffer from urinary incontinence.
* Be current user of TENA Slip, Flex, Pants or Comfort incontinence products or during the course of the study be willing to become user of TENA Slip Flex, Pants or Comfort incontinence products.
* If applicable, be on a stable regimen of medications for urinary incontinence.

Exclusion Criteria:

* Have frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
* Have severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss \& infection).
* Have any type of indwelling or external urinary catheter(s).
* Be anuric.
* Be of childbearing potential as determined by the investigator.
* Be managed using another automated or digital health technology incontinence management device.
* Have responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
* Have any other condition that makes participation in the clinical investigation
* Have a life expectancy of less than 90 days or be in receipt of palliative/terminal care.
* Have participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
* Be dependent on either alcohol or recreational drugs.
The Effect of L-lysine on Human Gastrointestinal Secretion: A Dose-finding Study Applying Magnetic Resonance Imaging (MRI)

This is a pilot dose-finding study, which is performed with a randomized, double-blind, 3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized sequence on three different study days in six healthy volunteers. Each study day involves the repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals. Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma concentration and samples of arterialized blood from ear lobe to measure glucose blood concentration will be collected


Eligibility Criteria:
Inclusion criteria: \> 18, \< 50 years Healthy BMI \> 19, \<24

Exclusion criteria: Age under 18 or above 50

* Pathologic underweight or overweight (BMI \<19 or \>24 (kg/m2))
* Previous gastrointestinal, cardio-respiratory (incl. arterial hypertension), hematologic (anaemia), renal, hepatic, atopic, alimentary disease, psychiatric disease, epilepsy, panic attacks, diabetes drug or alcohol abuse, lysinuria, galactosaemia
* Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Incretin-mimetics, non-steroidal anti-inflammatory drugs, Macrolidantibiotica
* Subjects unable to stop medication within 48 prior the study begins that alters serotonin blood profiles , including paracetamol, cumarine, mephenesin, phenobarbital, acetanilide, ephedrine, amphetamine, phentolamin, phenacetin, methocarbamol, acetylsalicylic acid, levodopa, promethazine, isoniazid, methenamine, streptozocin, chlorpromazine
* Positive helicobacter pylori test
* Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
* Presence of metallic implants, devices or metallic foreign bodies
* Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
* Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
* Mental capacity (DSM IV, inter alia Claustrophobia), which limits the capability to fulfill the demands of the study
* Known allergy or intolerance against capsaicin, locus bean gum, L-lysine, DOTAREM®, Fructose, Gluten, Galactose Known allergic reaction after prior injection of lidocaine (e.g. at the dentist )
* Known allergic reaction toward methylparaben (E218)
Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion

We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line.

The purpose of this study is to examine the incremental benefit of a innovative, robust, intuitive and portable, virtual reality(VR) imaging platform capable of displaying a tracked virtual needle tip with path trajectory along with the real time ultrasound(US) image of an internal jugular vein compared to US imaging of the internal jugular vein alone to reduce the complications associated with insertion of central lines.

The studies primary outcome is the difference in time to insert a central line, from needle insertion to placement and confirmation of the wire in the internal jugular vein, compared to standard insertions using ultrasound guidance alone. Secondary outcomes will include the number of needle withdrawals, the incidence of carotid puncture and the incidence of pneumothorax. Finally, a subjective VAS rating of 1 to 10 for ease of insertion will be collected from participating anesthesiologists.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Require a central line inserted in the left jugular vein
* Undergoing surgery

Exclusion Criteria:

* Contraindication to left jugular vein insertion (absent vein, infection at site)
* Permanent or temporary pacemaker
* Emergency surgery
Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is one of the most common chronic childhood inflammatory diseases that is characterized by permanent joint inflammation attributable to immune system disturbance.

Therapeutic exercises play an essential role as a non-pharmacologic treatment for children with JIA. It has effectively been used to reduce pain, improve muscular function, increase physical activity and promote quality of life in children with chronic musculoskeletal disorders. Clinical Pilates exercise is usually perceived as enjoyable activity by children with JIA, thereby, it can help them be more active for extended periods without causing discomfort while also allowing them to control their breathing and avoid becoming fatigued.

Eligibility Criteria:
Inclusion Criteria:

* Polyarticular JIA per the International League of Associations for Rheumatology classification.
* Age ranges from 10 to14 years.
* Stable medical treatment.

Exclusion Criteria:

* If they had contractures.
* Congenital anomalies.
* History of surgery.
* History of systemic disease
* Cardiorespiratory co-morbidity.
* Participation in regular exercises or sports activity.
Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SNM
* Age 9 to 25 years
* Male and female gender
* Preoperative Cobb \> 45° COBB
* Preoperative pelvic obliquity \> 10°
* Extent of scoliotic curve (expressed in COBB degrees) on supine whole spine X-ray

  ≤ 25% compared with magnitude of curve assessed on into spinal X-rays from supine sitting.
* Loss of walking ability
* Absence of emergency criteria for spinal surgery

Exclusion Criteria:

* Scoliosis with etiology other than SNM
* Pre-operative Cobb \< 45° COBB
* Preoperative pelvic obliquity \< 10°
* High anesthesiologic risk for severe respiratory deficit
* Criteria for surgical urgency
* Preserved ambulatory capacity
* Patients who did not perform follow-up at the Rizzoli Orthopaedic Institute;
* Patients whose parents/guardians have denied consent for access to their own medical records.
* Language barrier