cyrilzakka/clinical-trials huggingface dataset:
Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

The purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years of age
* meet criteria for amnestic-Mild Cognitive Impairment (MCI)
* have capacity to give informed consent
* have capacity to complete assessment measures

Exclusion Criteria:

* history of drug or alcohol dependence
* severe psychiatric conditions associated with psychosis (e.g., schizophrenia)
* recent stroke
* clinical diagnosis of probable Alzheimer's Disease
* history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., Parkinson's Disease, Korsakoff's, HIV)
* current use of Alzheimer's Disease medications (e.g., cholinesterase inhibitors, memantine)
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults

There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient elects to undergo laser-assisted tattoo removal

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
* Patient has participated in any previous clinical trial involving S-Caine Peel
A Study of Sotorasib in People With Brain Tumors

The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy
* Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy
* For all cohorts: no limit on prior CNS radiation or systemic therapyKPS ≥ 60
* Life expectancy \>12 weeks
* Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator
* Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):

  * Absolute neutrophil count (ANC) ≥1.0 × 10\^3/μL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)
  * Platelet count ≥10.0x10\^4/μL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x10\^4/μL are not eligible. (Platelet transfusion is not allowed within 1 week prior to C1D1)
  * Hemoglobin ≥ 7.0 g/dL (≥ 8 g/dL in gastric cancer / gastroesophageal cancer indications). Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible (Red blood cell transfusion is not allowed within 1 week prior to C1D1)
  * Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation
  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (\<5x ULN in participants with liver metastases)
  * Total bilirubin ≤1.5 × ULN) if no liver metastases or \<3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline

Exclusion Criteria:

* Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the Principal Investigator; reactions will be managed per standard institutional protocol
* Multiple primary malignancies within 3 years, with the exception of:

  * adequately resected non-melanoma skin cancer
  * carcinoma in situ of the cervix
  * Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider
  * curatively treated in-situ disease
  * other solid tumors curatively treated
  * for patients with metastatic breast cancer: contralateral breast cancer
Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters that are used by patients with a neurogenic bladder on daily clean intermittent catheterization. The device has already been demonstrated to be accurate compared to the gold standard in clinic urodynamics. This study will assess the patients and care givers ability and experience using the device in a home setting.

For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions.

This study utilizes a novel pressure monitoring device which is portable and attaches to the end of a standard urinary catheter. The investigators will be investigating if this device can be used by patients or their caregivers in a home setting.

This study will enroll patients with neurogenic bladder that currently perform clean intermittent catheterization on a daily basis as part of their regular care. The patients will be asked to use the device at least twice a day for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* must have diagnosed neurogenic bladder

Exclusion Criteria:

* None
Artificial Intelligent Accelerates the Learning Curve for Mastering Contrast-enhanced Ultrasound of Thyroid Nodules

The goal of this observational study is to learn about the learning curve for mastering the thyroid imaging reporting and data system of contrast-enhanced ultrasound with the assistance of artificial intelligence in patients with thyroid nodules. The main questions it aims to answer are:

1. Can we develop a artificial intelligent software to assist doctors in the diagnosis of thyroid nodules using contrast-enhanced ultrasound?
2. Can artificial intelligent reduce the number of cases and time for doctors to master the contrast-enhanced ultrasound diagnosis of thyroid nodules?

Participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. Researchers will compare the number of cases and time for doctors with and without artificial intelligent assistance to master the contrast-enhanced ultrasound diagnosis of thyroid nodules to see if artificial intelligent reduce the number of cases and time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound;
* Patients who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy;
* Patients with a final benign or malignant pathological results.

Exclusion Criteria:

* Patients with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology；
* Patients with a history of thyroid ablation or surgery;
* Patients with low-quality ultrasound images.
Ventilator-Associated Events: Prevalence, Outcome and Preventability

The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. The preventability of VAE will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope VAE.

This is a retrospective analysis of prospectively collected data, approved by the Research Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.

Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days.

At admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure.

Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable followed definition criteria of the National Healthcare Safety Network / Center for Disease Control and Prevention.

The percentage of adherence to the bundle of preventive measures of VAE prevention was registered.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.

Exclusion Criteria:

* Patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 days.
Assessment of Diagonal Branch Territory

This study was performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).

Bifurcation lesion is one of the most challenging lesion subsets in the field of percutaneous coronary intervention (PCI). Despite the recent advances in PCI techniques and stent technology, most randomized studies failed to prove the superiority of systematic 2 stenting strategy compared with provisional side branch intervention strategy.

A certain amount of ischemic burden is required to achieve the benefit of revascularization over medical treatment. Compared with major epicardial vessels, side branches are smaller, more variable in anatomy, supplying less myocardium and less clinically relevant. Therefore, it is important to assess the myocardial mass at risk of side branches to determine the appropriate treatment strategy for bifurcation lesions. However, how to define the clinically relevant side branches which can be associated with the benefit of revascularization in a cardiac catheterization laboratory is not well-known.

The investigators performed this study to investigate the anatomical attributes that determine ischemic burden and myocardial territory of diagonal branches and to develop a prediction model for a clinically relevant diagonal branch using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe jailed diagonal branch disease with available MPI in 3 months (MPI arm)
* Patients who had available FMM value of diagonal branches from a previous multicenter prospective CCTA registry (CCTA arm)

Exclusion Criteria:

* Patients with \>50% stenosis at left anterior descending coronary artery (LAD) or left circumflex artery (LCx), regional wall motion abnormality at LAD territory (MPI arm)
* Patients with diffuse diagonal branch disease (CCTA arm)
The Effect of Virtual Reality on Motor Functioning and Participation Abilities Among Children With DCD

The subjet of this study is to explore the effect of using virtual reality environment at the clinic and at home (using Timocco) on the motor and participation abilities of children with DCD (Developmental Coordination Disorder).

The study will examine the efficacy of using virtual reality gaming environment (Timocco) for treating children with DCD and the use of remote therapy, by shifting the focus of therapy from the clinic to the home environment, using the remote control system of Timocco for home practice.

The efficacy of using VR (Virtual Reality) as a therapeutic tool as an integral part of Occupational Therapy intervention will be examined in this study. The study will be conducted in two stages: the first will be conducted at the Child Development Center of the Clalit HMO (Health Maintenance Organization), and the second will take place in the child's home.

The first intervention will take approximately 8 to 10 weeks, during which eight data collection sessions will be conducted, each of 45 minutes duration.

The study group will integrate the use of Timocco in occupational therapy sessions while the control group will be given conventional occupational therapy without using Timocco.

In the second intervention, the study group will be given access to the virtual-reality environment of Timocco to be used at home, and will not include therapy sessions at the Child Development Center. An assessment before and after intervention will be held for both groups for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Children,
* native Hebrew speakers, between the ages of 4 and 6 diagnosed with DCD.

Exclusion Criteria:

* Children with complicated special needs (e.g., limited cognitive abilities, CP, ASD),
* children who received occupational or physical therapy interventions in the last 12 months.
Intermediate Dose of IV MTX as CNS Prophylaxis for High Risk DLBCL

Central nervous system (CNS) relapse is a devastating event of diffuse large B cell lymphoma (DLBCL). It occurs in 4%-7% of DLBCL in general and the rate is considerably higher in high-risk patients, resulting in a poor outcome.Effective methods of CNS prophylaxis have not yet been developed. Evidence for intrathecal or intravenous MTX are both controversial. In one previous study of PUMCH, IV MTX at a dose of 1g/m2 could significantly decrease the 2 year CNS relapse rate of high risk DLBCL(1.1% vs 12.1% for historic cohort, P=0.003). In current study, the investigators are aiming to confirm its efficacy through phase III study with intrathecal MTX as the controlled arm.

In this prospective, phase III, multicenter, randomized, controlled study, the investigatirs aim to compare the efficacy of intravenous MTX(IV arm) at a dose of 1g/m2 with intrathecal MTX(IT arm) in terms of preventing CNS relapse. All the patients will recieve RCHOP regimen as front-line treatment of DLBCL. Patients in IV arm will recieve 4 course of IV MTX, which is incorporated into the RCHOP, naming R-MTX-CHOP regimen. Patients in IT arm will be given intrathecal MTX for 4 courses (one time for each course). 2 year CNS relapse rate is the primary endpoint while 2 year PFS, 2 year OS and safety are the secondary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* with high CNS risk, which was defined as involvement of more than one extranodal site, or involvement of particular extranodal sites such as bone marrow, breasts, testes, paranasal sinuses, epidural space, adrenal glands, kidney and female genital system;
* first-line treatment planned to be RCHOP
* absence of CNS involvement at presentation

Exclusion Criteria:

* primary CNS lymphoma
* already have CNS involvement at diagnosis
* primary mediastinal lymphoma, intravascular large B-cell lymphoma, DLBCL leg-type, Burkitt lymphoma, high-grade lymphomas, double expressor lymphoma
* with active infection or other malignancy
* severe liver or kidney insufficiency
* allergy to any medication we plan to use
Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Rucotinib is an oral inhibitor of JAK1 and JAK2 tyrosine kinases. It may benefit some patients with NMOSD due to the important role of JAK/STAT signaling pathway in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

Male or female patients ≥ 18 years old; Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic; Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months; EDSS \<= 6.0; Rituximab should be used for at least 3 months if the condition is stable; Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc); Participation in another interventional trial within the last 3 months; Patients taking oral immunosuppressants such as azathioprine; Tumor disease currently or within last 5 years; Pregnant, breastfeeding, or child-bearing potential during the course of the study; Clinically relevant anemia, thrombocytopenia and dysfunction of the heart, liver, kidney or bone marrow.
Salbutamol, Pharmacogenetics and Breathing Mechanics

Athletes using asthma medications called β2-agonists win a disproportionately high number of medals at Olympic Games. Due to a large variety in the genes that affect how individuals respond to β2-agonists, the investigators will look at variations in the genetic response to these medications by dividing athletes into high-responders and low-responders. The investigators will then compare athletic performance after the inhalation of β2-agonists to placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing mechanics. Due to differences in their anatomy females may decrease the energy needed for breathing during high-intensity exercise to a greater extent compared to male athletes after the inhalation of β2-agonists.


Eligibility Criteria:
Inclusion Criteria:

* trained, experienced cyclists
* maximal oxygen consumption of at least 50ml/kg/min or 4l/min for women; and 60ml/kg/min or 5l/min for men
* athletes with and without exercise-induced bronchoconstriction

Exclusion Criteria:

* any uncontrolled heart or lung condition
* maximal oxygen consumption of less than 50ml/kg/min or 4L/min for women; and less than 60ml/kg/min or 5L/min for men
* pregnancy
* smoking
Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception

This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).

Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.

The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.


Eligibility Criteria:
Inclusion Criteria:

1. Non-pregnant, healthy females who are seeking an IUD for contraception
2. Age 18-40 years, inclusive at the time of enrollment
3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
4. Willing and able to sign the informed consent and to comply with the study protocol

Inclusion criteria for healthy control subjects:

1. Non-pregnant, healthy females
2. Age 18-40 years, inclusive at the time of enrollment
3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
4. Willing and able to sign the informed consent and to comply with the study protocol
5. Prior surgical sterilization or heterosexually abstinent

Exclusion Criteria:

1. Use of any hormonal or intrauterine contraceptive method within the past two months
2. Use of DMPA within the past 10 months
3. Any of the following within the past two months:

   * Pregnancy or breastfeeding
   * Surgery/biopsy of the vulva, vagina, or cervix
   * History of STI
   * New sexual partner
4. Evidence of vaginal/pelvic infection on screening

   * Abnormal wet mount (see description above)
   * Pelvic exam findings clinically consistent with infection
   * Positive screen for Gc, Ct, or HIV (will be excluded post randomization)
5. Active HSV/ulcerative disease in the genital tract or perineum
6. History of immunosuppression (diabetes, HIV, chronic steroid use)
7. Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
8. Use of any systemic or vaginal steroid or antibiotic within the past 30 days
9. Vaginal or anal intercourse within 1 week of sample collection
10. Heterosexual vaginal intercourse since last menses without condom use
11. History of hysterectomy
12. History of malignancy in the uterus or cervix
13. Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
14. Allergy to copper and/or intolerance to levonorgestrel
An Integrated and Personalized Lifestyle Approach for People with Parkinson's Disease

The goal of this study is to investigate the effects of a combined lifestyle program on the quality of life in people with Parkinson's Disease.

Participants will be randomly assigned to one of two groups, both receiving standard care, a Parkinson Lifestyle Decision aid and an intake meeting with a lifestyle coach. One group will work on their goals independently, while the other group will get guidance from the lifestyle coach throughout the 12-month program. The program focuses on self-management, exercise, nutrition, sleep and stress.

Participants will complete questionnaires after 0, 6 and 12 months, and use a wearable sensor for two weeks. The main outcome is quality of life over 12 months, measured with the PDQ-39 questionnaire. The study also examines personal goal achievements, symptom changes, and the economic effects of the program.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease (idiopathic) in all stages of severity
* Proficient in Dutch, for both the data collection (questionnaires) and the intervention (all of the apps/modules are in Dutch)
* Aged 18 or older

Exclusion Criteria:

* Cognitive impairments that do not allow to fill out the questionnaires, as judged by the researcher during the screening call.
* Not in possession of or no access to an electronic device that allows for (video) calls with a lifestyle coach, and to complete questionnaires.
* Planned surgery or a planned major change in healthcare provision.