cyrilzakka/clinical-trials huggingface dataset:
Human Single Neuron Recordings in Epilepsy Patients

This study uses single neuron recordings in pre-surgical epilepsy patients to uncover the neural mechanisms underlying memory formation and retrieval. A secondary aim is to improve diagnostic tools to identify epileptogenic tissue.


Eligibility Criteria:
Inclusion Criteria:

* Interest in participation.
* Temporal lobe epilepsy that is clinically being investigated with implantations of depth electrodes as part of the pre-surgical epilepsy monitoring.
* Cognitive/language skills sufficient to follow experimental instruction and maintain focus on the experiment.

Exclusion Criteria:

* Patient does not want to participate.
* Extra-temporal epilepsy, or electrode implantation strategy that does not allow the use of micro-macrowire electrodes.
* Cognitive/language skills insufficient to follow experimental instruction and maintain focus on the experiment.
Direct Molecular Characterization of Bacteria From ICU and From the REHAB

Investigators aim to directly investigate the molecular properties of bacteria from tracheal and urinary samples routinely taken in intensive care units (ICU) patients.

Investigators goal is to determine major bacterial activities and properties in the infected patient as a basis for more targeted, efficient antimicrobial discovery. Investigators will determine the abundance of dozens to hundreds of pathogen proteins in the samples and in in vitro cultures of the same pathogen strains using cutting-edge ultra-sensitive proteomics approaches (Parallel reaction Monitoring (PRM), Sequential Windowed Acquisition of All Theoretical Fragment Ion Mass Spectra (SWATH-MS). Data will be analyzed using dedicated mass spectrometry and proteomics packages using parametric and non-parametric statistics (false discovery rate determination based on decoy databases; t-tests of log-transformed abundance data with Benjamin-Hochberg corrections for multiple testing, normal distribution of the data will be evaluated by Kolmogorov-Smirnov test).

Based on experience from in vitro and animal infection experiments, a sample size of 10 can reveal 2fold differences in protein abundance among 500 top proteins at a significance of α = 0.05 and a power of β = 0.8 (after correction for multiple testing). However, it is possible that human patient samples have higher variance compared to animal infection models. Investigators will thus use a sequential statistics approach in which they continuously adjust sample size estimates based on the variance of the accumulating data. It may be possible that no sufficient sample sizes for all bacterial pathogens of interest will be reached within two years.

Eligibility Criteria:
Inclusion Criteria:

* confirmed infection of lung or urine by one or several members of a defined set of bacterial pathogens (Pseudomonas aeruginosa, E. coli, Klebsiella spp., Serratia marcescens, Enterobacter spp., Acinetobacter baumannii, Staphylococcus aureus, Streptococcus pneumonia

Exclusion Criteria:

* Proof of a refusal to the general research consent
* No detected bacteria
Application of Miglustat in Patients With Niemann-Pick Type C

To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type C patients.

Patients with Niemann-Pick C disease will be treated with Miglutat 200mg tid. Neurologic evaluation and safety will be monitored periodically.

Eligibility Criteria:
Inclusion Criteria:

* Confirm diagnosis of Niemann-Pick C disease
* Symptomatic including motor or mental symptoms

Exclusion Criteria:

* Unknown severe diarrhea for more than 7 day
* Allergy to miglustat
D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal Fibrosis

The goal of this observational study is to gain deeper insights into human macrophages and vitamin D, and their interplay, within Idiopathic Pulmonary Fibrosis (IPF).

The overall questions, it aims to answer, are the following:

Do IPF patients suffer from systemic and local (pulmonary) insufficient levels of vitamin D? Do IPF patients suffer from pro-fibrotic and pro-inflammatory pulmonary macrophages?


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of IPF, non-IPF ILD or lung cancer
* A signed informed consent

Exclusion Criteria:

* Do not speak Danish/Do not understand Danish
PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization.

Protein tyrosine phosphatase 1B (PTP1B) is a negative regulator of insulin signaling pathways involved in atherosclerosis. It has been shown that myeloid PTP1B deficiency protects against atherosclerosis.

As hypoxia has also been shown to increase PTP1B expression and activity, this study will evaluate the myeloid PTP1B expression and activity in patients with OSA as compared to controls and will investigate myeloid PTP1B involvement in the vascular pro inflammatory precess described in OSA.


Eligibility Criteria:
Inclusion Criteria:

* Overnight polysomnographic recording for suspected OSA
* Apnea hypopnea index ≥ 15 per hour for OSA patients
* Apnea hypopnea index \< 15 per hour for non OSA patients

Exclusion Criteria:

* past history of cardiovascular diseases
* diabetes
* dyslipidemia
* hypertension
* obesity (body mass index \> 35 kg/m2
* past history or ongoing inflammatory diseases
* cognition impairment
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* By Age
A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes (NeoEpitope)

Feasibility study for a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for these tumor neo-antigens in their lymph nodes


Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years Patient with HR+ , HER2- and node-positive (proven by cytology) invasive ductal carcinoma breast cancer, grade (SBR) II or III, and having an axillary dissection programmed, Or patient having cutaneous melanoma scheduled for a lymph node dissection at the Institut Curie including dissection of the lymph nodes draining the tumor, Voluntary having signed and dated written informed consents prior to any specific study procedure,

Exclusion Criteria:

Patients treated for a breast cancer who received neoadjuvant chemotherapy Patients treated for breast cancer with distant metastases (M+)• Only for patients with breast cancer: oral or systemic corticosteroids treatment received within 30 days prior surgery Patients on immunosuppressive treatment or diagnosed of an immunodeficiency Patients with known chronic viral infection as HIV1 or 2, HBV, HCV Patients with other cancer diagnosed within 5 years (except squamous cell cutaneous carcinomas) Patients without a French social security Patients deprived of liberty or placed under the authority of a tutor
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients

The main purpose of this study is to determine the degree to which Mindfulness-Based Stress Reduction, a group-based psychological therapy that includes mindfulness meditation exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with daily life among adult chronic pain patients.

The second purpose is to examine the role of attention in improving psychological and physical health for chronic pain patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult chronic pain patients who are proficient in English
* Capable of interacting with others in a group setting
* Capable of working with a computer

Exclusion Criteria:

* Alcohol or drug abuse (past history is acceptable as long as their situation has been stable for at least 3 months)
* Psychiatric psychosis (patients who have a past history of schizophrenia are eligible as long as they are currently stable)
* Current major depressive disorder
* Current severe social phobia
* At immediate risk for suicide
* Cerebral lesions or tumors (unless medically and cognitively stable)
* Neurological disease
* Medically unstable
* Cognitively unstable
* Previously participated in a mindfulness meditation program
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress

The aim of this study is to test the effects of a digital meditation intervention in a sample UCSF employees who report mild to moderate stress. We will randomize UCSF employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

The aim of this study is to test the effects of a digital meditation intervention in a sample UCSF employees who report moderate to high stress. We will randomize UCSF employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All study participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone).

Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 2000 participants (1000 per condition).

Eligibility Criteria:
Inclusion Criteria:

You may join if you:

* Have access to a smartphone or computer every day
* Are fluent in English
* Are a UCSF employee
* Report mild to moderate levels of stress
* Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent
* Are at least 18 years of age

Exclusion Criteria:

• You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

Rationale:

Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
* Participants must be 18 to 55 years old (inclusive) at the time of signing the ICF.
* Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive).

Exclusion Criteria:

* Have a history of relevant drug and/or food allergies.
* Known or suspected clinically relevant drug hypersensitivity to golimumab, AVT05, or any of its constituents, which in the opinion of the PI, contraindicates the participant's participation.
* Have any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (eg, malignancies or demyelinating disorders).
* Previous exposure to other TNF-α inhibitors including golimumab.
The Effect of Simulation in Gaining Skills to Nursing Students

This research is a randomized controlled study conducted to examine the effect of standard patient simulation training in providing nursing students with the ability to care for individuals with dementia.

The population of the research consisted of 100 students who were enrolled in the Nursing Faculty and took the "Psychiatric Nursing" course in 2020-2021 academic year. 84 students who were in the universe and completed the pre-test were randomly assigned to the experimental groups that received simulation training and the control groups that did not receive simulation training. The study was completed with 36 students in the experimental group and 35 students in the control group. Research data were collected with "Personal Coding System and Scale Cover Document", "Structured Student Information Form", "Dementia Information Test", "Case Study Form for Individuals Diagnosed with Dementia", "Standardized Mini Mental Examination", "Communication Skills Evaluation Form", Nursing Diagnosis Detection Skill Form" and "Modified-Simulation Effectiveness Tool".


Eligibility Criteria:
Inclusion Criteria:

* Registered in Hamidiye Faculty of Nursing,
* Taking a psychiatric nursing course in the spring semester of the 2020-2021 academic year,
* Do not have a communication problem at a level that prevents meeting,
* Students who volunteered to participate in the study were included in the study.

Exclusion Criteria:

* Not registered in Hamidiye Nursing Faculty,
* Those who did not take a psychiatric nursing course in the spring semester of the 2020-2021 academic year,
* Having a communication problem at a level that prevents meeting,
* Students who did not volunteer to participate in the study were excluded from the study.
Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

This is a prospective observational study done to know the etiology and outcomes of Acute Respiratory Distress Syndrome.

The study will be a prospective observational study and 64 patients with ARDS will be recruited . Written informed consent will be taken prior to inclusion of study. Study will be conducted in Medical ICU (C2 ICU) of AIIMS. Based on medical history and physical examination, radiology, biochemical and microbiological investigations etiology of ARDS will be decided.Sample will be taken at te eime of admission for estimation of inflammatory markers hsCRP,IL-1.IL-6,TNF ,Procalcitonin.From the available variables APACHE II, Sequential organ failure assessment score (SOFA), Simplified acute physiological score (SAPS)II and 3 will be calculated to assess the severity of ARDS.All patients will be given mechanical ventilation using the protocol followed by the ARDS Network low-tidal volume ventilation strategy.The data will be registered on ICU admission and there after every 24 hr. Day 0 will be defined as the interval from the time of ICU admission to 8:00 am the next day .Every day data will be recorded at a fixed time at 9 am. It will include Tidal volume Vt (ml/kg),respiratory rate/min, Minute ventilation(l/min),FiO2,PaO2/FiO2,Inspiratory flow(I:E), Ppeak (cm of H2O),Static respiratory compliance(ml/cm of water).Plateau pressure (Pplat), Peak end expiratory pressure (PEEP).Patient will be monitored throughout the course of illness and the outcome of ARDS will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects fulfilling the criteria of ARDS according to American-European consensus definition
2. Admitted in medical ICU(CII/CU)
3. No known previous lung pathology e.g. bronchiectasis, Interstitial lung disease

Exclusion Criteria:

1. HIV positive serology.
2. Chronic obstructive airway disease
3. Not giving consent for study
4. Known lung pathology
A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.

This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.

Duration per participant is up to 11 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, between 18 and 65 years of age, inclusive.
* Body weight between 70.0 and 90.0 kg, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
* Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -1.
* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
* History of light-headedness or syncope during blood collection or injection of medications.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
* If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breast-feeding.
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or 5 elimination half-lives of the respective investigational drug, whichever is longer, of the inclusion visit.
* Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma?

Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97% of 5-years survival rate. Conservative treatments are being more and more used, and intra arterial chemotherapy is one of the adjuvant treatments proposed to the children. The treatment is efficient in most cases, but a small proportion of children will have an early progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for early identification of children response to intra arterial chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* grade B to D retinoblastoma
* prescription of intra arterial chemotherapy

Exclusion Criteria:

* none
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.

Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.

Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage 2 or greater symptomatic rectocele
* Women electing to undergo surgical rectocele repair
* Women over age 21 years
* Women willing to comply with study procedures and follow-up

Exclusion Criteria:

* Pregnant or nursing women
* History of porcine allergy
* History of connective tissue disease, pelvic malignancy, or pelvic radiation
* Women undergoing concurrent sacral colpopexy
Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis

The aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life.

After obtaining the consent from patients and being informed about the study and potential risks , all patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of C-arm X-ray machine. The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, 6-months and 9-months after the treatment.

Eligibility Criteria:
* Inclusion Criteria:

  1. patients diagnosed with KOA based on the American College of Rheumatology criteria
  2. age 18-70 years
  3. grade 2 or 3 KOA based on the Kellgren-Lawrence classification
  4. patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
  5. duration of knee pain ≥ 3 months
  6. numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.
* Exclusion Criteria:

  1. grade 1 or 4 KOA based on the Kellgren-Lawrence classification
  2. severe liver, kidney, cardiovascular, and respiratory disease
  3. abnormal blood coagulation
  4. skin infections in the puncture region
  5. patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
  6. mental disorders or inability to complete the follow-up observational form
  7. patients with bilateral knee pain.
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)

Eligibility Criteria:
Inclusion Criteria:

1. de novo acute myeloid leukemia
2. age 60-80

Exclusion Criteria:

1. have no suitable donor or donor refused
2. patient refused to accept donor cells