cyrilzakka/clinical-trials huggingface dataset:
Adversity and Its Association With the Development and Expression of Rheumatic Diseases

Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.

With this background, the investigators wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness.

To answer this question, the investigators proposed conducting a study on outpatients diagnosed with rheumatoid arthritis treated at the INCMNSZ.

Patients who agree to participate will be asked to answer some questionnaires to report their perception of child abuse and abuse derived from suffering from rheumatoid arthritis, disease activity, disability, quality of life, anxiety, stress, depression, and resilience.

Additionally, a peripheral blood sample will be taken to evaluate cellular senescence through CD27, CD28, and CD57 expression, the relative expression of the p16INK4a gene in CD3+ lymphocytes, HLA-DR, CD25, and CD69, and telomere length. Finally, the expression of the severity of the disease will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a rheumatoid arthritis diagnosis, according to their primary rheumatologist who agrees to participate

Exclusion Criteria:

* Patients with a not confirmed rheumatoid arthritis diagnosis
Visual Outcome After Vitrectomy With Subretinal tPA Injection

evaluate the safety of Eva surgical system

The purpose of this retrospective study is to evaluate the safety and clinical results using this surgical technique when performed using the EVA surgical system and associated instrumentation and disposable surgical equipment

Eligibility Criteria:
Inclusion Criteria:

* patients with VTX subretinal tPA ( + phaco)
* patients with submacular bleeding

Exclusion Criteria:

* none
Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication

We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.

This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation/VR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations:

Hallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia.

Sahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration.

Alingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration.

Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11.

We also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. Postoperative data will include STAI-S, NRS, intraoperative sedative medication (type and dosage in mg/kg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward.

The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively. The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery.

The primary outcome effect of VR glasses on mg/kg of propofol used intraoperatively or another sedative drug and/or the amount of local anesthetic used in mg. The secondary outcome effect of VR glasses on anxiety-induced stress perioperatively, where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory (STAI-S).

Eligibility Criteria:
Inclusion Criteria:

* over 65 years, planed surgery in local anesthesia/regional anesthesia

Exclusion Criteria:

* dementia, unable to cooperate, cognitive impairment
Observational Study of Best Supportive Care With or Without Surgery, Chemo or Radiotherapy in Pts With Carcinoma of Lung

The purpose of this study is to establish a listing (database) of patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites. The information will be used to determine the results of various treatments for lung cancer subjects and to find where improvements can be made in safety, effectiveness, supportive care, treatment that eases tumors without curing them, treatments that cure tumors, prevention, and follow-up efforts. The database information will be compared to clinical trial data published in peer-reviewed journals and SEER outcome data. Patients will be acquired both before and after they are treated for lung cancer.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Those who are eligible for this treatment protocol will consist of:

  1. Patients with histologically diagnosed lung cancer.
  2. Patients receiving therapy should have an ECOG/Zubrod/SWOG performance status of \<3 at the time of the initiation of therapy.
  3. All newly diagnosed patients referred to an NMCC Alliance site will be eligible, as will patients with recurrent disease that are now referred to an NMCCA for their next therapy (such as those who move from out of state, or are referred for protocol therapy), though efforts will be made to obtain records of prior therapy administered elsewhere).

Exclusion Criteria:

* Patients not falling under any of the above criteria are not eligible for the study.
* Withdrawal of the informed consent at any point in the study excludes patient from the study.
Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with a high mortality rate in the ICU. Sepsis induced cardiomyopathy (SICM) is a multi-factorial process that appears in approximately 50% of patients with sepsis/septic shock and is associated with increased mortality. It is suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced and that the failing human heart increases the capacity to metabolize ketones. Previous studies have found acute beneficial hemodynamic effects of ketone esters in patients with chronic heart failure and cardiogenic shock, respectively. Improved hemodynamics and reduced systemic oxygen consumption as an effect of ketone esters might be of great benefit in patients admitted to the ICU. Thus, we aim to investigate the hemodynamic effects of ketone esters in patients with sepsis induced cardiomyopathy in this randomized, placebo-controlled, double-blinded, cross-over, acute intervention study. .


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age admitted to the the intensive care unit (ICU)
* LVEF \< 40% determined by a screening echocardiography (two projections: apical 4 chamber and 2 chamber) and analysed according to the Simpson biplane method
* Ability for study personnel to perform transthoracic echocardiography
* Suspected or documented infection (suspected infection is defined as ongoing antibiotic treatment and/or body fluid culture sampling performed within 72 hours before screening)

Exclusion Criteria:

* Diagnosis of heart failure with reduced ejection fraction prior to ICU admission according to health records
* Surgical cause of ICU admission
* For patients in shock: Other primary causes of shock than sepsis (i.e. hypovolemia, haemorrhage, cardiogenic etiology, pulmonary embolism, anaphylaxis)
* Blood pH \< 7.20
* Severe gastroparesis
* Inability to position a nasogastric tube
Automated Folliculometry Using Five-Dimensional Ultrasound

The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D ultrasound

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

72 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

full history taking including patient's age, parity,last menstrual period , past history of medical disorders, clinical examinations (General and abdominal).

Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of ovarian follicles after controlled ovarian stimulation by clomid 50 mg5×2×1 The automated software allows for automated three-dimensional follicular measurement.The software then analyzes the volume and automatically identifies all of the follicles in the ovary. The software also automatically generates several volumetric parameters of each and every identified follicle.

Eligibility Criteria:
Inclusion Criteria:

* all women between 25 to 35 years of age
* all women have a normal body mass index(18-25kg/M\^2)
* regular menstrual cycles
* all women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound U/S

Exclusion Criteria:

1. medical disorders
2. obesity. BMI\>30
Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program (NMDP)

Individuals interested in becoming prospective bone marrow donors and joining the Registry of the National Marrow Donor Program (NMDP) should do so by calling 301-496-0572, the phone number of the NIH Marrow Donor Center. An appointment will be made to have a health history taken and to have a buccal swab collected for tissue (HLA) typing. The current protocol only involves donors already registered with the NMDP, who have been identified as "perfect matches" for an unrelated patient requiring a bone marrow transplant, and who require expedited medical evaluation prior to marrow collection.

The National Marrow Donor Program (NMDP) was established in 1987 in order to (1) create a registry of volunteer, prospectively tissue-typed, unrelated bone marrow donors, (2) facilitate the performance of matched unrelated donor marrow transplants through a coordinated circuit of Donor Centers, Collection Centers and Transplant Centers throughout the United States, and (3) evaluate the outcome of such transplants and identify future areas of research in the field of unrelated donor marrow transplants. The NIH Marrow Donor Center, a participant in the NMDP, is currently the second largest hospital-based Donor Center in the nation, with approximately 55,900 active donors on its registry. 402 NIH unrelated donors to date have undergone 429 marrow or blood stem cell harvest for an NMDP recipient, and the current rate of such harvests is three per month. Once an HLA-matched donor in the NIH Donor Center registry is identified through the NMDP computer network, the donor must undergo a medical evaluation to determine suitability for marrow harvest. This evaluation consists of a medical history, a physical examination, routine blood work, EKG, chest x-ray, and urinalysis, and generally takes 4 to 6 weeks. A "third party" non-NIH physician usually performs the evaluation, with the costs reimbursed by the NMDP. Occasionally, an expedited evaluation of an unrelated donor must be performed, due to the urgency of the need for a transplant in the recipient, and there is insufficient time to accomplish this work-up using the routine "third-party" physician's office mechanism. This protocol shall provide a means by which prospective NIH unrelated marrow donors participating in the NMDP program can undergo an expedited medical evaluation to determine suitability for marrow donation. It is expected that not more than 5 to 10 donors per year shall require such expedited evaluation.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age 18-60.

Must meet same criteria as that of a volunteer blood donor.

EXCLUSION CRITERIA:

History of hepatitis.

History of intravenous use of illicit drugs.

History of activities that increase the risk of exposure to HIV or hepatitis viruses.

Confirmed positive test for HIV

Inability to tolerate general anesthesia.

Obesity.

Hypertension.

Asthma.

Diabetic patients will be excluded.

Pregnant patients will be excluded.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants

MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions.

The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy, adult participants.

In recent years, high-dose psilocybin has gained attention for it potential therapeutic benefit in many psychiatric conditions, however existing clinical data for low psilocybin doses are limited.

Microdoses are generally considered to be those absent of profound sensory and cognitive effects that would interfere with normal everyday functioning, but only a small number of prospective studies have evaluated microdoses and/or low doses in a controlled manner.

As a foundational study of the therapeutic use of psilocybin microdoses, this study will assess the safety, tolerability, pharmacokinetics and sensorial effects using a prospective, controlled, multiple dose regimen in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18 to 65 years old (inclusive) at the time of signing the informed consent form. Standard contraception measures are required for this clinical trial.
2. Healthy, in the opinion of the Investigator, based on prior (history of) or current (ongoing) medical and psychiatric screening assessments.
3. Participants with no clinically significant findings on physical examination, laboratory tests, and cardiac assessment.
4. Body mass index (BMI) within the range 18-32 kg/m2, inclusive.
5. Normal blood pressure.
6. Capable of giving signed informed consent which includes the requirements and restrictions as per the approved study protocol.

Exclusion Criteria:

1. Prior known exposure to psilocybin within the past 5 years.
2. Prior (history of) or current (ongoing) diagnosis, or first-degree relatives with clinically significant medical or psychiatric condition or disease.
3. History of or presence of cardiovascular disease.
4. Abnormal and clinically significant ECG.
5. History or presence of a neurodegenerative disorder such Alzheimer's disease or Parkinson's disease.
6. Use of medications that have CNS effects or affect performance.
7. Use of medications with serotonergic activity.
8. History or presence of hypersensitivity or idiosyncratic reaction to psilocybin or related compounds.
9. History of substance or alcohol abuse disorder in the last 1 year.
10. Participant who, for any reason, is deemed by the Investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
Optimization of the Treatment of Dry Eye Disease Caused by Meibomian Gland Dysfunction

An open label, randomized controlled study in a Norwegian population with meibomian gland dysfunction. Patients will be randomized to one of two groups: THERA°PEARL Eye Mask (Bausch \& Lomb Inc., New York, USA) or Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK). All patients will receive Hylo-comod (URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany).


Eligibility Criteria:
Inclusion Criteria:

* Meibomian Gland Dysfunction
* Eligible for heat treatment
* Ocular Surface Disease Index (OSDI) \>12
* Quality or expressibility score ≤20 years old: \>1 or \>20 years old: ≥1
* Non-invasive tear film break-up time (NITBUT) \<10 s in at least one eye
* Schirmer-1 test \>5 mm after 5 min

Exclusion Criteria:

* Glaucoma,
* Ocular allergy
* Autoimmune disease
* Contact lens-wear during study
* Current punctal plugging
* Pregnant/lactating
* Candidate for topical anti-inflammatory
* Cicatricial meibomian gland dysfunction
Cochlear Implant and Vestibular Function.

This study investigate weather one type of cochlear implant (CI) surgery (insertion of the electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or cochleostomy. They will be examined with a video head impulse test (vHIT) before and after CI surgery to clarify their vestibular function.

Cochlear implant is an advanced type of hearing advice. It consists of an outer microphone, which picks up sound and sends it through an electrode into the cochlear.

With a cochlear implant people, that are profoundly deaf or have severe hearing loss, can get their hearing back.

Vertigo is one of the most common side effects to cochlear implant surgery. In this study we will investigate if one type of CI surgery (insertion of the electrode via paracentesis of the round window) leads to less vertigo than another type of CI surgery (cochleostomy).

In the randomization there will be stratified according to age (60+/-), residual hearing (yes/no) and gain before surgery (+/-0,68). Three different surgeons will do the surgeries. All technical aspect of the surgery, other than the insertion of the electrode into cochlea, is being done identically.

Electrodes from Cochlear, MEDEL and AB is being used. We will compare the findings from the vHIT examination with the subject dizziness perceived of the patient.

The patients will be examined before surgery, the day after their surgery and one month after their surgery. The same examinator will perform all the vHIT tests. The test will be performed in continuation of the patient's other visits at the Department of Audiology and Department of Otorhinolaryngology -Head and Neck Surgery.

Eligibility Criteria:
Inclusion Criteria:

* deaf or severe hard of hearing
* normal or slightly affected vestibular function (gain \>0,50)

Exclusion Criteria:

* subjects with otosclerosis
* subject who will have the CI surgery for preservation of the residual hearing
Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults

Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors including physical activity (PA). The primary purpose of this study was to examine change in objectively measured PA in a randomized controlled pilot trial that tested a wearable sensor/device (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided to facilitate self-monitoring with a wearable tracker for instant feedback and website of daily PA summaries. Outcome measures were number of steps and minutes of PA by intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA compared to only the Fitbit One at 6-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* 18-69 years of age
* overweight or obese (otherwise healthy)
* does not meet recommended levels of PA (\>150 min/wk of MVPA)
* owns a personal mobile phone and able to use SMS text-messaging
* owns a personal computer, has access to Internet, able to operate the Fitbit One
* fluent in English
Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs

Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days.

The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging.

The study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging.

Eligibility Criteria:
Inclusion Criteria:

* Chronic edema of the lower limb
* Referred to compression bandaging
* Circumference of widest point of the lower leg between 35-75 cm

Exclusion Criteria:

* Wounds at the lower leg (at the widest circumference of the lower leg)
* Acute deep venous thrombosis in the leg
* Untreated cellulitis
* Severe heart- or kidneyfailure
* Severe peripheral neuropathy in the lower limbs