cyrilzakka/clinical-trials huggingface dataset:
Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals

Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA) in the blood. An example of that would be environmental changes, e.g. diet, acute illness, temperature. The main goal of this study is to study the impact of environmental changes in blood transcriptomics in healthy individuals over time.

The project is aiming to evaluate the impact of environmental changes on the blood transcriptome and to assess the feasibility of different sample collection materials for this purpose. Transcriptome from EDTA-DBS. Performing RNAseq from EDTA-DBS, Finger-Prick- DBS and PAXgene RNA tubes has resulted in different levels of analytical "background noise".

To measure the reflection of this noise, we aim to collect and evaluate blood samples of participating healthy individuals on different time points, to discover how suitable, the DBS is in detecting changes caused by environmental factors (diet, acute disease, temperature). The environmental factors should have variable severity of changes.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary, informed consent is obtained from the subject before enrollment in the study
* The subject is 18 years or older (≥18 years)
* Healthy participants, as declared by the subject
* Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study
* Available to participate for the planned duration of the study for which the screening is being done

Exclusion Criteria:

* • The subject had any clinically significant disease

  * Any clinically relevant history or the presence of e.g., respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. chronic disease
  * Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  * A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access
  * In the opinion of the investigator, subject is at high risk of non-compliance and is unsuitable in any other way to participate in this study
  * No informed consent obtained from the subject
Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery

The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.

Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI \> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.

Exclusion Criteria:

* Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI \< 40 kg/m2 will be excluded from this study.
Physiological Response and Experience Between Sitting in Bed and Sitting in a Chair in ICU

Background: In the work with early mobilization (EM), in intensive care, several types of EM are used A sitting in bed in semi- Fowler's position, sitting on the edge of the bed, and sitting in a chair. Nowadays, it is often possible to achieve a comfortable sitting in the beds in ICU. However, in a recent study by the same author group one of the findings was the importance to get out of bed. Getting out of bed was associated with decreasing feelings of hopelessness and being less ill. It also encouraged the will to fight for recovery.

There are few studies in intensive care that have examined what happens to circulation and oxygenation in various forms of sitting. Studies that examined the patient's own experience of sitting in bed compared to sitting in a chair are missing.

The aim is therefore to investigate physiological response and experience in patients in intensive care when sitting in bed or in a chair Method: Repeated measures randomized cross-over study Selection: Patients with respiratory and / or circulatory insufficiency requiring intensive care, Inclusion criteria: Approximately 30 respiratory and circulatory stable patients with emergency admission to intensive care. Aged over 18 years, who understands Swedish. The patient and / or relative are asked after the physician in charge has given medical approval. Recruitment is planned to be done by nurses in charge at the unit.

Exclusion criteria: Patients who have undergone planned surgery without complications.

Intervention: The participants in the study will be measured in two different positions; sitting in bed and sitting in chair. They are randomized to start either sitting in bed or in a chair and will sit for 20 minutes in each position, at 4 - hour intervals.

Data collection, physiological variables: The following physiological variables will be measured: Blood pressure and oxygenation by arterial needle and pulse by ECG. They will be measured before the intervention, at the beginning of the intervention, after ten minutes, at the end of the intervention and ten minutes afterwards Data collection, qualitative variables: Rating of the experience of exertion, pain and satisfaction.

Data analysis: Statistical analysis of differences between the two positions. For quantitative variables that are normally distributed, paired t-tests will be used. For qualitative variables and non-normally distributed quantitative variables, Wilcoxon character rank test or Mc Nemar test will be used


Eligibility Criteria:
Inclusion Criteria:

* emergency admission to intensive care
* age \>18 years
* understanding Swedish

Exclusion Criteria:

* Respiratory or circulatory instability where mobilization is contraindicated
Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia

evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity


Eligibility Criteria:
Inclusion criteria

1. Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
2. Patients scheduled for chemotherapy treatment.
3. Patients who range from 3 to 13 years old.
4. Patients with no history of any chemotherapy or radiotherapy. 5 -Both sexes Exclusion Criteria

1-Patients scheduled for radiotherapy treatment . 2-Existence of any signs or symptoms of oral mucositis. 3-Unwilling to participation in the study 4- Patients with any other systemic diseases or other neoplasms.
A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.

This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m\^2 at the Screening Visit and at the Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit.

Exclusion Criteria:

* The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses).
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply.
Pericapsular Nerve Group Block in Hip Arthroplasty

Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular.

This study will be conducted to evaluate the effect of ultrasound guided pericapsular nerve group block in hip arthroplasty surgery.

Hip joint is richly innervated, and the pain following hip arthroplasty is particularly severe. Effective postoperative analgesic technique especially in an elderly with significant comorbidities is challenging. (1) Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular. (2) These techniques have shown effective and safe postoperative pain control, resulting in lower opioid consumption, improved earlier rehabilitation and high patient satisfaction. (3) Pericapsular nerve group (PENG) block has been recently recommended by Giron-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve(AON) and obturator nerve in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (4)

Eligibility Criteria:
Inclusion Criteria:

* Patients will involve in the research if they will schedule for unilateral hip arthroplasty (THA) surgery.
* aged more than 50 years of both genders.
* have American society of anesthiologists physical status I-II and III.

Exclusion Criteria:

* Revision hip arthroplasty.
* hip arthroplasty. combined with subtrochanteric shortening osteotomy.
* drug allergy.
* regular narcotic use.
* renal \&/ or hepatic impairments.
* coagulopathy disorders.
Comparison of the Glidescope and Macintosh Laryngoscope for Double Lumen Endotracheal Tube Intubation

Patients undergoing chest surgery often require insertion of a breathing tube (double lumen tube) after they are unconscious. The double lumen tube enables the anaesthetist to ventilate (assist breathing) one lung at a time. The other lung is partially deflated to enable enough space for the surgeon to perform the procedure. The breathing tube is inserted with a laryngoscope (blade with a light at the end) so the vocal cords can be seen. This is standard medical practise. Two laryngoscopes are commonly used at Toronto General Hospital to insert the tube. The Macintosh laryngoscope has been is use for over 50 years and the Glidescope for over 10 years. Both devices have been extensively researched for single lumen tubes insertion and found to be very safe and effective. Research is limited to say which of the two laryngoscope is the most effective for double lumen tubes.

The Glidescope (GVL) has been extensively studied for single lumen tube intubation and found to be a very safe and useful device. It is a particularly useful for patients with difficult airways as it has a camera attached to the blade. Despite being used for double lumen tube (DLT) intubations, research of its effectiveness and safety, is lacking. The study aims to determine the speed and safety of the GVL for DLT insertion. This information will assist anaesthetists in choosing the appropriate laryngoscope for DLT intubation of their patients.

Eligibility Criteria:
Inclusion Criteria:

Population: planned elective lung surgery requiring general anaesthesia with a double lumen endotracheal intubation, signed informed patient consent.

Exclusion Criteria:

* Previous failed intubation,
* history of difficult intubation or anticipated difficult intubation (2 risk factors of mallampati score 3 or greater,
* incisor gap \< 3.5cm, thyromental distance \< 6.5cm,
* reduced neck extension and flexion),
* alternative method of intubation indicated eg rapid sequence intubation,
* fibreoptic intubation,
* contra-indication to a left double lumen tube eg endobronchial tumor,
* significant deviation or compression of the trachea and bronchi.,
* contraindication to one lung ventilation eg severe hypoxia or pulmonary hypertension,
* anticipated difficult bag mask ventilation,
* symptomatic gastro-oesophageal reflux,
* oral/pharyngeal/laryngeal carcinoma,
* loose teeth,
* allergy to rocuronium, BMI \> 40.
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

Understanding the quality of life and anorectal function changes in patients with middle and low rectal cancer after surgery can guide patients to recover after surgery and provide a valuable reference for surgeons in the selection of surgical methods. The purpose of this study is to: (1) Investigate the complication rate, recurrence and metastasis rate and survival of patients with middle and low rectal cancer. (2) QLQ-C30 and QLQ-CR29 questionnaires were used to assess the quality of life of patients with low- and middle-level rectal cancer at different periods after surgery. (3) Wexner constipation score and LARS syndrome score for anorectal function after operation for low rectal cancer. (4) The CIPE ejaculatory function score, IIEF-5 International Erectile Function Score, and FSFI-6 Female Sexual Function Index were used to assess the changes in sexual function of patients with low- and middle-position rectal cancer after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Postoperative patients with middle rectal cancer
2. Postoperative patients with low rectal cancer

Exclusion Criteria:

(1)Patients refused to participate
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.

The study treatment for this protocol is

* Loading dose of Cetuximab 400 mg/m2
* Weekly Cetuximab 250 mg/m2
* Bi-weekly Gemcitabine 50 mg/m2
* Daily Radiation for 28 fractions
* CT scan four weeks after completion of treatment
* Evaluation by surgeon for resectability

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of pancreatic adenocarcinoma
* Clinical stage I, II, or III disease
* Radiographically measurable disease
* Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
* Signed protocol consent
* Karnofsky performance status of at least 70%
* Age \> or = to 18 years
* Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.
* Absolute neutrophil count (ANC) \> 1500; platelets \> 100,000/ul.
* Creatinine \< 1.5 x upper limit of normal (ULN)
* Bilirubin \< 1.5 x ULN; AST \< 2.5 x ULN.

Exclusion Criteria:

* Acute hepatitis or known HIV
* Active or uncontrolled infection
* Significant history of cardiac disease
* Prior therapy which affects or targets the EGF pathway
* Prior severe infusion reaction to a monoclonal antibody
* Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents
* Any previous chemotherapy or abdominal or pelvic radiotherapy
* No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.
* Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
Gentamicin Intravesical Efficacy for Infection of Urinary Tract

Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).


Eligibility Criteria:
Inclusion Criteria:

* Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
* Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery

Exclusion Criteria:

* History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
* Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
* Intraoperative urinary tract injury
* Suppressive recurrent UTI treatment
* Chronic indwelling catheter/self-catheterization
* Unable to provide informed consent
* Severe renal impairment - glomerular filtration rate of less than 30 mL / minute
* Current pregnancy
* Currently incarcerated
Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by patient or legally valid representative
* Patients receiving high-dose MTX (\>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma)
* Age ≥ 18 years
* Serum MTX \>5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX \>1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX \>0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine \>1.5 × the upper limit of normal (ULN) and/or oliguria (urine output \< 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).

Exclusion Criteria:

* Pregnant or lactating females
* Unwillingness of patient or relative/legal representative to give informed consent
Intrapartum Study of Sterile and Clean Gloves

The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.

The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous or induced labor
* Rupture of membranes \< 12 hours
* Nulliparous or multiparous
* Gestational age greater than or equal to 34 weeks
* Age greater than or equal to 18

Exclusion Criteria:

* Contraindications to labor
* Multiple gestations
* Rupture of Membranes greater than 12 hours
* Gestational age less than 34 weeks
* Non-English speaking patients
A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis

It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in treatment of various etiologies of pain. However there are limited studies and research that prove its effectiveness in treating articular pain. The proposed study's primary aim is determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This study hypothesizes that PRF has analgesic properties immediately after treatment and at least 3 months afterwards compared to control treatment with physical therapy.

Additionally this research project addresses several other objectives including:

1. Provide a controlled study to determine the effectiveness of PRF for intra-articular pain
2. Determine how effective PRF is 1 month and 3 months after treatment for articular pain.
3. Further scientific evidence on the overall effectiveness of PRF
4. Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways.
5. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18
* Radiologic evidence of Kellgren-Lawrence knee arthritis between levels 1-3
* Satisfy the American College of Rheumatology criteria for knee osteoarthritis.

Exclusion Criteria:

* Failure to satisfy inclusion criteria
* Existence of general contraindications against percutaneous knee intervention including (e.g. infection, hemorrhagic diathesis, anticoagulated patients)
* Patients with pacemaker or stimulator implants
* Metallic hardware located in the treatment knee of choice
* High clinical suspicion for alternative diagnosis other than Knee Osteoarthritis
* VA defined vulnerable populations (e.g. adults with cognitive impairments, mentally retarded, non-english speaking, severe psychiatric disorders, prisoners, terminally ill patient, employees, homeless, pregnant).
* Any patient that would not be able to follow up at 1 and 3 months after intervention.
* Any patient unwilling to receive physical therapy