cyrilzakka/clinical-trials huggingface dataset:
Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been recommended to detect the virus. This procedure has been reported to be painful by 85% of children The aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a nasopharyngeal swab.

This was a RCT among children aged 8-17 years old who need a NPS. The primary outcome was pain intensity as measured by the Visual Analog Scale .


Eligibility Criteria:
Inclusion:

* 6-17 years old inclusively
* Children for whom a NPS was ordered

Exclusion:

* Children presenting with the following acute conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient as increased absorption of the medication might occur:

  * Nasal or airway burns, trauma or major anomaly
  * Cardiorespiratory compromise
* Children for whom an informed consent could not be obtained

  * Any other life-threatening condition or priority one patient requiring emergency support
  * Language barrier
* Children presenting with conditions that could prevent their ability to reliably report their pain:

  * Severe intellectual disability
  * Severe pain upon presentation
  * Administration of opiates prior to the NPS
* Children presenting with the following chronic conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient:

  * Hypersensitivity/allergy to the medication or a known component
  * Methemoglobinemia
  * G6PD deficiency
  * Familial malignant hyperthermia
  * Pseudocholinesterase deficiency
  * Severe hepatic impairment
  * Severe cardiac condition or use of antiarrhythmic medication
  * Risk of airway aspiration
Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

This study aims to assess the safety and efficacy of a novel advanced bolus calculator in subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm that requires five subject-specific parameters as input to generate a recommended bolus insulin dose:

* current blood glucose (mmol/L)
* target blood glucose (mmol/L)
* insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)
* total grams of carbohydrate in meals
* insulin sensitivity factor (reduction in glucose per 1 unit of insulin)

The Diabetes Technology team at Imperial College have developed a novel advanced bolus calculator. The complete integrated system consists of a commercially available smartphone that holds the novel advanced algorithm. The system requires regular updates of cases derived from retrospective blinded continuous glucose monitoring data and for this a commercially available glucose sensor will be used. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (blood glucose following a meal). The novel decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past.

The end-product is therefore a subject specific insulin bolus calculator that continues to improve with time. The project utilises commercially available glucose sensors and smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The aim of the ABC4D is to minimise high and low glucose excursions which are associated with the complications of diabetes including blindness, kidney failure, nerve damage and cardiovascular disease.

An interim analysis was conducted in Phase 4 after 25 participants completed the study (in line with the protocol) and it was agreed to stop the study at this stage. A further protocol amendment was approved by REC/MHRA to commence ABC4D phase 5 (different CT.gov number: NCT03963219).

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Diagnosis of T1DM for \> 1 year
* On MDI using a basal-bolus insulin regime
* Structured education in previous 3 years
* HbA1c ≤ 86mmol/mol
* No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Pregnant or planning pregnancy
* Breastfeeding
* Enrolled in other clinical trials
* Have active malignancy or under investigation for malignancy
* Addison's Disease
* Gastroparesis
* Autonomic neuropathy
* Concomitant use of GLP-1 analogues and gliptins
* Visual impairment
* Reduced manual dexterity
Biomarkers of Kidney Function in Transplant Medicine

Biomarkers of kidney function in transplant medicine is an international, multicentre, observational, non-interventional study.

The project is aimed at monitoring biomarkers of acute kidney dysfunction in deceased organ donors, living organ donors, and organ recipients.

The study is observational, without any changes from the standard care, including only selected laboratory assessments, from standard blood samples collected from the donors/recipients.

Informed consent will be required from living donors and recipients.

The mainly used current criteria of organ acceptability in transplant medicine include urine output and laboratory parameters of acute kidney dysfunction - serum levels of urea and creatinine. Literary sources show that these classic criteria of kidney dysfunction develop only with a significant reduction of (glomerular and tubular) kidney functions and return to normal only slowly after the function of the kidneys has been restored.

New possibilities of early kidney dysfunction diagnostics are being studied, using more sensitive tests - determination of biomarkers of acute kidney dysfunction. These may serve as decisive criteria for the safe use of organs from so-called marginal donors and identify early serious impairment of kidney function in donors with preserved urine output, without fulfilled criteria of acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* age 18+
* signed Informed Consent in case of living organ donors and recipients
* fulfillment of all legal requirements for organ harvesting from a deceased donor
* fulfillment of all ethical principles of end-of-life patient care
* medical suitability of organs for transplant use

Exclusion Criteria:

- disapproval of family members with the enrolment of the patient in the study
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy

The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 years and older, upper age limit of 45 years
* Female patient
* Patients undergoing any procedures for pregnancy diagnosis and confirmation
* English speaking

The following special population will be included:

* Pregnant women

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, and teenagers)
* Prisoners
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)

This is an observational, prospective, and transversal study, designed to evaluate the effectiveness of CELBREA® in women from the local community coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt, providing actualized data on the effectiveness of the device within the context of the real-world scenario. Because of its transverse nature, the observation period will be limited to the necessary amount of time to perform the initial consult, additional tests when prescribed by the physician, and the CELBREA® test.


Eligibility Criteria:
INCLUSION CRITERIA

1. Women ≥ 18 years old coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of:

   * Discomfort or breast symptoms including, but not limited to, signs or symptoms detected through a self-examination, changes of color or shape in the nipple, nipple discharge, change of appearance or color of breast skin, lumps, etc.
   * Refered for evaluation because of diagnostic doubt.
2. Capable of following the instructions necessary for the study.
3. Have signed the informed consent form.

EXCLUSION CRITERIA:

1. Women who are pregnant or lactating at the time of the study.
2. Women suffering from one of the following breast pathologies:

   * Personal history of breast cancer, previous or current.
   * Current chemotherapy or radiotherapy for any type of cancer.
   * History of breast surgery (reductive, reconstructive, mastectomy, lumpectomy, and others).
   * Fever.
   * Swelling or local infections on the breasts.
   * Open wounds in breast skin.
Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients

The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients

Stroke is a neurological pathology that can cause functional problems and an impairment to perform activities of daily living at home.

For this reason, these patients need the support of a caregiver. Caregivers of post-stroke patients often have also problems with their quality of life because of the care that they must provide. These problems appear mainly during the support tasks in the activities performed at the patient's home.

The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients

Eligibility Criteria:
Inclusion Criteria:

* Being caregivers of post-stroke patients
* Being over 18 years old

Exclusion Criteria:

* Being caregiver of patients with other neurological patients
Compressive Elastic Dressing Versus TR Band

Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses.

Previously, there were no specific devices for radial artery hemostasis. Many different types of dressings were used in various hospitals with no standardization. This raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications.

The primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems.

The hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients who agree to participate in the study and sign the consent form.
* Patients with an indication for coronary catheterization
* Clinically stable patients
* Patients with palpable pulses on at least one of the radial arteries.

Exclusion Criteria:

* Patients who are hemodynamically unstable (systolic blood pressure less 90mmhg)
* Patients with radial AV shunt for hemodialysis
* Patients with previous CABG using radial artery
* Patients with Renaud phenomenon or lymphedema
* Patients who had vascular problems at the puncture site before the hemostasis process started.
* Failure to obtain radial access
Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer

The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG treatment.

In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG.
* Evidence of disease recurrence within 1 year of previous BCG treatment
* Tumor tissue must be available from biopsy for study related immunohistochemical analysis
* If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment
* ECOG performance status of \<2
* Life expectancy of at least 6 months
* Adequate hematologic, renal and liver function
* Informed consent

Exclusion Criteria:

* No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months
* No prior radiation to the pelvis
* No gross hematuria within 1 week prior to planned week 1 treatment
* Cannot have previous intolerance to BCG
* Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history
* No evidence of metastatic disease
* No prior treatment with anti-CTLA-4 monoclonal antibody
* Can not be pregnant or lactating
* No history of autoimmune disorder
* No history of thyroid or adrenal insufficiency
* No history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, Crohn's or celiac disease, intractable urinary tract infection
The Effect of Foot Reflexology After Cesarean Section

Standardized, quality and evidence-based nursing care after cesarean section is important to prevent or minimize complications that may occur after cesarean section. This evidence-based care will contribute to the shortening of the recovery period of the mother, the early start of postpartum bowel movements, the decrease in the perceived pain level, and the increase in postpartum comfort, thus facilitating the adaptation to new life and roles. On the other hand, although a limited number of studies reported the effects of reflexology, no study investigating the effect of reflexology on pain, comfort level and GIS motility developed after SD was found. In this study, it was aimed to determine the effect of foot reflexology on pain, intestinal motility and comfort after cesarean section.

Hypothesis(s):

H1: Foot reflexology after cesarean section reduces the level of pain perception.

H2: Foot reflexology after cesarean section increases intestinal motility. H3: Foot reflexology after cesarean section increases postpartum comfort.


Eligibility Criteria:
Inclusion Criteria

* 18 and over,
* Performing SD under general anesthesia,
* Cesarean section at 37-42 weeks of gestation,
* The only live SD made,
* Written / verbal communication can be established,
* At least primary school graduate,
* Not having any problems during her pregnancy,
* Women who agree to participate in the study will be taken into the sample. Exclusion Criteria
* Being under 18 years old,
* Those who gave birth by cesarean section before 37-42 weeks of gestation,
* Having chronic constipation, diarrhea and using any laxative type medication,
* Having problems such as fractures, dislocations, arthritis, phlebitis, wounds, burns, fungus, eczema, inflammation in the foot tissue,
* Having cardiovascular system disease,
Fish Oil as Adjunct Treatment for Major Depressive Disorder

In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).

Participants are randomly assigned to two groups (n=60): control (placebo, soybean) and fish oil (containing EPA 1440mg, DHA 960mg). The experimental groups will be compared to placebo to evaluate if it may benefit clinical symptoms, cognitive symptoms and metabolic markers in MDD patients. We also plan to investigate the changes in markers of inflammation at the same time.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. Men or women aged 18-50 years
3. A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
4. HAMD total score≥21
5. No significantly modification of their diet from the time they sign consent to the end of study participation

Exclusion Criteria:

1. Suffering from other serious somatic diseases or comorbidities
2. Patients with serious nervous system disease
3. Patients in accordance with diagnostic standards of other mental illness
4. Patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months
5. Pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures
6. Patients with apparent suicide attempt or suicidal behavior
7. Any condition or medicines that may have an effect on biomarkers (within 1 week of the screening period or during whole trial period): long-term, regular use of NSAIDs, COX-2 inhibitors, immunosuppressant, steroids, interferon, chemotherapeutics, anticoagulants, malignancy, active autoimmune diseases, inflammatory bowel diseases, etc
8. Allergy history of PUFA
9. Intake of Fish oil more than 3g per day or eat fatty fish more than 3 times a week
Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor

The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor, and to compare with data from a historical control group that administered a conventional Cyclosporine formulation.


Eligibility Criteria:
Inclusion Criteria:

* Blood diseases for a standard risk group

  * Primary remission of AML (acute myeloid leukemia)
  * Primary remission of ALL (acute lymphocytic leukemia)
  * Secondary remission of ALL (acute lymphocytic leukemia)
  * SAA (severe aplastic anemia)
  * Chronic stage CML (chronic myeloid leukemia)
  * MDS (myelodysplastic syndrome)
  * Myeloma (multiple myeloma)
* A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor

Exclusion Criteria:

* A patient with renal impairment (serum creatinine level ≥ 1.5mg/dl or 130μmol/l, GFR≤ 30%)
* A pregnant or breastfeeding woman
* A woman who is unwilling or unable to practice appropriate contraception during the study
* A patient who is highly likely to experience aggravation during treatment due to active tuberculosis, other hepatic disease, hypertension, heart failure, chronic obstructive respiratory disease, etc.
* A patient with hypersensitivity to tacrolimus
Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -

Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma.
* Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0)
* ECOG-Grade 0-2
* Enlightenment and written declaration of consent to the participation.

Exclusion Criteria:

* Pregnant patients or patients in lactation period.
* Severe dysfunction of liver or kidneys
* Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis
* Epilepsy
* Hypersensitivity to components of loperamide or tincture of opium
* Ileus
* Toxic megacolon
* Pseudomembranous colitis/ antibiotic-associated colitis
* Diarrhea associated with fever and bloody stools
* Acute increase of colitis ulcerous or bacterial colitis caused by invasive pathogenes
* Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis
* Dysfunctional draining of biliary area, biliary colics.
* Concomitant or earlier addiction of alcohol or opiates
* Severe heart disease
* Pheochromocytoma
* Acute hepatic porphyria
* Cor pulmonale
* Morbus Addison
* Severe hypothyroidism
* Organisational problems or circumstances which prevent a complete collection of required data
* Artificial anus
* Participation in a clinical trial within the last 30 days before involvement
* Participation in an other clinical trial at the same time
Belatacept Pharmacokinetic Trial in Renal Transplantation

The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a living or deceased donor kidney
* First or second transplant
* Men and women, including women of childbearing potential, 18 years and older

Exclusion Criteria:

* Panel reactive antibodies ≥ 30%
* Significant infection