cyrilzakka/clinical-trials huggingface dataset:
Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass

52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.

Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.

Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.

Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.

Eligibility Criteria:
Inclusion Criteria:

- Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies

Exclusion Criteria:

* uncontrolled or perennial asthma
* other pulmonary disease
* known autoimmune or collagen disease
* chronic infection
* other significant disease
* severe atopic dermatitis
* use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications
* symptomatic sensitization to house dust mite or furry animals with daily exposure
* chronic upper airways disease
* pregnancy
* nursing
* obesity with BMI \>30
* withdrawn informed consent
Enteral Glutamine in Neurologically-injured Patients

Nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. Liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. Some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Nonpregnant females
* Aged 18-75 years old
* Glasgow Coma Scores of 3-12
* Injury Severity Scores greater than or equal to 20
* Requiring enteral nutrition for a minimum of 5 days

Exclusion Criteria:

* Documented hepatic dysfunction
* Acute renal failure (creatinine clearance \< 15 mL/min)
* Gastrointestinal malabsorptive disorder
* Infection at time of admission
Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy

The determination of the 2D6 genotype will enable us to determine the way flecainide is metabolized by the liver. Some individuals are poor metabolizers and some individuals are extensive metabolizers of the drug. This will also determine which patients will benefit from the drug.

Pharmacogenetics is the study of genetic variations on drug metabolizing enzymes and transporters. Pharmacogenetics is one of the first clinical applications of the Human Genome Project. Pharmacogenomics is the study of the role of interindividual genomics variability on drug response, efficacy, and metabolism. It correlates the effects of the entire expressed genome to the clinical usefulness and toxicity of a drug. Pharmacogenomics has the potential to change the way patients' therapy is optimized, allowing an era of "personalized medicine" in which patients will be divided into groups based on genetic markers that treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent AF
* Patients with a structurally normal heart
* Patients \> 18 YO
* Patients who signed an informed consent

Exclusion Criteria:

* Renal failure with creatinine clearance less than 40
* Elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality
* Pregnant patients
* Patients treated with psychiatric agents
Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure

Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4.52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered.

Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients.

The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 45 years old with lymphoma.
* Menarche \>2year
* Subject treated by chemotherapy-induced ovarian failure including alkylant agents (except less than 8 ABVD)
* Presence of both ovaries (ovarian biopsy or hemiovariectomy for cryopreservation before treatment is accepted).
* Ability to give written informed consent

Exclusion Criteria:

* Hormonal-sensible malignancy
* Chemotherapy or radiotherapy before the inclusion in the study
* Pelvic irradiation including the ovaries or TBI
* Pregnancy
* Patient weight above 110 kg
* Anamnesis of thrombo-embolic processes
* Severe hepatic or renal insufficiency
* Systolic blood pressure \>15mmHg or diastolic blood pressure \> 90mmHg
* Contraindication of IM injection
* Relevant ovarian abnormalities (Functional follicular cyst are tolerated)
* Anamnesis of premature ovarian failure or irregular cycle (repeated amenorrhoea \>2 months)
* Dubin-Johnson and Rotor Syndrome
Effects of Constructive Debriefing on Procedural Skills and Satisfaction of Nursing Students in Low Fidelity Context. A Randomized Controlled Trial.

Purposes: This study was set out to measure the effectiveness of constructive debriefing on procedural skills and satisfaction of nursing students in the low-fidelity context in comparison to traditional debriefing.

Method: The randomized controlled (Parallel double blinded) trial design was used.

Participant: Out of 51 approached, 34 students were selected from the list of participants by a data collector using simple random sampling technique. Following, block randomization was applied using Microsoft Excel to create two equivalent (n=17) groups i.e. experimental and non-experimental.

Setting: The study was conducted in private college of nursing Islamabad Pakistan Intervention: The experimental group received constructive debriefing and non-experimental group received the traditional debriefing. The data were collected using suctioning, sterile dressing skills checklist, and debriefing reflection subscale of Satisfaction with Simulation Experience Scale.


Eligibility Criteria:
Inclusion Criteria:

- Students who were enrolled in the Adult Health Nursing (AHN) course were included in the study

Exclusion Criteria:

* Studentsnts who were repeating the course and were absent for two or more days during skills demonstration and signing off were excluded
Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA

To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement

Participants were enrolled according to protocol requirements. Patients who meet all inclusion criteria and do not have any exclusion criteria will be considered for inclusion in the study and will provide the relevant information used orally and in writing. Patients were divided into four groups according to the dose of triamcinolone in the peripheral infiltrating anesthetic preparation. All of which are appropriate for their surgical treatment, and the purpose of the study is to determine which formula is clinically better. All patients enrolled in this study were voluntary participants and signed informed consent. On the day of the surgery, the anesthesiologist prepares a mixture of medications based on patient groups, which are then handed to the operating room nurse. The timing, dose, and site of injection were consistent. Before the prosthesis is installed, the mixture is injected into the upper part of the patella, the posterior joint capsule, and the patellar tendon. After the prosthesis was installed, the mixture was injected into the lateral joint capsule and subcutaneous tissue. The patient, the rehabilitation physician, and the ward nurse did not know the type of mixed drug preparation injected by the patient.

Eligibility Criteria:
Inclusion Criteria:

1. age in the range of 50 to 85 years old
2. patients with knee osteoarthritis requiring primary unilateral total knee replacement
3. the body mass index in the range of 18 to 36 kg/m2
4. possess the physical status I-III of American Society of Anesthesiologists
5. the patient and his family members agree and sign the informed consent

Exclusion Criteria:

1. Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.)
2. History of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, ligament reconstruction, etc
3. Flexion deformity ≥30°, internal and external varus deformity ≥15°
4. People allergic to the drugs used in this study
5. Patients who had used glucocorticoids within 3 months before surgery
Function of Circulating Exosomes in Sepsis-induced Immunosuppression

This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years with ≥ 2 chronic comorbidities
* Highly suspected bacterial infection based on clinical or radiologic evidence
* ≥ 2 systemic inflammatory response syndrome (SIRS) criteria
* Actual/anticipated admission to intensive care unit (ICU)
* Anticipated length of hospital stay ≥ 5 days

Exclusion Criteria:

* Pregnancy
* Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
* Current immunotherapy use
* Confirmed COVID-19 infection
Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis


Eligibility Criteria:
Key Inclusion Criteria:

1. Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
2. ISN/RPS 2003 Class III/IV lupus nephritis \[Type III(A), III (A+C), IV (A), and IV (A+C)\], with or without Class V, as confirmed by a renal biopsy.
3. Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
4. Has 24-hour urine protein excretion \> 1.0 g at screening.

Key Exclusion Criteria:

Exclusion criteria related to systemic lupus erythematous and other diseases:

1. Glomerulonephritis caused by reasons other than systemic lupus erythematous.
2. Sclerosis in \>50% of glomeruli on renal biopsy.
3. Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
4. Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve the self-efficacy of patients with locally advanced rectal cancer who are initiating multimodality treatment (e.g., total neoadjuvant therapy).

This is a randomized control trial that will be split into two phases. Study Phase I will test the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer who are initiating multimodality treatment. It is expected that this phase will enroll 20 participants. Study Phase II will test the efficacy of the psychoeducational intervention after it has been refined using findings from Study Phase I. It is expected this phase will enroll 100 participants.

In this study, participants will complete survey questions and will be randomly assigned to either receive the intervention (consisting of 4 coaching sessions with a study clinician, a comprehensive patient education guidebook, and a coaching session workbook) or enhanced usual care (consisting of an information resource guide for navigating information online).

It is expected that about 120 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years
2. Within 4 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)
3. Able to complete study procedures English or with the assistance of an interpreter

Exclusion Criteria:

1. Comorbid health condition that would interfere with study participation, as identified by cancer care team
2. Has undergone treatment for a prior colorectal cancer
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture

Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.

Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.

Exclusion Criteria:

* Patients who received antibiotics within two weeks from presentation
Early Mobilisation of the Distal Radius Fracture

The goal of this clinical trial is to demonstrate the effectiveness of early therapy in 14 patients with a distal radius fracture DRF resulting from injury, as the study group. Assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method (ORIF), compared to their nonoperated limb, after 6 months of early rehabilitation.

The main questions it aims to answer are:

1. Significantly faster recovery of independence from daily activities by the patient.
2. For economic reasons, patients often expect to return to work as soon as possible.

Participants will be subjected to functional examination to assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method.


Eligibility Criteria:
Inclusion Criteria:

* age range 18-60 years
* distal radius fracture
* ORIF procedure
* hand stabilisation plate (Medartis)

Exclusion Criteria:

* delayed rehabilitation protocol
* algodystrophy
PACMAN Ultrasound Recording Data Collection

Study to collect videos of ultrasound recordings during peripheral nerve block procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
* Informed consent executed

Exclusion Criteria:

* Patients unable to understand and provide written consent
* Infection at the injection site
* Allergy to local anesthetic agents
* Medical condition obscuring visualization
* Known neuropathy at or around target nerve for the PNB
* Inability to communicate with the investigator or hospital staff
Auriculotherapy in the Treatment of Dysmenorrhea

This study aims to determine if auriculotherapy is effective in the treatment of dysmenorrhoea. This intervention consists of fixation of yellow mustard seeds at specific points of the auricular pavilion (or area), with opaque tape. Half of the participants will have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while the other half will have only the adhesive plasters fixed, without the seeds for stimulation.

Primary dysmenorrhoea is responsible for the most part of dissatisfactions in the female class, in the face of discomforts which are caused monthly. For this, the income index of this woman in the work environment tends to reduce, thus harming the development of every sector to which she responds. The expected effects, after the intervention, will be positive, favoring a considerable improvement of the symptoms reported by the women. We chose auriculotherapy because it is a non-medicated, noninvasive intervention that is inexpensive.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, the individual must meet the following criteria:

  * Free and informed consent form, duly signed and dated
  * Consent to voluntarily participate in all study procedures and availability for the duration of the study
  * Female subjects
  * Age above of 18 years old
  * Enjoy good general health
  * Have active menstrual cycle
  * Complaint about dysmenorrhea

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  * Clinical diagnosis of endometriosis
  * Myomas
  * Pelvic inflammatory disease
  * Adenomyosis
  * In the active phase for treatment of cancer (chemotherapy or radiotherapy)
  * Women who are already in menopause
  * Pregnancy
The Effectiveness of Chlorhexidine Gluconate on Prevention of Catheter-Related Bloodstream Infections

Catheter-related bloodstream infections are associated with increased mortality, morbidity, and length of hospital stay. The incidence has decreased significantly with the strict implementation of preventive bundle cares and checklists in intensive care units. Bathing with solutions containing chlorhexidine has been included in preventive strategies in recent years. Although some studies have shown that chlorhexidine bathing reduces the frequency of hospital-associated infections, there are important differences in management of practice and adherence to practice in different facilities. The majority of the studies conducted include adult patients. According to the CDC guidelines, chlorhexidine bathing is recommended for children over 2 months of age to prevent catheter-related bloodstream infection. The aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing catheter-related bloodstream infections in pediatric patients with temporary central venous catheters.

In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to CDC diagnostic criteria. Microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. Infection with the resistant microorganism will be compared with the control group. Catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms.

Patients in both groups with a central catheter for longer than 48 hours will be treated with a standard bath every 72 hours. In addition to the control group, patients in the study group will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups will be compared in terms of catheter-related bloodstream infections and catheter colonization.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 2 months and 18 years who had a temporary central venous catheter
* Patients whose follow-up is continued for at least 48 hours with a central venous catheter

Exclusion Criteria:

* Patients younger than 2 months of age
* Patients with a intensive care unit stay shorter than 48 hours
* Immunosuppressive patients
* Patients with a history of allergic reaction to chlorhexidine
* Patients with skin lesions that interfere with skin cleansing with chlorhexidine
* Patients whose family did not give consent
Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.

The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is a commercially available soft contact lens (model: SiHy Daily). The number of enrolled subjects is 148, and clinical observation is performed for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with age of 18 to 45
* Spherical power: -0.25 to -10.00D
* Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
* Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;

  : The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
* BCVA of the left and right eye subjective refraction is greater than or equal to 5.0.

Exclusion Criteria:

* Need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones
* Dry eye syndrome
* Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
* Wearing a hard contact lens in the past 6 weeks
* Tear film break-up time is less than or equal to 5s
* Allergic to contact lenses and/or contact lenses
* Keratoconus or other irregular corneal patients
* Soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals
* Pregnant, lactating or plan to be pregnant
* Only one eye meets the requirements for enrollment
* Participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial
* Less than three months after the end of a drug clinical trial
* Determined by the investigator that could not be enrolled