cyrilzakka/clinical-trials huggingface dataset:
HIV Oral Testing Infographic Experiment

Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.

In the United States, approximately 1.1 million persons are living with HIV. Despite novel pharmacological breakthroughs, comprehensive models of health care, and targeted HIV testing initiatives, over 160,000 persons are still unaware of their HIV serostatus. Emerging adult, sexual minority, men of color are disproportionately affected. Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.

The overall study will focus on: (a) understanding facilitators and barriers to HIV self-testing among emerging adult MSM, (b) designing a HIV self-testing infographic that utilizes a simplicity model, (c) finalizing the HIV self-testing infographic with input from a leadership group of HIV community members, (d) conducting a pilot clinical trial with 300 emerging adult (ages 18-34), sexual minority, men of color to test if a collaboratively-designed HIV self-testing infographic can facilitate accurate and effective understanding of how to self-test for HIV when compared to paper-based, HIV self-testing information.

By conducting this study, we will gain beneficial insights necessary for presenting HIV self-testing instructions in a meaningful, relevant, and comprehensible way. The results of this pilot study have the potential to inform strategies regarding how self-testing instructions can be worded or visually presented in order to break both literacy and language barriers that affect testing utilization and results accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Understand and read English
* Assigned male sex at birth
* Self-identify as gay, same-gender-loving, or MSM
* Self-report being HIV-negative or unknown HIV serostatus

Exclusion Criteria:

• Persons with a known HIV diagnosis
Phage Therapy for the Treatment of a Chronic Enterococcus Faecium Periprosthetic Joint Infection

This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient.

The phage will be administered to the study patient during a 14 days period via intravenous and intra-articular. The patient will be monitored in clinic for up to 1 year.

This is a single-patient study, to assess a treatment option for a case of a recurrent methicillin-susceptible E. faecium infection in a prosthetic hip joint. The patient has repeatedly failed standard of care medical and surgical management.

Given the severity and chronicity of E. faecium infection and burden of infected hardware, the only option to achieve surgical source control would involve an aggressive, high risk surgical approach: a high amputation of the left leg to remove infected hardware and peri-implant bone and tissues. In the absence of any viable adjunctive antimicrobial therapy, this patient is at high risk of mortality and morbidity. It is therefore paramount that we explore alternative treatment modalities for the management of this infection, such as bacteriophage (phage) therapy.

The primary objective of this study is to investigate the preliminary efficacy, safety, and tolerability of systemic (intravenous) and intra-articular administration of a lytic phage (in our patient with chronic E. faecium PJI.

Secondary objectives will be documenting clinical changes pre- and post-therapy, as well as identifying adjunctive changes in biomarkers (C-reactive protein \[CRP\], erythrocyte sedimentation rate \[ESR\], and interleukin-6 \[IL-6\]) correlated with PJI as well as phage titres.

In this study, lytic phage prepared in injection-grade saline will be administered to the patient both intravenously and intraarticularly, twice a day for a duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.

The patient will remain in clinical follow-up for up to one year.

Eligibility Criteria:
Inclusion Criteria:

This N-of-1 Phage therapy is designed for one patient who meet the following conditions

* Willingness to provide signed and dated informed consent form to participate in the clinical study
* Chronic prosthetic joint infection
* History of multiple surgical and medication managements with no success

Exclusion Criteria:

* below 18 years of age
Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Objective: The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Design: Randomized double-blind controlled trial.

Setting and conduct:

* Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
* Patients will be randomly assigned to one of 2 groups: experimental group (taking a 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated.
* During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered.
* Main outcome measures: Anesthetic success during root canal treatment using HP VAS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in good health as determined by a medical history and oral questioning. (ASA I or II)
2. Age range is between 18 and 50 years.
3. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
4. Patients who can understand Heft Parker Visual Analogue Scales VAS.
5. Patients accepting to participate in the study and able to sign informed consent.

Exclusion Criteria:

1. Pregnant female patient.
2. Patients allergic to diclofenac potassium or mepivacaine.
3. Patients having active pain in more than one mandibular molar.
4. Patients who had taken analgesics in the 12 hours preceding the injection.
The Effect of Sujok Therapy on Cancer Symptoms

The aim of this study is to determine the effect of Sujok therapy on Pain, Fatigue, Insomnia, Nausea and Vomiting experienced by patients with gastrointestinal system cancer.

The aim of this study is to determine the effect of Sujok treatment on Pain, Fatigue, Insomnia, Nausea and Vomiting experienced by patients with gastrointestinal system cancer. Intervention and control groups will be determined by randomization. The scales to be used in the measurement will be applied to the individuals included in the study. Then, sujok therapy will be applied to the intervention group. After 6 sessions in weeks in total, measurement tools will be applied and evaluated again.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Fatigue Severity Measurement - Visual Analogue Scale (VAS) fatigue score of 3 and above,
* Pain Severity Measurement - Visual Analogue Scale (VAS) pain score of 3 and above,
* Measurement of Nausea and Vomiting Severity - Patients with a Visual Analogue Scale (VAS) nausea and vomiting score of 3 and above will be included.

Exclusion Criteria:

* Loss of sensation, amputation, injury, colostomy, etc., which will prevent practice in hands. patients will be excluded from the study.
Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy

The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.


Eligibility Criteria:
Inclusion Criteria:

* Men with benign prostate hypertrophy requiring surgical treatment
* Age up to 80 years
* Documented, dated, written Informed Consent
* Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery

Exclusion Criteria:

* Any unstable medical, psychiatric, or substance abuse disorder
* History of previous prostatectomy
* Patients suspect of prostate cancer
* Hereditary degenerative retinal disorder
* History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment
* Any cardiovascular condition
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Uncontrolled atrial fibrillation/flutter at screening
* Severe chronic or acute liver disease
* Chronic hematological disease which may lead to priapism
* Bleeding disorder
* Significant active peptic ulceration
* Resting hypotension
* History of positive test for Hepatitis B surface antigen or Hepatitis C
* Symptomatic postural hypotension within 6 months of Visit 1
* Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well
* Subjects who are taking nitrates or nitric oxide donors
* Subjects who are taking androgens or anti-androgens
* Subjects who are taking potent inhibitors of cytochrome P4503A4
* Subjects who have received any investigational drug within 30 days of Visit 1
* Using of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate
* Use of inhibitors of 5-alpha reductase after ablation of prostate
* Subjects with serum creatinine clearance \<30.0 mL/min
* Elevation of Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) \>3 times the upper limit of normal
* Subjects with known hypersensitivity to Vardenafil
* Subjects who are illiterate or unable to understand subject diaries
* Subjects who would be non-compliant with the study visit schedule
Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)

The health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers.

The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue.

The concentrated interdisciplinary rehabilitation is characterised by three phases;

1. Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change
2. Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below)
3. Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living

The concentrated intervention:

The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely:

* Initiate treatment when the patient is ready for change
* Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices").
* Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others.
* Use long sessions to ensure that they face a broad range of potential micro-choices
* Work side-by side with others going through an analogous pattern of change
* Prepare them for taking responsibility for integrating the change into every-day living

Main outcomes will be

1. Completion rates
2. Patient satisfaction
3. Changes to perception of illness
4. Patient activation

Secondary outcomes will be

1. Level of functioning
2. Qualitative description of participants' experiences


Eligibility Criteria:
Inclusion Criteria:

* Competent to consent
* Motivated to participate throughout the project
* Digital competence

Exclusion Criteria:

* Medical conditions that could preclude proper participation
* Unable to take care of everyday needs (nursing requirements)
* Cognitive failure
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing informed consent
* Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
* HbA1c (glycosylated haemoglobin) 7.0-10.0% \[53mmol/mol-86mmol/mol\] (both inclusive) by central laboratory analysis
* Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
* Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
* Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
* Body mass index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
* Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
* Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
* Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
* Screening calcitonin at least 50 ng/L
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world HRU and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r DLBCL.

Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy or allo-HSCT between January 1, 2017 to September 31, 2019 were identified from the Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Database. The CAR-T cohort was further classified into CAR-T IP and CAR-T OP cohorts based on the infusion setting.

The index date was defined as the date of CAR-T therapy administration or allo-HSCT. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.

Two sets of comparisons on HRU and healthcare reimbursement costs were conducted, one between IP vs. OP infusion of CAR-T, and the other between patients who received CAR-T therapy vs. allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

CAR-T cohort:

* Patients had at least one International Classification of Diseases, Tenth Revision (ICD- 10) diagnosis code for DLBCL.
* Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received
* Patients were at least 18 years of age as of the index date
* Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required

Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.

Allo-HSCT cohort:

* Patients had at least one ICD-10 diagnosis code for DLBCL.
* Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received
* Patients were at least 18 years of age as of the index date
* Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required

Exclusion Criteria:

- Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date
Effects of Aerobic and Diaphragmatic Exercises on Choir Singers

The goal of this randomized-controlled study is to compare the effects of diaphragmatic breathing exercise training provided by a physiotherapist and aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist on respiratory functions and voice performance in choir singers.

The main questions this study aims to answer are:

* Is diaphragmatic breathing exercise training provided by a physiotherapist effective in improving the respiratory functions of choir singers?
* Is diaphragmatic breathing exercise training provided by a physiotherapist effective in improving the vocal performance of choir singers?
* Does aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist have a greater effect on improving the respiratory functions of choir singers compared to diaphragmatic breathing exercise training applied alone?
* Does aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist have a greater effect on improving the vocal performance of choir singers compared to diaphragmatic breathing exercise training applied alone?

The research data are going to be collected by Sociodemographic Information Form, International Physical Activity Questionnaire-Short Form, Self-Performance Evaluation Questionnaire, Vocal Fatigue Index, Singing Voice Handicap Index, measurement of maximum phonation time, pulmonary function test, maximal inspiratory and expiratory pressure measurement, and 6-minute walk test.

In this study, it will be examined whether aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist improves respiratory functions and voice performance in choir singers more, when compared to diaphragmatic breathing exercise training applied alone.

The participants will be randomly divided into three groups: diaphragmatic breathing exercise training group, aerobic exercise training group applied in addition to diaphragmatic breathing exercise training, and control group.

Eligibility Criteria:
Inclusion Criteria:

* Being a chorist in an active choir that rehearses at least once a week for an average of 2 hours
* Having an inactive or minimally active physical activity level according to the International Physical Activity Questionnaire-Short Form
* Being between the ages of 25-60
* Being willing to participate in the study

Exclusion Criteria:

* Having a neurological or orthopedic disease
* Having a condition related to the cardiopulmonary system that would prevent exercise according to the Physical Activity Readiness Questionnaire (PAR-Q)
Effect of Sarcopenia on Hepatocellular Carcinoma(HCC) After Systemic Therapies

Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.

By tracking the short-term and long-term results of HCC patients treated with systemic therapy,the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after systemic treatments was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.All implementation details are based on the newest EuropeanWorking Group on Sarcopenia in Older People(EWGSOP) definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes, the differences were analyzed and the relationship between sarcopenia and prognosis of systemic treatments was explored.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hepatocellular carcinoma
* No cancer other than liver cancer has been diagnosed
* Age ≥18 years
* child-pugh score≤7

Exclusion Criteria:

* uncompleted standard tests and questionnaires
* received other therapies
* Patients who had other causes of muscle weakness (injury, fracture, stroke, etc.)
* Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
* lost follow-up