cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to \< 18 years of age.


Eligibility Criteria:
Key Inclusion Criteria:

* Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
* Weight ≥ 35 kg (77 lbs.)
* Plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 6 months
* CD4+ cell count \> 100 cells/μL
* No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
* Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
* No evidence of current hepatitis B virus (HBV) infection
* No evidence of current hepatitis C virus (HCV) infection

Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Key Exclusion Criteria:

* A new AIDS-defining condition diagnosed within the 30 days prior to Screening
* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
* Pregnant or lactating subjects

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

Colposcopy is an extremely important part of womens healthcare in the prevention of cervical cancer. Women report feeling extremely anxious attending colposcopy, due to the association with cancer and the intimate nature of the examination.

The goal of this clinical trial is to investigate where the use of virtual reality headsets during outpatient colposcopy appointments has any effect on womens' experience. The main question\[s\] it aims to answer are:

* Does the use of virtual reality headsets reduce anxiety in patients attending colposcopy
* Does the use of virtual reality headsets reduce pain in patients attending colposcopy

Patients will offered to enroll in the trial when they attend for their colposcopy appointment.

Participants will fill out a questionnaire to measure their anxiety beforehand and collect patient demographics.

They will be randomly allocated into the intervention arm or the control arm. This means they will either use virtual reality headset in addition to the standard care, or have standard colposcopy care only After their colposcopy, they will then be asked to to fill out another questionnaire to measure anxiety and pain levels.

If there is a comparison group: Researchers will compare the results from the women who had colposcopy while using the virtual reality headsets to women to see if there is any meaningful difference in anxiety while using the virtual reality headsets.


Eligibility Criteria:
Inclusion Criteria:

* Patients
* women over 18 years of age who attend for outpatient colposcopy and provide informed written consent
* Staff
* Have completed colposcopy training and be a registered member of the British Society of Colposcopy and Cervical Pathology (BSCCP)
* Informed written consent to take part in the trial.

Exclusion Criteria:

* Patients :
* Significant hearing or visual impairments that may effect communication
* Any known characteristics that may make the office procedure more difficult (eg. previous LLETZ, previous cervical conisation, uterine didelphis)
* Inability to provide consent.
* Denial or withdrawal of informed consent orally

Staff :

* The denial or withdrawal of informed consent.
* Trainee colposcopist performing clinic.
A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.

The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential or healthy male subjects who are between the ages of 18-45 years or 65 years of age or older.
* Body mass index (BMI) of 17.5 to 40 kg/m2

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Pregnant females; breastfeeding female subjects; male subjects with partners currently pregnant
* Treatment with another investigational drug within 30 days or 5 half-lives preceding the dose of study medication
* Blood donation within 60 days prior to dosing.
A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

1. To research the current situation of severe infection in children in China, and to investigate the incidence, prognosis and disease burden of severe infection in children in different regions of China. 2. Establish the risk prediction model and diagnosi model of severe infection in children, and verify the accuracy of the model in multi-center; 3. To study the effectiveness and safety of different treatments in real diagnosis and treatment, and to evaluate the efficacy of subgroups under different ages and high risk factors.

1.Children between 0 and 18 years old. 2.Severe pneumonia and/or sepsis.Patients were included who meet the guidline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children. 3.notifiable infectious diseases.4.The researcher believes that he is not suitable to participate in other situations in this study.5.Participants in other clinical trials in the same period.

Eligibility Criteria:
Inclusion Criteria:

1. Children between 0 and 18 years old.
2. Severe pneumonia and/or sepsis.

Exclusion Criteria:

1. notifiable infectious diseases.
2. The researcher believes that he is not suitable to participate in other situations in this study.
3. Participants in other clinical trials in the same period.
Telomeres and T-cell Receptor Excision Circles (TRECs) From Peripheral Blood in Normal Subjects Over Time

The Investigators have established a cohort of patients with recent-onset inflammatory arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to define novel biomarkers of poor outcomes. We want to study telomere length and T-cell Receptor Excision Circles (TREC) numbers in peripheral blood as new biomarkers.

This cohort of normal controls was established to be able to define the stability over short periods of time of telomere length and TREC numbers in normal individuals, in order to compare with arthritis patients.

It is difficult to establish early on the prognosis of patients with recent-onset polyarthritis. We want to know if we can use the length of telomeres in peripheral blood cells at baseline as a novel prognostic marker.

In order to be able to interpret our observations in arthritis patients over time, we need to compare these results with those observed in normal human controls adjusted for gender and for age groups.

These patients are first screened for the presence of acute or chronic severe diseases (cancer, cardiovascular, articular, et...). They then have genomic DNA extracted from peripheral blood at Baseline and at 3 months interval for a year than annually for a total duration of 5 years. A complete blood count is collected at each blood draw. At each blood draw, the appearance of acute or chronic diseases is noted.

Eligibility Criteria:
Inclusion Criteria:

Healthy-for-age subjects, as defined by Absence of acute infectious, traumatic or immunologic disease; Absence of severe chronic diseases Age and sex concordant with the stratification of patients from a longitudinal cohort of early inflammatory arthritis (EUPA)

Exclusion Criteria:

History of cancer (except a single episode of non-melanocytic skin cancer) Severe cardiovascular disease (i.e. difficult to control or requiring multiple drugs) Chronic infection Inflammatory arthritis Severe high blood pressure or diabetes (i.e. difficult to control or requiring multiple drugs) Any severe disease affecting function or difficult to control or requiring multiple drugs
The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia

INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients are recommended to have colonoscopy frequently. The aim of this study is to search the effect of DM on hemodynamics, procedure times, anesthetic consumption and complications in colonoscopy under sedoanalgesia.

MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of Başkent University, this study is planned to be prospective and double-blind in 50 type II diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of 18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy, previous adverse reactions to medications used in the study, history of anesthesia and sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic sensorymotor and autonomic neuropathy.

After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2, respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other effects will be recorded.

EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that diabetic patients have during colonoscopy and applying a special patient care protocol for these patients is suggested to improve the procedure and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18-65 years old
* Type II diabetic and non-diabetic

Exclusion Criteria:

* Age outside the range of 18-65 years
* ASA phsical status ≥ 3
* Inability to provide informed consent
* Pregnancy
* Previous adverse reactions to medications used in the study
* History of anesthesia and sedation in the last 7 days
* Psychiatric or emotional disorders
* Addiction to the opioids or sedatives used in the study
* Diabetic nephrophathy, high BUN and creatinine values
* Advanced stages of diabetic nonalcoholic liver disease and high liver function tests
* Diabetic sensorymotor and autonomic neuropathy
Chlorhexidine Gluconate Versus Povidone-iodine

A hysterectomy, or removal of the uterus, is a common surgery performed for a variety of reasons. During this surgery, to prevent infection, the vagina is thoroughly prepped with a cleansing solution, most commonly chlorhexidine gluconate or povidone-iodine. While studies have shown that chlorhexidine gluconate is better at killing bacteria people have raised concerns on how it affects the vaginal tissue. It is important to study these effects the cleansing solution surgeons use for this surgery can not only prevent infection but not cause harmful side effects.

The purpose of this study is to examine the effects of different vaginal operative preparations on the vaginal tissue and microbiome. Our primary working hypothesis is that chlorhexidine prep is more deleterious to vaginal tissue than povidone-iodine preparations.

Hypothesis 1: chlorhexidine gluconate is more disruptive to the vaginal microbiome than povidone-iodine Hypothesis 2: chlorhexidine gluconate leads to more vaginal atrophy than povidone-iodine

Eligibility Criteria:
* Inclusion Criteria:

  1. Females
  2. all races and ethnicities
  3. English-speaking
  4. pre-menoupausal
  5. undergoing gynecologic surgeries requiring vaginal operative preparation at Banner University Medical Center - Phoenix.

Exclusion Criteria:

1. Patients with dx of vaginitis or vulvovaginal atrophy at time of surgery
2. Patients with an allergy to povidone-iodine and/or Chlorhexidine Gluconate
3. Individuals with any skin conditions, as determined by the physician, which could interfere with the conduct of the study or increase the risks to the test subject including any open or healing cuts/incisions, abrasions, or broken skin in the testing area as determined by the physician
4. Currently menstruating
5. Be using or have used antibiotics, antifungals, topical steroids or antiviral (oral or topical in the testing areas) less than 12 weeks prior to visit
6. Have a history of or current, self-reported genital herpes
7. Have current or in the past 6 weeks, conditions such as

   1. Vaginal infection/bacterial vaginosis/yeast infection or sexually transmitted infection (Chlamydia, Gonorrhea or Trichomonas)/Hepatitis/HIV
   2. Vulvar infection
   3. Urinary tract infection
8. Sexual intercourse less than 48 hours prior to the visit
9. Current treatment for any skin conditions on the testing area
Intermittent Versus Continuous Tarceva Study

This is a randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.

To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* ECOG performance status of 0-2.
* Histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease.
* At least one unidimensionally measurable lesion with a diameter \>20 mm using conventional CT or MRI scans, or \> 10 mm with spiral CT
* No prior drug treatment or chemotherapy for metastatic disease.
* No prior HER2 or EGFR inhibitors. No prior Oxaliplatin in any clinical setting.
* Absolute granulocyte count \> 1.5 x 109/L, platelet count \> 100 x 109/L, hemoglobin level \> 9.0 g/L, INR \< 1.5.
* Adequate renal \& hepatic functions: serum creatinine \< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \> 50ml/min, serum bilirubin \< 1.5 x ULN, ALT \< 2.5 x ULN or \< 5 x ULN in case of liver metastases, albumin level \> 30g/dL).
* Prior adjuvant or neoadjuvant chemotherapy for non-metastatic CRC is allowed if \> 3 months has elapsed since the last dose of chemotherapy.
* Prior open surgery is allowed if \> 28 days\* has elapsed since the date of surgery, wound healing is satisfactory and recovery from any complications from the surgery is adequate. (\*For laparoscopic surgery, \> 14 days from the date of surgery).
* No serious medical conditions such as myocardial infarction within 6 months prior to entry, or any other medical conditions that might be aggravated by treatment

Exclusion Criteria:

* Prior history of any malignancies, except basal cell cancer of skin, cervical CIN.
* Treatment with radiotherapy \< 30 days.
* Pregnant or lactating females
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
* Patients who have not recovered from surgery or other medical illness such as infection.
* Evidence of central nervous system disease. Patients with a history of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from the study
* Patients lacking physical integrity of upper gastrointestinal tract or malabsorption syndrome or unable to swallow tablets.
* Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency).
* Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
* Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
* Known peripheral neuropathy ≥ NCI CTC grade 1.
* Current or recent (within 10 days prior to study treatment start) use of full-dose oral anticoagulant (e.g. warfarin) or thrombolytic agent.
INtervention Study In overweiGHT Patients With COPD

Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.


Eligibility Criteria:
Inclusion Criteria:

* 40 years or older at time of eligibility screening;
* Body mass index 25.0-44.9 kg/m2 (also see Figure 2);
* Smoked more than 10 pack-years of cigarettes;
* Shortness of breath;
* COPD;
* Able to participate fully in all study protocol/procedures including written informed consent process.

Exclusion Criteria:

* Inability to speak, read, or understand English;
* Active weight loss interventions;
* Expected weight loss because of alternate explanations, such as from illness;
* Unable to ambulate to weight scale for weight measurement;
* Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy \<18 months;
* Pregnant, lactating, or planning to become pregnant during the study period;
* Participation in other intervention studies.
mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence

If taken every day, PrEP is an effective method for preventing HIV. However, many prescribed PrEP in the U.S. do not take it every day, as prescribed. The goal of this study is to develop and test an intervention, facilitated by a mobile app, meant to improve adherence to PrEP. To that end, 60 individuals prescribed PrEP who do not take their PrEP every day as prescribed will be recruited. Participants will complete an initial research interview, receive a one-on-one PrEP adherence session with an adherence coach, and complete follow-up interviews at 1, 3, 6, and 12 months. In addition, some participants will be randomized to receive access to a mobile app and adherence coaching via the app for 12-months. The primary outcome is self-reported adherence to PrEP. This study will examine whether this intervention is effective at improving adherence to PrEP, is feasible to use, and found acceptable by those who use it.

HIV pre-exposure prophylaxis (PrEP), involves the use of antiretroviral (ART) medications (Truvada or Descovy) by persons uninfected with HIV to prevent HIV acquisition. The efficacy of PrEP for preventing HIV acquisition is highly impacted by one's medication adherence. Within the U.S., adherence to PrEP is suboptimal. Commonly cited barriers to PrEP adherence include forgetfulness, low HIV risk perception, stigma, and cost. There is a need for interventions that improve adherence to PrEP, are readily disseminable, and that make efficient use of resources. To that end the current project will examine the feasibility, acceptability, and preliminary efficacy of an intervention tailored for PrEP adherence, facilitated by mHealth. Individuals prescribed PrEP (n = 60) who report taking, on average, fewer than 6 doses per week in the past month will be recruited. Participants will be randomly assigned to the intervention (Carium) or control condition. Data collection will consist of a baseline interview and follow-ups at 1, 3, 6, and 12 months. The primary outcome is PrEP adherence. PrEP adherence will be measured via self-report, pill counts, and use of a urine test developed by UrSure. The urine test is for research use only and will only be used to detect the presence of PrEP in urine if participants self-report taking PrEP in the last 48 hours. It is expected that participants in the Carium condition, relative to control, will report better adherence to PrEP.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age,
* has a prescription for PrEP
* received first prescription for PrEP at least one month ago
* reports taking an average of fewer than 6 PrEP doses per week of over the past month
* has phone that is compatible with the Carium app.

Exclusion Criteria:

* cognitive impairment that would jeopardize informed consent and/or intervention comprehension
* active psychosis
* not fluent in English.
Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis

Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion. This is a single arm study with no control. All patients receive cell therapy.

Patients with verified diagnosis Hodgkin's lymphoma or non-Hodgkin's lymphoma will undergo peripheral blood stem cell mobilisation and collection (chemotherapy + G-CSF or G-CSF+Plerixafor).

After that high-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme).

Patient will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells infusion 48 hours after last administration of cytotoxic agent . Number of cells calculated according to patient's body weight (1,5-2,0 mln of cells/kg), time of infusion - 30 minutes. Two hours later patient will receive autologous peripheral blood cells infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffers from Hodgkin's lymphoma, non-Hodgkin's lymphoma with complete or partial remission.
* Patient is candidate to high-dose chemotherapy with subsequent autologous hematopoietic stem cell transplantation.
* Absence of infection, cardiovascular, respiratory, renal and hepatic dysfunctions, focal neurological symptoms.
* Karnofsky score at least 70.
* Patient successfully undergone mobilization of peripheral blood stem cells.
* Patient is familiar with Participant information sheet.
* Patient signed informed consent form.

Non-inclusion Criteria:

* Severe chronic comorbidity with symptoms of organ or system failure.
* Significant abnormalities in laboratory tests.
* Participation in other clinical trials (or intake of study drugs) within prior 3 months.
* Conditions restricting commitment to participating in the trial (dementia, neuropsychiatric disorders, drug and alcohol abuse)
* Patients with malignant solid tumors.
* Patients with medical history of heterotopic ossification.

Exclusion Criteria:

* Progression or relapse of lymphoma during therapy.
* Confirmed syphilis, HIV, hepatitis B or C infection
* Absence of clinical and laboratory signs of hematopoietic recovery and persistent enterocolitis at day 14 after the manipulation (Visit 15). While the patient remains in the hospital and continues treatment according to requirements of standard therapy