cyrilzakka/clinical-trials huggingface dataset:
Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)

Non-randomized, open label single arm trial conducted at Fenway Health as a single site. 100 subjects will be enrolled following a high risk sexual exposure in which HIV exposure is a concern. Each person will be provided with detailed informed consent and if they agree, will receive a 28 day regimen of BIC/F/TAF (Biktary) in a single fixed-dose tablet. Subjects will be seen for 3 visits over a period of four months in which assessments will be done to evaluate safety of product, tolerability of product and HIV status. All subjects will be compared to historical controls in the previous one daily TDF-based nPEP studies which were conducted at Fenway Health.

Eligibility Criteria:
Inclusion Criteria:

1. \> Age of 18 at time of first visit.
2. HIV uninfected
3. Willing and able to provide written informed consent.
4. Willing and able to provide adequate locator information.
5. Willing and able to return to all study visits.
6. Willing to participate in all study procedures.
7. Childbearing age: Willing to use contraception for as long as they are on study medication plus 7 days after. (Appendix A: list of approved contraception).
8. Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. A possible exposure could include:

   1. Condomless anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage); or
   2. Condomless penile exposure to cervicovaginal secretions or anorectal secretions from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage)

Exclusion Criteria:

1. An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
2. Pregnancy and/or breastfeeding.
3. People who are actively trying to become pregnant.
4. Acute or chronic hepatitis B infection.
5. Acute or chronic renal disease.
6. Creatinine clearance at or below 30 mL/min (Cockcroft-Gault0 Known intolerance or allergy to tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, or bictegravir.

8. Currently taking or plans to take prohibited medication while enrolled in the study. (Appendix B: complete list of prohibited medications).

9. Non-English speakers.
Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study

The purpose of this study is to evaluate a) the feasibility of applying a painful exercise program in the treatment of subacromial shoulder pain and b) the time needed to collect clinical outcomes for a future randomized controlled trial.

Exercise therapy is the first choice of treatment in the management of subacromial shoulder pain (SSP). Guidelines suggest active rehabilitation program for at least three months and existing research highlights the importance of progressive loaded exercise therapy at higher dosage. However, it is not clear which is the best type of exercise and if pain should be provoked during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim of the future randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program. Since the intervention consists in painful exercises, it is essential to test the rate of adherence in the intervention group (both during physiotherapist-led session and home-based exercises). Moreover, the practicability of clinical questionnaire via online survey will be tested and the time needed to collect clinical data will be calculated as well. Furthermore, feedback from physiotherapists and participants will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Shoulder pain for at least 3 months
* Pain in the antero-lateral shoulder region
* At least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc between 60° and 120°, external resistance test
* Resting pain should be at 2/10 maximum on verbal NRS scale
* All types of occupations were included: students, workers (including overhead workers or heavy duty workers), people on sick leave and retired people

Exclusion Criteria:

* Bilateral shoulder pain
* Corticosteroid injections 6 weeks prior to the study
* Pregnancy, inability to understand spoken or written Dutch
* Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
* Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation)
* Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
* Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints)
* Primary diagnosis of acromioclavicular pathology, shoulder instability
* A radiologically confirmed fracture or presence of calcification larger than 5 mm
* Presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy)
* More than 4h of training in sport overhead shoulder activities per week
Incretin Effect in People With Impaired Fasting Glucose

Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose \<5.6 mmol/l and 2h OGTT \<7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT \<7.8 mmol/l).

Exclusion Criteria:

* Subjects were excluded for: thyroid stimulating hormone \<50 or \>500 milliunits/L, fasting triglycerides \>10.3 mmol/l, creatinine \>130 μmol/l, elevated liver function tests (\>2 times normal), hematocrit \< 38%, or white blood cell count \<3.0 x 103. Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI \<25 or \>40 kg/m2. Diabetes or impaired glucose tolerance.
Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide

Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with At-Home vital tooth whitening using 20% carbamide peroxide

Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide 4h/day for a week, the sample will be divided into two groups : the experimental group will apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment, the control group will apply placebo paste 30 min/day after bleaching treatment,

Eligibility Criteria:
Inclusion Criteria:

* Good dental health
* Six maxillary anterior teeth present and healthy with no restorations or carious lesions
* Teeth darker than Vita A2 shade
* No history of teeth sensitivity
* No use of a desensitizing agent or desensitizing toothpaste in the past three months

Exclusion Criteria:

* Active caries or periodontal disease
* Allergies to bleaching agent or tray material
* pregnancy and breastfeeding during the trial
* tetracycline-stained teeth or fluoride or non-vital teeth
* Smoker
* Using tooth bleaching products during the last 3 years
Evaluation of Osseointegration Process of Dental Implants

Implant stability is critical to successful osseointegration, the direct structural connection between the dental implant surface and bone. Implant stability must therefore be measured to evaluate implant success. The study evaluated the osseointegration of different sizes with two devices measuring stability with different methods.

The 39 implants, 4.0 and 4.5 mm in diameter and 10 and 12 mm in length, in 19 patients were included. Hounsfield unit (HU) values obtained on cone beam computed tomography (CBCT) were recorded. Stabilities were measured with Periotest and resonance frequency analysis (RFA) at day 0 (intra-operative) and the 1st (T1), 4th (T4), and 12th (T12) weeks. Probing depth (PD) and bleeding on probing (BOP) scores were compared between T1 and T4.

Eligibility Criteria:
Inclusion Criteria:

* Absence of any systemic disease
* being older than 20 years of age
* having partial tooth deficiency in the posterior region of the lower jaw (molar tooth deficiency)
* having an indication for dental implant-supported fixed prosthesis
* at least 6 months had elapsed since the last tooth extraction in the area to be implanted
* having a soft tissue thickness of at least 1.5 mm and adherent gingival width of at least 2 mm
* the existence of panoramic and dental volumetric tomography images of the area to be implanted
* the presence of a suitable recipient bone for implantation with dental implants of the desired length and diameter
* completion of periodontal treatment and provision of oral hygiene training; and acceptable existing gingival health and oral hygiene for implant application (periodontally healthy) in the oral examinations performed following periodontal treatment.

Exclusion Criteria:

* being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System
Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)

The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.

Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter Intensive Care Unit (ICU) length of stay, as well as better resource rationalization. Actually there is no agreement on the best timing for tracheostomy. The aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. Secondary endpoints are: increase of ventilator free-days and mortality reduction.

Eligibility Criteria:
Inclusion Criteria:

* Oro/nasotracheal intubation for less than three days
* Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)

Exclusion Criteria:

* Oro/nasotracheal intubation \> three days
* Age \< 18 years
* Previous otolaryngologic or maxillofacial procedures
* Brain injury patients with intracranial pressure \> 20 mmHg without pharmacological treatment (or intracranial pressure \> 15 mmHg under specific pharmacological treatment) and with cerebral perfusion pressure \< 60 mmHg
* Pregnancy
* Ventilator associated pneumonia, hospital acquired pneumonia, community acquired pneumonia diagnosis before randomization
* Infection in the tracheostomic area
* Acute worsening of chronic obstructive pulmonary disease (COPD)
* Pre-existing malignancies in the tracheostomic area
* Immunosuppressed and/or immunodepressed patients:

  * leukocytes \< 1000/microliters
  * neutrophils \< 500/microliters
  * AIDS
  * long-term steroid treatment (daily dose \> 0.5 mg/kg for more than 30 days)
* Patients already enrolled in other trials
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency

The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.

Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy
* ECOG performance status points (PS) is 0-2
* Liver function:

A (mild hepatic dysfunction):

A1) total bilirubin within normal limit (ULN), while AST\> ULN;

A2) total bilirubin within1.0-1 .5 × ULN;

B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN

* No malabsorption or other gastrointestinal disorders effecting drug absorption
* Life expectancy: more than 12 weeks.

Exclusion Criteria:

* Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
* Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
* Patients with active hepatitis and cirrhosis.
Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections

This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.

This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.

Eligibility Criteria:
Inclusion Criteria:

* Pts undergoing sleeve gastrectomy
* Pts undergoing colectomy

Exclusion Criteria:

* Unable to give or understand consent
* All of the excised tissue will be needed for diagnostic purposes
Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

The aim of this study is to compare clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.

Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems.

For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.

Eligibility Criteria:
Inclusion Criteria:

1. Children with MIH in one fully erupted molar or more.
2. Age ranging from 7-12 years.
3. cooperative children
4. Good general health.

Exclusion Criteria:

1. patients participating in other experiments.
2. Patients with parents planning to move away within the following year.
3. Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
4. MIH-affected molars that have a very poor prognosis and require extraction.
5. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.
Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects

This study gave healthy people supplements with ginseng and astragalus saponin extracts (AstraGin), combined with whey protein, to explore whether it can promote amino acid absorption and thereby enhance protein nutritional status and muscle function.

This trial is a randomized, double-blind, crossover trial, and the research subjects are adult healthy subjects.

A randomized-double blind, crossover human trial. 30 healthy adults, subdivided into two groups, are randomized into treatments and placebo groups to ensure equally balanced randomization and comparability, considering factors including age, sex, and diet.

(2) The 1st round: Before each study day, all subjects took a 50 mg AstraGin/placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg AstraGin/placebo and 35 g of whey protein with 250 mL water.

(3) Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min to analyze the plasma concentration of amino acids.

(5) The washout period is seven days, during which the subjects maintain a stable lifestyle and dietary habits. The 2nd round: All subjects take a 50 mg Placebo/AstraGin capsule and conduct the procedure (same as the 1st round)

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults and aged 20-65 years.
* Subject has provided written informed consent to participate in the study.
* The subject is willing and able to comply with the study.

Exclusion Criteria:

* The subject is participating in another clinical trial thirty days prior to enrollment.
* Subject allergy to milk proteins
* Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kidney disease, current infections, and smoking were exclusion criteria.
* Subject has any medical condition or uses any medication, nutritional product, amino acids supplement, or program which might interfere with the conduct of the study or place the subject at risk.
* Subjects lost to follow-up, non-compliance, and concomitant medication.
Evaluation of the Long-term Efficacy and Safety of Monofocal Plate Haptic Intraocular Lens

Our study aims to determine the efficacy and safety of the monofocal plate haptic intraocular lens to be implanted in patients planning for cataract surgery and to determine the complications that may develop due to the lens.

This study was planned to be performed on 300 eyes with surgical indication due to cataracts in Van Yüzüncü Yıl University Faculty of Medicine Ophthalmology Outpatient Clinic. Uncorrected and best-corrected visual acuity, subjective refraction, slit-light biomicroscopy, optical biometry, anterior segment optical coherence tomography, intraocular pressure, endothelial cell count in the pre-and postoperative (1st, 3rd, and 12th months) controls of the patients. Fundus examination will be performed, and postoperative complications and accompanying ocular pathologies will be recorded. Data before and after surgery effectiveness will be evaluated. Reliability will be interpreted by considering postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender
* Assured follow-up examinations
* Biometry measurement preferably compatible with the Lenstar evaluation;
* IOL implanted into the capsular bag with IOL model Acriva BB UDM 611 (UVE material) in one or both eyes

Exclusion Criteria:

* BCVA not available preoperatively or better than 0.3 logMAR pre-op
* Patients unable to meet the limitations of the protocol or likely to non-cooperation during the trial
* Patients with peroperative complications (Such as capsulorhexis problems that affect centralization, failure of the IOL implanting into the bag, posterior capsular rupture, iris damage, vitreous loss, IOL damage, etc.)
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.

The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.

Eligibility Criteria:
Inclusion Criteria:

* Cases of bilateral visually significant cataract

Exclusion Criteria:

* Poor pupil dilation(less than 6 mm diameter).
* History of previous eye surgery or trauma
* History of use of eye drops affecting pupil size such as pilocarpine.
* Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine.
* Pediatric age group (less than 18 years old).
* Pupil abnormalities, such as anisocoria or neurological disorders.
* Associated glaucoma, uveitis, corneal, retinal or optic nerve disease.
* Cases scheduled for phacoemulsification under general anaesthesia (to exclude possible ocular and systemic effects or interactions of anaesthetic agents).
* Patients with bleeding tendency or on anti-coagulant therapy (because peribulbar and subconjunctival injections are used).