cyrilzakka/clinical-trials huggingface dataset:
Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women

The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when taken daily).

This is an open-label single-arm longitudinal clinical trial to estimate medication adherence and retention in a PrEP HIV prevention program that implements a combination intervention strategy that uses text-messages (iTAB) and a staged adherence counseling support strategy titrated from real-time drug levels in women at-risk for HIV acquisition.

A total of 135 participants will receive the combined intervention of text messaging adherence reminders and adherence support. The text messaging system consists of daily, personalized, automated 2-way text messages to maintain adherence and retention. Participants that have a low intracellular tenofovir diphosphate (TFV-DP) concentration will receive escalated, targeted adherence support. All participants will receive access to PrEP in accordance with standardized comprehensive methods of prescribing and clinical assessments that include safety monitoring as well as regular HIV and sexually transmitted infection (STI) screening. All participants will be followed for 48 weeks after enrollment and will receive a post study follow-up at 60 weeks. The primary endpoint will be measured at 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female at birth and identifies as female gender
* Age 18 years or older
* Able to understand and provide consent in English or Spanish
* HIV negative by 4th generation test (Ag/Ab test) or combination of enzymeimmunoassay (EIA) and HIV RNA
* Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula)

At-Risk Criteria (at least one):

* Condomless sex in the last 3 months with one or more male partners of unknown HIV status known to be at substantial risk of HIV infection (IDU, bisexual, sex for goods, recently incarcerated, from a country with HIV prevalence \>1%, interpersonal Partner Violence);
* STI (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months.
* Previous post-exposure prophylaxis (PEP) use during the last 12 months.
* Has at least one HIV-infected sexual partner for ≥4 weeks.
* Sex for exchange of money, goods or services

Exclusion Criteria:

* Pregnancy at enrollment.
* Any condition, which in the opinion of the provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PrEP medication dosing, such as active, untreated or unstable major mental illness (i.e. untreated psychotic disorder).
* Use of prohibited medications, in particular, agents known to be nephrotoxic or drugs slow in renal excretion.
* Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
* Signs or symptoms suspicious for Primary HIV Infection (PHI).
Effect of Natural Antibacterial Mouthwash on Taste, Salivary pH and Bacteria in High Caries Risk pt

Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

This study will be carried out to evaluate and compare the effect of propolis extract mouthwash and pomegranate (botanical name: Punica granatum) extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

Thats by taking unstimulated saliva samples at the morning before using the mouthwash, then taking another one after using the mouthwash and finally after 7 days, to make a bacterial culture and measure the salivary pH by a digital pH meter and evaluate taste changes by a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* High caries risk patients defined according to American Dental Association (ADA)
* Systematically healthy
* Not taking any medication interfering with saliva secretion
* Subjects who signed informed consent
* Age range from 17-50 years

Exclusion Criteria:

* Subjects suffering from any medical or systematic disease
* Smokers
* Pregnant females
* Allergy to any of the mouthwash ingredients
* Patients older than 50 years
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.

Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.

Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique may benefit children undergoing revision of ostomy.

Eligibility Criteria:
Inclusion Criteria:

* children undergoing revision or closure of ostomy
* American Society of Anesthesiologists Classification 1-3.
* age ≥ 3 months

Exclusion Criteria:

* children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic
* children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
* postoperative admission to the intensive care unit
* children with a known allergy to bupivacaine
* children with a history of chronic abdominal pain
* use of opioid analgesics prior to surgery
* pregnancy
* impaired renal function
* impaired hepatic function
* known impaired cardiac function
* hypersensitivity to sodium metabisulfite
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin

This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (IM) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn feeling.

Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory

This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin.

For the primary goal - to examine the effects of oxytocin peripheral nerves after tissue injury - the investigators chose the controlled ultraviolet sunburn model.

The investigators propose a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. Following baseline measures on each of the two study days, participants will receive an intramuscular injection of oxytocin (Pitocin®) in its indicated dose of 10 IU (17 μg) or an equivalent volume of saline.

In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand.

Pain threshold to punctate stimulation within the area of irradiation will be determined using calibrated von Frey filaments and an up-down sequential method which efficiently estimates median thresholds.

Thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°C using a computer controlled thermode for a period of 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 and \< 60 years of age,
* Body Mass Index (BMI) \<40
* Generally in good health as determined by the Principal Investigator based on prior medical history
* Normal blood pressure and resting heart rate without medication

Exclusion Criteria:

* Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk
* Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years.
* Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Partner-Assisted Emotional Disclosure for GI Cancer

The long-range goal of this research is to develop better ways of helping GI cancer patients and their caregivers cope more effectively with the demands of the disease. The study is designed to test the hypothesis that a partner-assisted emotional disclosure intervention will be more effective in enhancing patient' psychological adjustment than a cancer education condition.

The diagnosis and treatment of GI cancer is a traumatic and life-altering event. Many patients with GI cancer experience significant emotional distress and disruptions in their social relationships as well as multiple physical symptoms and limitations in physical activities. There is evidence that cancer patients who are able to confide their feelings and concerns about the cancer experience with supportive others, particularly their partners, fare better. patients who are able to discuss cancer openly with their partners report fewer emotional and physical complaints, and higher levels of self-esteem and perceived control. However, there are a number of barriers that often inhibit discussion of cancer-related feelings. The proposed study will examine the effect of a new partner-assisted emotional disclosure (ED) protocol for patients with GI cancer.

In this study, 200 patients diagnosed with GI cancer and their partners will be recruited to participate. The couples will be randomly assigned to one of two conditions: 1) partner-assisted emotional disclosure, or 2) cancer education. Assessment measures will be collected at evaluations conducted before and after treatment and at 8 weeks post treatment. All evaluations will be conducted over the phone. Information will also be collected from the physician and/or the patient's medical record at each of the three evaluations. Audiotapes of the partner-assisted emotional disclosure sessions will be transcribed and 10-minute segments will be randomly selected and analyzed to assess the extent to which patients express emotions and partners verbally reflect the partner's feeling in an empathic manner.

Eligibility Criteria:
Inclusion Criteria:

* cancer of the GI system (esophagus, stomach, pancreas, liver, or colorectal; Stage II, III or IV), a life-expectancy of at least 6 months, living with a spouse or intimate partner in a committed relationship, English speaking, and an identified medical oncologist.

Exclusion Criteria:

* None other than absence of inclusion criteria specified above
Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).

A placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. During the experimental session, subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. Presented is the time frame at which the peak change was strongest by treatment arm. The possible peak numbers could be 1, 3, 5, 7 and 10 minutes."

Eligibility Criteria:
Inclusion criteria:

* Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
* Smoke ≥ 5 and less than 20 cigarettes per day;
* Urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker (23)
* Not seeking treatment at the time of the study for nicotine dependence;
* In good health as verified by medical history, screening examination, and screening laboratory tests
* For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion criteria:

* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
* Current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
* Use of e-cigarettes more than 10 days in the past 30 days
* Urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Clinical and Laboratory Characteristics of a Population of Children and Adolescents With Newly Diagnosed Type 1 Diabetes and Insulin Requirements at Onset

The clinical implication of this study lies in the identification of factors that may predict reduced insulin sensitivity in children and adolescents at the onset of Type 1 Diabetes and would help the physician to undertake appropriate therapy more quickly by achieving the correct therapeutic dosage, in order to achieve good metabolic compensation at an early stage and thus reduce the time (and costs) of hospitalisation.

The primary aim of this observational, retrospective, single-centre, non-pharmacological study is to assess whether the presence of clinical and laboratory predictive factors at the onset of type 1 diabetes may be related to an increased insulin requirement in a population of pediatric and adolescent patients with diagnosis of type 1 diabetes between January 2014 and December 2018 at the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy. The secondary aim is to assess the insulin requirement 1 year after the onset of type 1 diabetes. This study consists of collection and analyses of clinical and laboratory data of patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 14 years at the time of diagnosis of type 1 diabetes;
* Diagnosis of type 1 diabetes confirmed between January 2014 and December 2018 at the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy;
* Patients with at least 1 year of follow-up after diagnosis od type 1 diabetes;
* Obtaining informed consent from parents/legal guardian of pediatric patients.

Exclusion Criteria:

* Patients with diabetes other that type 1;
* Patients followed at other centres at the time of onset of type 1 diabetes.
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone\* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

\* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

Eligibility Criteria:
Inclusion Criteria:

* Patient is less than or equal to 21 years of age
* Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
* Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion Criteria:

* Patients with favorable risk features
* Patients with unfavorable risk features
* Patients who have received prior therapy for Hodgkin lymphoma.
Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors

Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment arm.

Primary objective: Determine the MTD.

Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with specific SOC treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Malignant disease appropriate for initiating treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.
2. Must be able to read, understand, and sign the IRB approved Informed Consent Form.
3. At least 18 years old.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.

Exclusion Criteria:

1. Any other active invasive malignancy except non-melanoma skin cancers or cervical carcinoma in situ.
2. History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.
3. Received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic or hormonal therapy other than LHRH agonists.
4. Received prior radiation therapy within the past 4 weeks.
5. Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
6. Patient requires treatment with immunosuppressive agents other than corticosteroids appropriate for the SOC chemotherapy regimen or those at stable doses for at least 2 weeks.
Dreaming During Anaesthesia and Anaesthetic Depth

Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor).

In this study, we will record the depth of anaesthesia during surgery with the BIS monitor and then interview patients immediately upon emergence to determine whether they recall dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* American Society of Anesthesiologists physical status 1-3
* Non-cardiac surgery under relaxant general anaesthesia
* Tracheal extubation planned at end of surgery

Exclusion Criteria:

* Inadequate English language skills (due to language barrier, cognitive deficit or intellectual disability)
* Major drug abuse or psychiatric condition
* Expected to be unable to co-operate or be available for followup
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.

GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis or septic shock,
* Presence of infection,
* 2 SIRS criteria,
* Acute organ dysfunction,
* Immunoparalysis,
* Informed consent

Exclusion Criteria:

* Pregnancy,
* Known allergies to study medication or components,
* Moribound patient,
* Autoimmune disease,
* HIV-infection,
* Acute MI or pulmonary embolism,
* Cpr during last 72 hours,
* Patients who participate in a different clinical study
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer

This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.

This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Not on Immune modulating drugs
* Life expectancy less than 6 months

Exclusion Criteria:

* Unable to tolerate phlebotomy
* Germ cell or stromal cell cancers of the ovaries
* Active autoimmune disease