cyrilzakka/clinical-trials huggingface dataset:
Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction

The purpose of this study is to assess how Cannabidiol (CBD) impacts the effectiveness of oral contraceptive (birth control) pills and if CBD changes the possible side effects of birth control pills when CBD and birth control pills are taken at the same time.

This study explores the potential interaction between CBD and birth control pills by assessing serum levels of the contraceptive steroid hormones ethinyl estradiol and levonorgestrel in birth control pill users when they also use CBD.

Participants will be randomized to either the CBD or placebo for cycle one, followed by a washout cycle. For cycle three, participants will take the opposite of what they received in Cycle one. For example if they received CBD during cycle one they will take placebo for cycle 3.

Eligibility Criteria:
Inclusion Criteria:

* Have regular menses (every 21-35 days)
* Not at risk for pregnancy (not sexually active, using a barrier method of birth control, using a copper IUD for birth control, have a partner with a vasectomy, have had a tubal ligation, or in a same sex relationship)
* Generally healthy women between the age of 18 to 35 years old
* English speaking

Exclusion Criteria:

* Active users of hormonal contraception

  1. For combined methods, if they have recently stopped use, they must have had one normal menstrual cycle
  2. For prior Depo-Medroxyprogesterone Acetate users, they must be off of the medication for 2 months and be having regular menstrual cycles
* Pregnancy (less than 6 weeks prior), breastfeeding (less than 6 weeks prior),

  a. If participants have a normal menstrual cycle after these events, they may be considered for enrollment
* Any absolute/relative contraindications to EE and LNG (MEC category 3 or 4 \[12\]) including impaired liver function, history of deep venous thrombosis, hypertension (\> 140/90), diabetes with vascular changes, migraines with aura or neurological changes, history of myocardial infarction, pulmonary embolus, stroke or breast cancer.
* Use of CBD or THC products / Marijuana in the last 30 days
* Use of a known CYP450 inhibitor or inducer (other medication)
* BMI\>25
* Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
* Impaired liver or renal function
* Smoking/vaping/e-cigarettes
* Prior bariatric surgery
* Decisional impairment
* Incarceration
Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population

The primary goal of this study is to determine the most effective SARS-CoV-2 testing strategy for successful return of in-person school in the under-served communities of St. Louis.

Regular screening testing has been recommended by the CDC as an additive mitigation strategy for in-person schools in areas of high community transmission. We will compare the effectiveness and acceptance of two different school-based testing strategies among students and school staff (symptomatic testing only versus weekly surveillance testing plus symptomatic testing), measuring school-based SARS-CoV-2 transmission through a cluster randomized trial.

We will complete a cluster randomized trial to compare the incidence of school-based SARS-CoV-2 transmission between weekly screening testing of students and school staff versus testing only symptomatic students and staff. In this proposal, 16 middle and high schools from five school districts in the St. Louis metropolitan area will be cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. The symptomatic testing will be provided to the entire school community as well as household members of students and staff.

The second Aim will evaluate existing mitigation strategies utilized in schools and the rate of school-based SARS-CoV-2 transmission by defining the mitigation strategies utilized in participating schools through survey tools developed with CDC and their impact on school-based COVID-19 transmission and quantifying the rate of COVID-19 transmission in schools and the impact of this transmission on households through extensive interviews and testing of contacts and household members.

Our 3rd Aim involves partnering with community-based organizations to specify and address the social, ethical, and behavioral implications of in-person schooling during the COVID-19 pandemic and the impact of SARS-CoV-2 testing on the school and community. Listening sessions will be utilized to understand barriers and facilitators to testing, ethical concerns of the community in research participation, and the behavioral health impact of lack of in-person schooling.

Eligibility Criteria:
Inclusion Criteria:

* A student or staff in one of the five school districts.
* Household members of a student or staff member in the five school districts.

Exclusion Criteria:

* People not affiliated with the school.
Safety and Efficacy Evaluation of Decitabine With R-GDP

Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients

RR NHL patients will be treated with decitabin plus R-GDP , safety and efficacy will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory Non-Hodgkin's lymphoma(NHL) patiens.
2. Eastern Cooperative Oncology Group(ECOG) score 0-2
3. Expected survival \>3 months
4. Measurable disease.

Exclusion Criteria:

1. Patients who needs treatment with immunosuppressive agents
2. Hematosepsis or Uncontrolled active infection
3. History of epilepsy or other CNS disease.
4. Active hepatitis B , hepatitis C or HIV infection or any other uncontrolled active infection.
5. Pregnancy or breast-feeding women.
6. Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
7. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluatio
Caesarean Scar Revision With the UltraPulse

Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site.

Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control.

The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated scar side.


Eligibility Criteria:
Inclusion Criteria:

1. Females in good general health older than 22 years of age and younger than 55 years of age.
2. Presenting with a caesarean scar mature and stable caesarean scar (at least 1 year post procedure).
3. At least six months following termination of breast feeding.
4. Willing to give and sign an informed consent form and a photographic release form.
5. Willing to comply with study dosing and complete the entire course of the study .
6. Performed negative pregnancy test.

Exclusion Criteria:

1. Active bacterial, fungal, or viral infection in the treatment area.
2. Active cold sores, or herpes in the treatment area.
3. Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study .
4. History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
5. Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics).
6. History or presenting with a keloid scar.
7. Any current or recent treatment for cancer.
8. Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
9. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
10. Previous laser treatments on the same scar at least 0.5 year prior to this evaluation.
11. Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator .
12. Any other condition that may exclude patient for treatment per physician discretion.
13. Female subject who is pregnant, nursing an infant .
The INSPIRE-ASP UTI Trial

The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen.

Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.


Eligibility Criteria:
Facility Inclusion Criteria:

* HCA hospitals admitting adults for UTI
* Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age \>=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI. Prisoners were excluded from prompts and analysis.
Perioperative Use of NAC to Prevent AKI in Patients With Pre-existing Moderate Renal Insufficiency Following Cardiac Surgery

Acute kidney injury (AKI) or renal impairment is an established complication of cardiac surgery occurring with an incidence up to 30%, To date, no agent has conferred renal protection. Considerable interest has developed in the potential for Nacetylcysteine (NAC) to exert a renoprotective effect in patients undergoing cardiac surgery. Due to the beneficial effect of NAC on contrast nephropathy and its reported anti-inflammatory effects.

Acute kidney injury (AKI), is a well-known complication of cardiac surgery, with an incidence of up to 30% depending on the definition. AKI caused by cardiac surgery is the second most common cause of AKI in the intensive care unit and is a common and serious postoperative complication of cardiac surgery requiring cardiopulmonary bypass (CPB).

The pathogenesis of AKI after CPB is multifactorial, and is mostly due to hypo perfusion, reperfusion injury, activation of the systemic inflammatory response, and/or low cardiac output. Reperfusion will result in the formation of reactive oxygen species, resulting in injury to tissues.

The activation of the systemic inflammatory response is mostly due to the exposure of blood to the extracorporeal CPB circuit, resulting in the activation of the immune system, which is also mediated by the generation of reactive oxygen species. This results in increased recruitment of neutrophils, macrophages, and lymphocytes into the renal parenchyma, leading to AKI.

N-acetylcysteine (NAC) is well known for its antioxidant and free-radical scavenging properties, as well as its vasodilator properties. Its antioxidant properties enable it to prevent ischemic cell death, and as a free-radical scavenger, NAC mitigates the effect of increased reactive oxygen species caused by reperfusion. Hence, theoretically, NAC is able to counteract several mechanisms of kidney injury during cardiac surgery, namely, the systemic inflammatory response, free-radical injury, and ischemia.

In this study, we aimed to investigate if the perioperative use of acetylcysteine will prevent kidney injury after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria

* Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
* Pre-existing moderate renal insufficiency serum creatinine more than 1.5 mg/dL

Exclusion Criteria:

* Patients on hemodialysis preoperatively
* History of renal transplantation
* IV contrast within 4 days prior to surgery
* Urgent/emergent surgery
* Preoperative hemodynamic instability (intra-aortic balloon pump support or vasoactive medications)
* Planned off-pump surgery;
* Planned deep-hypothermic-circulatory-arrest
* known or suspected allergy to NAC
* Patient Refusal.
The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Success of Surgery

After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. In postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery


Eligibility Criteria:
Inclusion Criteria:

* stress incontinence
* resistant to medical treatment

Exclusion Criteria:

* had no surgery before
* has no accompanying uterine descensus
* has no neurogenic disorder
Chromocolonoscopy With Food-grade Dyes

Previous with methylene blue suggested that oral administration may be superior to conventional spray catheters. The main advantages claimed were better staining due to longer exposure to the dye, more uniform staining due to normal position of the intestines (during conventional chromocolonoscopy, patients are lying on one side), and a quicker and more comfortable procedure for the patients and endoscopy personnel.

Using food-grade dyes would enable higher dye loads and lower systemic side effects.

Food grade dyes will be administered orally during preparation with KleanPrep (total amount of 4 liters) in patients undergoing screening colonoscopy.

On day 1 patients will drink 3 l of the preparation solution, the last liter together with the last dose of dye will be administered 5 hours before scheduled colonoscopy.

Primary endpoints:

* quality of mucosal staining of colon (assessed by questionnaire)

Secondary endpoints:

* adenoma detection rate
* adverse events
* time of colonoscopy


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and post-menopausal females aged 18 to 75 y and scheduled for screening colonoscopy
* body weight ≥60 kg
* good health based on medical history, physical examination, a 12-lead electrocardiogram (ECG) and routine haematology and blood chemistry tests
* ability to understand and comply with the protocol
* written informed consent

Exclusion Criteria:

* standard criteria for bioavailability estimation of new drugs, namely (i) intake of any medication, (ii) a history of drug, caffeine (\>5 cups coffee/tea/day) or tobacco (≥10 cigarettes/day) abuse, (iii) history of alcohol consumption in excess of two drinks per day in males and one drink per day in females
* known or suspected hypersensitivity to food colourants,
* GI obstruction or perforation
* serious cardiovascular, renal or hepatic disease
* prolonged prothrombin time, elevated INR (international normalized ration)
* elevated serum creatinine
* any other severe underlying medical condition
Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)

This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy

Thalidomide has already been used as maintenance and/or consolidation after high-dose therapy followed by autologous stem cell transplantation. Despite a number of phase II and III studies the issues of right dose and duration of thalidomide and subsets of patients benefiting from it have not yet been settled We explored the maintenance therapy after thalidomide, dexamethasone and pegylated liposomal doxorubicin called ThaDD protocol. Patients with de novo or relapsed MM obtaining at least minor response after 4 to 6 ThaDD courses, were randomized to receive standard maintenance therapy with IFN 3 MU 3 times a week or an experimental maintenance therapy such as thalidomide 100 mg per day until relapse or intolerable side effects. Both groups also received pulsed dexamethasone 20 mg 4 days a month.

Eligibility Criteria:
Inclusion Criteria:

* patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
* Written consent

Exclusion Criteria:

* peripheral neuropathy \>= grade 2
* neutropenia \< 1000/mcl or thrombocytopenia \< 50000/mcl
* severe depression
* organ disfunction \> grade 2
Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer

This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.


Eligibility Criteria:
Inclusion Criteria:

* Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic
* Life expectancy of at least 3 months
* Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies

Exclusion Criteria:

* Active CNS metastases
* Have any history of seizure disorder or are taking prophylactic seizure medication
* Have an active viral, bacterial, or fungal infection
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy

There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.

The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).

External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.

However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.

The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.


Eligibility Criteria:
Inclusion Criteria:

* Patients 70 years and older with cancer or hematologic malignancies;
* Faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites;
* Addressed in onco-gériatric consultation in the usual routine care sector;
* Mastery of the French language;
* Patient affiliated to the social security system;
* Patient has given its written consent.

Exclusion Criteria:

* Life expectancy \<3 months
* Inability to communicate by telephone (deafness, speech disorder, ..)
* Inability collection of written consent
* Group 4 SiO (International Society of Geriatric Oncology), Performance status (PS) 4
* initial MMSE (Mini-Mental State Examination) \<18/30
* oncological treatment envisaged: analgesic radiotherapy or exclusive decompressive, brain radiation therapy in toto
* Patient under guardianship
Reduction of Remifentanil-related Complications

This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 year old
* ASA class 1-3 scheduled for elective surgery

Exclusion Criteria:

* history of neurologic or mental disorder
* uncontrolled pulmonary or cardiovascular disease
* history of adverse reactions to opioids
* history of drug abuse
HTO With and Without Arthroscopy

It remains unknown if a concomitant arthroscopic knee debridement would increase the benefits of surgery (quality of life and functional ability) for young active patients with medial compartment OA of the knee and varus alignmen. This additional procedure has a low incidence of morbidity and would potentially allow for treatment of meniscal tears and articular damage, as well as joint lavage to remove debris and inflammatory factors. A trial is needed to determine whether HTO with concomitant knee arthroscopy will result in better overall outcomes for this patient group.The objective is to compare the quality of life, functional status, pain, and swelling of patients who undergo an HTO with or without a concomitant knee joint arthroscopy to address additional joint pathology

Arthroscopy for degenerative conditions of the knee is among the most widely employed orthopaedic procedures, but its effectiveness (like the effectiveness of many surgical operations) has never been proven in prospective trials. The evidence supporting the use of arthroscopy in treatment algorithms for knee OA comes largely from case series and cohort studies. These studies have shown that about 50% of patients report pain relief following the procedure. Predictors of poor outcome following arthroscopy include marked mal-alignment, restricted range of motion, advanced radiographic changes, and prior surgery. Improved outcomes are predicted by preoperative mechanical symptoms caused by loose bodies, meniscal tears, or radiographic evidence of mild articular degeneration.

The proposed study is a randomized clinical trial.

Each patient will undergo a preoperative MRI of their affected knee joint to identify existing pathology (e.g. meniscal tears, loose bodies, chondral flaps). The results of the MRI will not be revealed to physicians, patients or data collectors. This will ensure that we have information on the existing joint pathology within each group and that prognostic variables between groups were sufficiently balanced (i.e. comparable rates of similar pathology per group). The primary outcome measure is self-reported quality of life (WOMAC). Secondary measures include self-reported functional ability (LEFS), swelling, pain and frequency of analgesic use (patient diary), and general health (SF-36). Assessments will take place preoperatively and at 3, 6 and 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients with medial compartment osteoarthritis as determined by clinical examination and plain radiographs.
* scheduled for an HTO

Exclusion Criteria:

1. Evidence of other significant knee pathology,
2. Active joint or systemic infection,
3. Major medical illness that would preclude undergoing surgery,
4. Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
5. Major psychiatric illness, developmental handicap or inability to read and understand the English language