cyrilzakka/clinical-trials huggingface dataset:
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

This randomized controlled trial aims to investigate the effect of an individually tailored lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy screening.

Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This study aims to investigate the effect of minimal, but individually tailored lifestyle advice and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on one-year changes in these behaviours in a population-based sample of men and women.

Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle are measured by a brief lifestyle questionnaire administered at prescreening and after one year. The intervention to the intervention arms is given after completion of the prescreening lifestyle questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study

Exclusion Criteria:

* Excluded from sigmoidoscopy screening due to medical reasons, previous colorectal cancer diagnosis, relocating out of the screening municipalities or previous colonoscopy in the last 12 months.
Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome

the study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the newborn and the bilirubin level after 72 hrs

the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that short time can improve the hemoglobin level and prevent anemia in the newborn with improvement of the iron stores for months in infancy without affection on the bilirubin level and the need for phototherapy. This is significant because of the rising rate of cesarean section all over the world make more children are liable for anemia, and by this simple technique it can be prevented.

Eligibility Criteria:
Inclusion Criteria:

* mother's age (20-40) years.
* pregnancy with a healthy singleton
* gestational age of 38-41 0/7 weeks
* uncomplicated pregnancy

Exclusion Criteria

* Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
* Rh-negative mothers. The fetal exclusion criteria
* fetus with evidence of intrauterine growth restriction
* infant with serious congenital anomalies.
Evaluating a Single-session Mental Health Intervention for UK University Students

The investigators are evaluating if an online single-session intervention, the Common Elements Toolbox (COMET) can improve mental health and wellbeing among UK university students.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old

Exclusion Criteria:

-
Intrastromal Correction of Ametropia by a Femtosecond Laser

This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive.

The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.


Eligibility Criteria:
Inclusion Criteria:

* age: \> 18 years
* stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
* in the case of presbyopia: minimum near add +2D to + 4D
* in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
* in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D
* BSCVA of the eye to be treated \>= 0.63
* patients are willing and in such conditions to come to the follow-up exams
* no further ocular pathologies

Exclusion Criteria:

* age: \< 18 years
* refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients)
* minimal pachymetry of \< 500µm
* K-mean \< 37 D or \> 60 D
* Difference (K-max minus K-min) \> 5D
* Difference cycloplegic refraction to subjective refraction more than 1 D (valid only for hyperopia correction)
* patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Exemption: standard cataract surgery.
* patients with one or more of the following ocular pathologies:

  * keratokonus
  * corneal scars
  * transplanted cornea
  * disorders of wound healing
  * trauma
  * glaucoma
  * epilepsia
  * nystagmus
  * lack of concentration
  * other complicated illnesses
  * diabetes mellitus
  * instable K-readings as a sign of instable cornea
  * weakness of connective tissue
  * sensitivity against the drugs used in the study
  * continuous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL.
  * patients in pregnancy or during lactation
  * patients who take part in another clinical trial
Effect of Atorvastatin on Subclinical Atherosclerosis

Statin administration is supposed to reduce subclinical atherosclerosis by decreasing LDL cholesterol levels, possibly via lipid-independent anti-inflammatory effect. Its pleiotropic properties also adding beneficial effect against CMV infection.

The investigators plan to study atorvastatin in virally- suppressed HIV-infected patients on stable ART with CMV seropositive and statin-naïve to evaluate the subclinical atherosclerosis changes assessed by carotid intima media thickness (CIMT).

Extended description of the protocol, including more technical information

Eligibility Criteria:
Inclusion Criteria:

* Ages between 20 to 45 years old
* Using stable ART at least 1 year
* Positive IgG CMV
* Viral load HIV RNA \<50 copies / ml

Exclusion Criteria:

* Undergoing hepatitis C DAA therapy
* Decompensated cirrhosis or acute liver failure
* History of coronary artery disease
* Diabetes mellitus
* History of of brain infection, epilepsy, stroke
* History of rhabdomyolysis or myopathy
* Pregnant or breastfeeding
* Severe depression
* Using statin therapy in the past 6 weeks
* History of statin hypersensitivity
* Framingham Risk Score above 10% within LDL ≥130
* Framingham Risk Score under 10% within LDL ≥160
* Out of Periodontitis Index (Upper right molars, top series, upper left molars, lower right molars, bottom series, lower left molars)
Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Objectives: To compare the safety and efficacy of nylon (polyamide) epidural catheter versus polyurethane epidural catheter in patients undergoing major orthopedic surgery under continuous epidural anesthesia.

Background: Continuous epidural anesthesia is the most common anesthetic technique used in orthopedic surgery. However, the use of epidural catheters is associated with complications. The insertion of the catheter may be associated with intravascular or intrathecal placement, nerve root irritation, paresthesia, kinking, hematoma, or breakage during catheter removal.

Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 60 patients undergoing major orthopedic surgery under continuous epidural anesthesia. Patients were randomly allocated into two equal groups; group N, using Nylon catheter, and group P, using Polyurethane catheter.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 60 years
* Body Mass Index (BMI) \< 35

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status \> II
* Age \< 21 years or \> 60 years
* Body Mass Index (BMI) ≥ 35
* Contraindications to regional anesthesia (including coagulopathy and infection at the injection site)
* Uncooperative patients
* Patients with known allergy to local anesthetics or opioids
St. Jude Medical Percutaneous Mitral Valve Repair Study

The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.

Subjects will be followed-up through 6 weeks post implantation.

Eligibility Criteria:
Inclusion Criteria:

* Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
* Subject has an ejection fraction (EF) ≥ 30%.
* Subject is of legal age (≥18 years old).
* Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.

Exclusion Criteria:

* Subject requires a complex mitral valve repair or has isolated anterior prolapse.
* Subject has mitral valve stenosis in which the annulus opening is \<10mm. Subject has valve disease other than mitral which requires surgical intervention.
* Subject requires a concomitant procedure.
* Subject has a pre-existing prosthetic valve in any position.
* Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
* Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device.
* Subject has renal insufficiency or is on chronic dialysis.
* Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
* Subject has a history of endocarditis or has active endocarditis.
* Subject has a history of autoimmune disease.
* Subject has significant known carotid artery disease.
* Subject has an aorto-mitral angle of \<110 degrees.
* Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).
Contraception for Solid Organ Transplant Patients: Utilizing Social Media

The purpose of this study is to use an electronic survey to explore Solid Organ Transplant patients' contraceptive knowledge and counseling. The results from this survey will be used to help identify awareness gaps to potentially develop targeted interventions for comprehensive education.

According to data from the U.S. Organ Procurement and Transplantation Network, 10,804 women received organ transplants in 2011. Of these women, 3896 (36%) were between the ages of 18 and 49. Women of reproductive age make up a significant part of the transplant recipient population, so pregnancy in these immunocompromised patients is a concern. The incidence of unwanted pregnancy (a subset of unintended pregnancies) among female kidney transplant recipients is 48%, while the national incidence is 25%. The American Society of Transplantation (AST) has come to a consensus that gestations in organ transplant patients be considered high risk and be managed by both transplant physicians and high-risk pregnancy specialists. Pregnancies after organ transplantation have a high incidence of low birth weight (less than 2.5 kg).

The risks posed to the woman herself, her transplanted organ, and fetus underscore the importance of having health care providers counsel transplant patients on family planning, including return to fertility, contraceptive use, and when pregnancy can be safely considered. Specifically the fetus may be exposed to teratogenic immunosuppressive transplant medications and pregnancy increases the risk for rejection of the transplanted organ. Therefore it is important that women are thoroughly counseled regarding contraceptive effectiveness and safety. Health care providers have a large impact on the reproductive decisions that patients make. In a study done in transplant clinics across the nation, the majority of respondents based their decision on whether to become pregnant on the guidance of the individual transplant physician.

Transplant specialists may not be comfortably providing family planning services directly to patients. The Center for Disease Control and Prevention's United States Medical Eligibility Criteria for Contraceptive Use has specific guidance on the safety of each contraceptive for women undergoing solid organ transplants. However, this guidance is based on limited safety data. This study aims to add to the literature available on this patient population although we are not assessing safety. In addition, this study will identify improvement opportunities to the care provided to transplant patients within our own Health System.

This research study is a unique collaboration between the Departments of Pharmacy, Nephrology, and Reproductive Medicine.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-50 years old, solid organ transplant in the last 5 years, and fluent in English.

Exclusion Criteria:

* Not sexually active with men, history of hysterectomy, history of oophorectomy
Quantitative Xylazine Measurement in ED

Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose (OD) Patients in the Emergency Department (ED)

Xylazine, a veterinary medication and alpha-2 agonist drug with clinical effects including prolonged sedation and skin/soft tissue wounds, has been increasingly detected with fentanyl in the illicit opioid supply. Due to its rapid emergence, limited knowledge exists regarding xylazine's health effects. In this proposed research, Dr. Love will measure xylazine and its metabolites in blood and urine samples using laboratory and point-of-care assays. Working at two New York City emergency departments, Dr. Love will collect waste serum and urine from opioid overdose patients to measure xylazine and its metabolite concentrations. The researcher will also perform qualitative assessment of urine samples with xylazine test strips to characterize urine xylazine detection using a harm reduction tool.

Eligibility Criteria:
Inclusion Criteria:

* ED patient
* Opioid OD (both NPS and non-NPS)
* Availability of waste blood specimens for analysis
* Availability of waste urine specimens for analysis

Exclusion Criteria:

- Children under 18
Effects of Walking Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility Criteria:
Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
Surgical Consent During the COVID-19 Pandemic

Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic


Eligibility Criteria:
Exclusion Criteria:

* Children (under 18 years old)
* Participants who lack capacity and therefore cannot be consented appropriately
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
* Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
* Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.

Concurrent Medication:

Excluded:

* Antiretroviral agents other than zidovudine (AZT).
* Didanosine (ddI).
* Antimycobacterial therapy.
* Rifampin.
* Isoniazid.
* Clofazimine.
* Ethambutol.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.
* Streptomycin.
* Other investigational drugs.
* If antimicrobial therapy is required to treat bacterial infections (= or \< 14 days), Adria Laboratories must be contacted prior to initiation of therapy.

Patients with the following are excluded:

* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
* Previous or current Mycobacterium avium complex (MAC) infection.
* Perceived patient unreliability or unavailability for frequent monitoring.

Prior Medication:

Excluded within 4 weeks of study entry:

* Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
* Antimycobacterial therapy.
* Rifampin.
* Isoniazid.
* Clofazimine.
* Ethambutol.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.

Required:

* Zidovudine (AZT).
* Antipneumocystis prophylactic therapy.

Required for at least 4 weeks prior to study entry:

* Zidovudine (AZT) or didanosine (ddI).
* Antipneumocystis prophylaxis.
Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation

The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment of patients with mastocytosis with handicap and bearing activating point mutations in the phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with one of the following documented mastocytosis:

   * Smouldering systemic mastocytosis
   * Indolent systemic mastocytosis with organomegaly
   * Indolent Systemic Mastocytosis having 2 infiltrated organs (skin and bone-marrow)
   * Any mastocytosis with in the last 6 months at least 3 anaphylactic shocks or syncops requiring either use of adrenaline or medical assistance
   * Cutaneous Mastocytosis (CM)
2. Skin biopsy-documented mastocytosis and evaluable disease based upon:

   * Histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin biopsy
   * Clinical criteria: typical skin lesions (maculopapular, urticaria pigmentosa, mastocytoma)
3. Missing data (c-kit molecular analysis not done) or documented presence of an activating point mutation in the phosphotransferase domain of c-kit such as D816V c-kit mutation in at least one infiltrated organ (bone marrow or skin)
4. Refractory to at least one of the symptomatic treatments such as:

   * Anti H1
   * Anti H2
   * Proton pump inhibitor
   * Osteoclast inhibitor
   * Cromoglycate Sodium
   * Antileukotriene
   * Other therapies used for the symptomatic care
5. Handicap defined as at least one of the following handicaps:

   * pruritus score ≥ 6
   * number of flushes per week ≥ 7
   * number of stools per day ≥ 4 ,
   * number of mictions per day ≥ 8 ,
   * QLQ-C30 score ≥ 60,
   * Hamilton score ≥ 10

Exclusion Criteria:

1. Patients with one of the following mastocytosis:

   * Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD)
   * Mast cell leukemia (MCL)
   * Aggressive systemic mastocytosis (ASM)
2. Patient with a major surgery within 2 weeks prior to study entry
3. No vulnerable population will be included in this study

   * Life expectancy \< 6 months.
   * Patient is \< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
   * Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
   * Patient has a severe and/or uncontrolled medical disease.
   * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥18
* History of and currently experiencing angina at least 3 times per week
* No obstructive coronary artery disease
* On stable medical therapy for 30 days prior to enrollment
* Must agree to use a reliable and acceptable method of contraception for the duration of participation
* Written informed consent

Exclusion Criteria:

* Myocardial infarction within 90 days
* Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
* Diagnosis of other specific cardiac disease
* Must meet LVEF and GFR requirements
* Current use of coumadin or DOACs
* Hypersensitivity to G-CSF, apheresis or study product components
* Positive for HIV, hepatitis B or hepatitis C
* Active inflammatory or autoimmune disease, or chronic immunosuppressive state
* Drug abuse
* Pregnant or lactating
* Malignant neoplasm within 5 years
* History of Sickle Cell Disease
* Participation in another clinical study within 90 days
Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

To determine the efficacy and safety of Botulax® in treatment of crow's feet line

1. Allocation: Randomized
2. Masking: Double Blind

Eligibility Criteria:
Inclusion Criteria:

* Male or female of at least 19 to 65 years old
* Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

* Subject with hypersensitivity to the investigational products or their components
* Female subject who are pregnant or lactating
* Subject who are unable to communicate or follow the instructions
* Subject who are not eligible for this study based on the judgment of an investigator