cyrilzakka/clinical-trials huggingface dataset:
Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.


Eligibility Criteria:
Inclusion Criteria:

* Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
* Stage T3 or T4 at MRI
* N0-2 at MRI
* M0 at CT scan
* Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents

Exclusion Criteria:

* Squamous cell carcinoma
* Adenocarcinoma Stage T1-2, any N
* T4 with one of the following:

with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy
KOrean Borderline Ovarian Tumor (KOBOT) Registry

The aim of this study is to collect data on Korean patients with borderline ovarian tumors.

The researchers retrospectively collected data on Korean patients with borderline ovarian tumors (BOTs) diagnosed, treated, and followed between November 1994 and February 2015 at institutions where placed in the Republic of Korea. And the researchers prospectively will collect data on all Korean patients with BOTs at institutions where placed in the Republic of Korea since March, 2015. If patients agree to participate in this KOBOT registry, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

Eligibility Criteria:
Inclusion Criteria:

* Patients with borderline ovarian tumors (BOTs) diagnosed, treated, and followed between November 1994 and February 2015 at institutions where placed in the Republic of Korea.
* All patients undergoing gynecologic surgery for BOTs at institutions where placed in the Republic of Korea since March, 2015

Exclusion Criteria:

* Patients who did not receive primary treatment or follow-up for at least 6 months at each institution were excluded from analysis
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.

Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.


Eligibility Criteria:
Inclusion Criteria:

* Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and \<1250g.

Exclusion Criteria:

* Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
* Blistering skin conditions
* Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):

  * Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.

    * Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams
    * Anencephaly
    * Confirmed Trisomy 13 or Trisomy 18 syndrome
    * Meconium staining of amniotic fluid
    * Birth assessment of gestational age \> 28 weeks or \>1250 grams
    * Maternal temp \>38 degrees C around the time of delivery.
Choice of Inhalation Device

In this study, asthma and COPD patients will be invited to participate after the consultation with their pulmonologist.

The intervention consists of three steps. The first step is to perform a deep inspiration. The second step is to demonstrate the correct use of a pMDI. The third step is to perform a strong inspiration into the In-Check Dial device over 5 different resistances.

The study will take place in the respiratory outpatient clinic. Patients will be invited to participate in the study after the consultation with the pulmonologist. All pulmonologists have a flowchart regarding the optimal choice of inhaler at their disposition.

Patients will be provided sufficient time to read the informed consent file and to ask questions about the study. After giving their informed consent they will be screened for eligibility by an investigator. Demographic data and characteristics will be retrieved from the medical record (EMD) of study participants.

The intervention will consist of three different steps.

First, the patient will perform a deep voluntary inspiration. The patient's ability to perform this inspiration will be assessed and scored by the investigator.

Secondly, the peak inspiratory flows (PIF) will be measured with an In-check Dial device over 5 different resistances.

The minimal and optimal peak inspiratory flow rates (PIFRs) differ by device. A minimum flow of 30 L/min is required for most DPI's. The optimal flow varies from 30 L/min to 35, 45, 50, 60 or 65 L/min.

Due to the fact that there is still discussion about the effectiveness of PIF's going from 30 to 60 L/min, an arbitrary cut-off value will be set at 45 L/min. This cut-off value for sufficient PIF will be measured over a moderate resistance to distinguish subtherapeutic from therapeutic levels. If the patient reaches a PIF lower than 45 L/min, the patient will be asked to make a second attempt.

Subsequently, the patient will receive education about the correct coordination, which is necessary in the use of dose inhalers. The patient will be evaluated for sufficient actuation-inhalation coordination, through a placebo pMDI.

The evaluation of the voluntary deep inspiration, PIF and coordination will be by pass or fail evaluation. Subsequently, the fitness of a patient to use any of the three inhaler classes will be determined by using a diagram designed by a Belgian expert group (unpublished to date; courtesy of Didier Cataldo, ULiège).

If a mismatch between prescribed inhaler and suitable inhaler types is found, the treating physician of the patient will be informed. By doing so, the investigators wish to avoid patients receiving prescriptions for inhalers that they cannot use properly.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients (GOLD II-IV)
* Patients with severe asthma
* Patients with mild-to moderate asthma aged \< 70y
* Patients with asthma aged ≥ 70y

Exclusion Criteria:

* Patients with asthma or COPD not on inhaled therapy for maintenance treatment
* Patients younger than 18y
* Patients unable to give their informed consent due to mental or physical disability
* Patients who don't speak French or Dutch
Cardiorenal Protective Diet

This study will evaluate providing fruits and vegetables in a sustainable community care clinic setting, in addition to routine medical care, to individuals with CKD (Stage 2-4) on CKD and CVD risk, or cardio-renal risk factors. Further, metabolomics profiling will be used to study how change in the diet affects disease risk. Data from this study will be published in peer-reviewed journals, presented at national conferences, and will serve as pilot data to guide and strengthen applications for NIH funding.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in a 3-month F\&V study.
* Positive urine dipstick (Proteinuria and/or Albumin-to-Creatinine Ratio \>=10).
* African-American (self-declared) race
* A current diagnosis of hypertension or a current blood pressure reading consistent with hypertension (SBP \>= 140 and/or DBP \>=90).
* Access to the internet via personal computer or mobile device.
* Ability to read and write in English.

Exclusion Criteria:

* Negative urine dipstick.
* Currently receiving dialysis or needing dialysis (Stage 5 Kidney Disease)
* Have received or need a kidney transplant.
* Pregnant or planning to become pregnant in the next 6 months.
* Baseline urine potassium \> 60mEq/g creatinine
* Negative diagnosis of hypertension or blood pressure reading (SBP \<140 or DBP \<90).
* Nephrotic proteinuria demonstrated on urine ACR measurement.
* Lacking access to the internet via personal computer or mobile device.
* Unable to read or write in English.
The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery

The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

The secondary objectives of this study are:

A-To compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours.

B-To evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the French social security system and the hospital.

C-To evaluate the prognostic value of elastographic measurements in the subgroup twins.

D-To study elastography variation according to patient outcomes.

E-Evaluate the reproducibility of intra-and inter-rater elastographic measurements.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm)
* Single or multiple pregnancy

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient has lost her water (placental rupture)
* History of cervical surgery
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence

In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome.

The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (\<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria.

The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 8 years
* Complaint of hypersomnolence and suspected central hypersomnolence
* Benefiting from a standardised assessment: clinical, biological and neurophysiological
* Lumbar puncture necessary for the assessment
* Sufficient cerebrospinal fluid taken for biological analysis (at least 1 ml)
* Signed informed consent

Exclusion Criteria:

* Contraindication to lumbar puncture
* Secondary hypersomnolence
* Refusal to participate in the study or refusal of the lumbar puncture
* Adult protected by law, or subject deprived of liberty, by judicial or administrative decision or patient under guardianship or curatorship
* Subject not affiliated to the French social security system
* Pregnant or breastfeeding woman
Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo

Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Currently the standard treatment for vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half of patients. The applications of autologous epidermal cells in the liquid phase is a promising new therapeutic approach of vitiligo.

The main goal of this study is to compare prospectively the repigmentation of vitiligo lesions induced by application of autologous epidermal cells in liquid phase associated with light therapy and light therapy alone.

Study's secondary goals: compare the applications of epidermal cells to phototherapy alone and phototherapy, in respect of:

* Obtain a repigmentation\> 70% (threshold considered aesthetically relevant)
* The occurrence of adverse events
* Patient satisfaction regarding the efficacy and safety of treatment

MAIN CRITERIA

* Rates of repigmentation of the vitiligo lesions to 12 months
* The lesions of the layers defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a computer.
* Digital photos is taken in order to illustrate the quantitative results above.

SECONDARY CRITERIA

* Repigmentation\> 70% of the vitiligo lesions at 12 months
* Rates of repigmentation of the vitiligo lesions at 12 months
* Side effects: the frequency, severity and time of occurrence will be reported for each treatment. Side effects are classified into grades according to World Health Organization (WHO) criteria.
* Patient satisfaction of the effectiveness and tolerance will be studied using visual analogue scales graded from 0 to 10.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients at least 18 years
* Subjects with a stable vitiligo (no new injury or lack of expansion of existing lesions in the last 12 months), with at least two vitiligo lesions of at least 10 cm2 located in the same anatomical location, and requiring treatment with UVB phototherapy.
* Topic with vitiligo
* Subjects who agreed to have a blood research with Human immunodeficiency virus (HIV), Human T-lymphotropic virus - 1 (HTLV-1), hepatitis B, hepatitis C, and human Chorionic Gonadotropinfor (hCG) women.
* For women of childbearing age, the use of effective contraception (birth control pills or Intrauterine Device (IUD)) for the duration of the study
* Topics able to participate and to respect it.
* Topics affiliated to social security.
* Topics that have signed a written informed consent before the start of the study.

Exclusion Criteria:

* Pregnant or nursing women.
* Subjects with a history of keloid scarring.
* Subjects with a history of melanoma.
* Subjects with a photodermatitis.
* Topics taking photosensitizing treatment.
* Subjects who received treatment for vitiligo in the 4 weeks before enrollment.
* Subjects with HIV testing, hepatitis B or hepatitis C positive.
* Major Topics protected by law
Comparing Targets of Expressive Writing

Expressive writing involves writing about one's deepest thoughts and feelings surrounding an emotional event. The current literature on the efficacy of expressive writing is mixed and warrants further investigation into how, when, and for whom expressive writing is an effective intervention. The goal of this study is to compare the efficacy of expressive writing interventions in young adults when people imagine that they're writing to themselves vs. a loved one. Participants will carry out an expressive writing exercise for 14 consecutive days. Participants are randomized into 3 groups: Self, Other, and Control. The Self group is instructed to write as if they were talking to themselves. The Other group is instructed to direct their writing to someone they feel close to. The Control group is asked to write down a factual description of their routine that day, and direct this writing to themselves. We will recruit participants until we have usable data from 53 participants per group (i.e., 159 in total).


Eligibility Criteria:
Inclusion Criteria:

* US-based
* Fluent English
* Combined GAD-7 and PHQ-8 score of ≥ 5

Exclusion Criteria:

* "Completion" of a writing session requires participants to spend at least 15 minutes on the writing page. We will monitor completion of the daily writing exercise, and will contact participants who miss or spend less than 15 minutes on the exercise. Participants who fail to complete 3 consecutive daily writing sessions will be deemed non-compliant, removed from the study, and paid a prorated amount for the tasks they have completed in the study.
Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina

This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling
* Diagnosis of laBCC or mBCC for the effectiveness analysis

Exclusion Criteria:

* None specified
ID Testing OUtreach in Carceral Hubs

This project will implement and evaluate an intervention that improves Human immunodeficiency virus (HIV) testing practices and HIV treatment in two jail sites in the Boston area: South Bay House of Corrections and Nashua Street Jail. HIV care is currently not well-integrated with the jails' existing intake and healthcare administration systems and medications for opioid use disorder (MOUD) program, and there continue to be gaps between jails and community healthcare. The investigators performed a qualitative exploration of the current landscape of HIV care in the carceral setting through interviews with people who are currently incarcerated and medical staff at both sites and are also conducting quantitative analyses of data from the Public Health Data Warehouse in cooperation with the Massachusetts Department of Public Health. The resultant information led to the ID-TOUCH (Infectious Disease Testing Outreach in Carceral Hubs) intervention.

ID-TOUCH consists of creating question sets in the newly developed electronic health record system for both sites that standardize the practice of offering HIV testing at two key touchpoints, or places where HIV care can be accessed: the nursing intake and the physical exam. Once the intervention has been effectively implemented by both sites, a pilot study will be done involving participants currently incarcerated. A baseline evaluation will be done to collect information how the incarcerated participants' use of the healthcare system while in jail, specifically focusing on infectious disease testing and care. There will also be two follow-up assessments, one week after release and 3 months after release. The follow-ups will focus on the previously incarcerated individuals' self-reported use of community healthcare systems. This includes community testing, PrEP (Pre-Exposure Prophylaxis), and self-reporting of high risk behaviors for HIV.

The primary goal of this study is to identify existing barriers in the carceral healthcare setting that prevent the improvement of HIV testing and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Incarcerated at South Bay House of Corrections or Nashua Street Jail
* Participant report of sentenced status at time of enrollment
* Comfortable speaking in English

Exclusion Criteria:

* Cognitive ability that prevents obtained consent or completion of study activities (defined through Research Assistant (RA) determination)
* Inability to complete assessments in English (defined through RA determination)
Sedation in Patients Undergoing GIT Endoscopy

Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial

Endoscopy plays a significant role in the diagnosis and treatment of gastrointestinal diseases. Sedation has been used in clinical practice to make the procedure more comfortable, and improve patient satisfaction by helping patients rest during the procedure. (1) (2) The most common complications in gastrointestinal endoscopy are not related to the procedure, but are related to sedation; they include cardio-respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vaso-vagal episodes (3).

Many studies have reported on use of propofol as a single agent for sedation during endoscopy. However propofol is often used in combination with another agent for other indications. The benefit of propofol in terms of shorter recovery and discharge times and higher patient satisfaction persists, when it is used in combination with other agents.

Propofol has limited analgesic effect and higher doses are often required, when it is used as a single agent for endonoscopy, resulting in higher sedation levels. Thus use of propofol in combination with other agents may be preferable to propofol alone. The combination may be easier to manage due to lower sedation levels and ability to reverse some of the sedation with the use of reversal agents for narcotics (4).

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients scheduled for GIT endoscopy 2. Age 18-60 years old 3. ASA I-II. 4. BMI less than 30

Exclusion Criteria:

* 1. Heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) 2. pulmonary disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, or lung cancer) 3. central nervous system abnormality 4. allergy to the study drugs 5. habitual sedative or analgesic use 6. pregnancy 7. Anticipated difficult airway.