cyrilzakka/clinical-trials huggingface dataset:
the Effect of Vitamin D in Crohn's Disease

To evaluate the efficacy and safety of 12-week goal-directed therapy in the treatment of refractory inflammatory patients, and to initially explore treatment options. Patients with potential risk factors for recurrence after surgery for Crohn's disease and a serum 25(OH)D concentration \<75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L.

The patients received oral liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL). A target 25(OH)D of 100-125 nmol/L was planned and the dose titrated 4-weekly.

Patients were evaluated at week 0 (screening visit), then 2- weekly until week 12, and at a follow-up visit at week 16. Key study endpoints were change in total 25(OH)D and attainment of level of 100e125 nmol/L. Intestinal inflammation was assessed via clinical disease activity (CDAI), faecal calprotectin (Calprotectin ELISA, Buhlmann, Basel, Switzerland), and circulating inflammatory markers (platelet count, serum albumin and C- reactive protein). Safety was assessed by direct questioning and 24- h urinary calcium excretion . Compliance was checked by dosing diaries completed by patients and measuring remaining cholecalciferol in bottles of the study drug.

Statistical analyses were performed using SPSS v20 (IBM Corporation, 2011) and GraphPad Prism v5.04 (Graphpad software, 2010). Dependent and independent samples t-tests, analysis of variance (ANOVA) and KruskaleWallis tests were used where appropriate. Associations with rise in 25(OH)D were examined by bivariate correlations. A p-value of 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Crohn's Disease
2. Must be able to swallow tablets
3. Have certain factors increase the risk of surgery in CD. include:

   * current smoking
   * fistulizing and stricturing disease behaviour
   * early steroid use (medical need for steroids for treatment of first flare)
   * disease in the end of the small bowel (i.e. ileum)
   * disease in the middle part of the small bowel (i.e. jejunum), and
   * young age at the time of the diagnosis.

Exclusion Criteria:

1. Other serious gastrointestinal diseases
2. pregnancy
3. hypercalcemia
4. hyperparathyroidism
5. chronic kidney disease and cardiovascular disease
Acupressure to Treat Nausea and Vomiting in HIV/AIDS Patients

The purpose of this study is to see whether acupressure (acupuncture using pressure applied by the hands instead of needles) can help nausea and vomiting in persons with HIV/AIDS.

This is a Phase I trial (a study to evaluate effectiveness in a small number of patients). Patients will get 4 acupressure treatments and will wear acupressure wristbands for 1 week. Patients will write down all drugs they take and will make a note of when they get nausea and vomiting. They also will give written answers to different questions. No drugs will be given as part of this study. Patients will be paid for participating.

Eligibility Criteria:
Inclusion Criteria:

* Are HIV-positive.
* Have nausea and/or vomiting an average of 2 times per day for at least 1 week.
Machine Learning to Predict Acute Care During Cancer Therapy

The objective of this study is to apply a validated machine-learning based model (SHIELD-RT, NCT04277650) to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters.

A previously described machine learning (ML)-based model accurately predicted ED visits or hospitalizations for cancer patients undergoing radiation therapy or chemoradiation. An IRB approved prospective randomized trial, SHIELD-RT (NCT04277650) found that preemptive intervention for patients undergoing radiation and chemoradiation based on the ML model's risk stratification decreased the relative risk of acute care visits by 50%, showing that ML-guided escalation of care improved personalized supportive care and treatment compliance while decreasing healthcare costs.

The objective of this study is to apply this validated ML based model to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters. Once validated, this study will add to the previously published body of evidence supporting a randomized trial evaluating the ML algorithm's ability to assign intervention for patients receiving systemic therapy at highest risk for acute care encounters.

Eligibility Criteria:
Inclusion Criteria:

* had treatment encounter in the Duke Medical Oncology department from January 7th, 2019 to June 30th, 2019
* DUHS medical record available

Exclusion Criteria:

-
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation

This is a multi-center, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years; \< 80 years
* Left atrium less than or equal to 6.5 cm (TTE)
* Symptomatic paroxysmal AF
* Provided written informed consent
* Refractory to at least one AAD (class I, II, III or IV)

Exclusion Criteria:

* Patients requiring concomitant surgery
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* Measured left ventricular wall thickness \> 1.5 cm
* History of coagulopathy
* Previous cardiac surgery
* Right ventricular outflow tract obstruction
* History of pericarditis
* Previous cerebrovascular accident (CVA), excluding fully resolved TIA
* Patients who have severe chronic obstructive pulmonary disease (COPD)
* Patients who have an active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF
* Patients who are contraindicated for anticoagulants
* Patients who are being treated for arrhythmias other than AF
* Patients who have had any previous AF or left atrial catheter ablation
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
* Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery

This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.

Rotator cuff surgery is a painful arthroscopic surgery. In outpatient surgery, the surgeons have to increase the security and surveillance after the surgery to reassure the patient and avoid complications.

Most patients receiving ambulatory rotator cuff surgery have high pain score, and management and aspects of the rehabilitation can be challenging. However, regular follow-up is still considered important in the early post-operative phase. In between the conventional appointment 6 weeks post op and 12 weeks post op, the surgeons have no status of the patient, and no markers to check if the postoperative care is evolving right.

Currently, the investigators are using a mobile application (Orthense by Digikare, Blagnac, France) to complement in-person postoperative follow-up care for patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing rotator cuff surgery. They must be able to use a mobile-app, and have an email address and internet connexion.

Exclusion Criteria:

* Unable to read French
A Blind Maneuver to Position an Endobronchial Blocker

One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.

The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery.

After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery who need one lung ventilation

Exclusion Criteria:

* patients who have a lesion in trachea or mainstem bronchi
* severe tracheal deviation
* patients who do not agree to informed consent
A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients

The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute coronary syndrome.

Due to withdraw of global phase 3 study (APPRAISE-2) for safety issue, B0661004 Data monitoring committee (DMC) also recommended terminating this study. Therefore, Pfizer decided to stop this study.

Eligibility Criteria:
Inclusion Criteria:

* Recent (≤ 7 days) ACS
* Clinically stable, and receiving standard treatment (patients must be treated with aspirin ≤ 100 mg/day, with or without clopidogrel 75 mg/day or ticlopidine 200 mg/day) based on the physician's judgment)

Exclusion Criteria:

* Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure planned in the 24 weeks (within treatment period) following randomization
* Persistent severe hypertension, defined as systolic blood pressure of ≥180 mm Hg or diastolic pressure of ≥110 mm Hg
* Active bleeding or at high risk for bleeding (e.g., cirrhosis of the liver, any history of intracranial hemorrhage).
IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration

Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only.


Eligibility Criteria:
Inclusion Criteria:

1. The patients were 18-80 years old and diagnosed as malignant solid tumor by pathology;
2. Patients with persistent cancer pain and NRS score ≥ 7 during previous 24 hours;
3. Patients who did not receive radiotherapy, chemotherapy or targeted therapy within 7 days before randomization and trial；
4. Patients or his/her caregivers who are able to fill out the questionnaire forms ;
5. Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;
6. Without psychiatric problems;
7. ECOG performance status ≤3;
8. Patients who did not receive the trial drug within 14 days before the trial；
9. The subjects voluntarily signed the informed consent.

Exclusion Criteria:

1. The pain is confirmed not due to cancer;
2. Patients with severe post-operative pain;
3. Patients with paralytic ileus;
4. Patients with brain metastasis;
5. Patients hypersensitive to opioids;
6. Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade;
7. Patients who cannot take drugs orally;
8. Patients with an incoercible nausea or vomiting;
9. Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;
10. Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;
11. Alcoholic patients;
12. Patients with other conditions or reasons causing the patients unable to complete the clinical trial.
Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

Fatigue is commonly experienced in numerous pathologies, including schizophrenia. Research has shown that chronic fatigue can exacerbate clinical symptoms.

Several evidence-based interventions for fatigue syndrome have been shown to be effective in other medical conditions, but up to this date no research has assessed interventions in fatigue management within psychotic populations.

The aim of this study is to evaluate (in a multisite single blind randomized clinical trial) the efficacy of a cognitive-behavioral therapy (CBT) intervention of fatigue management in people diagnosed with schizophrenia. Secondary objectives include the examination of changes in fatigue scores as well as clinical symptoms, physical \& cognitive functioning, quality of life at 9-month post CBT intervention. Another aim in this study is to assess - MICROBIATE

The investigators hypothesize that following the CBT treatment intervention, patients will demonstrate reduced level of fatigue. No change in the severity of fatigue is expected in the group receiving treatment as usual.


Eligibility Criteria:
Inclusion criteria:

1. Aged between 18 and 60 years,
2. patients with a diagnosis of schizophrenia according to DSM 5 validated after a clinical evaluation by one psychiatrist investigators,
3. patients with a score at the 4th subscale of "Multidimensional Fatigue Inventory " greater or equal to 10
4. patients with a follow-up in a day hospital at inclusion,
5. subjects must be able to attend all scheduled visits and comply with all trial procedures,

Non inclusion criteria:

1. subject unable to read or/and write French,
2. planned long-term stay outside of the study region that prevents compliance with the visit plan,
3. patients with a history of severe brain trauma,
4. patients with a history of neurological pathology,
5. patients pregnant or breast-feeding
6. patients deprived of liberty
7. patients participating in another ongoing biomedical study
8. patients not affiliated with a French social security scheme or beneficiary of such a scheme
9. Absence of signed informed consent form by the patient and the patient's tutor if he has one
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.

The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic procedures
* Apfel Score 0, I, II, III and IV
* ASA I / II

Exclusion Criteria:

* Patients with surgery converted to open before thirty minutes of surgery
* Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
* Patient who have to any cognitive impairment
* Illiterate patients
* Patients who refuse to participate in the study
Exploration of the Utility of Dental-dedicated MRI for Dentistry

This description observational research is comparative in design, that is comparing existing standard clinical dental images, not obtained in this study, to test (i.e., ddMRI) images. The standard clinical dental images consist of radiographs, such as bitewings, periapical, panoramic, cone-beam CT, and medical CT, as well medical MRIs of the temporomandibular joints (TMJ).The conceptualization of research questions, study designing, and interpretation of imaging data has and will involve content expertise in all ddMRI research.

Patients recruited from dental clinics at the University of Minnesota School of Dentistry will be screened for eligibility and asked to complete an MRI safety screening questionnaire. Eligible individuals will be invited to participate in at least one study visit, during which an MRI scan will be performed. At the end of the session, participants will complete a short questionnaire about their experience during the scan.

Eligibility Criteria:
Inclusion Criteria:

1. Patient Age: 18 years old or older
2. Receiving imaging for routine dental care
3. Does not have a serious medical condition
4. Is not pregnant or is not potentially pregnant
5. Is willing and able to give consent in English
6. Has the ability to manage their own calendar and schedule appointments
7. Willing to have a separate 2-hour appointment to have an MRI

Exclusion Criteria:

1. Unable to consent to participant in English
2. Serious health condition, which includes but not limited to renal failure/on dialysis, unstable heart disease (uncontrolled arrhythmia, cardiomyopathy and/or unable to lay flat, within 1 month of cardiac catheterization or myocardial infarction), unstable cerebral vascular disease (within 1 month of stroke and/or stent placement), diabetes (type I or II) not controlled by medication or diet, uncontrolled seizures, uncontrolled hyperthyroidism, non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema), uncontrolled movement disorder, and liver failure
3. Pregnant and/or intending to become pregnant,
4. Prisoner and/or not able to manage their own scheduling
5. Screen positive on MR safety questionnaire, specifically including people that have worked with or otherwise been exposure to metal particles and have the potential for such particles to be embed within them.
Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment

vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment


Eligibility Criteria:
Inclusion Criteria:

* patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
* patients indicated for removable retainer

Exclusion Criteria:

* any systemic disease
* chronic medication uptake
* bad oral hygiene pathological conditions of temporomandibular joint
Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)

The aim of this study was to investigate the effects of gait training on ground level, combining BWS and FES in people following chronic stroke.

The body weight support system (BWS) associated to a treadmill as well as to a functional electrical stimulation (FES) of the common peroneal nerve, has been proposed as a strategy for gait training in people following stroke. Moreover, it has also considered that the ground level is the most common locomotion surface, and that there is little information about the effects of gait training, on this kind of surface, in people with hemiparesis.

Eligibility Criteria:
Inclusion Criteria:

* Elapsed time since stroke longer than 6 months
* Spasticity classified under level 3 according to the Modified Ashworth Scale
* The ability to walk classified at levels 2, 3 or 4 according to the Functional Ambulation Category

Exclusion Criteria:

* Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
* Severe lung disease
* Orthopedic disorders
* Cognitive deficits