cyrilzakka/clinical-trials huggingface dataset:
Simulation Training vs Workplace-Based Supervision in Psychiatry

The purpose of this study is to evaluate and compare the effectiveness of two forms of clinical skills training for teaching emergency psychiatry skills to doctors who have just started to work in psychiatry

Junior doctors starting work in psychiatry soon encounter a number of situations in the workplace for which they have had little or no preparation either at medical school or from work in other specialities. They will encounter clinically complex situations such as rapid tranquillisation, crisis presentations of self-harm, suicide risk assessment, overseeing supervised confinement and making decisions to admit or discharge mentally ill patients. Furthermore, many of these situations occur out of hours when there is little direct senior supervision available. The traditional induction programme is delivered in a didactic format, which does not encourage effective learning, nor does it allow any opportunity to practise or acquire hands-on skills or non-technical skills such as interprofessional communication, leadership and situational awareness. In the interests of patient safety and improving the quality of care and patient's experience, there is an urgent need to identify ways of improving induction and quickly equipping junior doctors with the clinical skills necessary to practise safely in psychiatry. We propose to evaluate and compare two approached to improved skills training in psychiatry: 1. workplace-based observation and feedback; 2. simulation training.

All new junior doctors starting work in the South London and Maudsley NHS Foundation Trust, London, UK, in August 2011 will be invited to take part in a randomised controlled trial of training in addition to the standard induction. Following a day of lectures on relevant clinical topics, participants will be randomly allocated to receive either observed workplace-based training by a more senior doctor during their on-call duties, or a two-day simulation-based training course. Before and after the training, assessments of participants' clinical skills and attitudes will be carried out by questionnaires and by observations of simulated clinical encounters. Changes in performance will be compared between the two groups. Longer term evaluation will be carried out by means of qualitative interviews and simulated clinical encounters once participants have been working for several months.

Eligibility Criteria:
Inclusion Criteria:

* Junior doctors starting work at the South London and Maudsley NHS Foundation Trust in August 2011 in any of the following grades: 1. Core Psychiatric Training; 2. Foundation Training; 3. General Practice Vocational Training; 4. Core Trainee 1-3 equivalent posts, e.g. long-term locums

Exclusion Criteria:

* Unwillingness to participate in the study
* Inability to attend the training programme or participate in the evaluation
Shaolin Dan Tian Breathing Fosters Relaxed and Attentive Mind

The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique.

Neuroelectrophysiological studies on various types of meditative breathing revealed its association with either a relaxing (i.e., enhanced alpha asymmetry) or an attentive state (i.e., enhanced intra- and inter-hemispheric theta coherence). The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique. This technique consists of two components -- Passive DTB and Active DTB, and is considered not only as a relaxation exercise but also a form of Qigong. Based upon some pilot neuroimaging data and clinical observation, it was hypothesized that after familiarizing with the method, practicing DTB can induce both relaxing and attentive states. Twenty-two adults received training on the DTB (experimental group) for one month. They were instructed to practice the technique daily, and at each practice, until they felt warm and/or relaxed. Twenty age-, gender- and education-matched adults receiving conventional progressive muscle relaxation training were recruited as control. All participation was voluntary. Quantitative EEG and bio-physiological data were collected at baseline and post training. Eyes-closed resting EEG data before and immediately after each type of breathing were obtained individually at two time points.

Eligibility Criteria:
Inclusion Criteria:

* healthy controls
* age 20 to 60 years

Exclusion Criteria:

* history of head injury,
* seizure,
* stroke,
* other CNS diseases or psychiatric illnesses of psychosis or mania.
Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)

This study is being done to see if patients with metastatic solid tumors (hematologic malignancies and lymphoma excluded) who have a specific genetic mutation in patients' tumor (the SF3B1, U2AF1 or SRSF2 mutation), are more likely to respond to immunotherapy agents that are now commercially available.

This is a non-therapeutic study, meaning that while Johns Hopkins is providing a treatment recommendation based on participants' genetic information, participants and participants' oncologist will decide ultimately what to do, and participants' oncologist will monitor participants' day to day care while on therapy. Participation involves allowing the investigators access to participants' sequencing report and medical records, providing a blood sample (about 8 tablespoons) at baseline and possibly again after three months, and answering questionnaires. If participants join the study, a panel of experts (Johns Hopkins Molecular Tumor Board) will review participants' genetic information participants entered and make a determination regarding treatment recommendation. Blood will be collected at baseline irrespective of what treatment is recommended. If immunotherapy is recommended, the investigators may collect blood again at 3 months. Participants and participants' oncologist will ultimately decide if participants proceed with the recommend treatment or not; the recommendation made from Johns Hopkins is not binding in any way. Participants' oncologist will continue with usual care according to standard practices while participants are on therapy. The investigators will get health information and conduct questionnaires with participants and participants' oncologist to assess how participants are doing on therapy. The main risks are the discomforts of the blood draw (which are expected to be minor and not last), boredom from completing questionnaires and the risk that information may become known to people outside of the study. Participants may or may not benefit directly from being in the study and there is no payment for participation.

Eligibility Criteria:
Inclusion Criteria:

* Performance status eligible for immune checkpoint blockade as determined by local physician
* Able to demonstrate histologically proven locally advanced or metastatic solid tumors (hematologic malignancies and lymphoma excluded)
* genomic testing demonstrating a spliceosome mutation (SF3B1, U2AF1 or SRSF2)

Exclusion Criteria:

* Local physician determines has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Local physician determines the patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate
Transversus Abdominis Plane (TAP) Block for Cesarean Section

The purpose of this study is to determine whether a transversus abdominis plane (TAP) block with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-CS chronic pain.

Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3 million cesarean deliveries per year in the US, this is bound to create a significant health problem. One way to address this health burden is to refine techniques that may help control the pain women experience after CS and ultimately reduce the potential to develop chronic pain.

The purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (TAP) block to reduce the amount of hyperalgesia women develop around their incision after CS. Measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain. Since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help diminish the incidence of chronic pain after CS. In addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery.

The primary aim of this study is to evaluate the benefits of two different solutions injected by TAP block technique on postoperative peri-incisional hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia
* English speaking (UW Site) or Portuguese speaking (Brazil site)
* aged between 18 and 45 years
* BMI \< 40
* ASA physical status class I or II

Exclusion Criteria:

* laboring women undergoing a non-scheduled cesarean delivery
* non-English speaking (UW Site) or non-Portuguese speaking (Brazil site)
* previous spinal surgery
* contraindications for neuraxial anesthesia
* allergy to local anesthetic, ultrasound conduction gel, or Clonidine
* history of chronic pain
* inability to receive intraoperative Toradol
Effect of Various Virtual Reality Exercise Individuals With Low Back Pain

Posture is defined as the best position formed by the segments that make up the body in a harmonious arrangement with each other. Muscle strength, which is one of the primary factors in providing a static or dynamic posture, is achieved thanks to the antigravity muscles that keep the body upright against gravity. Proper posture is ensured by a good body balance.

Advances in technology can influence healthcare providers to create alternative and new treatment options. SG/LV applications have also gained momentum in the field of rehabilitation. Studies have shown that 12-week programs, especially in diseases affecting the balance and vestibular system, can achieve more effective results than standard physiotherapy programs in both upper and lower extremity functions, balance, walking parameters, fall risk and cognitive parameters. The use of popular video game-based exercises, such as XBOX, or "exergaming," has evolved to become therapeutic tools for rehabilitation. Accessible as technology evolves into more and more, equipment like biodex could be an alternative way to assess and train balance

Eligibility Criteria:
Inclusion Criteria:

* 18-60 with nonspecific chronic low back pain

Exclusion criteria from the study:

* Cognitive impairment
* Disc herniation
* Neurological deficit
* Respiratory problems
Bioequivalence Study for an Isotretinoin

The objective of this study was to confirm if two formulations of isotretionin (capsules) are bioequivalent.

Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fed conditions.

The population was composed of 36 healthy volunteers, male adults between 18-45 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Male volunteers. Ages between 18 and 45 years old. BMI (Body Mass Index) between 20 to 26 kg/m2. Anti-doping tests negative results. Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase, Lactic Dehydrogenase, AST, ALT, Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac VIH, AgsHB and RPR (luetic test), must fall within an interval between minimum and maximum values in connection to said tests accepted values.

Normal Electrocardiogram and Chest X-rays. In exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. These cases must be approved by clinical area and declared as "Non-clinically significant".

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Exclusion Criteria:

Electrocardiographic Anomalies; radiological Anti-doping tests positive results, Positive results regarding RPR; VIH and AgsHB tests. Personal or family history of allergy to medication in question. Having any kind of allergy, since these persons are in higher risk of suffering from medicamentous allergy.

Tobacco use. Recreational drug use. Persons undergoing any medical treatment. Existence of concurrent or intercurrent disease. Existence of justified doubt regarding questionnaire answers truthfulness. Having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study.

Presence of clinically important gastrointestinal diseases or malabsorption history during the last year.

Presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption.

Narcotics or alcohol addiction history requiring treatment. Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998.

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Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily sign the informed consent form (ICF).
* Age ≥ 18 years old, either male or female.
* Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0.
* Eastern Cooperative Oncology Group (ECOG) score of 0-2;
* Expected life expectancy is greater than 12 weeks;
* Patients with a total or near-total thyroidectomy within 12 months prior to randomized.
* Low iodine diet for two weeks prior to randomized.

Exclusion Criteria:

* patients with recent history of 131I whole body scan within 2 weeks prior to randomized.
* Pregnant or breast feeding women.
* patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
* Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
* Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase

The purpose of this study is to determine whether MPN patient are able to adhere to a dietary intervention. Participants will be randomized to one of two healthy diets. Participants will receive in person dietician counseling and online curriculum. Adherence will be measured using online surveys and phone diet recalls. Changes in inflammatory markers in blood will also be measured at 5 time points during this 15 week study.

This is a 15 week study, including 10 weeks of active diet intervention. Each participant will receive one dietician counseling session at the beginning of the diet intervention period, two brief follow up dietician phone calls, and 10 diet education handouts delivered via email each week. The main objective of this protocol is to test whether MPN patients can adhere to a diet intervention. The investigators will measure adherence in both arms with patient reported diet recall every two weeks via internet surveys. As exploratory endpoints the investigators will measure changes in inflammatory markers, symptom burden, physical activity level, sleep, and gut microbiome in participants over the course of the study. If successful, the investigators plan to use this intervention in a larger trial to assess whether a diet intervention can effectively change symptom burden and inflammation in MPN patients.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosis of Myeloproliferative Neoplasm (MPN) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Myelofibrosis (MF)
* Any type of previous therapy is allowed
* ECOG performance status ≤2
* Life expectancy of greater than 20 weeks
* Has an email address and can access the internet
* Able to read and understand English

Exclusion Criteria:

* Children
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of proven, probable, or possible invasive aspergillosis.
* Hematologic malignancy or allogeneic hematopoetic stem cell transplant.

Exclusion Criteria:

* Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
* Chronic invasive aspergillosis.
* Receipt of antifungal treatment for more than 96 hours.
* Severe liver dysfunction.
Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy

Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR \[Part 1\] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR \[Part 2\].


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects ≥ 18 years of age and \< 76 years of age
* Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
* Study eye must have NCIDME (Part 1) or CIDME (Part 2)
* Study eye must be moderate to severe NPDR

Key Exclusion Criteria:

* Prior laser treatment for DR in the study eye within 12 months from Screening Visit
A Study in Postoperative Pancreatic Fistula

The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF.

The definition of POPF released by ISGPS in 2016 still seems to have certain deficiency. For example, in both definitions in 2005 and 2016, the re-operation is used as an important judgment index of "Grade C POPF". But a unified standard or consensus is still lacked for the indication of POPF re-operation, which may finally impact the diagnosis of "Grade C POPF". Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of POPF;
* Aged 18 or older;
* Of either sex.

Exclusion Criteria:

* No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.
Marcaine Use in Laparoscopic Gynecological Surgery

The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.

Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.

Eligibility Criteria:
Inclusion Criteria:

* • Ages 18-50

  * BMI 20-35
  * Gynecologic ambulatory cases only
  * Total of 3 incisions, with left and right incisions both being 5mm-10mm in size
  * Not taking pain medications prior to surgery
  * Length of surgery up to 3 hours
  * PACU stay up to 6 hours
  * Willing and able to sign informed consent

Exclusion Criteria:

* • Age or BMI out of range

  * Surgery longer than 3 hours or PACU stay longer than 6 hours
  * patients with chronic pelvic pain
  * Oncologic cases
  * Pregnant patients