cyrilzakka/clinical-trials huggingface dataset:
Add-on Video-based Training on Mental Status Examination Skills

The goal of this clinical triall is to investigate the training effect of access to authentic patient video on mental status examination performance among 5th year Danish medical students.

Aim:

To investigate if

* Students with add-on access to an authentic patient video e-library have improved Mental Status Examination precision compared to students that only have an add-on e-library with simulated patient videos.
* Number of videos watched correlate to mental status examination test scores.

The main study is a a two-armed, pragmatic cluster-randomised, superiority, partial-blinded, randomized controlled trial where the interventions are e-learning courses that serves as add-on learning material during the psychiatric clerkship.

Two student groups are compared. The experimental intervention(V) is a larger e-learning module, where the students have access to 23 authentic patient video vignettes and an e-module on mental status exam including demonstration videos with simulated patients (actor videos). The comparator students (N-V) only have access to the e-module on mental status exam including demonstration videos with simulated patients. All students participate in the regular Psychiatry curriculum i.e. 16 lectures in one week and psychiatric clerkship in three weeks.

As students have their clerkship in 10 different facilities across the Island of Zealand, we carry out cluster-randomization based on clerkship location.

Communication, recruitment and data management is carried out within the university teaching platform (CANVAS), by manual extraction, and by questionnaires distributed by SurveyXact.

Eligibility Criteria:
Inclusion Criteria:

* Consent
* 5th year medical student at the University of Copenhagen on the psychiatric clinical rotation

Exclusion Criteria:

* Previous acess to the video library.
Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia

This is a pilot study assessing fMRI changes and neurocognitive function in women with pre-eclampsia and healthy controls. Neurocognitive testing will be done during pregnancy and after delivery up to 2-6 weeks postpartum. fMRI will be done after delivery up to 2-6 weeks postpartum. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population. The aims of this pilot study are therefore to 1) Determine the frequency and nature of co-morbid DTI white matter patency and fMRI functional connectivity changes in women with pre-eclampsia/eclampsia and 2) Determine the relationship between DTI white matter patency and fMRI functional connectivity changes to measurable alterations in cognitive function in this patient population.


Eligibility Criteria:
Inclusion Criteria:Severe Pre-Eclampsia defined by

* Symptoms of central nervous system dysfunction (New onset cerebral or visual disturbance, such as: Photopsia, scotomata, cortical blindness, retinal vasospasm)
* Severe headache (ie, incapacitating, "the worst headache I've ever had") or headache that persists and progresses despite analgesic therapy
* Altered mental status
* Hepatic abnormality (Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by an alternative diagnosis or serum transaminase concentration ≥ twice normal, or both)
* Severe blood pressure elevation (Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on two occasions at least four hours apart while the patient is on bedrest (unless the patient is on antihypertensive therapy))
* Thrombocytopenia (\<100,000 platelets/microL)
* Renal abnormality (Progressive renal insufficiency (serum creatinine \>1.1 mg/dL or doubling of serum creatinine concentration in the absence of other renal disease))
* Pulmonary edema

  15 English-speaking pregnant controls with uncomplicated pregnancy matched by age and gestational age will be enrolled from the antenatal clinic or the labor ward.

Exclusion Criteria:

* History of symptomatic cerebrovascular disease with substantial residual deficit
* History of alcoholism
* History of psychiatric illness
* History of claustrophobia
* Renal failure (creatinine \> 2.0 mg/dl)
* Patients with less than a 7th grade education or unable to read and thus unable complete the neuropsychological testing
* Patients with bodily implants unsafe for MRI use
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)

This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a number of clinical malaria cases in children less than 5 years of age and the improvement of hemoglobin levels in the overall population.


Eligibility Criteria:
Inclusion:

* Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).
* Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)

Exclusion:

* Body weight \<5 kg.
* Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.
* Presence of severe malaria signs and symptoms
* First trimester of pregnancy.
* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
* Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.
* Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.
* Taking drugs which may be metabolized by cytochrome enzyme CYP2D6
Interplay Between Interleukin-6 and Glucagon in the Regulation of Human Amino Acid and Protein Homeostasis

The goal of this proof-of-concept study is to learn if interleukin-6 changes the effect of glucagon in healthy volunteers. The main question it aims to answer is:

Does IL-6 influence how effectively glucagon lowers the concentration of amino acids in blood? Researchers will compare the infusion of normal saline and a blocker of the receptor for interleukin-6 to see if blocking interluekin-6 changes how effectively glucagon lowers the concentration of amino acids in blood.

Participants will be asked to

* receive either an infusion of normal saline or the interleukin-6 receptor blocker
* participate in a study visit three weeks later at which they will receive infusions of hormones and amino acids to mimic the concentrations of the hormones insulin and glucagon during fasting or fed conditions
* labelled glucose, glycerol and amino acids will also be infused continuously to track the fate of these molecules
* during the hormone infusions blood samples will be taken repeatedly


Eligibility Criteria:
Inclusion criteria:

* Age 18 to 50 years
* BMI 18.5 - 25 kg/m2
* Stable body weight in the past 6 months before study initiation
* Women should be anovulatory on non-cyclic hormone replacement or hormonal contraception

Exclusion criteria:

* Previous medical history for any chronic condition in the last three months, active disease or abnormal physical examination as verified by a qualified physician
* Body weight unstable in the past 6 months
* Use of tobacco/nicotine
* Alcohol consumption \>30g/day
* Participation in an investigational drug trial within the past two months
* Current intake of any drugs (prescribed, over the counter or recreational)
* Known allergy to tocilizumab
* Pregnant or lactating women,
* Inability or unwillingness to provide informed consent
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab

A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab

A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)

Eligibility Criteria:
Inclusion Criteria:

* healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential

Exclusion Criteria:

* no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.
* Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.
* Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..

Exclusion Criteria:

* Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.
* Shift workers who work between 12am (midnight) and 6am.
* Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.
* Other diseases / conditions as listed in the protocol.
A Phase II Study of Maintenance With Azacitidine in MDS Patients

A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.

The primary objective is response duration (MDS or AML)

A academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation

Eligibility Criteria:
Inclusion Criteria:

* MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO classification (see appendix 1) or CMML with WBC \< 13 109/l RAEB-T according to the FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with available bone marrow cytogenetics at diagnosis of AML

AND

in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it

Exclusion Criteria:

* AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC\< 13 109/l
* Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune disorder)
* Patients eligible for allogeneic bone marrow transplantation (with a identified donor)
* Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia \> 1.5 normal value ALAT and ASAT \> 3N
* Bilirubin \> 2 N, unless due to dyserythropoiesis
* Known hypersensitivity to azacitidine or mannitol
* Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
* Uncontrolled infection,
* WHO Performance status \> 2
* Life expectancy less than 3 months
Cervicothoracic Junction Mobilization Versus Eccentric Muscle Energy Technique in Mechanical Cervical Pain

1. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on mechanical cervical pain.
2. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on cervical disability.
3. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on cervical ROM.


Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study.

  1. Females
  2. Age between 18-45 years.
  3. Diagnosed with mechanical cervical pain.

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.

  1. Pregnant Females
  2. Any previous history of trauma or surgery
  3. Diagnosed with mechanical cervical pain due to disc herniation, radiculopathy or any other cervical malignancy.
Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps

Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps. Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary medical management to prevent continued growth. More recently high dose topical nasal steroid sprays are used. It is thought that the higher dose will penetrate the sinus cavities at an increased dose and will allow for greater control of polyp growth. Safety studies have been performed which have shown no suppression of the pituitary axis with long term high dose topical steroid or changes in intraocular pressure. However, studies in efficacy are limited despite their widespread use. The objective of this study will be to compare the effectiveness of two topical nasal steroid sprays in patients with recurrent nasal polyps.

Recruitment plan- Patients with nasal polyps who have had sinus surgery at least 3 months prior and documented nasal polyps by endoscopy will be prospectively recruited. This will be a randomized blinded study. Patients will be randomized into two groups- group 1 will received topical fluticasone and group 2 will receive topical dexamethasone spray to the nasal cavity. The investigator will be blinded as to which group the subjects are placed in. The medications will be given out from the inland compounding pharmacy located at 24747 Redlands Blvd, in Loma Linda.

Procedures

1. At the time of enrollment nasal endoscopy will be performed to confirm the diagnosis of nasal polyps and to grade the size of the polyps. Polyp size will be graded by the following scale: 0- no polyps, 1- polypoid mucosa, 2- polyps within sinus not occluding ostium, 3- polyps occluding ostium filling nasal cavity
2. Subjects will be asked to fill out a SNOT 20 survey before the start of therapy.
3. Subjects will be randomized into 2 groups by the flip of a coin. The investigator will be blinded to which group the subject is placed in. The pharmacist (Raylene Mote, Inland compounding pharmacy) who compounds the medications will be the only one aware of which medication was given.
4. Subjects will pick up their medication at the inland compounding pharmacy and will be instructed to use the nasal spray- 2 sprays twice a day for 6 weeks.
5. After 6 weeks the subjects will return to the office for repeat nasal endoscopy and will be asked to fill out a SNOT 20 survey.
6. Continued therapy of the nasal steroid spray will be at the discretion of the physician. If subjects do not appear to be responding the nasal steroid spray the medication will be altered as deemed medically necessary.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with nasal polyps who have had sinus surgery at least 3 months prior to enrollment.

Exclusion Criteria:

* Allergy to steroids
* Glaucoma
* Cataracts
Outcomes of Injections in Patients Waiting for Total Knee Replacement

A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.

The objective of this research is to evaluate the short-term results of viscosupplementation in patients with advanced osteoarthritis of the knee.

There is a bigger demand of patients requiring total knee arthroplasty than the number of surgeries performed by the Unified Health System in Brazil. For this reason the queues to perform this surgery are huge and time-consuming in the referral hospitals. Whereas all these patients are suffering from severe pain and limiting, and awaiting the surgery for a few years, it is necessary to try any treatment, even if temporary, to ease the pain and suffering of those patients.

A double-blind randomized prospective study will be held at Hospital Federal dos Servidores do Estado do Rio de Janeiro, with patients from the waiting list for Total Knee Arthroplasty who accept to participate and sign the informed consent form. Will be selected the last 150 knees in TKA queue. Patients will be randomized and divided in 3 groups of 50 knees. A group will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile Triamcinolone Hexacetonide solution 20 mg/ml). A second group will be subjected to administration of 6 ml of Hylan GF20. The third group will receive Hylan GF20 associated with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of Hylan GF20). The injection technique will be the same for all patients. The outcome results will be measured by a form with patient data, functional scores (Knee Society Score and Lysholm) before treatment and at one, three and six months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
* Acceptance and signature of the TFCC;

Exclusion Criteria:

* Infiltration of the knee for the past 6 months;
* Allergic to any substance used in the study;
* Prior infection in the knee.
Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone

The use of combined oral contraceptives has been associated with increased risk of adverse cardiovascular events. The exact mechanism by which these drugs exert this influence is uncertain. It is possible that changes in autonomic nervous system are involved. The objective of these study was to evaluate the effect of the use of a contraceptive containing 20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in healthy women. Few studies have been conducted in the field of hormonal contraception and evaluation of the autonomic nervous system work and no prospective, controlled study was published so far. These study will be the first.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 years old
* no use of hormonal contraceptives for at least 6 months before the study
* need for contraceptive method
* willingness to participate in the study

Exclusion Criteria:

* positive pregnancy test
* category 3 or 4 classification on WHO's Medical Eligibility Criteria for Contraceptive
* smoking
* obesity
* fasting glucose above 100 mg/dL
* abnormalities in lipid profile
* use of other medications
Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and Their Combination in Constipation and Bloatedness

Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl and simeticone compared with the efficacy and tolerability of the single products in patients suffering from constipation and bloatedness


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of constipation, defined as acute and habitual constipation; concomitantly patient must have complaint of bloated feeling
* Patient was to be 18 years of age or older
* Females who were of child bearing potential must have a negative pre-study urine pregnancy test and must be using oral or barrier contraceptive methods throughout the study. If oral contraceptives were used, the patient must be using them for at least 3 months prior to enrolment into the study
* Patient must be willing to maintain a diary throughout the study
* Patient must be otherwise in good health
* Patient must sign an informed consent form which has been prepared in accordance with the Declaration of Helsinki

Exclusion Criteria:

* Patient had drug-induced constipation resulting from drugs such as opioids, dopaminergics, antacids, anticholinergics or diuretics
* Patient had a history of organic diseases of the colon such as tumors, stricture, and acute or chronic inflammatory diseases, ileus, acute surgical abdominal conditions such as acute appendicitis, or organic diseases of the rectum and anus such as fissures, fistulas, perianal abscesses, and eczema of the perianal skin
* Patient exhibited evidence of active gastrointestinal disease
* Patient was diagnosed as having intestinal obstruction, had any undiagnosed abdominal symptoms, or was in severe dehydration
* Patient had a history of major gastrointestinal surgery
* Patient had a history of hypersensitivity to substances of the triarylmethane class
* Patient had a history of hypersensitivity to substances of the class of parahydroxybenzoic esters (para group allergy)
* Patient had a history of drug or alcohol abuse
* Patient had received bisacodyl for the treatment of another indication or in a previous study within the last 7 days before enrolment.
* Patient had ingested any drug in the past week before enrolment that in the opinion of the investigator would have an effect on gastrointestinal motility (e.g. anti-cholinergic medications, opioids, smooth muscle relaxants or antacids)
* Patient required the use of a drug, other than study drug, or dietary supplement to relieve the symptoms of constipation at any time during the baseline or treatment phases of this study
* Patient was currently taking any form of tetracycline antibiotics
* Patient was a nursing mother
* Patient had received any investigational drug within the previous 4 weeks prior to enrolment
* Patient had any condition that would interfere with the completion of this study, or that would decrease the likelihood of obtaining valid results