cyrilzakka/clinical-trials huggingface dataset:
Innovative Treatments in Pneumonia (ITIP) 3

This is a prospective observational study assessing the clinical outcomes of children 2 to 59 months of age with both pneumonia and other co-morbidities presenting to a tertiary hospital outpatient setting in Malawi, Africa who are most at risk for mortality or have other complications and thus, are typically excluded from childhood pneumonia studies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 2 to 59 months of age.
* Excluded from enrollment in Innovative Treatment in Pneumonia (ITIP) 1 and ITIP2 clinical trials due to presence of any of the following:
* Hypoxia (SaO2 \< 90% on room air, as assessed by a pulse oximeter).
* Severe respiratory distress (e.g., presence of grunting, nasal flaring, head nodding, or severe chest-indrawing).
* Severe malaria, classified by World Health Organization (WHO) guidelines on hospital care for children, including a positive malaria rapid antibody test result.
* Severe anemia, classified by WHO Integrated Management of Childhood Illness (IMCI) guidelines (i.e., severe palmar pallor) only if a positive malaria rapid antibody test result.
* severe acute malnutrition (SAM) (i.e., weight for height/length \< -3 SD, mid-upper arm circumference (MUAC) \<115, or edema).
* HIV-1 seropositivity or HIV-1 exposure, assessed as follows: An HIV-positive result upon rapid antibody testing.
* If a child is less than 24 months of age and has an HIV-negative result upon rapid antibody test documented from the past three months, the child's biological mother's HIV status will need to be assessed. If the mother is HIV-positive, the child will be included. If the mother does not have documentation of an HIV-negative test result from the past 3 months, she will be tested via rapid antibody testing to determine the child's eligibility for this study.
* Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up (in the inpatient ward, returning to KCH for a scheduled study follow-up visit, and by phone) for the planned duration of the study.

Exclusion Criteria:

* Possible tuberculosis (coughing for more than 14 days).
* Stridor when calm.
* Severe anemia, classified by WHO IMCI guidelines (i.e., severe palmar pallor) if a negative malaria rapid antibody test result.
* Known allergy to penicillin or amoxicillin.
* Receipt of an antibiotic treatment in the 48 hours prior to the study based on caregiver's self-report and/or documentation in child's medical record.
* Living outside Lilongwe urban area, the study catchment area.
* Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardize the child's health.
* Participation in a clinical study of an investigational product within 12 weeks prior to enrollment or planning to begin participation during this study.
* Prior participation in ITIP1, ITIP2 or ITIP3 during a previous pneumonia diagnosis.
A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.


Eligibility Criteria:
Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25(Upper Normal Range)
* Total Bilirubin \> 1.5 (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg
Analysis of SARS-CoV2 Urine Viral Particles and Association With Proximal Tubular Dysfunction

The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)


Eligibility Criteria:
Inclusion Criteria:

* Person and / or trustworthy person who has received complete information on the organization of the research and who has not opposed their participation and the use of their data
* Hospitalized for ≥ 48 hours and ≤ 10 days
* SARS-CoV-2 positive nasopharyngeal sample
* Severity criteria: Lung involvement described as compatible with SARS-CoV-2 on radiography or scanner and partial pressure of oxygne (PaO2) / Fraction of inspired oxygen (FiO2) ≤ 300 mmHg and / or respiratory rate (RR) ≥ 30 / min

Exclusion Criteria:

* Known chronic kidney disease, or initial Glomerular Filtration Rate (GFR) \<60 ml / min / 1.73m2 or Renal Transplant
* Known proteinuria
* Known proximal tubulopathy
* Treatment with Forxiga
Monocular Action Video Game Treatment of Amblyopia

This study evaluates the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments.

Amblyopia is the condition in which there is a decrease in monocular visual acuity or, less frequently, binocular, in absence of structural anomalies or ocular pathology. It is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development.

The aim of this study is reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia.

A randomized clinical trial will be performed to evaluate the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments. The participants will be distributed in two groups. The first group will include those participants who will follow a daily occlusive treatment and the second group will include patients who will be treated with monocular therapy with video-games.The sample will include subjects between 4 to 10 years old with a diagnosis of refractive and / or strabismic amblyopia.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-10 years old
* Anisometropic amblyopia
* Strabismic amblyopia or mixed
* Interocular visual acuity (VA) difference of at least 0.2 logMAR
* No history of eye surgery

Exclusion Criteria:

* Non-comitant and/or large constant strabismus (\>30 prism diopters)
* Any ocular pathological condition or nystagmus
Digital Sizing for Orthopaedic Hip Implants

Hip implants come in different sizes. Currently, surgeons predict the implant size that will be needed using an analogue method whereby photos of the implant sizes are overlaid on the x-rays. In this study, we propose to use a digital, computerized method of templating which we expect will be more accurate than the overlay method.


Eligibility Criteria:
Inclusion Criteria:

* Patients booked for primary total hip arthroplasty with non-cemented prosthesis.
* No previous surgery/fractures to acetabulum or femur or hip.
* No gross bony abnormality except for osteoarthritis and avascular necrosis.

Exclusion Criteria:

* Cancer or tumor suspected, morbid obesity, revision, previous acetabular/femur/hip surgery, gross bony deformity, calibration bar not completely pictured on radiograph, unsuccessful surgery fracture/cancer/cemented prosthesis used.
Effectiveness of Aquatic Exercise on Fatigue, Neuropathy and Quality of Life Among Cancer Patients

The majority of cancer patients experience exhaustion, fatigue, and neuropathy that impact their participation in daily activities and reduce their quality of life. In addition, they may affect the ability to function at work and delay a return to employment. Studies have demonstrated that physical activity has a positive effect and consequently, patients being treated for cancer are advised to avoid inactivity. Various studies have described Tai Chi practice as beneficial in reducing exhaustion and fatigue to some extent, and have suggested that it may improve the quality of life of cancer patients. The environment in which physical activity takes place is also important. The properties of water and their effect on the submerged human body may be particularly beneficial for cancer patients. A previous study among breast cancer patients reported that exercise in deep water significantly reduced exhaustion and fatigue compared to patients who received only regular treatment. The practice of Tai Chi in water is termed Ai Chi.

The objectives of the present study are to examine the effects of an Ai Chi program as compared to an intervention group undergoing identical physical exercise on land, and a third group with no additional exercise in cancer patients on:(A)time to return to work, work hours, perception of work-related difficulties, and work absenteeism;(B)activity and participation in the daily life and quality of life; and(C)exhaustion, fatigue, and neuropathy.

This is a randomized clinical trial. 150 cancer patients aged 18-65 years will be recruited. Subjects who meet the recruitment criteria will be randomly divided into one of three groups:(a)Water exercise (Ai Chi);(b)Identical land exercise; and(c)Control-who will not perform additional physical activity or receive any extra treatments. The exercise program will be scheduled for 30 minutes twice a week for 8 weeks. Research tools include:(1)WHODAS 2.0;(2)EORTC QLQ-C30; (3)Piper Fatigue Scale;(4) Employment Barriers Questionnaire;(5) Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20);and(6)Date of return to work and duration of working hours - self-report by the study participants.

Data will be collected before the intervention, after 8 weeks of intervention, and then at 3, 12, and 24 months from the end of the intervention. The investigators will perform a series of mixed variance analyzes to identify relationships and associations between groups and with time within a group (independent variables).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer (stage 3 colon cancer patients and breast cancer patients with lymph node involvement). recruitment of colorectal cancer patients and breast cancer patients for the study will be within 3 months of cessation of chemotherapy treatment.
* a score above 26 on the cognitive MOCA test.

Exclusion Criteria:

* Volunteers with orthopedic disabilities / injuries that in the opinion of the attending physician prevent their participation in physical exercise
* Volunteers engaged in other physical activity on a regular basis
Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are:

type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).

The primary aim of this trial is to compare the effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). Compared to rTMS, dTMS delivers a broader magnetic field, which in turn reduces coil positioning error and maximizes the probability of optimal cortical stimulation. A past RCT comparing both approaches found a greater depression score decrease and response/remission rates for dTMS, but was short of reaching significance for remission rates (primary outcome). Critical components of this RCT were suboptimal, including too few treatment sessions and insufficient statistical power, both of which could have obscured an actual difference between modalities. Proof of a more effective type of TMS over another would translate into increased odds of improvement for TRD patients who live with a chronic and disabling illness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode
* HRSD-17 score of at least 18
* No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration
* On a stable antidepressant regimen for the past four weeks before screening
* Patients with a chronic depressive episode \>2 years and who have previously received ECT or ketamine will be eligible to participate

Exclusion Criteria:

* Having previously received TMS;
* Substance use disorder within the last three months
* Diagnosis of bipolar or psychosis spectrum disorder
* Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD
* Concomitant major unstable medical or neurological illness
* Intracranial implant, cardiac pacemaker or implanted medication pump
* Significant laboratory abnormality;
* Active suicidal intent
* Pregnancy
* If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change
* Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness
Rhinocort Aqua Versus Placebo and Fluticasone Propionate

The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* At least a 2 year documented history of seasonal allergic rhinitis
* who, in the opinion of the investigator,
* is a candidate for treatment with nasal steroids based on a history of either

  * a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or
  * b) prior successful treatment with nasal steroids.
* A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specifies in the protocol.
Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia

The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights. The main question it aims to answer are:

• the enhancement of tDCS on the effect of VRET Participants will randomly allocated to tDCS active stimulated group and sham stimulated group and receive VRET.


Eligibility Criteria:
Inclusion Criteria:

* the score of the AQ-Anxiety had to be at least 45.45(1SD below the mean of a previous acrophobia sample(Cohen, 1977));
* the participants had the avoidance behaviors in daily life and recognized the fear of height was excessive and unnecessary (the severity of fear of heights not less than 5 points at a scale from 0 to 10).

Exclusion Criteria:

* previous treatment for acrophobia, history or family history of any mental disorder (except for acrophobia), metal parts in the head, medical implants, increased intracranial pressure, pregnancy, current involvement in psycho- or pharmacotherapy, and cardiovascular or neurological diseases.
Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy

Oral mucositis (OM) is a common side effect of systemic chemotherapy (CT) in cancer patients. The aim of this study was to investigate the effect of hyaluronic acid (HA) gel on OM in children receiving CT.


Eligibility Criteria:
Inclusion Criteria:

* children who receive chemotherapy
* hospitalized patient

Exclusion Criteria:

- Allergy about using drugs
Probiotics for Prevention of Antibiotic-associated Diarrhea

The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving antibiotic therapy.

A common complication of antibiotic use is antibiotic-induced diarrhea (AAD). AAD is the result of disrupted microflora, occurring two to eight weeks after antibiotic use. Probiotic supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea, improving quality of life and reducing symptoms associated with antibiotic administration.

The proposed study will be a prospective, randomized, double blind, placebo-controlled trial that will assess the efficacy of the Jarro-Dophilus EPS probiotics formula for the prevention of AAD.

In addition,a subgroup of participants will be requested to provide one fecal sample at the initiation of the study and one sample in the last three days of probiotic (or placebo) treatment. The samples will undergo microbial analysis for routine C \& S(Salmonella, Shigella, Campylobacter, Ecoli 0157, Yersinia), VRE, Yeast, Fungus culture (moulds) and C. difficile toxin.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics

Exclusion Criteria:

* Treatment with an antibiotic two weeks prior to study entry
* Underlying long term gastrointestinal disease (i.e., Ulcerative Colitis, Crohn's Disease, irritable bowel syndrome, ileostomy, colostomy)
* Pregnant or lactating
* Immunocompromised state
* Chronic illness such as Hepatitis B, Hepatitis C, renal failure
* Inability to provide informed consent, inability to speak or write in English
* Receiving tube feeds
* Insufficiently functional (physically and cognitively) to complete the study diary and questionnaires.
Cognitive Behavioral Group Therapy for Trichotillomania (Hair Pulling Disorder)

This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy for trichotillomania at three clinical sites in Norway.

The Norwegian Trichotillomania Project is a multicenter study that aims at evaluating the effectiveness of behavioral group therapy for TTM, i.e., ACT (Acceptance and commitment therapy) enhanced habit reversal training (ACT-enhanced HRT).

Participants are adults or adolescents (16 year or older) who fulfill criteria for TTM according to DSM-IV. Inclusion started in January 2013 and will be completed by Mai 2016. Treatment is delivered at three treatment sites in Norway; in Kristiansand, Oslo, and Trondheim. Treatment is manualized, following the manual of Twohig and Woods, and consists of ten group sessions of three hours delivered at consecutive weeks, and two or three booster sessions during the first year after treatment.

Treatment outcome is evaluated by three outcome measures; the Massachusetts General Hospital - Hairpulling Scale (self-report); the National Institute of Mental Health Trichotillomania Severity Scale (clinical interview, conducted by independent evaluators); and the Clinical Global Impression Scale for TTM. Outcome is measured at three points in time; at baseline, at the end of treatment, and at one-year follow-up. Mixed models procedures in SPSS is used to analyze longitudinal data.

The first paper will be written on patients admitted to treatment from January 2013 to September 2014, and includes 53 patients (49 women and four men). By January 2016, fifty-one patients (96%) had participated in the one-year follow-up evaluation.

Eligibility Criteria:
* Inclusion Criteria:

  * Clinical diagnosis of Trichotillomania
  * Age between 16 and 67
* Exclusion Criteria:

  * schizophrenia spectrum disorder
  * substance addiction
  * severe antisocial, schizotypal, or paranoid personality disorder
  * severe eating disorder,
  * ongoing suicidal ideation
  * pervasive developmental disorder
  * mental retardation and severe sequelae after brain injury.
Anesthetic Technique for AV Fistulae Creation

This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.

The primary objectives of the study are:

1. To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
2. To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.

The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).

Eligibility Criteria:
Inclusion Criteria:

* Age 21-70 years old
* Able to give informed consent
* Creation of first time AV fistula
* Possible 3 month follow up visit
* ASA-I-IV

Exclusion Criteria:

* BMI ≥40
* Repeated AV fistula creation,
* ASA -V,
* Allergic to local anesthetic agents,
* Significant lung and cardiac disease,
* Infection at the site of regional anesthesia,
* Pre-existing peripheral nerve damage,
* Significant bleeding disorders,
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation

Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation
* persistent atrial fibrillation \< 2 month
* indication for catheter ablation
* LEF \> 50%
* diameter LA \< 50 mm

Exclusion Criteria:

* intracardial thrombus
* atrial fibrillation with underlying curable disease
* renal failure \> stage I
* contraindication for anticoagulation
* life expectancy \< 12 month
* previous PVI
* pregnancy