cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Diagnostic Approaches for Malaria and Pneumonia

This research investigates the diagnostic accuracy of various diagnostic approaches for malaria and pneumonia in under-five children presenting to primary healthcare centres in Benin City, Nigeria.

Of the preventable and treatable diseases, both malaria and pneumonia are significant contributors to under-five mortality in Nigeria. To reduce the burden of these diseases, the Integrated Management of Childhood Illness (IMCI) guidelines were developed by the World Health Organisation (WHO) to be used at first point of contact (e.g., primary healthcare centres) with children under the age of five years old. Preliminary literature review suggests that although interventions based on numerous diagnostic approaches have been trialed, burden from malaria and pneumonia remains unacceptably high in Nigeria, suggesting limited effectiveness of existing approaches. Therefore, this study aims to compare the accuracy of different early diagnostic approaches used in the community(for e.g. the WHO Integrated Management of Childhood Illness (IMCI) guidelines versus the gold standard diagnostic tests comprising microscopy in malaria and chest radiography in pneumonia) in children under the age of five years presenting with suspected malaria and pneumonia to primary healthcare centres in Benin City, Edo State of Nigeria.

The research will compare the accuracy of these various diagnostic approaches using measures such as sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve. The research will also assess patient outcomes like complications, hospitalisation and death following a diagnosis of either pneumonia or malaria in all study participants as well as costs associated with malaria and pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Suspected malaria (symptoms reported by caregiver that are consistent with malaria: high temperature, chills and no other probable diagnosis)
* Suspected pneumonia (fever, cough, shortness of breath/difficulty in breathing, with or without chills and no other probable diagnosis)
* Willingness of caregiver to provide written or verbal consent in the presence of a witness.

Exclusion Criteria:

None
A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 (also known as pacibekitug) in participants with chronic kidney disease and elevated hs-CRP.

Previous clinical studies have suggested that IL-6-driven inflammation plays a key role in the pathogenesis of cardiovascular diseases including atherosclerotic cardiovascular disease (ASCVD) and heart failure. This Phase 2 study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006, a fully human monoclonal antibody against IL-6. TOUR006 binds the IL-6 cytokine and inhibits downstream IL-6 signaling, thereby reducing the pharmacodynamic marker, hs-CRP.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at time of ICF signature.
* Serum hs-CRP level ≥2.0 mg/L and \<15 mg/L
* Diagnosis of chronic kidney disease, eGFR ≥15 and \<60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR\>200 mg/g
* Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.
* Agreement to comply with contraception and reproduction restrictions

Exclusion Criteria:

* Clinical evidence or suspicion of active infection
* Current or recent COVID-19 infection within 30 days
* Serious infection within 6 months or more than 1 such episode within 18 months
* Any history of a serious opportunistic infection within 18 months
* Known history of immunodeficiency
* History of gastrointestinal ulceration or perforation within 12 months
* History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
* History of GI bleeding requiring hospitalization and/or transfusion within 6 months
* New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months
* Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months
Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease

Chronic Graft-versus-Host Disease (cGVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow transplantation. cGVHD usually occurs after 100 days following transplantation and develops in 20-60% of transplant recipients. The incidence of cGVHD varies depending on the age of the marrow recipient, the use of sibling or unrelated donor bone marrow, the use of unmanipulated T cell-depleted bone marrow, and perhaps other factors. Clinically, cGVHD is characterized by multi-system disease, which frequently mimics the clinical features of autoimmune diseases. The manifestations include skin changes (lichenoid and sclerodermatous changes, changes in pigmentation, loss of accessory structures such as hair, dystrophic nails, and rash), joint contractures, severe cramping, hepatic dysfunctions, sicca syndrome, obstructive lung disease, esophageal dysmotility, weight loss, polyserositis, immunodeficiency, and autoantibodies including anti-nuclear antibody, anti-erythrocyte antibodies, and anti-platelet antibodies.

A large number of children with cGVHD have to deal with many years of a disfiguring and painful chronic illness with the side effects of long term steroid use. The number of stem cell transplants done in children is only growing given that we are now transplanting patients with a variety of nonmalignant disorders and given the use of alternative donor sources. The broad categories of limited and extensive cGVHD are recognized by clinicians, but are not particularly useful in clinical practice. Since cGVHD may involve almost every organ system adn since cGVHD constitutes a waxing and waning nature, cGVHD makes clinical management very difficult and complicated. Currently, there is a symptoms scale used in the adult population for measuring symptom burden for adults with cGVHD. This scale is called the "Lee Symptoms Scale". The purpose of this project is to develop a scale that is similar in design to the Lee Scale, but it is specifically designed to measure the burden of cGVHD in the pediatric population

Eligibility Criteria:
Inclusion Criteria:

* 5-18 years of age
* Prior allogeneic Stem Cell Transplant, with any graft source, donor type, and GVHD prophylaxis allowed
* Clinical diagnosis of cGVHD
* Need for systemic treatment, defined as any medication or intervention delivered
* No evidence of primary disease relapse
* Signed, informed consent, and if applicable, adolescent assent

Exclusion Criteria:

* Inability to give signed informed consent
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.

This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emergency Department Observation Unit (EDOU) of William Beaumont Hospital, a high volume, university affiliated 952 bed suburban teaching hospital.

Patients will be given a seven-day supply of tamsulosin (0.4mg daily) or placebo. They will also be given a prescription for Vicodin (30 pills) and Ibuprofen (600mg, 30 pills). They will be called on days 1, 2, 3, 7, and 10 following the index visit regarding passage of stone or 48 hours without pain. Patients will be asked to call in if they pass their stone or are without pain for 48 hours. Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review.

The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain. Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Study exclusion criteria:

* Stone not documented on imaging
* Stones \>10mm
* Pregnancy
* Age \<18 years
* Evidence of infection with an obstructing stone
* Obstructing stone in a solitary kidney
* Currently taking tamsulosin, vardenafil, nifedipine, or steroids
* Contraindications or allergy to tamsulosin
* Ureteral surgery
* Patients that are unable to understand consent
* Patients that are unable to comply with follow-up

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients with acutely symptomatic renal colic pain
* Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Exclusion Criteria:

* Stones not documented on imaging
* Stones \>10mm
* Pregnancy
* Age \<18 years
* Evidence of infection with an obstructing stone
* Obstructing stone in a solitary kidney
* Currently taking tamsulosin, vardenafil, nifedipine, or steroids
* Contraindications or allergy to tamsulosin
* Ureteral surgery
* Patients that are unable to understand consent
* Patients that are unable to comply with follow-up
Abobotulinumtoxina Efficacy in Post-Traumatic Headache

This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.

Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age 18-65
* meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
* average pain score of greater than 4/10 in severity on the numerical rating system
* Rancho Los Amigos cognitive scale score greater than seven.

Exclusion Criteria:

* Uncontrolled medical condition other than PTH
* Severe additional chronic pain complaint which could not be distinguished from headache pain
* pregnancy, breast feeding,
* prior treatment with botulinum toxin within one year of enrollment
* current substance abuse/dependence
* medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
* poorly controlled psychiatric
* initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
* ongoing disability or litigation claim.
Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia

In this study, the investigators aim to evaluate patient satisfaction between three methods of obtaining informed consent for anaesthesia. Patients are asked to partake in a short survey after being informed about the anaesthetic procedure either conventionally in the anesthesia department, telephonically or digitally.

Patient satisfaction plays an important role to improve the process of medical procedures as well as patient outcome. Evaluating the subjectively experienced satisfaction is challenging. The investigators will use a questionnaire and assess waiting times in the process to determine patient satisfaction between digital, telephonic and conventional obtaining of informed consent for anaesthesia.

In this questionnaire study, patients are asked to partake in a survey after the process of obtaining consent for anaesthesia is completed. The questionnaire covers aspects of patient satisfaction with the process, such as subjective assessment of comprehensibility, waiting time and privacy.

Patients are divided into three groups. In one group, consent is obtained conventionally, in form of a visit to our anaesthesia department. In the other two groups, consent is obtained telephonically and digitally, respectively. Patients are not randomised into these groups, but included into the study after the process of obtaining consent by one of the three methods mentioned above is completed.

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom consent for anaesthesia is obtained

Exclusion Criteria:

* Age \< 18 years
* Language barrier
* Patients with appointed legal guardians
* Patients unable to provide informed consent
A Study of Empirical Antifungal Therapy With Itraconazole

The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.

This is a retrospective study ie, a study that looks backward in time, usually using medical records and interviews with patients who are already known to have a disease, in patients with itraconazole intravenous prescription as an empirical (based on practical experience) antifungal agent. This study collects baseline information about underlying disease, sign of fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell) count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500 cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day with no definite external factor or a body temperature of ≥38 Celsius degrees continued for at least 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neutropenic fever who receive therapy for inhibiting or preventing development of neoplasms (abnormal growth of tissue) or stem cell transplantation (stem cell is a cell whose daughter cells may differentiate into other cell types) for hematologic malignancies (cancers that affect blood, bone marrow and lymph nodes)
* Patients who receive itraconazole intravenous (IV) treatment for more than 7 days

Exclusion Criteria:

* Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
* Fever due to documented fungal infection
* Hepatic dysfunction
* Kidney abnormalities
* Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines

This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in patients with Chronic Migraine.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic migraines
* 15 or more headache days over a 30 day period
* A minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxinA dosing between 155 and 195 units

Exclusion Criteria:

* Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
Effects of Rhythmic Balance Auditory Vision Training And Strength Training With Autism Spectrum Disorder.

Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and nonverbal communication. Rhythmic Balance Auditory Vision Training (RBAVT) a therapeutic approach which helps in improving coordination and balance in individuals with various neurological conditions. Strength training enhance physical health and muscle development. Thus, the purpose of this study is to compare the effects of rhythmic balance auditory vision training and strength training on motor function and cognition in children with autism spectrum disorder.

This randomized clinical trial will be conducted in Autism center Lahore. Sample of 76 patients will be recruited in this trial by using the convenience sampling technique. Participants will be randomly allocated in two groups using lottery method. Group A will receive Rhythmic balance visual auditory exercise. Group B will receive strength training exercises. Both groups will receive routine physical therapy as baseline treatment. All the participants will receive 3 sessions per week for 12 weeks.Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) will be used assessment tool to measure fine and gross motor skills and Wisconsin Card Sorting Test (WCST) will be assessment tool that evaluates cognitive flexibility and problem-solving abilities.

Eligibility Criteria:
Inclusion Criteria:

1. Age range between 6 and 12 years.
2. Rating Scale (CARS) with scores ranging from 30 to 36.
3. Confirmation of the diagnosis of autism by a psychiatrist based on Diagnostic and Statistical manual of Mental Disorders.
4. Physical and cognitive ability

Exclusion Criteria:

1. Children with history of auditory, visual, or respiratory deficits, or fixed deformities of the extremities.
2. Medical contraindications such as orthopedic or acute conditions that hinder participation in the exercise program.
3. History of psychotropic medication within the last 4 weeks.
Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography

This study aims to:

* analyze prospectively the prevalence of subclinical oculomotor disorders (OMDs) in different phenotypes of Multiple Sclerosis (MS) and to study correlations with brain MRI T2 data.
* highlight link between modification of visual exploration strategies to decode emotions, and social behavioral disorders, in patients with demyelinating disease, from early to clinically definite stages.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female.
* 18 years old and above.
* Sufficient written and oral expression in French.
* Covered by a health insurance system
* Written informed consent signed by the patient.
* For the MS group:

  \* Patient diagnosed according to diagnostic criteria established by Polman et al. (2010): Radiologically Isolated Syndrome compatible with MS (RIS), Clinically Isolated Syndrome compatible with MS (CIS), Relapsing-Remitting MS, Secondary Progressive MS, or Primary Progressive MS.

  \* Hospitalized or coming to perform a consultation.
* For the control group: No cognitive impairment (non pathological Mini-Mental State Examination (MMSE), according to age, gender and socio-cultural level).

Exclusion Criteria:

* General anaesthesia within 3 months.
* Ophthalmological problems preventing a video-oculography examination.
* Oculomotor disorders:

  * For the control group: "fixation disorders" or "ocular tracking disorders".
  * For the MS group: atypical disorders.
* Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
* Other neurological or ophthalmological disorders than MS
* History of stroke.
* Psychotropic drugs consummation.
Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication


Eligibility Criteria:
Inclusion Criteria:

* Patients with uncomplicated, essential hypertension

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.
Reciprocal Inhibition Versus Reciprocal Facilitation In Spinal Cord Injury Patients

Reciprocal inhibition is a medulla spinalis control mechanism that facilitates motor activities in healthy people. As the agonist muscle contracts, the antagonist muscle is inhibited so that the agonist action can take place properly. In the literature, there are studies showing that in patients with upper motor neuron lesions, this reverses, and reciprocal facilitation occurs instead of inhibition. However, there is no clear situation in this regard, there is a need for more methodologically sound studies. Our aim in this study is to investigate the presence of reciprocal facilitation in patients with spinal cord lesions (SCL).

Reciprocal inhibition is a spinal segmental control mechanism that facilitates motor activities in healthy people and is also used in treating spasticity. Considering the current literature, there are some studies claiming that this is reversed in patients with upper motor neuron lesions and that there is reciprocal facilitation instead of inhibition. However, the proposed evidence is not convincing. Our aim in this study was to investigate the presence of reciprocal facilitation in detail in patients with upper motor neuron lesions. This study was conducted in five patients with spinal cord lesions and five healthy individuals. Both the tibialis anterior and soleus muscles of the cases were recorded using surface and multi-motor unit electromyography (EMG) electrodes. To elicit an H reflex in the soleus muscle, an electric current was delivered through the popliteal fossa using the monopolar technique. The Achilles tendon was tapped with the reflex hammer to elicit a T reflex. Since the H-reflex and T-reflex responses were detected in the tibialis anterior muscle surface and multi-motor unit EMG recordings, the findings were evaluated as direct stimulation, cross-talk, and reciprocal facilitation. Methodologically, This research aimed to be a guiding study for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spinal cord injury between the ages of 18-60
* A minimum of 6 months of SCL history
* Soleus spasticity

Exclusion Criteria:

* Patients with premorbid neuromuscular disease
* History of autonomic dysreflexia
* Patients in the spinal shock period
* Those who have a coronavirus disease clinic
* Less than 2 hours sitting tolerance