cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic

Tuberculosis in children is a major public health problem and it contributes 10% of the total TB cases worldwide. TB treatment outcomes in children are challenged by insufficient consideration of the relationships between doses administered, concentrations achieved and eventual desirable and undesirable effects (pharmacodynamics) of TB drugs. Rifampicin is a pivotal TB drug and data from adults suggest that a much higher dose of rifampicin (35 mg/kg instead of 10 mg/kg), resulting in much higher rifampicin exposures in plasma, is safe and tolerable and may provide a higher efficacy. The dose needed in children to achieve the same exposure in plasma is unknown.

Tuberculosis (TB) in children is a major public health problem . It has a global estimate of \>100,000 deaths per year and is included in the top ten causes of mortality in children worldwide. Children contribute 10% of the total TB cases worldwide. More than 75% of the worldwide estimated cases of TB in children occur in the 30 high burden countries, Tanzania being one of them. The enormous burden of pediatric TB in these countries is due to the TB epidemic amongst adults and the simultaneous HIV pandemic and a child less than 14 years of age whether HIV infected or not is at a high risk of developing the disease. Subsequent dissemination of the mycobacterium and progression of the disease is also fast in children.

Knowledge on the efficacy and safety of medicines for children is still very limited and sometimes children are still being treated as small adults. However, adult dosing cannot be logically extrapolated to children according to weight or age because of different pharmacokinetics, i.e. the relationship between doses administered and exposures (drug concentrations) achieved, in children as compared with adults . More specifically, these pharmacokinetic differences occur in the subsequent processes of absorption, distribution, metabolism and elimination of drugs, which are subject to physiological changes due to growth and development in children. Especially in young children, maturation of liver metabolism pathways and renal function are not completed.

In contrast, the pharmacodynamics of a drug, i.e. the relationship between concentrations achieved and eventual response is generally considered similar between adults and children, although differences in drug metabolism between children and adults may lead to differences in susceptibility to some adverse drug reactions. Thus, because of the differences in pharmacokinetics in children with different ages, they should not receive the same drug doses on mg/kg base as adults, and drug dosage selection in children should rather be based upon stages of growth and development. These drug doses should target the exposures that are efficacious in adults.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 14 years with newly diagnosed Tuberculosis

Exclusion Criteria:

* Children with elevated liver function
* Children allergic to first line anti-TB drugs
Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation

This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy \[MRS\] scan) with light stimulation. To test whether any MRS findings are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be included in this study.

This study will include males and females between the ages of 18 and 55 years. Participants will include adults with stable bipolar disorder or schizophrenia as well as healthy controls. The study involves a one-time visit that includes a clinical evaluation, laboratory tests, and a magnetic resonance scan that will last approximately 90 minutes. The procedures can also be separated into two study visits, if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Male of female
* 18-55 years
* Bipolar, currently euthymic OR schizophrenia, stable, OR healthy control with no history of psychiatric illness
* On stable medication with no changes in the two weeks prior to enrollment

Exclusion Criteria:

* History of substance abuse or dependence within 3 months of enrollment
* Positive urine drug screen
* Significant medical or neurological illness
* Pregnancy
* Any contraindication to magnetic resonance scanning, including claustrophobia
Hypertension in Hemodialysis

How high blood pressure in hemodialysis patients should be diagnosed and treated using medications or without medications is the purpose of this study.


Eligibility Criteria:
- Adults with hypertension on hemodialysis Hypertensive, long-term (3 months or more) hemodialysis patients will be studied over a 6 hemodialysis baseline phase during which 44-hour interdialytic ambulatory BP will be performed and baseline symptoms collected. Patients with well-controlled hypertension, on anti-hypertensive therapy will have blood pressure medications withdrawn until they become hypertensive as assessed by 44-hour interdialytic ambulatory blood pressure recording. We will exclude patients who have had vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months, ambulatory BP \>170 mm Hg systolic or \>100 mm Hg diastolic, those who miss 2 or more hemodialysis treatments in the previous month, abuse street-drugs, require home oxygen, have symptomatic congestive heart failure or are morbidly obese (body mass index \> 40 kg/m2).
Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.

The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).

Eligibility Criteria:
Inclusion Criteria:

* acute phase of stroke
* first stroke episode.
* no history of peripheral nerve injury or musculoskeletal disease
* no contracture of the affected wrist or fingers (Modified Ashworth\<3)
* no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study.
* paralysis of the wrist and fingers

Exclusion Criteria:

* unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
* scored greater than 4 points on the Beck Depression Inventory (BDI)
* more than 30 points in the State Trait Anxiety Inventory (STAI)
Clinical Trial of New Elastomer for Maxillofacial Prosthetics

The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.

Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field that:

* treats few patients, making the subspecialty unprofitable for manufacturers to develop new materials;
* offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding; and
* provides a dental solution to an essentially medical problem.

Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements. There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase 2 clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products.

This research is a controlled, randomized, single-crossover, double-blinded investigator-initiated multicenter Phase 3 clinical trial treating 100 patients that evaluates:

* experimental thermoplastic CPE; and
* control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional and subjective characteristics, and on the quality of life.

The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.

Eligibility Criteria:
Inclusion Criteria:

* Requires treatment for developmental or acquired extraoral facial defect
* Fully healed wound (6 months after surgery and/or radiation)
* Defect no larger than 9 x 12 cm (3.5 x 4.5 inches, the diameter of a giant bronze flask)
* Cognizant enough to answer questionnaires
* Agrees to wear the prosthesis at least 6 hours per day
* Agrees to use the prescribed adhesive (Epithane-3 - now called Daro Adhesive Extra Strength) and clean and store as instructed
* Plans to be able to return to the research institution for a 10 month period
* Able to manage prosthesis him/herself or with caregiver for a 10 month period
* Karnofsky score greater than or equal to 60 (www.hospicepatients.org/karnofsky.html)
* No framework or implant/magnet retention
* No multiple recurrences of tumor
* No hypersensitivity to adhesives or test materials
* No current systemic or topical facial steroid treatment
* Not legally blind
* Not expected to have further surgeries to defect, radiation therapy, or other cytoreductive therapy over the next 10 months
* No evidence of active skin condition/disease
* Not an infectious risk patient
Needs Assessment Among Carers of Someone With Suicidal Thoughts

With this study the investigators would like to gain insight into the experienced needs carers of individuals with suicidal thoughts, who attempted suicide or who died by suicide. By carers the investigators mean everyone who knows/knew someone close to them who is thinking about suicide, attempted suicide or died by suicide. By mapping out these needs, the investigators hope to better support carers and develop/improve initiatives and tools.

The investigators examine this by means of an online one-time questionnaire. In this questionnaire the investigators ask the participants questions about what it is like to be a carer and what are some of the experienced needs, as well as experiences with existing initiatives/tools.


Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* Someone close to them has experienced suicidal thoughts, attempted suicide or died by suicide in the past three years
* Access to internet
* Understand sufficient Dutch (to complete the questionnaire)

Exclusion Criteria:

* /
Characterization of the Relationship Between the Human Mesolimbic Reward System and Immune Functioning

The purpose of this study is to characterize the link between neurobehavioral measures of the mesolimbic reward system and immune functioning in healthy individuals, via fMRI neurofeedback modulation of mesolimbic reward system, and the consecutive assesment of immune response to Hepatitis B vaccination.

For many years, the link between mental processes and physical health has remained obscure. Yet, over time, studies have begun to shed light on the intimate relationship between one's physical condition and mental state. One body of research aimed at elucidating the mind-body relationship is the study of the placebo effect. Placebo effects result mainly from conscious expectations to become healthy in therapeutic settings, and from unconscious conditioned responses to therapeutical settings that predict beneficial outcomes. Both processes are asociated with the neuronal reward system, which mediates reward processing, reward valuation and value based-learning. However, it remains unclear how do these processes mediated by the reward system promote therapeutic effects?

A recent study established a causal relationship between mesolimbic activation (VTA) and a measurable immunological response in mice. Stimulation of the VTA increased anti-bacterial immune functioning, an effect that was mediated by sympathetic nervous system, which is regulated by the brain and innervates all immune organs.

In light of these findings, the current study aims to assess the relationship between reward-related brain activation and immune functions in humans. fMRI Neurofeedback, a task that allows individuals to self modulate specified neural patterns in real-time, will be used to induce mesolimbic activation, following which healthy individuals will vaccinate against Hepatitis B. Immunological effects will be assessed by comparing immunological measures with respect to Hepatitis B prior and following mesolimbic activation and Hepatitis B vaccination.

The long-term goal of this study is to demonstrate a causal link between reward activation and an objective measurable physiological response of great significance, and to develop the means for individuals to exploit such mechanism for boosting immune functioning. i.e. to harness endogenous reward-related brain activation to strengthen the immune system, for clinical pathologies such as autoimmune diseases, maleble pathogens, cancer, etc.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Normal or corrected to normal vision
* Compatibility with general MRI requirements

Exclusion Criteria:

* History of neurological or psychiatric diseases that lead to hospitalization
* Have received Hepatitis B vaccination in the last 10 years
* Memory/cognitive neurological impairments
* Chronic heart disease, diabities, high blood pressure, or autoimmune disease.
Effects of Multimodal Treatment of Headache in a Day Clinic Service

The observational study aims to investigate the effects of a multimodal treatment program for headache patients in a day clinic service. The setting provides one week of treatment including a combination of medical consultation, physiotherapy, psychological therapy, occupational therapy, progressive muscle relaxation and disease specific education.

Outcome measures are the disease-specific impact on daily activities, general quality of life, psychological impact and headache frequency. Moreover, the study sought to identify parameters that best predict efficacy of the intervention. Therefore, standardized questionnaires are established in three points in time, to evaluate the pre- and post-treatment status.

duration of treatment: 5 days; first questionnaire (V0): minimal 4 weeks prior to the treatment appointment; second questionnaire (V1): on the first day of the treatment program; third questionnaire (V2 / Follow up): 3 month (+- 6 weeks) after finishing the treatment; data collection through patient self-report; Follow-up via mail

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a headache disorder
* written informed consent for collecting and analysing data and conducting a follow-up evaluation

Exclusion Criteria:

* premature interruption of the treatment
* repeated treatment
Role of Serum Total Antioxidant Level in Preterm Labor

The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.

Study design:

This is a prospective case-control study.

Setting:

The study will be conducted at Ain Shams University Maternity Hospital.

Population of the study:

A total of 70 pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital.

Patient will be divided in to two groups. Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation \< 2cm and effacement\< 50%) which will deliver within one week maximum after hospitalization.

Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit.

Every case will be subjected to:-

1. Written informed consent before the study.
2. Complete history .
3. Complete general and abdominal examination.
4. Infection markers(CRP,WBCs count, urine analysis ).
5. Gestational age determination by the last menstrual date or Ultrasonography.
6. Local pelvic examination.

Eligibility Criteria:
Inclusion Criteria:

* Preterm labor(pregnant between 28th and 37th week).
* Singleton pregnancy.
* Amnion membranes were intact

Exclusion Criteria:

* Past history of preterm labor or premature delivery.
* Urinary tract infections and any other infections.
* Poly- or oligohydramnios.
* Fetal distress, fetal or uterine anomaly.
* Membranes rupture and placenta pathology.
* Preeclampsia or intrauterine growth retardation
Effectiveness of Aurix Therapy in Venous Leg Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, randomized trial in which venous leg ulcers will be treated using Aurix and standard of care and compared 1:1 to patients receiving undefined Usual and Customary Care (UCC).

Eligibility Criteria:
Inclusion Criteria:

1. Medicare eligible
2. ≥18 years of age
3. Proven venous disease
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
5. For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected as Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
6. Debrided ulcer size between 2 cm2 and 200 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate compression regimen
9. Duration ≥ 1 month at first visit
10. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician

Exclusion Criteria:

1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
2. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
3. Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
4. Patients on chemotherapeutic agents or any malignancy in the wound area
5. Subjects who are cognitively impaired
6. Serum albumin of less than 2.5 g/dL
7. Plasma Platelet count of less than 100 x 109/L
8. Hemoglobin of less than 10.5 g/dL
9. Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended.

The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Erosion of atheromatous plaque results in release of cholesterol crystal embolism that ultimately occlude medium-sized arterioles and capillaries of the kidney, skin, gastrointestinal tract and central nervous system. The diagnosis relies on histopathological demonstration of cholesterol cristal embolism in any target organ, or can be assumed if the 3 following criteria are met (1) presence of one or more precipitating factors (2) renal function deterioration in atherosclerotic patients (3) ischemic changes of the extremities or demonstration of retinal CCE. Despite the dismal prognosis in multisystem CCE mortality the optimal treatment remains unknown.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended. The benefit of prednisone is uncertain, but its dramatic impact has been underlined in several short retrospective series, even with moderate daily dosage (0,2-0,5 mg/kg). However, adverse side effects of steroid therapy in uremic elderly with CCE have not been assessed. In addition, the optimal duration of the treatment has not been assessed. The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven CCE or clinically diagnosed CCE as assessed on the 3 following criteria : presence of one or more precipitating factors renal function deterioration in atherosclerotic patients ischemic changes of the extremities or demonstration of retinal embolism
* Severe CCE as defined by either acute renal failure (S creatinine \> 125 micromol/l and increase \> 25 % of baseline), or severe abdominal changes (hemorrhage, infarction, perforation or weight loss \> 5 % of body weight) or severe central nervous system neurological complication

Exclusion Criteria:

* CCE unproven, or restricted to one organ, or non-active contraindication to prednisone.
Evaluation of an Innovative Speech-enabled Translator in Emergency Settings

Survey-based satisfaction, performance and technical features evaluation of a speech-enabled fixed-phrase translation tool (BabelDR) in an emergency department.


Eligibility Criteria:
Inclusion Criteria:

* As per inclusion criteria, patients were required to have no understanding of French, thus making a diagnostic interview by the doctors impossible.

Exclusion Criteria:

* Exclusion criteria concerned patients who shared a common language with the doctor and/or were not able to read in their native language.