cyrilzakka/clinical-trials huggingface dataset:
Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali

The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artemether-lumefantrine (AL) with and without a single dose of 0.25mg/kg primaquine (PQ) and sulfadoxine-pyrimethamine with amodiaquine (SPAQ) with and without single dose of 1.66mg/kg tafenoquine (TQ). Outcome measures will include infectivity to mosquitoes at 2, 5 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.

Full protocol available on request.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 10 years and ≤ 50 years
* G6PD-normal defined by Carestart rapid diagnostic test or the OSMMR2000 G6PD qualitative test
* Absence of symptomatic falciparum malaria, defined by fever on enrolment
* Presence of P. falciparum gametocytes on thick blood film at a density \>16 gametocytes/μL (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells)
* Absence of other non-P. falciparum species on blood film
* Hemoglobin ≥ 10 g/dL
* Individuals weighing \< = 80 kg
* No evidence of acute severe or chronic disease
* Written, informed consent

Exclusion Criteria:

* Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (β-hCG) will be used.
* Detection of a non-P. falciparum species by microscopy
* Previous reaction to study drugs / known allergy to study drugs
* Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia \> 100,000 parasites / μL)
* Signs of acute or chronic illness, including hepatitis
* The use of other medication (except for paracetamol and/or aspirin)
* Use of antimalarial drugs over the past 7 days (as reported by the participant)
* Clinically significant illness (intercurrent illness e.g., pneumonia, pre-existing condition e.g., renal disease, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhea or any signs of malnutrition as defined clinically)
* Signs of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, Child Pugh stage B or C)
* Signs, symptoms or known renal impairment
* Clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin \< 10 g/dL, platelets \< 50,000/μl, White Blood Cell count (WBC) \< 2000/μl, serum creatinine \>2.0mg/dL, or ALT or AST more than 3 times the upper limit of normal for age.
* Blood transfusion in the last 90 days.
* Consistent with the long half-life of tafenoquine, effective contraception should be continued for 5 half-lives (3 months) after the end of treatment.
* History of psychiatric disorders
A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder

The purpose of this study is to assess long-term safety and tolerability in adult patients who have completed a previous atomoxetine study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the B4Z-JE-LYEE study (NCT00962104) and signed the Informed Consent Document (ICD).
* Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, required by the protocol.
* Patients must possess an educational level and degree of understanding of the language of their country that enables them to communicate suitably with the investigator and study coordinator.

Exclusion Criteria:

* Patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy within previous study except for those taking benzodiazepines analogs for anxiety. The dosage of diazepam equivalents should not be more than 5 milligrams/day (mg/day).
* Patients who, in the opinion of the investigator, are at serious suicidal risk or serious risk of harming others, or whose score for Item 11 on the Hamilton Depression Rating Scale-17 items is equal or more than 2 at randomization or screening.
* Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine or require treatment with excluded medications.
* Patients with a history of allergy to atomoxetine, severe allergies to more than 1 class of medications, or multiple adverse drug reactions.
* Patients who have received treatment within the past 30 days with a drug that has not received regulatory approval for any indication at the time the informed consent document is obtained.
Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France

The present study will be conducted to assess the following research questions in real-life conditions in France:

What are the patient and disease characteristics, comorbidities and treatment history in NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles different from one treatment pattern to another when initiating a new AC treatment?

What are the HCP's reasons for discontinuing the previous AC strategy for initiating and choosing the newly initiated AC treatment in NVAF patients?

What are the conditions of newly-initiated apixaban prescriptions in NVAF patients: prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Diagnosed with non valvular atrial fibrillation (NVAF)
* Prescribed with a newly initiated AC treatment (apixaban, other NOACs or VKAs). Newly initiated AC treatment is defined as any AC treatment initiated within the past 3 months, including day of enrolment

Exclusion Criteria:

* Patients with atrial fibrillation (AF) due to reversible causes
* Patients with a diagnosis of VAF. The term VAF is used to imply that AF is related to rheumatic valvular disease (predominantly mitral stenosis) or prosthetic heart valves
* Patients participating in an ongoing clinical trial in AF
Evaluation of Kidney Function in Children With Brain Tumors

Clinical measurement of renal function is generally performed using either laboratory tests or nuclear medicine techniques, however, both of these techniques suffer from some limitations. Notably the lab tests only assess global, rather than individual kidney, function and the nuclear medicine tests are demanding to perform well. Children with brain tumors are often treated with chemotherapeutic in order to try and kill the cancer. Amongst the known side effect of some of the drugs used in the chemotherapy is the fact that they may damage the kidneys. For this reason the function of the kidneys is assessed using a laboratory test at 3 or 6 months intervals during the treatment. In addition, to the problem mentioned above the tests also require a separate visit to the hospital. Children with brain tumors who are undergoing chemotherapy also routinely have contrast-enhanced MRI of the brain performed at intervals of three months in order to evaluate the response of the tumor to the chemotherapy. Recently, MRI techniques have been developed which can evaluate single kidney renal function. The aim of this study is to establish if a single MRI exam can be used to assess both the effect of the chemotherapy on both the tumor and the renal function. The results of the MRI measurement of the single kidney renal function would be combined to provide a measure of global renal function and this would be compared with that obtained from the laboratory test. The MRI exam will require only require an extra 10 minutes of scanning time and will not affect the rest of the MRI exam in any way.

This study is being performed to validate a new technique for measuring kidney function. Patients are being asked to volunteer for this study because they require serial contrast enhanced MR scans to monitor their response to chemotherapy. Because some chemo-therapeutic agents can be toxic to the kidney the patient's kidney function will also be evaluated using conventional methods, and the results of these tests can be compared to those obtained using MRI. We plan to study 50 children in this study. The additional procedure for measuring renal function will add 10 minutes to the duration of the MRI exam and will have no effect on the routine brain study. If validated the proposed MRI technique would allow renal function to be evaluated at the time of a routine, contrast enhanced MRI exam and would avoid additional testing using radioactive tracers or urine collection over 24 hours.

If successful, MRI could be used to measure single kidney renal function in all any patient undergoing a routine MRI exam by simply extending the scanning time by a maximum of 10 minutes. This would save such patients additional visits to the hospital and would have the advantage of measuring single kidney, rather than global, renal function.


Eligibility Criteria:
Inclusion Criteria:

* All children currently enrolled, and who will be enrolled during the course of the study, in the chemotheraphy program at Children's Healthcare of Atlanta at Scottish Rite

Exclusion Criteria:

-
Brain Stimulation for Neurological Patients

This is a prospective double-blind randomized placebo-controlled crossover clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
* At least 3 months of stable antidementive therapy or no antidementive therapy necessary
* Signed written informed consent
* Monthly pregnancy test for women in childbearing years
* Age \>= 18 years

Exclusion Criteria:

* Non-compliance with the protocol
* Pregnant or breastfeeding women
* Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
* Hemophilia or other blood clotting disorders
* Cortisone treatment within the last 6 weeks before first treatment
* Thrombosis
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 or older (inclusive)
* Subject is able to participate for the duration of the study
* Subject is willing to sign an informed consent

Exclusion Criteria:

* Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
* Physiologic abnormalities that prevent proper application of pulse oximetry sensor
* Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment

The investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level.

The investigators will include at least 90 patients in study. Blood tests will taken before and after tadalafil treatment and will store at -80 celcius degree.

Eligibility Criteria:
Inclusion Criteria:

• Patients with erectile dysfuction

Exclusion Criteria:

* Psychogenic erectile dysfunction
* Erectile dysfunction associated with hormonal disorders
* Drug related erectile dysfunction
DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
* Scheduled for DSAEK or DMEK
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
* Pregnancy or possible pregnancy during the study period
* Preoperative macular edema and/or ongoing treatment for macular edema
* Re-transplantation
* In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
* Aphakic eyes (eyes without a biological or artificial intraocular lens)
* Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
Integrating Family Planning Into Postabortion Care

A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.

A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.

Eligibility Criteria:
Inclusion Criteria:

* For Facilities: APHIA II facilities supported by the ESD project in Central Province and Nairobi, Kenya where: (1) PAC services are provided, (2) at least one provider has received PAC and Youth-friendly PAC training, (3) Community mobilization has been initiated, (4) PAC equipment and supplies have been procured, (5) PAC job aids have been distributed.
* For Clients: Women aged 15 years or older who have received PAC services at a study facility and who have a telephone on which they can be contacted
* For Providers: Any person who offers PAC services at a study facility
Accuracy of Current Techniques in Quantifying Ketone Levels

The purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years

Exclusion Criteria:

* taking medications that affect blood pressure, insulin, or renal function, having meta-bolic syndrome factors such as type 2 diabetes, being pregnant, and/or indicating a pre-existing health condition on the health history questionnaire
Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children

Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal treatment of E-ESBL is nearly impossible at this time.

Our aim was to describe the characteristics and treatments of urinary tract infections caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.

In this prospective observational study between March 2013 and March 2017, children (0 to 18 years) with ESBL-E UTI were enrolled in 24 pediatric departments in France. Clinical and biological characteristics, risk factors of infection of E-ESBL, first and second lines of antibiotic therapies were analyzed. The investigators used the Kaplan-Meier method to estimate the time to fever defervescence and hospitalization duration, and Log-rank test to assess equality of survivor functions. The investigators also analyzed the resistance patterns and molecular characterization of ESBL types in the isolates.

Eligibility Criteria:
Inclusion Criteria:

* All inpatient or outpatient under 18 years with UTI (cystitis or febrile UTI)
* Clinical signs associated with a positive E-ESBL in urine culture dependent urine collection method as previously described (Stein R, EAU/ESPU guidelines) and an antibiotic treatment targeting this strain.

Exclusion Criteria:

* Refusal to participate in the study
* Children with mixed microbial strains and repeated infections were excluded
Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis

MS patients were randomly divided into traditional therapy and traditional therapy + cervical mobilization groups. While muscle strengthening, stretching, balance and coordination exercises were given to the traditional group, cervical mobilization was applied in addition to these in cervical group. Patients received treatments twice a week for 4 weeks. The effect of the applied treatment on the tonus and plantar pressure distribution was analyzed. Treatments were interrupted for 4 weeks and the groups continued with the treatment they did not receive (crossover design). The group that received traditional treatment in the first period completed traditional + cervical mobilization, and the other group with traditional + cervical mobilization traditionally completed the treatment.

Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. The cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to improvement of balance. As improve balance, the plantar pressure distribution of patients may change.

Eligibility Criteria:
Inclusion Criteria:

* Expanded Disability Status Scale (EDSS) score was between 2-5,
* According to the modified Ashworth Scale, spasticity is between 1 and 3,
* EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
* medical condition is stable and no medication changes were made in the last month,
* Vertebro-basillar test negative,
* Not have any other neurological disorder and orthopedic problem to prevent participation in this study
* A score of at least 24 from the Mini Mental Test,

Exclusion Criteria:

* presence of psychiatric or severe cognitive dysfunction,
* pregnancy,
* Having a neurological disease other than MS,

  * having had an attack in the last 3 months,
* Botulinum toxin application within the last 6 months,
* participating in physiotherapy program in the last 6 months
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
* Age of the participant at the time of migraine onset \< 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
* 4 to 14 migraine days in the 28-day baseline period per eDiary
* Failed oral migraine prophylaxis medications from 2 to 4 medication classes

Exclusion Criteria:

* Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
* Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
* In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
* Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
* Has ≥ 15 headache days in the 28-day baseline period per eDiary
* Clinically significant cardiovascular or cerebrovascular disease
* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
* Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018
The Use of Music Therapy in the Prevention of Falls

The purpose of this study is to determine whether listening to music will demonstrate changes in human postural stability and whether those changes might be useful in fall prevention strategies.

Falls are a serious health issue and are the greatest cause of death in the elderly. The use of music therapy in fall prevention has not been reported in the literature. This investigation will provide experimental support to the assumption that music therapy may prevent falls and that certain music can affect increases in postural stability using randomly selected subjects, validated posturography and a full experimental design.

Computer dynamic posturography (CDP) tests will provide stability scores in volunteer subjects who have had no previous history of falls or vertigo. Subjects will be randomized into several different music listening groups and one control group. Examiners will be blinded as to the music listened to and the outcome measurements. Subjects will be blinded as to their posturographic measurements. The music listening groups will be given a daily specific music listening task. CDP tests will be obtained 10 minutes, 1 week and 1 month after subject's treatment. Music selection will include Mozart, Nolwenn Leroy and others suggested to change human stability.

Eligibility Criteria:
Inclusion Criteria:

* No history of previous fall(s) or dizziness

Exclusion Criteria:

* History of previous fall(s) or dizziness